(170 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a surgical suture, with no mention of AI or ML.
No
The device, DemeDIOX Barbed polydioxanone suture, is described as a surgical suture primarily used for soft tissue approximation. While it aids in the healing process by holding tissue together, its primary function is mechanical approximation rather than directly treating a disease or condition. It is a surgical tool, not a therapeutic agent.
No
The device is an absorbable surgical suture used for soft tissue approximation. It is a tool for treatment (approximation of tissue), not for diagnosis.
No
The device description clearly states it is a physical surgical suture made of polyester, poly (p-dioxanone), which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where use of absorbable sutures is appropriate." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a surgical suture, a physical implant used to hold tissue together.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening.
The device is clearly a surgical tool used in vivo (within the body) for tissue repair.
N/A
Intended Use / Indications for Use
DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
DemeDIOX Barbed Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures with the exception of diameter. DemeDIOX Barbed Suture consists of an absorbable monofilament strand thread with spiral unidirectional barbs and is available with or without needles in a suture size 5-0 to 2. The material is dyed with D&C Violet No.2. and contains no additives. The barbing allows for tissue approximation without the use of surgical knots.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter and suture length, extractable color and sterility to methods outlined in USP 42.
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
Not Found
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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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November 7, 2019
DemeTECH Corporation Tracy Chadwrick Director of Quality 14175 NW 60th Ave Miami Lakes, Florida 33014
Re: K191361
Trade/Device Name: DemeDIOX Barbed Absorbable Surgical Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: May 10, 2019 Received: May 21, 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 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
1
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 mediation-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,
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191361
Device Name
DemeDIOX Barbed Absorbable Surgical Suture
Indications for Use (Describe)
DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Registration Use (Part 31 CFR 901.3, Subpart B) | ☐ One-Time Contact Use (31 CFR 901.3, Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------- | -------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
| Submission Date: | 11/07/2019 |
|---|---|
| K191361 | |
| SUBMITTER INFORMATION: | |
| Company Name: | DemeTECH Corporation |
| Company Address: | 14175 NW 60th Avenue, Miami Lakes, FL 33014 |
| Contact Person: | Tracy Chadwrick |
| Phone: 305-824-1048 Ext 131 | |
| Tracy.Chadwrick@demetech.us | |
| Device Trade Name: | DemeDIOX Barbed Absorbable Surgical Suture |
| Device Common Name: | POLYDIOXANONE monofilament synthetic absorbable sutures |
| Class: | Class II |
| Classification: | 21 CFR 878.4840 |
| Absorbable Barbed Polydioxanone Surgical Suture | |
| Product Code: | NEW |
Predicate Devices:
The predicate is Ethicon PDS Barbed Suture, 510(k) - K113004 (The primary predicate), and the original DemeTECH Polydioxanone Synthetic Monofilament (PDO) Absorbable Suture, 510(k) -K082097 (Additional predicate).
Device Description:
DemeDIOX Barbed Absorbable Surgical Suture is an absorbable, sterile surgical monofilament suture composed of polyester, poly (p-dioxanone). The DemeTECH Suture meets all requirements in the latest edition of the USP monograph for absorbable surgical sutures with the exception of diameter. DemeDIOX Barbed Suture consists of an absorbable monofilament strand thread with spiral unidirectional barbs and is available with or without needles in a suture size 5-0 to 2. The material is dyed with D&C Violet No.2. and contains no additives. The barbing allows for tissue approximation without the use of surgical knots.
Intended Use:
DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
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Image /page/4/Picture/0 description: The image contains the logo for "DemeTECH". To the left of the company name is a light blue triangular shape. The company name is in bold black font.
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 resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter and suture length, extractable color and sterility to methods outlined in USP 42.
Substantial Equivalence:
| Comparison Items | DemeTECH
DemeDIOX Barbed
Absorbable Suture | DemeTECH
DemeDIOX Absorbable
Suture
| Ethicon
PDS Barbed Suture
(Primary Predicate> |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| FDA ID# | K191361 | K082097 | K113004 |
| Product Code | NEW | Same | Same |
| Common Name | Polydioxanone Barbed
Absorbable Suture | Same | Same |
| Suture Characteristic | Barbed Absorbable
Polydioxanone surgical
suture | Absorbable
Polydioxanone surgical
suture | Same |
| Labeling | Sterile, Single Use | Same | Same |
| Intended Use | Soft tissue approximation | Same | Same |
| Technical Characteristics | Monofilament, synthetic
spiral unidirectional
Barbed absorbable
suture is prepared from
polyester, poly-(p-
dioxanone) | Monofilament, synthetic
non-Barbed absorbable
suture is prepared from
polyester, poly-(p-
dioxanone) | Same |
| Material | Prepared from polyester,
poly-(p-dioxanone) | Same | Same |
| Sizes | 5-0, 4-0, 3-0, 2-0, 1-0, 0, 1, 2 | 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 1-0, 0, 1, 2 | 3-0, 2-0, 1-0, 0, 1 |
| Sterilization | Ethylene Oxide (EO) | Same | Same |
| USP Requirements | Suture Material meets or
exceeds requirements for
"Absorbable Surgical
Suture" in USP 42 except
diameter. | Suture Material meets or
exceeds requirements for
"Absorbable Surgical
Suture" in USP 42 | Suture Material meets or
exceeds requirements for
"Absorbable Surgical
Suture" in USP 42 except
diameter |
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Image /page/5/Picture/1 description: The image shows the DemeTECH logo. The logo consists of a light blue circular icon on the left and the company name "DemeTECH" in bold, black letters on the right. A registered trademark symbol is located to the right of the company name.
| Comparison Items | DemeTECH
DemeDIOX Barbed
Absorbable Suture | DemeTECH
DemeDIOX Absorbable
Suture
| Ethicon
PDS Barbed Suture
(Primary Predicate> |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------|
| Tensile Strength
Requirements | Suture Material meets or
exceeds the performance
requirements defined in
the USP 42 for "Tensile
Strength" | Same | Same |
| Needle Attachment
Requirements | Suture Material meets or
exceeds the performance
requirements defined in
the USP 42 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 | Same | Same |
| Suture Packaging | Suture Material is
packaged in a same or
equivalent manner with
sterile single or double
package having labeling
conforming to 21 CFR | Same | Same |
Clinical Tests Performed:
No clinical trials were conducted
Conclusion:
DemeDIOX Barbed Absorbable Surgical Suture is composed of the same material as the predicated devices DemeTECH DemeDIOX Polydioxanone Absorbable Suture and the Ethicon PDS Barbed Suture. It also has the same design being a sterile, flexible, monofilament absorbable thread meeting all the requirements of the United States Pharmacopeia with the exception diameter due to the small barbs created on the suture. 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 DemeDIOX Barbed Absorbable 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).