(280 days)
Not Found
No
The 510(k) summary describes a surgical suture, a physical medical device, and contains no mention of AI, ML, image processing, or data-driven algorithms.
No.
The DemeTECH Nylon Nonabsorbable Suture is a surgical suture used for tissue approximation and ligation, which is a tool for surgical repair, not a device that provides therapy or treats a condition itself.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a "surgical suture," which is a physical, hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation" during surgical procedures. This is a direct surgical intervention on the body, not a test performed on samples taken from the body.
- Device Description: The device is a "surgical suture," which is a physical material used to close wounds or tie off blood vessels during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting substances, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This suture does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GAR
Device Description
The DemeTECH Nylon Nonabsorbable Suture is a single use, individually packaged, disposable nonabsorbable nylon (polyamide) surgical suture.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 878.5020 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.
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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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