(54 days)
Not Found
No
The summary describes a biological graft material for surgical repair and does not mention any computational or algorithmic components, let alone AI/ML.
No.
The device is a tissue graft intended to reinforce soft tissue, not to treat a disease or condition itself.
No
The device is a graft intended for surgical implantation to reinforce soft tissue, not to diagnose a condition.
No
The device description clearly states it is a physical graft manufactured from porcine tissue, supplied sterile and packaged. It is intended for implantation, indicating a physical, non-software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "implantation to reinforce soft tissue where weakness exists in the urological anatomy." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details a graft made from porcine tissue, designed to be implanted. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a treatment, or screen for diseases.
- Anatomical Site: The anatomical sites mentioned (urological anatomy, tunica albuginea) are where the device is implanted, not where samples are taken for analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a therapeutic implant used in surgery.
N/A
Intended Use / Indications for Use
The SURGISIS® Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease. This device is supplied sterile and is intended for one-time use only.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
The SURGISIS® Peyronie's Repair Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in an oval configuration. The device is packaged in a lyophilized (dried) state, and is supplied sterile in a sealed double pouch system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological anatomy, tunica albuginea
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)
The SURGIS® Peyronie's Repair Graft met the requirements of extensive biocompatibility testing, viral inactivation testing, and mechanical testing, demonstrating suitability for use.
Outcomes from the evaluation of the SURGISIS® Peyronie's Repair Graft provide evidence of its suitability for use in soft tissue repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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9 510(K) SUMMARY
Submitted by:
Perry W. Guinn VP Regulatory Affairs and Quality Assurance Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 497-3355 August 8, 2006
OCT - 2 2006
Device: Trade Name: Common/Usual Name: Proposed Classification Name:
SURGISIS® Peyronie's Repair Graft Surgical Mesh Surgical Mesh 21 CFR §878.3300 (79FTM) Class II
Intended Use:
The SURGISIS® Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease. This device is supplied sterile and is intended for one-time use only.
Predicate Devices:
The SURGISIS® Peyronie's Repair Graft is similar in terms of substantial equivalence to the following predicate devices: SuRGISIS® Sling (K992159) and SURGIS/S® Mesh (K980431) devices, both manufactured by Cook Biotech Incorporated, and AMS Collagen Dermal Matrix (K050445) manufactured by American Medical Systems.
Device Description:
The SURGISIS® Peyronie's Repair Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in an oval configuration. The device is packaged in a lyophilized (dried) state, and is supplied sterile in a sealed double pouch system.
1
510(k) Premarket Notification: SURGIS® Peyronie's Repair Graft
ft 17
K06330
2/3
Substantial Equivalence:
The SURGISIS® Peyronie's Repair Graft is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of section 510(k) substantial equivalence, as shown through bench and biocompatibility testing.
Discussion of Tests and Test Results:
The SURGIS® Peyronie's Repair Graft met the requirements of extensive biocompatibility testing, viral inactivation testing, and mechanical testing, demonstrating suitability for use.
Conclusions Drawn from Tests:
Outcomes from the evaluation of the SURGISIS® Peyronie's Repair Graft provide evidence of its suitability for use in soft tissue repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics.
2
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
000 - 2 2006
Cook Biotech Incorporated % Mr. Perry W. Guinn Vice President. Regulatory Affairs & Quality Assurance 1425 Innovation Place West Lafayette. IN 47906
Re: K062320
Trade/Device Name: Surgisis" Peyronie's Repair Graft Regulation Number: 21 CFR 878.3300 Regulation Name Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 8. 2006 Received: August 9, 2006
Dear Mr. Guinn:
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 iegally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the snactment 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 ail 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
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
3
Page 2 – Mr. Perry W. Guinn
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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Pa
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K06)30
Indications for Use
510(k) Number (if known):
Device Name: SURGISIS® Peyronie's Repair Graft
Indications For Use:
The SURGIS® Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease. The device is supplied sterile and is intended for one-time use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concerrence of CDRH, Office of Device Evaluation (ODE)
Ro
Division Sign-Or Division of General, Restes .. and Neurological Devices
Page 1 of _ _ _ _ _
510(k) Number: K062320