Y-GLIDE

K072745 · Thomas Medical Products, Inc. · DTL · Jan 4, 2008 · Cardiovascular

Device Facts

• Record ID: K072745
• Device Name: Y-GLIDE
• Applicant: Thomas Medical Products, Inc.
• Product Code: DTL · Cardiovascular
• Decision Date: Jan 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

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.

Device Story

Y-Glide Hemostatic Valve Wye Adapter; manual device used during transluminal procedures. Features hemostasis valve with primary seal, secondary locking seal, rotating luer lock, and sideport. Primary seal opens by depressing cap for valve flushing and device introduction/withdrawal; closes automatically to minimize fluid loss. Secondary locking seal engages via internal threads by rotating cap while depressing; provides secure positioning of inserted devices and permits pressure injections up to 450 psi. Used by clinicians to maintain hemostasis while managing diagnostic/interventional tools.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, visual/physical inspection, and technical analysis of design and performance characteristics.

Technological Characteristics

Hemostatic valve wye adapter with primary seal and secondary locking seal. Features rotating luer lock and sideport. Supports pressure injections up to 450 psi (30.6 Atm). Accommodates devices up to 0.120" (3.04 mm) OD. Manual operation.

Indications for Use

Indicated for maintaining a hemostatic seal around diagnostic or interventional devices (up to 3.04 mm OD) during transluminal procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Guidant CoPilot Bleedback Control Valve (K991102)

Submission Summary (Full Text)

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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 Parkway<br>Malvern, 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 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.).

#### 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 [phone]. 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 [phone] or [phone] 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:

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.

__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