Who is the manufacturer of WEGO-PDO Barbed Suture?

Foosin Medical Supplies Inc., Ltd. filed the 510(k) submission for WEGO-PDO Barbed Suture (K201139).

What is the FDA product code for WEGO-PDO Barbed 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 WEGO-PDO Barbed Suture?

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

What are the predicate devices for WEGO-PDO Barbed Suture?

QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone) (K113744); QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone) (K120827).

Who can help prepare an FDA 510(k) submission like WEGO-PDO Barbed 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.

WEGO-PDO Barbed Suture

K201139 · Foosin Medical Supplies Inc., Ltd. · NEW · Oct 20, 2020 · General, Plastic Surgery

Device Facts

Record ID	K201139
Device Name	WEGO-PDO Barbed Suture
Applicant	Foosin Medical Supplies Inc., Ltd.
Product Code	NEW · General, Plastic Surgery
Decision Date	Oct 20, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4840
Device Class	Class 2
Attributes	Therapeutic

Intended Use

WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Device Story

WEGO-PDO Barbed Suture is a monofilament, absorbable surgical suture composed of poly(p-dioxanone). The device features small unidirectional or bidirectional barbs along its length, allowing for tissue approximation without the need for surgical knots. It is provided sterile, single-use, and may be supplied with or without stainless steel needles of various types (Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt, Diamond). The device is used by clinicians for soft tissue approximation. The barbs secure the suture within the tissue, eliminating knot-tying requirements, which simplifies the closure process and potentially benefits the patient by reducing procedure time and tissue trauma. The device is available in various lengths, diameters (USP 5-0 to USP 2), and colors (dyed or undyed).

Clinical Evidence

No clinical study is included in this submission. Bench testing only.

Technological Characteristics

Material: poly(p-dioxanone) suture; stainless steel needles. Design: monofilament, barbed (unidirectional/bidirectional). Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: USP 42-NF 37 (diameter, tensile strength, needle attachment), ISO 10993 (biocompatibility), ASTM F88/F1929/F1140 (packaging).

Indications for Use

Indicated for soft tissue approximation in patients where an absorbable suture is appropriate.

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

QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone) (K113744)
QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone) (K120827)

