The VASORING* VRC Vascular Ring Connector is indicated for use as a connector for attaching a vascular graft to native tissue where conditions preclude a conventional end-to-end sutured anastomosis.

Device Description

The vascular ring connector is made of biocompatible titanium alloy. Placed in the vascular prosthesis to form a Graft-Connector Unit, it can be used as an intraluminal graft. The braided ligature tape (Ethicon® Nylon Tape) is for tying the ring connector from outside of the blood vessel to provide sutureless anastomosis that is time-saving. There are two grooves on the outer surface of the connector: the narrow groove is for suture fixation between the connector and the vascular prosthesis; and the wider groove is for ligature fixation between the connector and the blood vessel. The titanium alloy allows the ring connector to be of thin-wall design which gives larger inner diameter while maintaining adequate mechanical strength at the anastomotic sites.

AI/ML Overview

The provided text describes a pre-market notification (510(k) submission) for the VASORING* VRC Vascular Ring Connector. It details the device, its intended use, and the performance summaries provided to the FDA to establish substantial equivalence to predicate devices.

However, the document does not describe specific acceptance criteria in a quantitative manner nor does it provide detailed descriptions of the studies that would typically prove a device meets such criteria. Instead, it offers a high-level summary of tests performed and their general satisfactory outcomes.

Therefore, for aspects of your request that require specific numerical acceptance criteria or detailed study methodologies (like sample sizes, ground truth establishment for training, or MRMC study details), the information is not present in the provided text.

Below is the information that can be extracted or reasonably inferred from the given document, along with an explanation of what is not available.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated/Inferred)	Reported Device Performance
Functional/Performance Requirements: Device must meet all functional and performance requirements for its intended use as a vascular ring connector.	"Bench testing was performed to ensure that VASORING* VRC will meet all functional and performance requirements for its intended use. All bench tests... demonstrated satisfactory performance."
Material Biocompatibility: Material must be biocompatible according to international standards.	"The titanium alloy connector was also tested for material biocompatibility per ISO 10993 guidelines... biocompatibility tests... demonstrated satisfactory performance."
Thrombogenicity: Device must not induce significant or adverse thrombogenic phenomena.	"Two pre-clinical animal studies were performed to investigate the thrombogenicity phenomena; a 4-hours study to assess immediate impact of using the VRC for anastomoses, and the other was a 20-week observation of the test animals... thrombogenicity studies demonstrated satisfactory performance."
Equivalence to Predicate Device: The device should be substantially equivalent to legally marketed predicate devices for its intended use.	"The VASORING* VRC Vascular Ring Connector is identical to the Meadox Intra-Aortic Graft polyester connector with respect to intended use." (This is a claim made for substantial equivalence, not a direct performance metric). The FDA determined the device is "substantially equivalent" for the stated indications for use.

Missing Information: The document does not provide specific quantitative thresholds or definitions for "satisfactory performance" for any of the criteria (e.g., maximum allowable thrombus formation, specific tensile strength values for the connector, etc.).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not specified. The document mentions "two pre-clinical animal studies" but does not give the number of animals used.
Data Provenance:
- Country of Origin: The submitting company (SUNWEI TECH Co. Ltd.) is based in Taipei, TAIWAN. While bench and animal studies likely occurred in Taiwan or a contracted facility, the specific location of the studies is not stated.
- Retrospective or Prospective: The animal studies were prospective ("a 4-hours study" and "a 20-week observation"). Bench testing would also be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable in the context of this device and report. The device is a physical medical implant (a vascular connector). Its performance is assessed through bench tests and animal studies, not through interpretation of medical images or data by human experts for "ground truth" as relevant to AI/diagnostic studies. The "ground truth" for these tests would be objective measurements (e.g., blood flow, thrombus formation, material integrity) rather than expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers/experts in studies involving subjective interpretations (e.g., radiology for AI model ground truth). The performance of this vascular connector is assessed through objective, empirical tests in a lab and animal setting.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for diagnostic medical devices or AI-assisted diagnostic tools where human interpretation is a key component. The VASORING* VRC is a vascular connector, a physical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical vascular connector, not an algorithm or AI system. Its performance is inherent to the device itself and its interaction with biological systems, not an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For bench testing: The ground truth would be objective physical and mechanical measurements (e.g., tensile strength, flow rate, pressure resistance, dimensions) against predefined engineering specifications.
For biocompatibility testing: The ground truth would be laboratory test results against ISO 10993 cytotoxicity, sensitization, irritation, genotoxicity, etc., standards.
For thrombogenicity studies (animal studies): The ground truth would be histopathological examination, physiological measurements (e.g., blood flow), and visual assessment of thrombus formation in the animal models.

