(99 days)
Not Found
No
The device description focuses on mechanical components and functions (hemostasis valve, locking seal, luer lock, sideport) and does not mention any computational or algorithmic processes indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is used for maintaining a hemostatic seal during medical procedures and for securing devices, but it does not directly prevent, diagnose, or treat a disease or condition itself.
No
This device is a hemostatic adapter used to maintain a seal during transluminal procedures involving diagnostic/interventional devices. It does not perform any diagnostic functions itself.
No
The device description clearly details a physical medical device with mechanical components (hemostasis valve, secondary locking seal, rotating luer lock, sideport, cap, threads) and does not mention any software functionality.
Based on the provided information, the Y-Glide™ Hemostatic Wye Adapter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for maintaining a hemostatic seal during transluminal procedures using diagnostic/interventional devices. This describes a device used in vivo (within the body) during a medical procedure, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a mechanical device with seals, valves, and ports for managing fluid and device insertion during a procedure. This aligns with a medical device used during intervention, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD tests.
Therefore, the Y-Glide™ Hemostatic Wye Adapter is a medical device used during interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DTL
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.).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 |
| 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
1
(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
2
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.
3
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
4
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)
eeomQ
on of Cardiovascular Devices
510(k) Number ko72745