(220 days)
Not Found
No
The description focuses on mechanical mechanisms for suture delivery and does not mention any computational or learning components.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used to assist in surgical procedures (creating a vascular anastomosis), which is a part of treatment, but the device itself does not directly treat or prevent a condition. It is a surgical tool.
No
Explanation: The device description states its purpose is to deliver sutures for creating a vascular anastomosis, which is a surgical procedure, not a diagnostic one. It assists in treatment rather than identifying a condition.
No
The device description clearly outlines a hand-held physical device with mechanical components (needle insertion mechanism, handle deployment mechanism, rods, needles, switches, gear) used for delivering sutures. It is not solely software.
Based on the provided information, the Vesseal device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Vesseal is a surgical device used to physically deliver sutures to assist in creating a vascular anastomosis within the body.
- The intended use and device description clearly describe a surgical tool. It's designed to manipulate and join blood vessels, not to analyze biological samples.
- There is no mention of analyzing samples, reagents, or any diagnostic purpose. The device's function is purely mechanical and procedural.
Therefore, the Vesseal falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GAR
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:
- 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.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arteries of 2-4mm in diameter
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)
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
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) | ||
|---|---|---|
| ☒ 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) |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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:
-
- 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.
-
- 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.