The Quest Vessel Catheter is intended for use in cardiovascular surgical procedures to test the integrity of vein grafts prior to attachment to coronary arteries, and to facilitate antegrade cardioplegia administration directly down the vein graft following completion of the distal anastomosis.

Device Description

Saphenous vein cannulae are used during cardiopulmonary bypass to test the integrity of vein grafts prior to attachment to the coronary arteries and to facilitate antegrade cardioplegia administration directly down the vein graft following completion of the distal anastomosis.

The harvested vein graft must be tested for leaks or weakened areas prior to attachment to the coronaries to assure a competent conduit. To accomplish this, a small vessel cannula with a tapered shaft is inserted into one end of the graft and secured with a suture. Barbs or bulbous tips on the shaft of the cannula prevent the tied vein from slipping off. The opposite end has a female luer fitting for attachment to a saline-filled syringe. The graft may then be inflated with the saline at low pressures to test for leaks.

The surgeon cuts the graft to a suitable length and proceeds with attachment of the distal anastomosis. When indicated, the surgeon may decide to perfuse cardioplegia through the cannula-graft to the heart using a vein graft perfusion set attached to the cardioplegia delivery line. This allows nourishment to reach those areas of the heart that may not have been well perfused previously due to the arterial occlusion. Furthermore, the surgeon may use the cannula to assess the quality of the distal anastomosis by visual examination under pressure.

Materials:
• Cannula body: Clear ABS
• Duckbill valve: Silicone

Dimensions:
• Length: 2.00"
• I.D.: .06"
• O.D. 2nd barb: .16"

Connections: Female luer with taper per ISO 594/1

AI/ML Overview

This document describes the Quest Vessel Catheter, intended for cardiovascular surgical procedures to test vein graft integrity and facilitate antegrade cardioplegia administration. The filing is a 510(k) summary demonstrating substantial equivalence to a predicate device, the DLP Vessel Cannula (K791832).

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

The document does not explicitly state "acceptance criteria" with numerical targets for each performance test. Instead, it describes a comparative testing approach, aiming to demonstrate "substantially equivalent performance" to the predicate device. The performance sections primarily list the types of tests conducted:

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Pressure drop evaluation	Substantially equivalent to predicate device (DLP Vessel Cannula)	Performed on both Quest and DLP devices; demonstrated substantial equivalence.
Leak testing	Substantially equivalent to predicate device (DLP Vessel Cannula)	Performed on both Quest and DLP devices; demonstrated substantial equivalence.
Bond strength	Substantially equivalent to predicate device (DLP Vessel Cannula)	Performed on both Quest and DLP devices; demonstrated substantial equivalence.
Duckbill valve cracking pressure	Substantially equivalent to predicate device (DLP Vessel Cannula)	Performed on both Quest and DLP devices; demonstrated substantial equivalence.
Package integrity	Substantially equivalent to predicate device (DLP Vessel Cannula)	Performed on both Quest and DLP devices; demonstrated substantial equivalence.
Material Biocompatibility	Conformance to ISO 10993 standards	Performed in accordance with ISO 10993 standards.

2. Sample sizes used for the test set and the data provenance

The document does not specify the exact sample sizes used for each performance test (e.g., number of catheters tested for pressure drop, leaks, etc.). It only states that tests were conducted on "both the Quest device and the DLP device."

The data provenance is not explicitly stated in terms of country of origin, nor is it categorized as retrospective or prospective. Given that this is a 510(k) premarket notification for a medical device designed for cardiovascular surgery, the tests would be performed in a laboratory setting by the manufacturer (Quest Medical, Inc. based in Allen, TX, USA) to support the regulatory submission. Therefore, the data would be considered prospective for the purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this type of device and study. The "ground truth" for performance testing of a physical medical device like a catheter typically involves objective measurements and scientific standards rather than expert clinical judgment or consensus on, for example, image interpretation. The performance tests described (pressure drop, leak testing, bond strength, etc.) rely on quantifiable physical properties and engineering principles, not an expert panel to establish a clinical ground truth.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessments, such as evaluating medical images, where there might be disagreement between reviewers. For physical performance tests of a medical device, the results are generally objective measurements that do not require clinical adjudication.