8. The sample size for the training set

This question is not applicable as there is no "training set" in the context of this device. A training set is used for machine learning models. This device's performance is established through traditional engineering and biological testing, not by training an algorithm.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

Summary

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KO61626 p. Lof2

SUNWEI TECH Co. Ltd. Pre-market Notification for VASORING* VRC

OCT - 5 2006

VASORING* VRC Vascular Ring Connector of 6mm and Larger Diameter 510(k) Summary of Safety and Effectiveness

1. Sumbitter's Name:

SUNWEI TECH Co. Ltd. 3rd Floor, 42, Sec. 2, Jhongcheng Road, Shih Lin District Taipei 111, TAIWAN Contact: Cassy Mao, Director of Operations.

2. Name of Device

Common/Usual Name:	Vascular Ring Connector
Proprietary Name:	VASORING* VRC Vascular Ring Connector
Classification Name:	Prostheses, Vascular Graft, of 6mm and Greater Diameter

3. Predicate Device

Trade Name	510(k) Number	Decision Date
Meadox Intra-Aortic Graft	K881283	05/26/1988
Titanium GREENFIELD Vena Cava Filter	K874096	11/04/1988
St. Jude Symmetry Aortic Clip	K003446	05/21/2001

4. Device Description

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K061626
p. 2 of 2

5. Indication for Use

The VASORING* VRC Vascular Ring Connector is indicated for use as a connector for attaching a vascular graft to native tissue where conditions preclude a conventional end-to-end sutured anastomosis.

6. Technological Characteristics

The VASORING* VRC Vascular Ring Connector is identical to the Meadox Intra-Aortic Graft polyester connector with respect to intended use. The titanium alloy ring is of cylindrical shape with an outside diameter ranging from 6mm to 30mm for use with various sizes of aorta to achieve proper anastomoses.

7. Performance Summary

Bench testing was performed to ensure that VASORING* VRC will meet all functional and performance requirements for its intended use. The titanium alloy connector was also tested for material biocompatibility per ISO 10993 guidelines. Two pre-clinical animal studies were performed to investigate the thrombogenicity phenomena; a 4-hours study to assess immediate impact of using the VRC for anastomoses, and the other was a 20-week observation of the test animals. All bench tests, biocompatibility tests, and thrombogenicity studies demonstrated satisfactory performance of the VASORING* VRC connectors.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 5 2006

SUNWEI TECH Co. Ltd c/o Joseph J. Chang, PhD, P.E. Consultant Innomedtech LLC 7128 Staffordshire Street Houston, TX 77030

Re: K061626

Vasoring VRC Vascular Ring Connector Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (Two) Product Code: DSY Dated: September 21, 2006 Received: September 22, 2006

Dear Dr. Chang:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Joseph J. Chang, PhD, P.E.

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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

R. lohner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Hcalth

Enclosure

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Indications for Use

510(k) Number (if known): K061626

Device Name: VASORING VRC Vascular Ring Connector

Indications For Use:

The VASORING VRC Vascular Ring Connector is indicated for use as a connector for attaching a vascular graft to native tissue where conditions preclude a conventional end-to-end sutured anastomosis.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sung R. backing

(Division September Division of Cardiovascular Devices

510(k) Namia Ko 6 162 162 6 162 6 ----------

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”