(37 days)
Not Found
No
The summary describes a standard surgical mesh made of polyester and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for hernia repair, which is a therapeutic intervention aimed at correcting a medical condition.
No
Explanation: The device, Parietex™ Monofilament Polyester Mesh, is indicated for hernia repair, which is a treatment/surgical function, not a diagnostic one. The description focuses on its material and shape as an implant, not on detecting or identifying a medical condition.
No
The device description clearly states it is a "non-absorbable bi-dimensional monofilament polyester knitting," which is a physical mesh, 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 "inguinal and ventral hernia repair." This is a surgical procedure performed in vivo (within the body) to repair a physical defect.
- Device Description: The device is a "non-absorbable bi-dimensional monofilament polyester knitting." This describes a physical implant used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens outside the body.
Therefore, the Parietex™ Monofilament Polyester Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Parietex™ Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.
Product codes
FTL
Device Description
PARIETEX™ - Monofilament Polyester Mesh is made out of a non-absorbable bi-dimensional monofilament polyester knitting and is available in rectangular shape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inguinal and ventral hernia repair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Bench testing has been conducted to evaluate the performance characteristics of PARIETEX™ - Monofilament Polyester Mesh. Testing has shown that the PARIETEX™ - Monofilament Polyester Mesh is similar in performance characteristics to the predicate MERSILENE™.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MERSILENE™ (Ethicon), K081126
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
| K090858 | 510(k) Summary of Safety and Effectiveness | ||
|---|---|---|---|
| SUBMITTER: | Sofradim Production | ||
| 116, avenue du formans | |||
| 01600 Trevoux, France | |||
| Phone: 33 0 4 74 08 90 00 | |||
| CONTACT PERSON: | Angela L. Bunn, RAC | ||
| Associate Manager, Regulatory Affairs | |||
| Covidien | |||
| 60 Middletown Avenue | |||
| North Haven, CT 06473 USA | |||
| Phone: (203) 492-5325 | MAY - 6 2009 | ||
| DATE PREPARED: | March 27, 2009 | ||
| TRADE/PROPRIETARY NAME: | PARIETEX™ - Monofilament Polyester Mesh | ||
| COMMON/USUAL NAME: | Surgical Mesh | ||
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric | ||
| PREDICATE DEVICE(S): | MERSILENE™ (Ethicon) (Preamendment device, marketed | ||
| prior to May 28, 1976) | |||
| PARIETEX™ COMPOSITE Mono PM Mesh (K081126) | |||
| DEVICE DESCRIPTION: | PARIETEX™ - Monofilament Polyester Mesh is made out of a | ||
| non-absorbable bi-dimensional monofilament polyester knitting | |||
| and is available in rectangular shape. | |||
| INTENDED USE: | PARIETEX™ - Monofilament Polyester Mesh is indicated for | ||
| inguinal and ventral hernia repair. | |||
| TECHNOLOGICAL | |||
| CHARACTERISTICS: | The technological characteristics of PARIETEX™ - | ||
| Monofilament Polyester Meshes are similar to those of the | |||
| predicate devices. The proposed device is similar to the | |||
| predicate device (PARIETEX™ Composite Mono PM Mesh) in | |||
| that the base materials of polyester are the same. In regards | |||
| to other technological aspects the predicate device | |||
| (MERSILENE™) are similar in form and function. | |||
| MATERIALS: | PARIETEX™ - Monofilament Polyester Mesh is comprised of | ||
| biocompatible materials that are in compliance with ISO | |||
| 10993-1 and/or USP standards. | |||
| PERFORMANCE DATA: | Bench testing has been conducted to evaluate the | ||
| performance characteristics of PARIETEX™ - Monofilament | |||
| Polyester Mesh. Testing has shown that the PARIETEX™ - | |||
| Monofilament Polyester Mesh is similar in performance | |||
| characteristics to the predicate MERSILENE™. |
PARIETEX™ - Monofilament Polyester Mesh
.
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1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
MAY - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sofradim Production % Covidien Ms. Angela L. Bunn, RAC 60 Middletown Avenue North Haven, Connecticut 06473
Re: K090858
Trade/Device Name: ParietexTM Monofilament Polyester Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 27, 2009 Received: March 30, 2009
Dear Ms. Bunn:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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
2
Page 2 - Ms. Angela L. Bunn, RAC
(240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Mil. B.P. Ogle
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Parietex™ Monofilament Polyester Mesh
Indications For Use:
The Parietex™ Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.
Prescription Use X (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)
Daniel Krane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number KD90858