Intended Use

Intra-Site^® is derived from placental connective tissue and is intended for homologous use to supplement or support damaged or inadequate connective tissue in the recipient.

Storage

Intra-Site^® has been terminally sterilized and the vial of allograft material is sealed and packaged in double Tyvek™ pouches. The product should be stored between -4 degrees and +40 degrees Celsius. It is the responsibility of the distributors, tissue dispensing services, and/or clinicians to safely store the allograft in an appropriate location to maintain the shelf-life of the allograft. The allograft is marked with an expiration date and should be used before the end of the shelf-life date.

Preparations for Use

1. Thoroughly examine the outer Tyvek™ pouches to ensure the integrity of the sterile packaging. Do not use the product if the pouch as been compromised.
2. Carefully open the outer Tyvek™ pouch allowing access to the inside sterile pouch. (Please do not place the outer pouch on the sterile field.)
3. Using appropriate aseptic technique, open the outer pouch and deliver the inner pouch containing the sterile vial to the sterile field.
4. Remove the vial from the sterile inner pouch and place in the sterile field.
5. In advance of opening the vial, vigorously shake it to ensure that the allograft is well mixed. Twist off the vial cap and draw the allograft material with an appropriately sized sterile needle into a sterile syringe.
6. Place the allograft into the desired recipient site.
7. Allograft material should be used within 1 hour of opening the sterile vial. Otherwise, the allograft should be discarded.

Donor Screening

The allograft material in the Intra-Site^® product is derived from donated tissue from healthy human donors. The allograft has been determined eligible for transplant by the manufacturer’s Medical Director after review of medical and social history, hospital records, infectious disease screening and testing. The donor was tested and found negative or non-reactive to all standard infectious diseases and contaminations. Testing has been completed by an FDA registered third-party laboratory in accordance with the Clinical Laboratory Improvement Amendment (CLIA) of 1988 and 42 CFR part 493 or has met the equivalent requirements as determined by the Centers of Medicare and Medicaid Services (CMS).

Warning and Precautions

• Intended for use in one patient on a single occasion on prescription of a qualified healthcare clinician.
• Do not attempt to re-sterilize the allograft.
• Do not use if the package integrity has been compromised.
• Allograft has been processed and irradiated for sterility. Caution should be used if a patient is allergic to latex, hydrogen peroxide, isopropyl alcohol as traces of these reagents may be present in the allograft material.
• ReNovo Bioscience and its manufacturer makes no claims concerning the biologic or biomechanical properties of the allograft. All tissue is procured, processed, stored and distributed in accordance with the Standards of the American Association of Tissue Banks.
• ReNovo Bioscience and its manufacturer disclaim all responsibility and liability for any misuse of the tissue provided on the prescription of a clinician.
• Allogenic tissue products may induce an immunologic response in some recipients. The possibility that a patient may develop alloantibodies should be considered for any patients who may have a history of previous allograft transplants.

Returned Goods Policy

Due to tracking of allograft tissue, no product will be allowed to be returned once the product has been shipped.

Donor Tracking Form

Renovo Bioscience  has created an online Allograft Tracking System to assist in the post-implantation tracking. To utilize this system, please go to  https://t.u5a.us/Renovo and follow the instruction for tracking recipients. The end-user can access this information at any time and is easier than filling out a Donor Tracking Form and returning it to the manufacturer. Please feel free to call Renovo Bioscience at 800-440-9314 if you have any additional questions.

Note: Federal regulations (21 CFR 1271 and Joint Commission Standards) require proper tracking of all allograft material distributed in the U.S. It is the responsibility of the end-user to maintain the records for the purpose of appropriate tracking and reporting.

Severe Adverse Event (SAE) Reporting

If clinicians observe any adverse outcomes that can be associated with use of the allograft, it should be immediately reported to ReNovo Bioscience at contact@renovobioscience.com or 800-440-9314.