(326 days)
No
The summary describes a surgical mesh for rotator cuff repair and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as "intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery," fulfilling a therapeutic purpose.
No.
The device is a surgical mesh intended for the reinforcement of soft tissues during rotator cuff repair surgery, not for diagnosing conditions.
No
The device description clearly states it is a non-absorbable mesh manufactured from physical materials (polycarbonate polyurethane-urea matrix and standard polyester suture), indicating it is a physical medical device, 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 reinforcement of soft tissues during rotator cuff repair surgery. This is a surgical implant used in vivo (within the body) to support tissue repair.
- Device Description: The device is a surgical mesh made from synthetic materials, designed to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly intended for surgical implantation in vivo.
N/A
Intended Use / Indications for Use
The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery.
The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.
Product codes
FTL
Device Description
The Biomerix Surgical Mesh is a non-absorbable mesh manufactured from a polycarbonate polyurethane-urea matrix and standard polyester suture. The Biomerix Surgical Mesh is provided sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues (during rotator cuff repair surgery)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Material testing was performed to demonstrate that the material properties are suitable for the intended use.
Bench testing was performed to demonstrate that the devices as manufactured meet the performance specifications. Test results demonstrate that the device meets the specifications and is acceptable for clinical use.
Extensive biocompatibility testing per ISO 10993-1 was performed to demonstrate that the material is safe and biostable.
Animal testing demonstrates the ability of the mesh to support tissue ingrowth and mechanically reinforce the repair as compared to surgical controls, without any adverse clinical effects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DePuy Restore® Orthobiologic Soft Tissue Implant, K031969, Artimplant AB Sportmesh™ (K052830), Ethicon Mersilene Polyester Fiber Mesh (pre-amendment), Zimmer Collagen Repair Patch (K053562)
Reference Device(s)
Biomerix Vascular Occlusion Device (K043371)
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
Sponsor:
Biomerix
page 1 of 2
Biomerix Surgical Mesh
K070961
APPENDIX B 510(K) SUMMARY
| Applicant Name: | Biomerix Corporation
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone: (301) 998-6152
Fax: (301) 984-4368 | FEB 25 2003 |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Christina L Kichula
Director, RA/QA | |
| Date Prepared: | February 13, 2008 | |
| Device Trade Name: | Biomerix Surgical Mesh | |
| Device Common Name: | Polymeric surgical mesh | |
| Classification Name: | Mesh, surgical, polymeric | |
| Predicate Devices: | DePuy Restore® Orthobiologic Soft Tissue Implant,
K031969
Artimplant AB Sportmesh™ (K052830)
Ethicon Mersilene Polyester Fiber Mesh (pre-
amendment)
Zimmer Collagen Repair Patch (K053562)
Biomerix Vascular Occlusion Device (K043371) | |
| Device Description: | The Biomerix Surgical Mesh is a non-absorbable mesh
manufactured from a polycarbonate polyurethane-urea
matrix and standard polyester suture. The Biomerix
Surgical Mesh is provided sterile for single use. | |
| Intended Use: | The Biomerix Surgical Mesh is intended for the
reinforcement of the soft tissues which are repaired by
suture or suture anchors during rotator cuff repair
surgery.
The mesh is not intended to replace normal body
structure or provide full mechanical strength to support
the rotator cuff. Sutures used to repair the tear, and
sutures or bone anchor systems used to attach the
tissue to the bone, provide mechanical strength for
tendon repair | |
| Device Technological
Characteristics and
Comparison to
Predicate Device(s): | The Biomerix Surgical Mesh is similar in materials,
design, performance and intended use to other surgical
mesh devices.
Any differences in the above characteristics have been
adequately tested to support substantial equivalence. | |
| Performance Data: | Material testing was performed to demonstrate that the
material properties are suitable for the intended use. | |
| | Bench testing was performed to demonstrate that the
devices as manufactured meet the performance
specifications. Test results demonstrate that the device
meets the specifications and is acceptable for clinical
use. | |
| | Extensive biocompatibility testing per ISO 10993-1 was
performed to demonstrate that the material is safe and
biostable. | |
| | Animal testing demonstrates the ability of the mesh to
support tissue ingrowth and mechanically reinforce the
repair as compared to surgical controls, without any
adverse clinical effects. | |
| Conclusion: | Based on the material, biocompatibility, bench, and
animal testing, and the proposed device labeling, the
Biomerix Surgical Mesh is substantially equivalent to the
identified predicate devices in terms of intended use,
safety, and effectiveness. | |
1
Sponsor:
Biomerix
070961 page 242
Biomerix Surgical Mesh
K070961
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.
FEB 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomerix Corporation % Ms. Christina L. Kichula, RAC Director, RA/QA 1700 Rockville Pike, Suite 400 Rockville, Maryland 20852
Re: K070961
Trade/Device Name: Biomerix Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 13, 2008 Received: February 14, 2008
Dear Ms. Kichula:
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 set 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.
3
Page 2 – Ms. Christina L. Kichula, RAC
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) 276-0115. 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 Biometric's (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 at (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 vours.
Mark N. Mulhearn
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX A
| Indications for Use | |
|---|---|
| --------------------- | -- |
510(k) Number (if known):
Device Name: Biomerix Surgical Mesh
Indications for Use:
The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery.
The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Selem
Division of General, Restorative, and Neurological Levices
510(k) Number L070921 Page 1 of 1