The Y-Glide™ Hemostatic Wye Adapter is to be used for maintaining a hemostatic seal around inserted devices with an outside diameter up to 0.120" (3.04 mm) during the use of diagnostic/interventional devices for transluminal procedures.

Device Description

The Thomas Medical Products Inc. Y-Glide™ Hemostatic Valve Wye Adapter contains a hemostasis valve with a secondary locking seal, a rotating luer lock, and a sideport. The primary hemostasis seal is opened by depressing the cap thereby enabling valve flushing, and a conduit for introduction and withdrawal of diagnostic/interventional devices. When the cap is not depressed, the seal returns to the closed position to allow device positioning with minimal fluid loss. The secondary locking seal can be adjusted when the internal threads are engaged, by rotating the cap clockwise while slightly depressing it until the threads catch. Clockwise turns of the cap thereafter will close the locking seal. Rotating counterclockwise will open the locking seal. Closing the locking seal will secure the position of the inserted diagnostic/interventional device and/or permit pressure injections up to 450 psi (30.6 Atm.).

AI/ML Overview

The provided text does not describe a study that uses acceptance criteria and reports device performance in the way typically expected for an AI/ML device.

This document is a 510(k) summary for a physical medical device, specifically a hemostatic valve wye adapter. The regulatory pathway for this type of device (Class II, 510(k)) focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against predefined quantitative acceptance criteria through a clinical or algorithmic study as would be the case for an AI/ML diagnostic tool.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document because the described evaluation process is different.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not relevant:

1. Table of acceptance criteria and the reported device performance

This document does not describe quantitative acceptance criteria and reported performance in the typical sense of a study for an AI/ML diagnostic. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance" assessment is based on a comparison of characteristics.

Acceptance Criteria (for Substantial Equivalence Comparison)	Reported Device Performance (vs. Predicate)
Same intended use	Same intended use
Same or similar technical characteristics	Same or similar technical characteristics
Where technical characteristics differ:	Differences analyzed, demonstrating device is as safe and effective (or as unsafe/ineffective) as the predicate.
- No new types of safety or effectiveness issues raised	Achieved
- Technical analysis demonstrates as safe and effective	Achieved
Elements of Comparison:
Visual comparison	Not explicitly detailed, but implied as part of the rationale.
Indication for use	Same.
Instructions for use	Compared, assumed to be equivalent or appropriately addressed.
Sterility	Compared, assumed to be equivalent or appropriately addressed.
Design and performance	Compared, assumed to be equivalent or appropriately addressed.
Energy used or delivered	Not applicable (mechanical device).
Materials	Compared, assumed to be equivalent or appropriately addressed.
Biocompatibility	Compared, assumed to be equivalent or appropriately addressed.
Manufacturing processes	Compared, assumed to be equivalent or appropriately addressed.
Packaging	Compared, assumed to be equivalent or appropriately addressed.
Labeling	Compared, assumed to be equivalent or appropriately addressed.
Safety and effectiveness	Assessed to be equivalent.

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

Not applicable. This document describes a 510(k) submission for a physical medical device, not an AI/ML diagnostic. There is no "test set" in the sense of a dataset for an algorithm. The evaluation is based on a comparison to a predicate device and engineering analyses rather than a clinical study with a patient sample.

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)

Not applicable. No ground truth determination by experts is described for a test set in this 510(k) summary. The assessment is primarily engineering-focused and regulatory-focused, comparing the new device to a predicate.

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

Not applicable. There is no "test set" or adjudication method described in this document.

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. This document is for a physical medical device (hemostatic valve), not an AI/ML product. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

Not applicable. This device is a passive physical component; there is no algorithm or standalone performance in the context of AI/ML.

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

Not applicable. For this type of device, "ground truth" as understood in AI/ML is not relevant. The "truth" for substantial equivalence lies in demonstrating that the device's characteristics, safety, and effectiveness are comparable to a legally marketed predicate device. This is typically supported by bench testing, material comparisons, and adherence to relevant standards, rather than clinical outcomes or diagnostic accuracy against a "ground truth" diagnosis.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" or ground truth establishment for it.

Summary

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510(k) SUMMARY SECTION VI:

[as required by section 807.92(c)]

Submitter's Information: A.

Name:	Thomas Medical Products, Inc.
Address:	65 Great Valley ParkwayMalvern, PA 19355
Telephone Number:	610.296.3000
Facsimile:	610.296.4591
Contact Person:	Tim Stoudt
Title:	Manager, QA Engineering / RA
Date Submission Prepared:	September 21, 2007

B. Device Information:

Not assigned at the time of submission Trade name: Classification Name(s): Cardiopulmonary bypass adapter, stopcock, manifold, or fitting (21 CFR §870.4290) Common or usual name(s): Hemostatic Wye Adapter

Legally marketed device to which equivalence is claimed: C.

Guidant [Abbott] CoPilot Bleedback Control Valve - K991102

D. Description of the device:

The secondary locking seal can be adjusted when the internal threads are engaged, by rotating the cap clockwise while slightly depressing it until the threads catch. Clockwise turns of the cap thereafter will close the locking seal. Rotating counterclockwise will open the locking seal. Closing the locking seal will secure the position of the inserted diagnostic/interventional device and/or permit pressure injections up to 450 psi (30.6 Atm.).

E. Intended use of the device:

The Y-Glide Hemostatic Valve Wye Adapter is to be used for maintaining a hemostatic seal around inserted devices with an outside diameter up to 0.120" (3.04 mm) during the use of diagnostic/interventional devices for transluminal procedures.

F. Summary of the technological characteristics of the device compared to the predicate device:

The technological characteristics of the device are the same or very similar to those of the predicate device.

JAN - 4 2008

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(ذ Substantial equivalence rationale:

Visual and physical inspection as well as technical analysis of the legally marketed predicate device (Guidant CoPilot, K991102) compared with the TMP Y-Glide Hemostatic Wye Adapter (K072745) demonstrates that;

(1) the two devices have the same intended use,
(2) the two devices have the same or similar technical characteristics, and
(3) where the technical characteristics differ;
- (a) no new types of safety or effectiveness issues are raised, and
- (b) the technical analysis of the differences demonstrate that the TMP Y-Glide is as safe and effective as the legally marketed device (the converse is also true that the TMP Y-Glide is as un-safe and ineffective as the legally marketed device).

Elements of comparison include:

· Visual comparison
· Indication for use
· Instructions for use
· Sterility
· Design and performance
· Energy used or delivered
· Materials
· Biocompatibility
· Manufacturing processes
· Packaging
· Labeling
· Safety and effectiveness

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Public Health Service

Image /page/2/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

JAN - 4 2008

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Thomas Medical Products, Inc. c/o Mr. Tim Stoudt Manager, QA/RA 65 Great Valley Parkway Malvern, PA 19355

Re: K072745

Y-Glide™ Hemostatic Wye Adapter Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold or fitting Regulatory Class: Class II (two) Product Code: DTL Dated: May 25, 2007 Received: September 27, 2007

Dear Mr. Stoudt:

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 - Mr. Tim Stoudt

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 yours,
Elmlee

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

Enclosure

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STATEMENT: INDICATION FOR USE

K072745 510 (k) Number:

Y-Glide™ Hemostatic Wye Adapter Device Name:

Indications for Use:

X__ Prescription Use Over the Counter Use (Part 21 CFR 801 Subpart D) and/or (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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on of Cardiovascular Devices

510(k) Number ko72745

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.