(90 days)
Not Found
Not Found
No
The device description and intended use describe a physical mesh system for hernia repair, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is a hernia system intended for the repair of abdominal wall hernia defects, which is a therapeutic intervention.
No
The device description states that the PROLENE Hernia System is a "sterile, pre-shaped three dimensional device" intended for the "repair of abdominal wall hernia defects." This indicates a therapeutic or reconstructive function, not a diagnostic one. There is no mention of it being used to detect or identify a condition.
No
The device description clearly states it is a "sterile, pre-shaped three dimensional device constructed of an onlay patch connected by a cylinder to a circular or oblong underlay patch," indicating it is a physical implant, not software.
Based on the provided information, the PROLENE Hernia System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "repair of abdominal wall hernia defects." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "sterile, pre-shaped three dimensional device constructed of an onlay patch connected by a cylinder to a circular or oblong underlay patch." This is a physical implant used in surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. The PROLENE Hernia System does not perform this function. It is a therapeutic device used to repair a physical defect.
Therefore, the PROLENE Hernia System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PROLENE Hernia System is intended to be used for the repair of abdominal wall hernia defects.
The PROLENE (Polypropylene) Hemia System is indicated for the rs of the controllers in defects The PROLEINE (1 Siffect propped and hernia defects.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The PROLENE Hernia System is a sterile, pre-shaped three dimensional device constructed of an onlay patch connected by a cylinder to a circular or oblong 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall
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)
Nonclinical laboratory testing was not performed.
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.
Not Found
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
FEB-18-1999 ଉପ: 55 ETHICON REG. AFF.
2/03/99
SECTION 7 K984220
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary of Safety and Effectiveness | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
|---|---|
| MODIFIED DEVICE NAME: PROLENE* (Polypropylene) Hernia System | |
| PREDICATE DEVICE NAME: PROLENE* (Polypropylene) Hernia System | |
| 510(k) SUMMARY | |
| Device Description | The PROLENE Hernia System is a sterile, pre-shaped three dimensional device constructed of an onlay patch connected by a cylinder to a circular or oblong 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. |
| Intended Use | The PROLENE Hernia System is intended to be used for the repair of abdominal wall hernia defects. |
Continued on next page
PROLENE* (Polypropylene) Hernia System ETHICON, Inc.
1
FEB-18-1999 088:56
·
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued
| Indications Statement | The PROLENE Hernia System is indicated for the repair of
abdominal wall hernia defects. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The modified device has identical technological characteristics to
the predicate device. |
| Performance Data | Nonclinical laboratory testing was not performed. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
new device is substantially equivalent to the Predicate Device
under the Federal Food, Drug, and Cosmetic Act. |
| Contact | Gregory R. Jones
Director, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151 |
| Date | |
2
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized representation of a human figure with three wavy lines extending from the head, resembling hair or a symbolic representation of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 1999
Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc. Route 22 West Somerville, New Jersey 08876
Re: K984220 Trade Name: PROLENE* (Polypropylene) HERNIA SYSTEM Regulatory Class: II Product Code: FTL Dated: November 24, 1998 Received: November 25, 1998
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 requirement, as set forth in the Quality System Regulation (QS) 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.
3
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,
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
4
16:19 FEB-18-1899
ETHICON, INC. NED/GT
Image /page/4/Picture/3 description: The image shows a series of numbers and letters in a stylized, handwritten font. The characters appear to be 'K94220'. The characters are bold and black, contrasting with the white background. The style of the characters gives the image an artistic or calligraphic feel.
INDICATION FOR USE
PROLENE* (Polypropylene) HERNIA SYSTEM.
510(k) Number (if known):
Device Name:
Indications for Use:
The PROLENE (Polypropylene) Hemia System is indicated for the
rs of the controllers in defects The PROLEINE (1 Siffect propped and hernia defects.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON
CE IN SEE OF AND NOTWER BAGE JE NEEDED) ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| Over-The Counter Use |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K984220 |
|---|---|
| --------------- | --------- |
(Optional Format 1-2-9G)
PROLENE* (Polypropylene) Hemia System ETHICON, Inc.
iii