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

This section is not applicable. An MRMC study is relevant to imaging diagnostics or other areas where algorithms assist human "readers" (e.g., radiologists interpreting images). The Quest Vessel Catheter is a physical medical device used in surgery, not a diagnostic tool where human 'readers' interact with AI.

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

This section is not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for evaluating the performance of this device is based on objective physical and engineering measurements against established standards and comparison to a legally marketed predicate device. This includes:

Quantitative measurements: such as pressure drop, leak detection, bond strength, and cracking pressure, which can be objectively measured using laboratory equipment.
Material standards: Conformance to ISO 10993 for biocompatibility.
Comparison to predicate device: The fundamental "ground truth" for substantial equivalence is demonstrating that the new device performs comparably to the predicate device across all relevant safety and effectiveness parameters.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

This section is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process.

Summary

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NOV - 6 1997

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in This summary of of exceptirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared:	May 23, 1997
Company:	Quest Medical, Inc.One Allentown ParkwayAllen, TX 75002-4211
Contact:Phone Number:Fax Number:	Krista Oakes, Regulatory Affairs Manager972-390-9800972-390-2881

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Quest Vessel Catheter 510(k) Summary of Safety and Effectiveness

Device Information:

Trade Name:	Quest Vessel Catheter
Common Name:	Saphenous Vein Cannula
Classification Name:	Cardiopulmonary Bypass Vascular Catheter, Cannula, orTubing

Predicate Device:

DLP Vessel Cannula (Ref. 510(k) # K791832)

Device Description:

Materials:

• Cannula body:	Clear ABS
• Duckbill valve:	Silicone
Dimensions:
• Length:	2.00"
• I.D.:	.06"
• O.D. 2nd barb:	.16"
Connections:	Female luer with taper per ISO 594/1

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Intended Use:

The Quest Vessel Catheter is intended for use in cardiovascular surgical THE Quest Tobber Caster Car vein grafts prior to attachment to coronary procodures to to to facilitate antegrade cardioplegia administration directly down the vein graft following completion of the distal anastomosis.

Comparison To Predicate Device:

The following table illustrates the comparison between the modified device and the original, legally marketed device.

	DLP (PredicateDevice)	Quest Device
Intended Use:	Facilitate testing andperfusion of vesselduring cardiopulmonarybypass	Facilitate testing andperfusion of vesselduring cardiopulmonarybypass
Design Features:	Clear body, soft plastictip, female luer lock,optional duckbill valve	Clear body, soft plastictip, female luer lock,optional duckbill valve
Materials:• Body• Valve	PVCSilicone	Clear ABSSilicone
Dimensions:• Length:• I.D.:• O.D. 2nd barb:	(estimated)2.00".06".16"	2.00".06".16"
Packaging:		Tyvek/mylar peel pouch
Labeling:	Labeled as sterile, non-pyrogenic prescriptiondevice	Labeled as sterile, non-pyrogenic prescriptiondevice
Expiration Date:	3 years	1 year

Non-clinical Testing:

Performance Testing

The following laboratory tests were conducted on both the Quest device and the DLP device to demonstrate substantially equivalent performance:

Pressure drop evaluation .
Leak testing .
Bond strength .
Duckbill valve cracking pressure .
Package integrity .

Biocompatibility Testing

Material biocompatibility testing has been performed in accordance with ISO 10993 standards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 1997

Ms. Krista Oakes Requlatory Affairs Manager Quest Medical, Inc. Allentown Parkway Allen, Texas 75002-4211

Re : K971928 Quest Vessel Catheter Requlatory Class: II (Two) Product Code: DWF Dated: September 29, 1997 Received: September 30, 1997

Dear Ms. Oakes:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Collehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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routine

1.0010

Counine

K 971928 510(k) #:

Device Name: Quest Vessel Catheter

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K 97 1928

Prescription Use	X	OR	Over-The-Counter Use
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(Per 21 CFR 801.109) `

Over-The-Counter Use

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).