(148 days)
No
The summary describes a resorbable collagen scaffold for soft tissue repair and does not mention any AI or ML components.
Yes
The device is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries, which constitutes a therapeutic purpose.
No
The device is a collagen scaffold intended for the reinforcement and repair of soft tissue injuries, not for diagnosing medical conditions.
No
The device description clearly states it is a "resorbable collagen matrix comprised primarily of bovine type I collagen," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical repair and reinforcement of soft tissue injuries of the medial meniscus. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a resorbable collagen matrix used as a scaffold for tissue regeneration within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the ReGen Collagen Scaffold does not involve any testing of samples or diagnostic procedures.
The device is clearly intended for direct surgical implantation and tissue support within the body, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The ReGen Collagen Scaffold (CS) is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact mentscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.
Product codes
FTM, OLC
Device Description
The ReGen Collagen Scaffold (CS) is a resorbable collagen matrix comprised primarily of bovine type I collagen. The CS is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue. The surgeon trims the device to the size necessary for repair of the damaged or weakened soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medial meniscus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
This trial had two separately controlled and randomized arms; one arm consisted of 157 patients with no prior surgery to the involved meniscus (Acute) and the other 154 patients with one to three prior treatments to the involved meniscus (Chronic). Patients were followed for a mean of 59 months. Data from this IDE study and a publication in the July issue of the Journal of Bone and Joint Surgery analyzing the data from this multicenter clinical trial were used to support the substantial equivalence of this device.
Key Metrics
Not Found
Predicate Device(s)
K031969, K001738, K982330, K050337, K031188, K051766, K974540, K980431, K992159, K034039, K043259, K041923, K992556, K013625, K021056, K043366, K050355
Reference Device(s)
K024199, K032673, K034039, K052830, K014200
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
DEC 1 8 2008
510(K) SUMMARY FOR COLLAGEN SCAFFOLD (CS) -
1082070
Submission Prepared: 12/15/08
Applicant Information
John Dichiara Senior Vice President Regulatory, Clinical, and Quality ReGen Biologics, Inc. 411 Hackensack Avenue, 10th floor Hackensack, NJ 07601
Device Information
| Device Name: | ReGen Collagen Scaffold (CS) |
|---|---|
| Common Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh, 21 CFR 878.3300 |
| Classification Code: | FTM |
| Reviewing Panel: | Orthopedic Devices |
Predicate Devices
- Restore Orthobiologic Implant, DePuy Orthopaedics, Inc. (K031969, K001738 and K982330);
- . SIS Fistula Plug, Cook Biotech, Inc. (K050337);
- . TissueMend, OrthoMend, TEI Biosciences, Inc. (K031188 and K051766);
- ◆ Surgisis Mesh, Cook Biotech, Inc. (K974540, K980431, K992159, K034039);
- . BioBlanket Surgical Mesh, Kensey Nash, Corp. (K043259 and K041923);
- . ZCR Patch, Permacol, Tissue Science Laboratories PLC (K992556, K013625, K021056, K043366, K050355):
1
- . IMMIX Film, OsteoBiologics, Inc. (K024199 and K032673);
- SIS Plastic Surgery Matrix, Cook Biotech, Inc. . (K034039)
- Sportmesh, Artimplant (K052830) ●
- . Optimesh, Spineology, Inc. (K014200)
- Marlex Mesh, Davol, Inc. (Pre-amendment). ●
Device Description
The ReGen Collagen Scaffold (CS) is a resorbable collagen matrix comprised primarily of bovine type I collagen. The CS is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue. The surgeon trims the device to the size necessary for repair of the damaged or weakened soft tissue.
Intended Use
The ReGen Collagen Scaffold (CS) is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.
Substantial Equivalence
The ReGen Biologics Collagen Scaffold (CS) has the same intended use and similar technological characteristics to the predicate surgical mesh devices, including; the DePuy Restore® Orthobiologic Soft Tissue Implant (K982330, K001738, K031969), the Cook Biotech SIS Fistula Plug (K050337), the TEI Biosciences TissueMend and OrthoMend (K031188, K051766), the Cook Biotech Surgisis Mesh, the Kensey Nash BioBlanket™ Surgical Mesh (K043259, K041923), the Tissue Sciences Laboratories' Permacol and ZCR Patch (K992556, K013625, K021056, K043366, K050355), the Organogenesis CuffPatch (K042809), the Cook Biotech SIS Plastic Surgery Matrix (K034039), the Artimplant Sportmesh (K052830) and the Spineology Optimesh (K014200). Any differences identified do not raise now types of safety or effectiveness questions. The questions common to all resorbable surgical meshes have been addressed in this
2
submission by biomechanical, biocompatibility, animal testing, and clinical studies with the device, including a prospective, randomized multicenter clinical trial that was conducted under an IDE.
This trial had two separately controlled and randomized arms; one arm consisted of 157 patients with no prior surgery to the involved meniscus (Acute) and the other 154 patients with one to three prior treatments to the involved meniscus (Chronic). Patients were followed for a mean of 59 months. Data from this IDE study and a publication in the July issue of the Journal of Bone and Joint Surgery analyzing the data from this multicenter clinical trial were used to support the substantial equivalence of this device. Data from this submission were presented at the November 14, 2008 meeting of the Orthopaedic and Rehabilitation Devices Panel Meeting for the purpose of providing FDA with advice and recommendations.
Based on the data presented, the CS is substantially equivalent to the predicate devices with respect to intended use, material of composition, and technological characteristics.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The symbol in the center consists of three stylized, curved lines that resemble a person with outstretched arms.
DEC 18 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Dichiara ReGen Biologics 411 Hackensack Avenue Hackensack, NJ 07601
Re: K082079
Regen Collagen Scaffold Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OLC Dated: July 22, 2008 Received: July 23, 2008
Dear Mr. Dichiara:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sel forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. John Dichiara
... ... ..
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems an 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Datiel G. Schultz, M.D., F.A.C.S. Director Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
-
- 1
510(k) Number (if known): K082079
Device Name: ReGen Collagen Scaffold (CS)
Indications for Use:
ה
The ReGen Collagen Scaffold (CS) is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact mentscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH | |
|---|---|
| --------------------- | -- |