(230 days)
None
No
The device description and intended use are for a physical mesh material, and there is no mention of AI, ML, or any software component that would utilize such technology.
Yes
The device, SupraMESH EXTRA™ nylon mesh, is indicated for use as a hernia mesh and for plastic and reconstructive surgery, which are therapeutic applications.
No
The device is a surgical mesh used for hernia repair and plastic/reconstructive surgery, which is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical mesh panel woven from nylon suture, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "hernia mesh and for plastic and reconstructive surgery." This describes a device used in vivo (within the body) for surgical repair and reconstruction.
- Device Description: The description details a physical mesh panel made of nylon, designed to be implanted. This is consistent with a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical support and repair within the body.
N/A
Intended Use / Indications for Use
SupraMESH EXTRA™ nylon mesh is indicated for use as a hernia mesh and for plastic and reconstructive surgery.
Product codes
FTL
Device Description
SupraMESH EXTRA™ nylon mesh is an 18" x 18" mesh panel woven from USP size 3-0 SUPRAMID EXTRA® nylon suture (FDA N80-838). The nylon used to manufacture this SUPRAMID EXTRA® nylon suture (FDA N80-838) is nylon 6. The knit description of the SupraMESH EXTRA™ nylon mesh panel is 1 x 1 Tricot stitch mesh.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
SEP 1 5 2008
Image /page/0/Picture/1 description: The image shows the text "S. JACKSON, INC." in a bold, outlined font. The letters are large and blocky, with a distinct outline that makes them stand out. The text is arranged horizontally, with each letter evenly spaced.
080216
pg 1 of 2
sutures & Impla 15 Roth Street · P.O. Box 4487 · Alexandria, VA 22303
4.0 SUMMARY OF SAFETY AND EFFECTIVENESS
ADMINISTRATIVE INFORMATON 4.1
SPONSOR IDENTIFICATION 4.11
S. Jackson, Inc. 15 Roth Street Alexandria, VA 22314 Contact Person: Mr. Janko Jackson, President e-mail: supramid@mindspring.com Telephone: 703-370-4900 Fax: 703-370-1679
ESTABLISHMENT REGISTRATION NUMBER: 1111225 4.12
OFFICIAL CONTACT PERSON 4.13
Norman F. Estrin, Ph.D. President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin(a)yourFDAconsultant.com Tel: (301) 279 -2899 Fax: (301) 294-0126
4.14 DATE OF PREPARATION OF THIS SUMMARY: January 13, 2008
4.15 PROPRIETARY (TRADE) NAME: SupraMESH EXTRA™
- 4.16 COMMON NAME: Surgical Mesh
- 4.17 CLASSIFICATION NAME: Mesh, Surgical, Polymeric
- 4.18 REGULATION NUMBERS: 21 CFR 878.3300
- 4.19 PROPOSED REGULATORY CLASS: Class 2
- 4.20 DEVICE PRODUCT CODES: FTL
- 4.21 MEDICAL SPECIALTIES: General and Plastic Surgery
Phone (800) 368-5225 and (703)370-4900 · Fax (703) 370-1679
1
K080216
pg 20f2
4.2 DESCRIPTION OF THE DEVICE
SupraMESH EXTRA™ nylon mesh is an 18" x 18" mesh panel woven from USP size 3-0 SUPRAMID EXTRA® nylon suture (FDA N80-838). The nylon used to manufacture this SUPRAMID EXTRA® nylon suture (FDA N80-838) is nylon 6. The knit description of the SupraMESH EXTRA™ nylon mesh panel is 1 x 1 Tricot stitch mesh,
S. Jackson, Inc. currently manufactures Supramid Extra Surgical Mesh (marketed as SupraMESH®) sterile mesh sheets under FDA K831723, K852011 and K831724. SupraMESH EXTRA™ nylon mesh is substantially equivalent to Supramid Extra Surgical Mesh (marketed as SupraMESH®) FDA K831723. K852011 and K831724 in design and function and shares the same indications for use.
INDICATIONS FOR USE 4.3
SupraMESH EXTRA™ nylon mesh is indicated for use as a hernia mesh and for plastic and reconstructive surgery.
PREDICATE DEVICES 4.4 Supramid Extra Surgical Mesh (marketed as SupraMESH®) FDA K831723, K852011 and K831724.
SUBSTANTIAL EQUIVALENCE 4.5
SupraMESH EXTRA™ nylon mesh is substantially equivalent to Supramid Extra Surgical Mesh (marketed as SupraMESH®) FDA K831723, K852011 and K831724 with regard to indications for use and safety and effectiveness.
4.6 CONCLUSION
SupraMESH EXTRA™ nylon mesh raises no new safety/efficiency issues and has the same indications for use as the predicate device cited.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling an eagle or bird in flight, rendered in black. Surrounding the symbol is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle, framing the central symbol.
SEP 1 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
S. Jackson, Inc. % Estrin Consulting Group, Inc. Mr. Norman R. Estrin President 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K080216
Trade/Device Name: SupraMESH EXTRA™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: August 21, 2008 Received: August 22, 2008
Dear Mr. Estrin:
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 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.
3
Page 2 - Mr. Norman R. Estrin
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K080216
Device Trade/Proprietary Name: SupraMESH EXTRA™
Indications for Use:
SupraMESH EXTRA™ nylon mesh is indicated for use as a hernia mesh and for plastic and reconstructive surgery.
Page 1_of_1_
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Kuumy R. Sence FOR M. MELKERSON
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K080216