(259 days)
Not Found
No
The summary describes a physical surgical mesh device with an inflatable balloon and fixation threads, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as a "parietal prosthesis" intended for "hernia repair requiring reinforcement with nonabsorbable support material," indicating it is used to treat a medical condition.
No
The device is described as a "parietal prosthesis with inflatable expansion balloon and fixation threads" intended for hernia repair, indicating it is a therapeutic device for reinforcement, not a diagnostic one.
No
The device description clearly states it is a "parietal prosthesis with inflatable expansion balloon and fixation threads," indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hernia repair requiring reinforcement with nonabsorbable support material." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as a "parietal prosthesis with inflatable expansion balloon and fixation threads." This is a physical implant used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The provided information does not mention any such use or interaction with biological specimens.
Therefore, the BIOMESH® CA.B.S.'Air® Composite is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BIOMESH® CA.B.S.'Air® Composite is intended for use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.
Product codes
FTL, OQL
Device Description
BIOMESH® CA.B.S.'Air® Composite medical devices are parietal prosthesis with inflatable expansion balloon and fixation threads.
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
BIOMESH® CA.B.S.'Air® Composite conforms to the special control "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh".
Key Metrics
Not Found
Predicate Device(s)
CABS'AIR (K072962), VENTRALEX HERNIA PATCH (K021736)
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
510 (k) BIOMESH CA.B.S. AIR COMPOSITE - K093196 - Additional information - S1 Response to Letter of 01-Dec-09
.
COUSIN
S I A T E C H
page 1/2
JUN 2 5 2010
510(k) Summary
As required by section 807.92(c)
| Submitter | COUSIN BIOTECH
8 rue Abbe Bonpain
F59117 WERVICQ SUD FRANCE |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PELLETIER Regulatory Affairs Manager
f.pelletier@cousin-biotech.com |
| Preparation date | 02nd October, 2009 |
| Trade Name | BIOMESH® CA.B.S.'Air® Composite |
| Common Name | POLYMERIC SURGICAL MESH |
| Classification Name | MESH SURGICAL POLYMERIC |
| Class | II |
| Product Code | FTL |
| CFR section | 878.3300 |
| Device panel | General & Plastic Surgery |
| Legally marketed predicate devices | BIOMESH® CA.B.S.'Air® Composite is compared to
CABS'AIR (K072962) manufactured by COUSIN BIOTECH, INC and VENTRALEX HERNIA PATCH (K021736) manufactured by C.R. BARD, INC |
| Description | BIOMESH® CA.B.S.'Air® Composite medical devices are
parietal prosthesis with inflatable expansion balloon and
fixation threads. |
and the mail of the state of the state of the comments of the comments of
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Page 57 / 64
And Artist
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| Intended Use | BIOMESH® CA.B.S.'Air® Composite is intended for use in
all forms of hernia repair requiring reinforcement with
nonabsorbable support material. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data | BIOMESH® CA.B.S.'Air® Composite conforms to the
special control "Guidance for the Preparation of a
Premarket Notification Application for a Surgical Mesh". |
| Substantial
equivalence | BIOMESH® CA.B.S.'Air® Composite has the same
fundamental scientific technology, operating principle
and intended use as predicate devices. |
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 stylized depiction of an eagle or bird-like figure with outstretched wings, positioned to the right. To the left of the bird is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is oriented to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 5 2010
Cousin Biotech S.A.S. % Mr. Franck Pelletier Regulatory Affairs Manager 8 rue de l'Abbé Bonpain Wervicq SUD 59117 France
Re: K093196
Trade/Device Name: BIOMESH® CA.B.S.'AIR® Composite Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OQL Dated: June 18, 2010 Received: June 21, 2010
Dear Mr. Pelletier:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Franck Pelletier
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Fok Nphm Dih
Nir
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510k Premarket Notification BIOMESH® CA.B.S.'Air® Composite
COUSIN
BIOTECH
INDICATIONS FOR USE
510(k) Number (if known): K093196 Device Name: BIOMESH® CA.B.S.'Air® Composite Indications for Use:
BIOMESH® CA.B.S.'Air® Composite is intended for use in all forms of hernia repair requiring reinforcement with nonabsorbable support material.
Over-The-Counter Use _ Prescription Use く and/or (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093196
Page 14 /361