Who is the manufacturer of Vesseal?

Lydus Medical , Ltd. filed the 510(k) submission for Vesseal (K221280).

What is the FDA product code for Vesseal?

GAW. It is classified under 21 CFR 878.5010 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Vesseal?

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

What are the predicate devices for Vesseal?

Crownjun Nylon Suture (K192420); Abbott Vascular Suture Anastomosis device (K013683).

Who can help prepare an FDA 510(k) submission like Vesseal?

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.

Vesseal

K221280 · Lydus Medical , Ltd. · GAW · Dec 9, 2022 · General, Plastic Surgery

Device Facts

Record ID	K221280
Device Name	Vesseal
Applicant	Lydus Medical , Ltd.
Product Code	GAW · General, Plastic Surgery
Decision Date	Dec 9, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5010
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Vesseal is intended for use in the delivery of 8 interrupted sutures to assist the surgeon in the creation of a vascular anastomosis in arteries of 2-4mm in diameter. It is not intended for use in coronary artery grafts.

Device Story

Hand-held device for microvascular anastomosis; enables simultaneous deployment of 8 double-armed 9-0 to 7-0 nylon sutures. Device features needle insertion mechanism with two rod protrusions for vessel location, opening, and positioning; handle deployment mechanism with switches for needle release and gear for rod rotation. Used by surgeons in clinical settings. Device delivers sutures from inside out around vessel circumference. Facilitates precise suture placement; assists in creating vascular anastomosis; potentially reduces procedure time and improves consistency compared to manual suturing.

Clinical Evidence

Supported by bench testing (dimensional verification, corrosion, simulated use, needle penetration, suture/needle attachment, knot pull, bending/bonding), biocompatibility testing, sterilization/shelf-life validation (ISO 11135-1), usability testing, and a comparative GLP animal study.

Technological Characteristics

Hand-held mechanical device; stainless steel needles; USP 7-0 to 9-0 nylon sutures. Sterilized via EtO. Standalone, single-use, sterile device. No software or electronic components.

Indications for Use

Indicated for surgeons creating vascular anastomosis in 2-4mm diameter arteries using 8 interrupted sutures. Not for use in coronary artery grafts.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

Special Controls

*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.

Predicate Devices

Crownjun Nylon Suture (K192420)
Abbott Vascular Suture Anastomosis device (K013683)

Related Devices

K020940 — SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X · Sutura, Inc. · Apr 17, 2002
K013683 — MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE · Abbott Vascular, Inc. · Dec 6, 2001
K012865 — SUPERSTITCH VASCULAR SUTURING DEVICE · Sutura, Inc. · Sep 25, 2001
K113763 — SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE · Nobles Medical Technologies Ii, Inc. · Mar 16, 2012
K982278 — MICRINS MICRO ANASTOMOSIS CLAMP · Micrins Surgical, Inc. · Mar 26, 1999

Submission Summary (Full Text)

