(69 days)
Not Found
No
The device description focuses on the material properties and physical structure of the surgical mesh and foam, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is used for surgical repair of damaged or ruptured soft tissue to provide wound support, increase opportunity for bridging, and prevent wound dehiscence during the healing process, falling under the definition of a therapeutic device.
No
Explanation: The device is a surgical mesh used for repairing damaged soft tissue, not for diagnosis. Its description focuses on structural and therapeutic properties, not on detecting or identifying medical conditions.
No
The device description clearly describes a physical surgical mesh product made of foam and mesh components, 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 damaged or ruptured soft tissue. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical mesh designed to provide physical support and aid in tissue healing. It is implanted into the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, not to be implanted or used directly in surgical repair of tissue.
N/A
Intended Use / Indications for Use
Reinforced Absorbable Synthetic Surgical Mesh is indicated for use in the surgical repair of damaged or ruptured soft tissue where reinforcing or bridging materials are needed. This device is intended for one-time use.
Product codes
FTL
Device Description
The reinforced absorbable synthetic surgical mesh is a foam encased mesh. The foam component is a biocompatible elastomeric polymer that is bioabsorbable. This elastomer exhibits a high percent elongation, while possessing good tensile strength and good recovery characteristics. It has been found to be non-antigenic, non-pyrogenic, and elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the foam component provides wound support as well as increases the opportunity for bridging to occur due to its porosity. The mesh component is a woven polydioxanone mesh that is used to provide wound support during the healing process. It has been found to be non-antigenic, non-pyrogenic, and also elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the mesh component retains strength for a period of time long enough to permit sufficient healing, preventing wound dehiscence.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 biocompatibility testing for AFB and PDS™ Mesh are sufficient and applicable to the reinforced absorbable synthetic surgical mesh. Accordingly, no additional biocompatibility or animal testing on the reinforced absorbable synthetic surgical mesh was performed.
Key Metrics
Not Found
Predicate Device(s)
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
I.
SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 1 2 2002 GENERAL INFORMATION Center for Biomaterials and Advanced A. Submitted By: Technologies, Medical Devices Group, a division of Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 (908) 218-2041 Tel: (908) 218-3679 Fax: Contact Person: David A. Dalessandro At address above Reinforced Absorbable Synthetic Surgical B. Device Trade Name: Mesh Surgical Mesh Common Name: Classification Name: Mesh, Surgical, Polymeric FTL, 21 CFR 878.3300 C. Predicate Device(s): Manufacturer Product Name 510(k) No. PDSTM (polydioxanone) Mesh Ethicon, Inc. K844228
J&J Corporate AFB (Absorbable Foam K014183 Biomaterials Center Buttress)
D. Device Description:
The reinforced absorbable synthetic surgical mesh is a foam encased mesh. The foam component is a biocompatible elastomeric polymer that is bioabsorbable. This elastomer exhibits a high percent elongation, while possessing good tensile strength and good recovery characteristics. It has been found to be non-antigenic, non-pyrogenic, and elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the foam component provides wound support as well as increases the opportunity for bridging to occur due to its porosity. The mesh component is a woven polydioxanone mesh that is used to provide wound support during the healing process. It has been found to be non-antigenic, non-pyrogenic, and also elicits a slight, but typical, tissue reaction during absorption. Therapeutically, the mesh component retains strength for a period of time long enough to permit sufficient healing, preventing wound dehiscence.
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Accordingly, no or minimal undesirable side effects occur during the healing process.
-
Indications for Use: E.
Reinforced Absorbable Synthetic Surgical Mesh is indicated for use in the surgical repair of damaged or ruptured soft tissue where reinforcing or bridging materials are needed. This device is intended for one-time use. -
F. Technological Comparison:
The reinforced absorbable synthetic surgical mesh and PDSTM Mesh (K844228) have similar indications for use and overall function and perform in a similar manner with respect to reinforcement of soft tissue wound strength. The reinforced absorbable synthetic surgical mesh has similar absorption, degradation, and burst strength to the predicate device.
The foam component of the reinforced absorbable synthetic surgical mesh functions and performs in the same manner as AFB (Absorbable Foam Buttress) (K014183).
II. TESTING
The biocompatibility testing for AFB and PDS™ Mesh are sufficient and applicable to the reinforced absorbable synthetic surgical mesh. Accordingly, no additional biocompatibility or animal testing on the reinforced absorbable synthetic surgical mesh was performed.
III. CONCLUSIONS
In summary, Center for Biomaterials and Advanced Technologies, Medical Devices Group, a division of Ethicon, Inc. has demonstrated that the intended use for the reinforced absorbable synthetic surgical mesh is the same as the original devices. The technological characteristics have been described in sufficient detail to demonstrate that they are the same as the original devices. Therefore, this premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug, & Cosmetic Act and its amendments.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Center for Biomaterials and Advanced Technologies Melissa Mahall c/o Bio-Reg Associates 11800 Baltimore Avenue, Suite 105
Beltsville. Maryland 20705
Re: K023328
Trade/Device Name: Reinforced Absorbable Synthetic Surgical Mesh Regulation Number: 878.3300 Regulation Name: Polymeric Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: October 2, 2002 Received: October 4, 2002
Dear Ms. Mahall:
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.
If your device is classified (see above) into either 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
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Page 2 – Ms. Melissa Mahall
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
KOZ3328
Device Name:
Reinforced Absorbable Synthetic Surgical Mesh
Sponsor Name:
Center for Biomaterials and Advanced Technologies, Medical Devices Group, a division of Ethicon, Inc.
Indications for Use:
Reinforced Absorbable Synthetic Surgical Mesh is indicated for use in the surgical repair of damaged or ruptured soft tissue where reinforcing or bridging materials are needed. This device is intended for one-time use.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-The-Counter Use
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Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023328