Related Devices

K160705 — Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, · Y. Jacobs Medical, Inc. · Nov 23, 2016
K132268 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN · Surgical Specialties Corporation Dba Angiotech · Aug 23, 2013
K113744 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) · Angiotech · Feb 1, 2012
K120827 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) · Angiotech · Jul 13, 2012
K123877 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN · Surgical Specialties Corp. Dba Angiotech · Jan 2, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 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 20, 2020 Foosin Medical Supplies Inc., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, 200120 China Re: K201139 Trade/Device Name: WEGO-PDO Barbed Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: September 15, 2020 Received: September 17, 2020 Dear Diana Hong: 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 {1}------------------------------------------------ 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 (OS) 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) K201139 Device Name WEGO-PDO Barbed Suture Indications for Use (Describe) WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate. 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) ### 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}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K201139 - 1. Date of Preparation: 10/9/2020 - 2. Sponsor Identification Foosin Medical Supplies Inc., Ltd. No.20, Xingshan Road, Weihai Torch Hi-tech Science Park, Weihai, Shandong, 264210, China Establishment Registration Number: 3006562124 Contact Person: Zhipeng Yang Position: President of Technology Tel: +86-631-5660576 Fax: +86-631-5621680 Email: Foosin-ce@163.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person) #### Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net - 4. Identification of Proposed Device Trade Name: WEGO-PDO Barbed Suture Common Name: Absorbable Polydioxanone Surgical Suture Size: USP 5-0, USP 4-0, USP 3-0, USP 2-0, USP 0, USP 1, USP 2 Regulatory Information Classification Name: Absorbable polydioxanone surgical suture Classification: II {4}------------------------------------------------ Product Code: NEW Regulation Number: CFR 878.4840 Review Panel: General & Plastic Surgery Indications for Use: WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate. Device Description The propose device, WEGO-PDO Barbed Suture, is monofilament, absorbable surgical suture. It is intended for soft tissue approximation where use of an absorbable suture is appropriate. The proposed devices are provided sterile and single use. The proposed device is composed of suture with or without the needle. The sutures with no needle attachments are only available with bi-directional barbs of 7*7 cm, 10*10 cm, 24*24 cm and 30*30 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2. The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots. The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight. The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types. The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years. #### 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K113744 Product Name: QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone) Manufacturer: Angiotech Predicate Device 2 510(k) Number: K120827 Product Name: QuillTM PDO Knotless Tissue-Closure Device (Polydioxanone) {5}------------------------------------------------ Manufacturer: Angiotech - Non-Clinical Test Conclusion 6. Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - > USP 42-NF 37:2019 Absorbable Surgical Suture - USP 42-NF 37:2019 <85> Bacterial Endotoxins Limit; > - USP 42-NF 37:2019 <71> Sterility Test > - > USP 42-NF 37:2019 <861> Sutures - Diameter - > USP 42-NF 37:2019 <871> Sutures - Needle Attachment - > USP 42-NF 37:2019 <881> Tensile Strength - > ISO 10993-3:2014 Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity; - > ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood - > ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity; - > ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation; - > ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization; - > ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity; - > ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] - > ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials - A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration; - > ASTM F1140-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages The following stability testing was performed to support the proposed shelf life: Performance and Package Integrity Test Report after Real time Aging (three years) - 7. Clinical Test Conclusion No clinical study is included in this submission. {6}------------------------------------------------ #### 8. Substantially Equivalent (SE) Comparison Table 1 Comparison of Technology Characteristics | Item | Proposed Device | Predicate Device 1 | Predicate Device 2 | Remark | | | |---------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----|------------------| | Product Code | NEW | K113744 | K120827 | SE | | | | Regulation Number | CFR 878.4840 | CFR 878.4840 | CFR 878.4840 | SE | | | | Class | II | II | II | SE | | | | Indications for Use | WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate. | QuillTM PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. | QuillTM PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. | SE Analysis 1 | | | | Configuration | Suture and Needle | Suture and Needle | Suture and Needle | SE | | | | Welded Loop | Manufacture Method Purpose Length | Ultrasonically welded a basic fixation loop and secure the fixation loop portion to robust tissue 10mm | Manufacture Method Purpose Length | Ultrasonically welded help to form a secondary variable loop and secure the device at the distal end 10mm | N/A | SE Analysis 2 | | Sterility | EO Sterilized | EO Sterilized | EO Sterilized | SE | | | | SAL | $1.0×10^{-6}$ | $1.0×10^{-6}$ | $1.0×10^{-6}$ | SE | | | | Single Use | Yes | Yes | Yes | SE | | | | SUTURE | | | | | | | | Material | poly (p-dioxanone) | poly (p-dioxanone) | poly (p-dioxanone) | SE | | | {7}------------------------------------------------ | Color | Undyed; dyed violet with D&C Violet No.2 | dyed violet with D&C Violet No.2 | dyed violet with D&C Violet No.2 | SE Analysis 3 | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------| | Absorbable / Non-absorbable | Absorbable | Absorbable | Absorbable | SE | | Braided / Monofilament | Monofilament | Monofilament | Monofilament | SE | | Type of barbs | Uni-directional, Bi-directional | Uni-directional, | Bi-directional | SE Analysis 4 | | Suture Size | USP 5-0, USP 4-0, USP 3-0, USP 2-0, USP 0, USP 1, USP 2 | USP 0 | USP 4-0, USP 3-0, USP 2-0, USP 0, USP 1, USP 2 | SE Analysis 5 | | Suture Length | Models of uni-directional barb :15cm, 20 cm, 30 cm, 45 cm, 60 cm, 70 cm