{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. December 9, 2022 Lydus Medical Ltd. % Orly Maor Regulatory consultant 25 Sirkin Street Kfar Saba, 4442156 Israel Re: K221280 Trade/Device Name: Vesseal Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable Polyamide Surgical Suture Regulatory Class: Class II Product Code: GAR Dated: October 26, 2022 Received: November 4, 2022 Dear Orly Maor: 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 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, Digitally signed by Ankurita Ankurita Datta -S patta -s Date: 2022.12.09 12:47:47 -05'00" for Katherine Trivedi Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use Statement DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K221280 Device Name Vesseal Indications for Use (Describe) The Vesseal is intended for use in the delivery of 8 interrupted sutures to assist the surgeon in the creation of a vascular anastomosis in arteries of 2-4mm in diameter. It is not intended for use in coronary artery grafts. | Type of Use (Select one or both, as applicable) | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <table style="border:none;"><tr><td> <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black; text-align:center;"> ☒ </div> Prescription Use (Part 21 CFR 801 Subpart D) </td><td> <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black; text-align:center;"> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black; text-align:center;"> ☒ </div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black; text-align:center;"> </div> Over-The-Counter Use (21 CFR 801 Subpart C) | | <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black; text-align:center;"> ☒ </div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block; vertical-align:middle; width:15px; height:15px; border:1px solid black; text-align:center;"> </div> Over-The-Counter Use (21 CFR 801 Subpart C) | | PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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](mailto: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."* FORM FDA 3881 (6/20) Page 1 of 1 FDA PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # 510(k) Summary K221280 ### Date Prepared: December 8, 2022 #### SUBMITTER I. Lydus Medical Ltd. 13 Zarhin St. Ra'anana, 4366241, Israel Phone: +972-76-8899-809 info@lydus-medical.com ### Contact Person Orly Maor 25 Sirkin Street Kfar Saba 44421 Israel Tel: +972-9-7453607 oram.ma(@gmail.com #### II. DEVICE Device Trade Name: Vesseal Device Common Name: Suture, Nonabsorbable, Synthetic, Polyamide Classification: 21 CFR 878.5020 Class: Class II Product Code: GAR #### III. PREDICATE DEVICE - K192420, Kono Seisakusho Co., Ltd. Crownjun Nylon Suture ● - K013683, Abbott Vascular Suture Anastomosis device #### IV. DEVICE DESCRIPTION The Vesseal is a hand-held device, enabling simultaneous deployment of 8 double-armed 9-0 to 7-0 nylon sutures (USP certified). The sutures are delivered from the inside out, around the circumference of two ends of blood vessels (ranging in size from 2mm to 4mm) to assist in the creation of a microvascular anastomosis. The Vesseal is comprised of two main mechanisms: - 1. The needle insertion mechanism contains two rod protrusions, intended for locating the blood vessel, opening, mounting, and positioning them relative to the stopper mechanism. Each rod {4}------------------------------------------------ stores, 8 curved needles that allow the transition of the double-armed nylon sutures during deployment. - 2. The handle deployment mechanism features right and left switches to deploy the needles on the respective rod side, and the gear to rotate the rod and enable access to its entire perimeter. ### INDICATIONS FOR USE V. The Vesseal is intended for use in the delivery of 8 interrupted sutures to assist the surgeon in the creation of a vascular anastomosis in arteries of 2-4mm in diameter. It is not intended for use in coronary artery grafts. #### OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. COMPARISON PREDICATE DEVICE The Vesseal has the same intended use as the predicate device(s) and the indications for use are similar to that of the predicate device(s). A comparison of the Vesseal and predicate devices is provided in the table below: | | Lydus Ltd. Vesseal | Kono Seisakusho Co., Ltd. Crownjun Nylon Suture | Abbott Vascular Suture Anastomosis Device | SE Justification | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | K221280 | K192420 | K013683 | | | Product Code | GAR | GAR | GAW | Same as the predicate | | CFR | 878.5020 | 878.5020 | 878.5010 | Same as the predicate device Crownjun Nylon Suture | | Intended Use | The Vesseal is intended for use in the delivery of 8 interrupted sutures to assist the surgeon in the creation of a vascular anastomosis in arteries of 2-4mm in diameter. It is not intended for use in coronary artery grafts. | CROWNJUN Nylon Suture is intended to join the edges of soft- tissue wound or incision to ligate soft tissues. | The Abbott Vascular Suture Anastomosis device is intended for use in the delivery of 10 interrupted sutures to assist the surgeon in the creation of a vascular anastomosis. | Same as the predicate. The exclusion of using the device for coronary artery graft does not change the intended use. | | Suture Materials | Nylon | Nylon | Polypropylene | Same as the predicate. | | Suture Size | USP 7-0 to USP 9-0 | Ranging from USP size 12-0 through USP 0 | USP 7-0 | Same within the range. The additional sizes do not alter device safety or effectiveness as demonstrated in the testing. | {5}------------------------------------------------ | Number of Sutures | 8 | N/A | 10 | Similar- within the predicate device number of sutures | |----------------------|-------------------------------------------------------------|---------------------|-------------------------------------------------------------|--------------------------------------------------------------| | Anastomosis type | End-to End | N/A | End-to End and Side- to-Side | Same- within the predicate device features | | Delivery Method | Needle passed through the tissue with suture attached | N/A | Needle passed through the tissue with suture attached | Similar to the predicate device | | Delivery Needle | Material-Stainless Steel Taper point | N/A | Material-Unknown Taper point | Similar to the predicate device | | Sterilization | EtO | EtO | EtO | Same | | How Provided | Single use, sterile | Single use, sterile | Single use, sterile | Same | ## VII. PERFORMANCE DATA The following performance data were used to support of the substantial equivalence determination: - Biocompatibility testing on the Vesseal delivery device and suture material (including ● long-term and short-term biocompatibility endpoints) - Sterilization, Packaging, and Shelf-Life testing per ISO 11135-1 ● - Bench Testing including dimensional verification, corrosion, simulated use, needle ● penetration, suture and needle attachment, suture knot pull testing, bending and bonding process qualification - Usability testing to evaluate the use-related safety and effectiveness of Vesseal when ● used by qualified user via observational data, knowledge task data, and interview data. - . A comparative GLP Animal Study ## VIII. CONCLUSION The Vesseal is substantially equivalent to the predicate devices in indications for use, fundamental scientific technology, and technological characteristics.