(76 days)
The PROLENE Polypropylene Mesh Hernia Device is intended to be used for the repair of indirect and direct inguinal hernia defects.
The PROLENE Mesh Hernia Device is indicated for the repair of inguinal hernia defects, both indirect and direct.
The PROLENE Polypropylene Mesh Hernia Device is a sterile, pre-shaped, three dimensional device constructed of an onlay patch connected by a mesh cylinder to a circular underlay patch. The material is undyed PROLENE* polypropylene mesh constructed of knitted non-absorbable polypropylene filaments identical to that used in PROLENE* polypropylene nonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.
The device, PROLENE Polypropylene Mesh Hernia Device, is intended for the repair of indirect and direct inguinal hernia defects.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effective in repairing inguinal hernias | Demonstrated effectiveness in repairing inguinal hernias in a preclinical study. |
| Maintains its position in the inguinal canal without the aid of sutures | Demonstrated maintenance of position in the inguinal canal without sutures in a preclinical study. |
| Permits postoperative tissue ingrowth | Demonstrated in a preclinical study. |
| Demonstrates functionality | Demonstrated in a preclinical study. |
| Comparable technological characteristics to predicate device (BARD® Marlex® Mesh PerFix® Plug) | The device is also a pre-shaped, three-dimensional device constructed of knitted polypropylene monofilaments, similar to the predicate. |
| Nonreactive material | Material (PROLENE polypropylene) is reported to be nonreactive when used as a suture. |
| Retains strength indefinitely in clinical use | Material (PROLENE polypropylene) is reported to retain strength indefinitely in clinical use when used as a suture. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that a "preclinical study" was conducted. However, it does not specify the sample size used for this study (e.g., number of animals or specific experimental units). It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study was a preclinical one, and it's not clear if "experts" in the human clinical sense were involved in establishing ground truth for the animal model.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a preclinical study, not a clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a physical surgical mesh and not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth was likely established through observational data and assessment of biological outcomes in the preclinical study. This would include direct observation of hernia repair, assessment of device position, and histological examination to confirm tissue ingrowth and functionality within the animal model.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" for this device would be its design and manufacturing process, and performance verification would come from the preclinical study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI/ML algorithm.
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SEP 1 0 1997
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SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary ofSafety and Effectiveness | Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug and Cosmetic Act,respecting safety and effectiveness is summarized below. Forthe convenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "...510(k) Summariesand 510(k) Statements..." (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requestingit from the Agency. |
|---|---|
| NEW DEVICE NAME: ETHICON PROLENE* Polypropylene MeshHernia Device Nonabsorbable Synthetic Surgical Mesh Implant. | |
| PREDICATE DEVICE NAME: BARD® Marlex® Mesh PerFix® PlugNonabsorbable Polypropylene Surgical Mesh Device. | |
| 510(k) SUMMARY | |
| Device Description | The PROLENE Polypropylene Mesh Hernia Device is a sterile,pre-shaped, three dimensional device constructed of an onlaypatch connected by a mesh cylinder to a circular underlay patch.The material is undyed PROLENE* polypropylene meshconstructed of knitted non-absorbable polypropylene filamentsidentical to that used in PROLENE* polypropylenenonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). Thismaterial, when used as a suture, has been reported to benonreactive and to retain its strength indefinitely in clinical use. |
| Intended Use | The PROLENE Mesh Hernia Device is intended to be used forthe repair of indirect and direct inguinal hernia defects.. |
| Indications Statement | The PROLENE Mesh Hernia Device is indicated for the repairof inguinal hernia defects, both indirect and direct. |
| TechnologicalCharacteristics | The modified device has comparable technological characteristicsto the predicate device. Both devices are pre-shaped, threedimensional devices constructed of knitted polypropylenemonofilaments. |
| When compared to the predicate device, the PROLENE MeshHernia Device is a single device which requires no sutures tosecure into place. The PerFix Plug is available as two separatepieces in which the fluted mesh must be sutured into place. | |
| Performance Data | ETHICON, Inc has conducted a preclinical study to show thatthe PROLENE Mesh Hernia Device is effective in repairinginguinal hernias, maintaining its position in the inguinal canalwithout the aid of sutures. Postoperative tissue ingrowth andfunctionality were demonstrated. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that themodified device is substantially equivalent to the PredicateDevice under the Federal Food, Drug, and Cosmetic Act. |
PROLENE Polypropylene Mesh Hernia Device ETHICON, Inc.
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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued
Continued on next page
- Trademark
PROLENE Polypropylene Mesh Hernia Device ETHICON, Inc.
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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Contact
Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
Date
June 25, 1997
PROLENE Polypropylene Mesh Hernia Device ETHICON, Inc.
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Image /page/3/Picture/11 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 1997
Mr. Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. PO Box 151 Somerville, New Jersey 08876-0151
Re: K972412
Trade Name: PROLENE Polypropylene Mesh Hernia Device Regulatory Class: II Product Code: FTL Dated: June 25, 1997 Received: June 26, 1997
Dear Mr. Jones:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Gregory R. Jones
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
tsoblef
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
A. A. M.
Indications for Use:
PROLENE Polypropylene Mesh Hernia Device_ The PROLENE Polypropylene Mesh Hernia Device is indicated
for the repair of indirect and direct inguinal hernia defects.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K97241 |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Format 1-2-9G)
§ 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.