Models of bidirectional barb :7*7 cm, 10*10 cm, 14*14 cm, 18*18cm, 24*24 cm, 30*30 cm,36*36 cm, 40*40 cm, 45*45 cm | 20 cm, 30 cm, 45 cm | 7*7 cm, 10*10 cm, 14*14 cm, 16*16cm, 24*24 cm, 30*30m, 36*36 cm | SE Analysis 6 | | Diameter of Suture | The suture diameters of proposed device comply with the diameter requirement listed in USP <861> Diameter. | The suture diameters of proposed device complies with the diameter requirement listed in USP <861> Diameter. | The suture diameters of proposed device complies with the diameter requirement listed in USP <861> Diameter. | SE | | Tensile Strength | The tensile strengths of proposed device comply with the tensile requirement listed in USP <881> Tensile Strength | The tensile strengths of proposed device complies with the tensile requirement listed in USP <881> Tensile Strength | The tensile strengths of proposed device complies with the tensile requirement listed in USP <881> Tensile Strength | SE | | Needle Attachment | | | | | | | The bond between suture and needle of the applicant device meet the requirements defined in USP <871>. | The bond between suture and needle of the applicant device meet the requirements defined in USP <871>. NEEDLE | The bond between suture and needle of the applicant device meet the requirements defined in USP <871>. | SE | | | | | | | | Cytotoxicity | No cytotoxicity. | The specific test items are unknown. However, the product should meet the | The specific test items are unknown. However, the product should meet | SE | | Max Sensitization | No skin sensitization. | requirements of ISO10993 series standards. | the requirements of ISO10993 series standards. | Analysis 7 | | Intracutaneous Reactivity Test | No intracutaneous reactivity. | SUTURE | | | | | | | | | | Cytotoxicity | No cytotoxicity. | | | | | Max Sensitization | No skin sensitization. | | | | | Intracutaneous Reactivity Test | No intracutaneous reactivity. | | | | | Acute Systemic Toxicity Test | No systemic toxicity. | | The specific test items are unknown. However, the product should meet the requirements of ISO10993 series standards. | SE Analysis 8 | | Genotoxicity | No genotoxicity. | The specific test items are unknown. | | | | Pyrogenicity | No potential febrile reaction. | However, the product should meet the | | | | Muscle Implantation Study | No reaction to the tissue. | requirements of ISO10993 series standards. | | | | Sub chronic Toxicity Study | No systemic toxicity. | | | | | Hemolysis Test (Direct Contact) | No Hemolysis | | | | | Hemolysis Test (Indirect Contact) | No Hemolysis | | | | {8}------------------------------------------------ {9}------------------------------------------------ #### SE Analysis 1 - Indications for Use The indications for use of Predicate device 1 and Predicate device 2 includes the material (Polydioxanone) of suture. Although the indications for use of Proposed Device does not include the material of suture, the suture's material of Proposed Device is also Polydioxanone. Therefore, this item is considered to be substantially equivalent. #### SE Analysis 2- Welded Loop The manufacture method and length of proposed device's and predicate device's welded loop are same. Although the purpose of proposed device's and predicate device's welded loop is different, the proposed suture and predicate suture have the same material, technological characteristic, and intended use. Therefore, this item is considered to be substantially equivalent. #### SE Analysis 3- Color The suture of Predicate Device 1 and Predicate Device 2 is dyed. The suture of Proposed Device is available in undyed and dye. The color of Proposed Device 1 and Predicate Device 1 and Predicate Device 2's suture is dyed with D&C Violet No. 2. The Proposed Device has more undyed suture than the Predicate Device 1 and Predicate Device 2. The test reports for the undyed suture of Proposed Device provided in this submission, including performance test, and stability demonstrates that the undyed Proposed Device complied with the requirements of USP Absorbable Surgical Suture. Therefore, this item is considered to be substantially equivalent. #### SE Analysis 4- Type of barbs The barbs of Proposed Device include uni-directional barb and bi-directional barbs. The uni-directional barb of Proposed Device is same with the barb of Predicate Device 1. The bi-directional barb of Proposed Device is same with the barb of Predicate Device 2. Therefore, this item is considered to be substantially equivalent. #### SE Analysis 5- Suture Size The suture sizes of Proposed Device and Predicate Device 2 are both identified in the currently recognized United States Pharmacopoeia; although the range of suture size of Proposed Device is more than that of the Predicate Device 2, the suture sizes of Proposed Device comply with the requirements listed in USP Monograph for Absorbable Surgical Suture. Additionally, the proposed suture and predicate suture have the same material, technological characteristic, and intended use. Therefore, this item is considered to be substantially equivalent. #### SE Analysis 6- Suture Length The requirements for suture length of Proposed Device and Predicate Device 1 and Predicate Device 2 are both identified in the currently recognized United States Pharmacopoeia; although we do not know the exact suture length of Predicate Device 1 and Predicate Device 2, the suture lengths of Proposed Device comply with the requirements listed in USP Monograph for Absorbable Surgical Suture. Additionally, the proposed suture and predicate suture have the same material, technological characteristic, and intended use. Therefore, this item is considered to be substantially equivalent. #### SE Analysis 7- Needle Biocompatibilitv {10}------------------------------------------------ The needle biocompatibility of Proposed Device and Predicate Device 1 and Predicate Device 2 are should meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device 1 and Predicate Device 2, but the needle biocompatibility tests of Proposed Device have been performed in Cytotoxicity, Sensitization and Intracutaneous Reactivity Test. These studies can demonstrate the needle biocompatibility of Proposed Device. Therefore, this item is considered to be substantially equivalent. ## SE Analysis 8- Suture Biocompatibility The biocompatibility of Proposed Device and Predicate Device 1 and Predicate Device 2 meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device 1 and Predicate Device 2, the biocompatibility tests of Proposed Device have been performed in Cytotoxicity, Max Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test, Genotoxicity, Pyrogenicity, Muscle Implantation Study, Sub chronic Toxicity Study, Hemolysis Test (Direct Contact) and Hemolysis Test (Indirect Contact). These studies can demonstrate the biocompatibility of Proposed Device. Therefore, this item is considered to be substantially equivalent. #### 9. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.