(118 days)
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No
The document describes a surgical suture and its physical properties and testing, with no mention of AI or ML technology.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, not for treating a disease or condition.
No
This device, DemeTECH PTFE Suture, is described as a nonabsorbable, sterile surgical monofilament suture used for soft tissue approximation and/or ligation. Its purpose is to repair or close tissues, not to diagnose a medical condition.
No
The device description clearly states it is a physical surgical suture made of polytetrafluoroethylene, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue approximation and/or ligation" in surgical procedures. This is a direct medical intervention on a patient's body.
- Device Description: The description details a surgical suture, a physical material used to close wounds or tie off blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, and peripheral neural tissue.
Product codes (comma separated list FDA assigned to the subject device)
NBY
Device Description
DemeTECH PTFE Suture is a nonabsorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene. The DemeTECH PTFE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is undyed and contains no additives and is white in appearance and may be provided with or without an attached needle(s).
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and in-vitro and in-vivo resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in USP 39.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2018
Demetech Corporation Ms. Linda Hernandez Head of Quality 14175 NW 60th Ave. Miami Lakes, Florida 33014
Re: K181578
Trade/Device Name: DemeTECH PTFE Nonabsorbable Surgical Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: April 6, 2018 Received: June 15, 2018
Dear Ms. Hernandez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Peter L. Hudson -S 2018.10.11 09:33:52 -04'00'
For:
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181578
Device Name DemeTECH PTFE Suture
Indications for Use (Describe)
The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, and peripheral neural tissue.
| Type of Use (Select one or both, as applicable) |
|---|
| Exempted from/Qualified for SEE Waiver (Attach Sheet) |
| Long-Term Agreement with SEE Waiver |
| | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for "DemeTECH". The logo consists of a light blue triangle on the left side and the company name in bold, black letters on the right side. The triangle is a three-dimensional shape with a gradient of light blue, giving it a modern and technological appearance.
Section 5 - 510(k) Summary
This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92. This summary demonstrates the equivalence of Demetech Sutures to those of the legally marked devices listed.
| A. | Applicant: | Demetech Corporation,
14175 NW 60th Ave.
Miami Lakes FL. 33014 |
|----|------------------------|----------------------------------------------------------------------|
| B. | Contact Person: | Luis Arguello
Phone: 305-824-1048 Ext 113
luis@demetech.us |
| C. | Date Summary Prepared: | April 6, 2018 |
| | Trade Name: | XXX |
| | Common Name: | PTFE Nonabsorbable Surgical Suture |
| | Classification Name: | Non-absorbable expanded polytetrafluorethylene
surgical suture |
| | Product Code: | NBY
21 CFR 878.5035
Class II |
- D. Predicate Devices: The DemeTECH PTFE Suture is substantially equivalent to the predicates Cytoplast PTFE suture and Look PTFE Suture in which the basic features and intended uses are the same. Any differences between the DemeTECH PTFE Suture and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
E. Device Description:
DemeTECH PTFE Suture is a nonabsorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene. The DemeTECH PTFE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is undyed and contains no additives and is white in appearance and may be provided with or without an attached needle(s).
- F. Intended Use:
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The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery, and peripheral neural tissue.
Non-Clinical Tests Performed: G.
Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and in-vitro and in-vivo resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in USP 39.
| COMPARISON TABLE | ||||||
|---|---|---|---|---|---|---|
| Comparison Items | Demetech PTFE | |||||
| Nonabsorbable Suture | Look PTFE | |||||
| Nonabsorbable | ||||||
| Suture | Cytoplast PTFE | |||||
| Nonabsorbable | ||||||
| Suture | ||||||
| Product Code | NBY | Same | Same | |||
| Common Name | PTFE nonabsorbable suture | Same | Same | |||
| Suture Characteristic | Nonabsorbable | |||||
| polytetrafluoroethylene | ||||||
| surgical suture | Same | Same | ||||
| Labeling | Sterile, Single Use | Same | Same | |||
| Intended Use | Approximation or ligation of | |||||
| soft tissues | Same | Same | ||||
| Technical Characteristics | Monofilament, uncoated, | |||||
| synthetic nonabsorbable | ||||||
| suture | Same | Same | ||||
| Material | High-density | |||||
| polytetrafluoroethylene | ||||||
| (PTFE) | Same | Same | ||||
| Sizes | 2-0 | Same | Same | |||
| Sterilization | Ethylene Oxide (EO) | Same | Same |
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Image /page/5/Picture/1 description: The image shows the DemeTECH logo. The logo consists of a blue circle with a white triangle inside on the left and the word "DemeTECH" in black on the right. The word "DemeTECH" is in a bold, sans-serif font, and the "R" in "TECH" has a registered trademark symbol next to it.
| USP Performance Requirements | Suture Material meets or
exceeds performance
requirements for
"Nonabsorbable Surgical
Suture" in USP 39. | Same | Same |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Tensile Strength Requirements | Suture Material meets or
exceeds the performance
requirements defined in
USP for "Tensile Strength" | Same | Same |
| Needle Attachment Requirements | Suture Material meets or
exceeds the performance
requirements defined in
USP for "Needle
Attachment" | Same | Same |
| Suture Length Requirements | Suture Material meets or
exceeds the performance
requirements defined in
USP for "Suture Length
Requirement" (95% of
stated label length) | Same | Same |
| Suture Packaging | Device wound onto inner
support card, within a Tyvek
/ Poly pouch | Device wound
onto inner support
card, within a
Tyvek/Poly Primary
Pouch; inside a
Tyvek / Poly
secondary pouch | Device wound
onto inner support
card, within a
Tyvek / Poly pouch |
H. Clinical Tests Performed:
No clinical trials were conducted
l. Conclusion:
DemeTECH PTFE Nonabsorbable Surgical Suture is composed of the same material as the predicated devices and has the same design being a sterile, monofilament nonabsorbable thread meeting all the requirements of the United States Pharmacopeia. DemeTECH's material used was selected based on known biocompatibility (per ISO 10993) and established history of use in the surgical suture industry.
The biocompatibility data and the results of performance testing presented, demonstrate the substantial equivalence of DemeTECH PTFE Nonabsorbable Surgical Suture to that of the predicate devices. It further demonstrates conformance with the USP, ISO 10993 and FDA Guidance for Surgical Suture 510(k).
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Image /page/6/Picture/1 description: The image contains the logo for DemeTECH. The logo consists of a blue circle with a white triangular shape inside, followed by the company name "DemeTECH" in bold, black letters. The registered trademark symbol is located to the right of the company name.
Based on the 510(k) summaries and the information provided herein we conclude that DemeTECH PTFE Nonabsorbable Surgical Suture is substantially equivalent for its intended purpose.