(22 days)
No
The summary describes a surgical mesh made of polyester and a collagen-based hydrogel. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The changes described are purely mechanical (addition of a flap).
No.
The device is a surgical mesh used for tissue reinforcement during surgical repair of hernias and abdominal wall defects, which is a structural implant rather than a device that delivers therapy.
No
The device is a surgical mesh used for tissue reinforcement, not for diagnosing conditions.
No
The device is a surgical mesh made of polyester and collagen, which are physical materials, not software. The description details its physical composition and intended use in surgical procedures.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reinforcement of tissues during surgical repair," specifically for hernias and abdominal wall repair. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a surgical mesh made of polyester and a collagen-based hydrogel, designed for placement within the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is clearly designed for surgical implantation in vivo.
N/A
Intended Use / Indications for Use
The PCO-OS and PCO-OB meshes are used for the reinforcement of tissues during surgical repair. They are indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable polyester mesh provides long-term reinforcement of soft tissues. On the opposite side, the resorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Product codes
FTL
Device Description
The PARIETEX COMPOSITE PCO-OS and PCO-OB Meshes are surgical meshes used during open (laparotomy) procedures or during laparoscopic procedures. The meshes are made from polyethylene terephtalate (polyester) and a collagen-based hydrogel component. The hydrophilic collagen film does not affect the physical performance characteristics of the meshes but serves to separate the coated side of the meshes from underlying tissues to minimize tissue attachment and ingrowth. The PCO-OB and PCO-OS Meshes are offered in several sizes and shapes to accommodate the type and approach of the surgical procedure. The Sofradim PCO-OS and PCO-OB Meshes are identical to the predicate PARIETEX COMPOSITE (PCO) meshes (K002699 and K040998) with the exception of the addition of a bi-dimensional textile flap to the current threedimensional reinforcement on the PCO Mesh. This flap is manufactured and sewn to the three-dimensional textile with the same polyester yarn as described in the predicate PCO meshes as well as other PARIETEX meshes (K982532 and K003990). The bidimensional flap has been added to the parent PCO Meshes to ease placement and fixation of the mesh during open surgery.
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
The polyester mesh material used is not modified and remains the same as that described in the current PCO file (K002699(textile) and K040998-(collagen source)). A study was conducted and demonstrated that the sewing of the additional flap does not adversely affect the safety or effectiveness of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
KOSO 197 EB 1 8 2005
510(k) Summary for PARIETEX COMPOSITE PCO-OS and PCO-OB Mesh
1. SPONSOR
Sofradim Production 116 Avenue du Formans 01600 Trevoux France
Contact: Christophe COSSON 33 (0)4 74 08 90 00 Telephone: Facsimile: 33 (0)4 74 08 90 02
2. DEVICE NAME
Proprietary Name: PARIETEX COMPOSITE PCO-OS and PCO-OB Mesh Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh
3. PREDICATE DEVICES
Sofradim PARIETEX COMPOSITE Meshes, K002699 and K040998
Bard Composix Kugel Mesh, K003323
4. DEVICE DESCRIPTION
The PARIETEX COMPOSITE PCO-OS and PCO-OB Meshes are surgical meshes used during open (laparotomy) procedures or during laparoscopic procedures. The meshes are made from polyethylene terephtalate (polyester) and a collagen-based hydrogel component. The hydrophilic collagen film does not affect the physical performance characteristics of the meshes but serves to separate the coated side of the meshes from underlying tissues to minimize tissue attachment and ingrowth. The
1
PCO-OB and PCO-OS Meshes are offered in several sizes and shapes to accommodate the type and approach of the surgical procedure.
The Sofradim PCO-OS and PCO-OB Meshes are identical to the predicate PARIETEX COMPOSITE (PCO) meshes (K002699 and K040998) with the exception of the addition of a bi-dimensional textile flap to the current threedimensional reinforcement on the PCO Mesh. This flap is manufactured and sewn to the three-dimensional textile with the same polyester yarn as described in the predicate PCO meshes as well as other PARIETEX meshes (K982532 and K003990). The bidimensional flap has been added to the parent PCO Meshes to ease placement and fixation of the mesh during open surgery.
INTENDED USE ડ.
The PARIETEX COMPOSITE PCO-OS and PCO-OB Meshes are used for the reinforcement of tissues during surgical repair. They are indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e., pertaining to the walls) reinforcement of tissues. The non-resorbable polyester meshes provide long-term reinforcement of soft tissues. On the opposite side, the resorbable hydrophilic film minimizes tissue attachment to the meshes in case of direct contact with the viscera.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The PCO-OS and PCO-OB Meshes are identical to the predicate PCO meshes with the exception of the addition of a bi-dimensional textile flap to the current threedimensional reinforcement. This flap is manufactured and sewn to the original threedimensional textile with the same polyester yarn as described for the predicate PCO meshes. The absorbable hydrophilic film is unchanged.
PERFORMANCE TESTING 7.
The polyester mesh material used is not modified and remains the same as that described in the current PCO file (K002699(textile) and K040998-(collagen source)). A study was conducted and demonstrated that the sewing of the additional flap does not adversely affect the safety or effectiveness of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three arms or wings extending upwards.
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sofradim Production c/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K050187
Trade/Device Name: PARIETEX® COMPOSITE PCO-OS and PCO-OB Meshes Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 25, 2005 Received: January 27, 2005
Dear Ms. McNamara-Cullinane:
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 for about in 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.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 - Ms. Mary McNamara-Cullinane, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter wir anow you to cognification of substantial equivalence of your device to a legally prematication. The 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), please if you desire specific arrantiance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisoranding of reference to pour responsibilities under the Act from the Division of Small other general mionnation of Jour Corpumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C Provost
te Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO50187
Indications for Use
510(k) Number (if known):
PARIETEX® COMPOSITE PCO-OS and PCO-OB Meshes Device Name:
Indications for Use:
The PCO-OS and PCO-OB meshes are used for the reinforcement of tissues during surgical repair. They are indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable polyester mesh provides long-term reinforcement of soft tissues. On the opposite side, the resorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
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)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K050187
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