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 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 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.

AI/ML Overview

The given text is a 510(k) summary for the medical device "Vesseal". There is no mention of acceptance criteria or a study that proves the device meets acceptance criteria. The document describes the device, its intended use, comparison to predicate devices, and the types of performance data used to support substantial equivalence.

Therefore, I cannot provide an answer based on the provided text.

Summary

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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

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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

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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)

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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FORM FDA 3881 (6/20)

Page 1 of 1 FDA

PSC Publishing Services (301) 443-6740 EF

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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 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

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stores, 8 curved needles that allow the transition of the double-armed nylon sutures during deployment.

1. 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.

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 SeisakushoCo., Ltd.Crownjun NylonSuture	Abbott VascularSuture AnastomosisDevice	SE Justification
510(k) number	K221280	K192420	K013683
Product Code	GAR	GAR	GAW	Same as thepredicate
CFR	878.5020	878.5020	878.5010	Same as thepredicate deviceCrownjun NylonSuture
Intended Use	The Vesseal isintended for use inthe delivery of 8interrupted sutures toassist the surgeon inthe creation of avascular anastomosisin arteries of 2-4mmin diameter.It is not intended foruse in coronary arterygrafts.	CROWNJUNNylon Suture isintended to join theedges of soft- tissuewound or incision toligate soft tissues.	The Abbott VascularSuture Anastomosisdevice is intended foruse in the delivery of10 interrupted suturesto assist the surgeonin the creation of avascular anastomosis.	Same as thepredicate.The exclusion of usingthe device for coronaryartery graft does notchange the intendeduse.
SutureMaterials	Nylon	Nylon	Polypropylene	Same as thepredicate.
Suture Size	USP 7-0 to USP 9-0	Ranging from USPsize 12-0through USP 0	USP 7-0	Same within therange.The additional sizes donot alter device safetyor effectiveness asdemonstrated in thetesting.

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Number ofSutures	8	N/A	10	Similar- within thepredicate devicenumber of sutures
Anastomosistype	End-to End	N/A	End-to End and Side-to-Side	Same- within thepredicate devicefeatures
DeliveryMethod	Needle passed throughthe tissue with sutureattached	N/A	Needle passed throughthe tissue with sutureattached	Similar to thepredicate device
DeliveryNeedle	Material-StainlessSteelTaper point	N/A	Material-UnknownTaper point	Similar to thepredicate 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.

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
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.(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.