(42 days)
K/DEN number not found.
Not Found
No
The summary describes a surgical mesh made of polypropylene and focuses on its material properties and mechanical strength. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device is a surgical mesh used for structural repair, not for treating diseases or conditions in a therapeutic manner beyond providing mechanical reinforcement.
No
Explanation: The device, Modified PROLENE mesh, is intended for the repair of hernia and other fascial deficiencies, indicating it is a therapeutic or surgical device rather than one used for diagnosis.
No
The device description clearly states it is a mesh constructed of knitted filaments of extruded polypropylene, 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 of hernias and other fascial deficiencies. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical mesh made of polypropylene, designed to be implanted in the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue to provide diagnostic information. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
Modified PROLENE mesh is intended for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material, to obtain the desired surgical result. Modified PROLENE mesh is intended for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material.
Product codes
Not Found
Device Description
Modified PROLENE mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE suture nonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). The mesh is approximately 0.027 inches thick. This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use. When compared to the predicate device, Modified PROLENE mesh differs in the additional sizes that are being supplied and a key hole shape which is being provided precut as a convenience to the surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Burst strength testing was conducted to compare the predicate device and the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
K96253c
AUG - 9 1996
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
Information supporting claims of substantial equivalence, as 510(k) Summary of Safety and Effectiveness 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. NEW DEVICE NAME: Modified PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh PREDICATE DEVICE NAME: PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh 510(k) SUMMARY Device Description Modified PROLENE mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE suture nonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). The mesh is approximately 0.027 inches thick. This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use. Modified PROLENE mesh is intended for the repair of hernia Intended Use and other fascial deficiencies that require the addition of a reinforcing or bridging material, to obtain the desired surgical result. Continued on next page
Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh ETHICON, Inc.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
| 510(k) SUMMARY, Continued | |
|---|---|
| Intended Use (continued) | Modified PROLENE mesh has the same intended use as the |
| preamendment predicate device PROLENE mesh. | |
| Indications Statement | Modified PROLENE mesh is intended for the repair of hernia |
| and other fascial deficiencies that require the addition of a | |
| reinforcing or bridging material. | |
| Technological | |
| Characteristics | The modified device has the same technological characteristics |
| as the predicate device. There is no change in chemistry, | |
| material or composition. |
When compared to the predicate device, Modified PROLENE
mesh differs in the additional sizes that are being supplied and a
key hole shape which is being provided precut as a convenience
to the surgeon. |
| Performance Data | Burst strength testing was conducted to compare the predicate
device and the modified device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
modified device is substantially equivalent to the Predicate
Device under the Federal Food, Drug, and Cosmetic Act. |
| | Continued on next page |
Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh ETHICON, Inc.
2
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Contact
John D. Paulson, Ph.D. 1 Vice President, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
:
Date
June 25, 1996
Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh ETHICON, Inc.