Who is the manufacturer of DemeDIOX Barbed Absorbable Surgical Suture?

Demetech Corporation filed the 510(k) submission for DemeDIOX Barbed Absorbable Surgical Suture (K191361).

What is the FDA product code for DemeDIOX Barbed Absorbable Surgical Suture?

NEW. It is classified under 21 CFR 878.4840 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DemeDIOX Barbed Absorbable Surgical Suture?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DemeDIOX Barbed Absorbable Surgical Suture?

Ethicon PDS Barbed Suture (K113004); DemeTECH Polydioxanone Synthetic Monofilament (PDO) Absorbable Suture (K082097).

Who can help prepare an FDA 510(k) submission like DemeDIOX Barbed Absorbable Surgical Suture?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DemeDIOX Barbed Absorbable Surgical Suture

K191361 · Demetech Corporation · NEW · Nov 7, 2019 · General, Plastic Surgery

Device Facts

Record ID	K191361
Device Name	DemeDIOX Barbed Absorbable Surgical Suture
Applicant	Demetech Corporation
Product Code	NEW · General, Plastic Surgery
Decision Date	Nov 7, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4840
Device Class	Class 2
Attributes	Therapeutic

Intended Use

DemeDIOX Barbed polydioxanone suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Device Story

DemeDIOX Barbed Absorbable Surgical Suture is a sterile, monofilament, synthetic absorbable suture composed of poly(p-dioxanone). The device features spiral unidirectional barbs along the strand, allowing for tissue approximation without the need for surgical knots. It is available in sizes 5-0 to 2, with or without needles, and is dyed with D&C Violet No. 2. The device is intended for use by surgeons in clinical settings for soft tissue approximation. By eliminating the need for knots, the device simplifies the suturing process and provides secure tissue approximation. It is absorbed by the body over time, consistent with standard polydioxanone suture performance.

Clinical Evidence

No clinical trials were conducted. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility testing per ISO 10993-1, in-vitro resorption studies, and physical/functional testing (suture diameter, length, tensile strength, needle attachment) per USP 42 standards.

Technological Characteristics

Material: poly(p-dioxanone) (polyester). Form: monofilament with spiral unidirectional barbs. Sizes: 5-0 to 2. Sterilization: Ethylene Oxide (EO). Conformance: USP 42 (except diameter), ISO 10993-1 biocompatibility. Dye: D&C Violet No. 2.

Indications for Use

Indicated for soft tissue approximation in patients requiring absorbable sutures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Ethicon PDS Barbed Suture (K113004)
DemeTECH Polydioxanone Synthetic Monofilament (PDO) Absorbable Suture (K082097)

Related Devices

K123877 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN · Surgical Specialties Corp. Dba Angiotech · Jan 2, 2013
K160705 — Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, · Y. Jacobs Medical, Inc. · Nov 23, 2016
K201139 — WEGO-PDO Barbed Suture · Foosin Medical Supplies Inc., Ltd. · Oct 20, 2020
K120827 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) · Angiotech · Jul 13, 2012
K150553 — Filbloc · Assut Europe · May 19, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for "DemeTECH". To the left of the company name is a blue circular logo with a white triangle inside. The company name is written in a bold, black font. # 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. {4}------------------------------------------------ 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 <Additional Predicate> | 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 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the text "K191361 Page 3 of 3". This text appears to be a document identifier and page number. The document identifier is K191361, and the page number is 3 of 3, indicating that this is the last page of the document. 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 <Additional Predicate> | 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" <881> | Same | Same | | Needle Attachment Requirements | Suture Material meets or exceeds the performance requirements defined in the USP 42 for "Needle Attachment" <871> | 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).