(75 days)
The DemeTECH Silk 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 Silk Nonabsorbable Suture is a black braided, individually packaged nonabsorbable silk surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes or supplied without needles.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DemeTECH Silk Nonabsorbable Suture:
This document is a 510(k) summary for a medical device regulatory submission, not a detailed scientific study publication. As such, it focuses on demonstrating substantial equivalence to a predicate device and compliance with established standards, rather than presenting a comprehensive research study with detailed methodology and extensive performance data common for novel high-risk devices.
Based on the provided information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent to predicate device: Grams Silk Nonabsorbable Suture (K003001) | Demonstrated as equivalent to the predicate device. |
| Meets United States Pharmacopeia (USP) 23 requirements for Nonabsorbable Surgical Sutures. | Meets USP 23 requirements for Nonabsorbable Surgical Sutures. |
| Meets United States Pharmacopeia (USP) 24 requirements for Nonabsorbable Surgical Sutures. | Meets USP 24 requirements for Nonabsorbable Surgical Sutures. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of a clinical trial or performance study. The evaluation appears to be based on physical and material properties testing to demonstrate compliance with USP standards and equivalence to the predicate device. No details about data provenance (e.g., country of origin, retrospective/prospective) are provided, as this type of information is typically associated with clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission relies on established standards (USP) and comparison to a legally marketed predicate device. There is no mention of "ground truth" derived from expert consensus in a clinical context for this type of device. The "experts" involved would be those performing the specified physical and chemical tests to USP standards and those reviewing the equivalence claims.
4. Adjudication Method
Not applicable. Adjudication methods are typically used in clinical studies where multiple human readers or experts assess cases to establish a consensus ground truth. This is not the type of study described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for imaging or diagnostic AI devices where human readers interpret data with and without AI assistance. This device is a surgical suture, and such a study is not applicable to its evaluation.
6. Standalone Performance Study
The statement "The DemeTECH Silk 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" indicates that standalone performance (i.e., the suture itself meeting defined metrics) was evaluated against the USP standards. This could be considered a form of standalone testing, though not in the context of an "algorithm only" as typical for AI. The "study" here refers to the testing conducted to show compliance with these material standards.
7. Type of Ground Truth Used
The "ground truth" used for this device is based on United States Pharmacopeia (USP) 23 and 24 requirements for Nonabsorbable Surgical Sutures and the specifications of the legally marketed predicate device (Grams Silk Nonabsorbable Suture). This means the device's physical, chemical, and performance characteristics were compared against established, standardized benchmarks.
8. Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning or AI models. This submission is for a physical medical device (suture) and does not involve AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI training set involved. The "ground truth" for the device's characteristics was established by the USP standards themselves, which define the required properties for surgical sutures, and by the characteristics of the predicate device.
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DEMETECH CORP 510(k) Summary of Safety and Effectiveness
for 510 (k) No. KO23029
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
DemeTECH Corp (A)(1) Submitter's name: Submitter's address: 12119 SW 131 Ave. Miami, FL 33186
Submitter's telephone number:
Mr. Luis Arguello, President Contact Person:
Date Summary Prepared: September 7, 2002
- (2) Trade or proprietary device name: DemeTECH Silk Nonabsorbable Suture
Common or usual name: Silk Nonabsorbable Surgical Suture
Classification Name: Natural Nonabsorbable Silk Surgical Suture Panel: General and Plastic Surgery Class: II
- (3) Legally marketed predicate device: Grams Silk Nonabsorbable Suture [Grams American Suture, Inc., Grafton, WI] (510(k) No .: K003001)
- (4) Subject device description:
The DemeTECH Silk Nonabsorbable Suture is a black braided, individually packaged nonabsorbable silk surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes or supplied without needles.
-
(5) Subject device intended use:
The DemeTECH Silk 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 Silk 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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "HUMAN SERVICES - USA" are arranged in a circular pattern above the caduceus, and the word "DEPARTMENT" is arranged in a circular pattern below the caduceus.
NOV 2 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DemeTECH Corporation Luis Arguello President 12119 SW 131 Avenue Miami, Florida 33186
Re: K023029
Trade/Device Name: DemeTech™ Silk Nonabsorbable Suture Regulation Number: 878.5030 Regulation Name: Natural nonabsorable silk surgical suture Regulatory Class: Class II Product Code: GAP Dated: September 7, 2002 Received: September 11, 2002
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
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Page 2 -- Mr. Luis Arguello
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. Parrott
(c) 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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DEMETECH CORP
510 (k) Premarket Notification DemeTECH Silk Nonabsorbable Suture
C. Indications for use of the Device
510(k) Number): Not known
Device Name: DemeTECH Silk Nonabsorbable Suture
Indications for Use:
The DemeTECH Silk Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriaine C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023029
Prescription Use X er-the-Counter Use (Per 21 CFR 801.109)
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§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.