(127 days)
Not Found
No
The device description and performance studies focus on the physical properties and material composition of a surgical suture, with no mention of AI or ML capabilities.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a medical device but not classified as a therapeutic device. Therapeutic devices are typically those that administer treatment, such as drug delivery systems or devices for rehabilitation.
No
This device is a surgical suture used for approximation and/or ligation of soft tissues, which is a treatment/repair function, not a diagnostic one.
No
The device description clearly states it is a surgical suture, which is a physical medical device, not software.
Based on the provided information, the DemeFORCE Suture is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "sterile surgical monofilament suture composed of Ultra-high-molecular-weight polyethylene." This is a physical material used to hold tissues together during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The DemeFORCE Suture does not perform any such function.
The information clearly indicates that this is a surgical implant/device used in vivo (within the living body) during a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
DemeFORCE Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
DemeTECH DemeFORCE Suture is a nonabsorbable, sterile surgical monofilament suture composed of Ultra-high-molecular-weight polyethylene. The DemeTECH UHMWPE 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 available in different colors and may be provided with or without an attached needle(s).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
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 41.
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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.
0
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 & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 31, 2019
DemeTECH Corporation Tracy Chadwrick Director of Quality 14175 NW 60th Ave Miami Lakes, Florida 33014
Re: K190777
Trade/Device Name: DemeTECH DemeFORCE Nonabsorbable Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: April 29, 2019 Received: April 29, 2019
Dear Tracy Chadwrick:
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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Nina Mezu-Nwaba, PharmD., MPH., MSc, CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190777
Device Name
DemeTECH DemeFORCE Nonabsorbable Surgical Suture
Indications for Use (Describe)
DemeFORCE Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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005 – 510K 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: | Tracy Chadwrick
Phone: 305-824-1048
tracy.chadwrick@demetech.us |
| C. Date Summary Prepared: | February 07, 2019 |
| Trade Name: | DemeTECH DemeFORCE Surgical Suture |
| Common Name: | Ultra-high-molecular-weight polyethylene (UHMWPE)
Nonabsorbable Surgical Suture |
| Classification Name: | Non-absorbable poly(ethylene terephthalate)
surgical suture |
| Product Code: | GAT
21 CFR 878.5000
Class II |
- D. Predicate Devices: The DemeTECH UHMWPE Suture is substantially equivalent to the predicates Arthrex (UHMWPE) and Force Fiber OrthoTape Nonabsorbable Suture in which the basic features and intended uses are the same. Any differences between the DemeTECH UHMWPE Suture and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
- Teleflex Medical Incorporated, Force Fiber® OrthoTape™ reference 510k number K150438
- Arthrex Incorporation, Arthrex (UHMWPE) reference 510k number K122374
- E. Device Description:
DemeTECH DemeFORCE Suture is a nonabsorbable, sterile surgical monofilament suture composed of Ultra-high-molecular-weight polyethylene. The DemeTECH UHMWPE 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 available in different colors and may be provided with or without an attached needle(s).
- F. Intended Use:
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DemeFORCE Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries
- G. Non-Clinical Tests Performed:
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 41.
| COMPARISON TABLE | |||
|---|---|---|---|
| Comparison Items | Demetech DemeFORCE | ||
| Nonabsorbable Suture | Force Fiber®OrthoTape™ | ||
| Nonabsorbable Suture | Arthrex (UHMWPE) | ||
| Nonabsorbable Suture | |||
| Product Code | GAT | GAT | GAT |
| Common Name | UHMWPE and Polyester | ||
| Nonabsorbable suture | UHMWPE and Polyester | ||
| Nonabsorbable suture | UHMWPE and Polyester | ||
| Nonabsorbable suture | |||
| Suture Characteristic | Nonabsorbable multicolor | ||
| co-braid of UHMWPE and | |||
| Polyester surgical suture | Nonabsorbable multicolor | ||
| co-braid of UHMWPE and | |||
| other materials surgical | |||
| suture | Nonabsorbable | ||
| multicolor co-braid of | |||
| UHMWPE and other | |||
| materials surgical suture | |||
| Labeling | Sterile, Single Use | Sterile, Single Use | Sterile, Single Use |
| Intended Use | Approximation or ligation | ||
| of soft tissues | Same, does not include | ||
| exclusions in indications | |||
| statement. | Same, also includes | ||
| cardiovascular as well as | |||
| repair of the dura mater. | |||
| Technical Characteristics | USP Nonabsorbable suture | USP Nonabsorbable | |
| suture | USP Nonabsorbable | ||
| suture | |||
| Material | UHMWPE and Polyester | ||
| (UHMWPE) | UHMWPE alone or with | ||
| Polyester, nylon 6,6 or | |||
| polypropylene (UHMWPE) | UHMWPE and Polyester | ||
| (UHMWPE) | |||
| Sizes | 7, 6, 5, 4, 3, 2, 1, 0, 1-0, 2-0 | 6, 5, 4, 3, 2, 1, 0, 1-0, 2-0 | 6, 5, 4, 3, 2, 1, 0, 1-0, 2-0 |
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
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| USP Performance
Requirements | Suture Material meets or exceeds
performance requirements for
"Nonabsorbable Surgical Suture"
in USP 41. | Suture Material meets or
exceeds performance
requirements for
"Nonabsorbable Surgical
Suture" in USP 41. | Suture Material meets or
exceeds performance
requirements for
"Nonabsorbable Surgical
Suture" in USP 41. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tensile Strength
Requirements | Suture Material meets or exceeds
the performance requirements
defined in USP for "Tensile
Strength" | Suture Material meets or
exceeds the performance
requirements defined in
USP for "Tensile Strength"
| Suture Material meets or
exceeds the performance
requirements defined in
USP for "Tensile Strength"
|
| Needle Attachment
Requirements | Suture Material meets or exceeds
the performance requirements
defined in USP for "Needle
Attachment" | Suture Material meets or
exceeds the performance
requirements defined in
USP for "Needle
Attachment" | Suture Material meets or
exceeds the performance
requirements defined in
USP for "Needle
Attachment" |
| Suture Length
Requirements | Suture Material meets or exceeds
the performance requirements
defined in USP for "Suture Length
Requirement" (95% of stated label
length) | Suture Material meets or
exceeds the performance
requirements defined in
USP for "Suture Length
Requirement" (95% of
stated label length) | Suture Material meets or
exceeds the performance
requirements defined in
USP for "Suture Length
Requirement" (95% of
stated label length) |
| 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 DemeFORCE Nonabsorbable Surgical Suture is composed of the same material as are the predicated devices and the same design' being a sterile, flexible, threads meeting the requirements of the United States Pharmacopeia. DemeTECH DemeFORCE Surgical Suture is manufactured in the same manner as the predicate devices in operations considered standard in the fiber industry forming the finished suture fiber in bulk. The manufacturer supplies these bulk fibers to DemeTECH with the same materials as it sells to other suture manufacturers including those with cleared 510K submissions.
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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Based on the 510(k) summaries and the information provided herein we conclude that DemeTECH DemeFORCE Nonabsorbable Surgical Suture is substantially equivalent and as safe and effective as the predicate device.