(280 days)
The DemeTECH Nylon Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
The DemeTECH Nylon Nonabsorbable Suture is a single use, individually packaged, disposable nonabsorbable nylon (polyamide) surgical suture.
The provided text is related to the 510(k) submission for the DemeTECH Nylon Nonabsorbable Suture. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to USP standards for a medical device (suture), not an AI/ML powered device. Therefore, many of the requested categories for AI/ML study information (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.
However, I can provide the acceptance criteria table and the reported device performance, which is focused on equivalence and meeting safety/performance standards, as detailed in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to a legally marketed predicate device (Grams Nylon Nonabsorbable Suture - K003000). | The DemeTECH Nylon Nonabsorbable Suture has been demonstrated as equivalent to the predicate device. |
| Compliance with United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures. | The DemeTECH Nylon Nonabsorbable Suture meets United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures. |
| Intended Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures. | The device's intended use statement aligns with its established equivalence and USP compliance, supporting its use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. |
The following information cannot be extracted from the provided text for this medical device (suture), as these concepts typically apply to AI/ML powered devices or clinical efficacy studies that are not detailed in a 510(k) summary for a non-active medical device:
- Sample size used for the test set and the data provenance: Not applicable/not provided for a suture's physical performance testing. Testing would typically involve laboratory analysis of material properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for suture performance is based on standardized physical and chemical tests.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical medical device (suture) and not an AI-powered diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: For a suture, ground truth is based on standardized physical and chemical properties as defined by the USP (United States Pharmacopeia) and established engineering/material science principles.
- The sample size for the training set: Not applicable. There is no "training set" in the context of a physical medical device like a suture.
- How the ground truth for the training set was established: Not applicable.
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JUN 1 8 2003 510(k) Summary of Safety and Effectiveness ECH CORP
for 510 (k) No. KO23028
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| (A)(1) Submitter's name: | DemeTECH Corp |
|---|---|
| Submitter's address: | 12119 SW 131 Ave.Miami, FL 33186 |
Submitter's telephone number: (305) 251-2700
Contact Person: Mr. Luis Arguello, President
Date Summary Prepared: September 7, 2002
- (2) Trade or proprietary device name: DemeTECH Nylon Nonabsorbable Suture
Common or usual name: Nylon Nonabsorbable Surgical Suture
Classification Name: Nonabsorbable Polyamide Surgical Suture Panel: General and Plastic Surgery Class: II
- (3) Legally marketed predicate device: Grams Nylon Nonabsorbable Suture [Grams American Suture, Inc., Grafton, WI] (510(k) No.: K003000)
- (4) Subject device description:
The DemeTECH Nylon Nonabsorbable Suture is a single use, individually packaged, disposable nonabsorbable nylon (polyamide) surgical suture.
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(5) Subject device intended use:
The DemeTECH Nylon Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures. -
(6) Performance data:
The DemeTECH Nylon Nonabsorbable Suture has been demonstrated as both equivalent to the predicate device and meets United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing right, stacked on top of each other, creating a sense of depth and unity.
Public Health Service
JUN 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Luis Arguello President DemeTECH Corporation 12119 SW 131 Avenue Miami, Florida 33186
Re: K023028
Trade/Device Name: DemeTECH Nylon Nonabsorbable Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: April 25, 2003 Received: May 8, 2003
Dear Mr. Arguello:
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.
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Page 2 - Mr. Luis Arguello
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) you may obtain. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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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DEMETECH CORP
510 (k) Premarket Notification DemeTECH Nylon Nonabsorbable Suture
C. Indications for use of the Device
Page 1 of 1
510(k) Number): Not known
DemeTECH Nylon Nonabsorbable Suture Device Name:
Indications for Use:
The DemeTECH Nylon Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K0 23028
Prescription Use_X (Per 21 CFR 801.109)
or Over-the-Counter Use
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§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.