K Number

Device Name

Attachable Cath Lab Hemostasis Valve

Manufacturer

GALT MEDICAL CORP.

Date Cleared

2015-12-02

(90 days)

Product Code

DTL

Regulation Number

870.4290

Intended Use

The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.

Device Description

The Galt Medical Attachable Cath Lab Hemostasis Valve assembly consists of a molded hub with an integrated hemostasis valve, sideport tubing with 3 way stopcock. The design of the Attachable Cath Lab Hemostasis Valve is derived directly from the current line of Galt Medical Cath Lab Introducer Sheath (K043525). The subject and predicate device are both have an integrated hemostasis valve, and side port tubing with stopcock.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K990975, K043525, K112398

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and functional testing, with no mention of AI/ML terms or data-driven performance metrics.

Therapeutic

No
The device is described as a hemostasis valve used to minimize blood loss during the introduction of other devices into the vasculature. It does not exert a therapeutic effect itself, but rather facilitates a medical procedure.

Diagnostic

No
The device is described as a hemostasis valve used to minimize blood loss during the introduction of catheters and other intravascular devices; its function is related to surgical procedures and not to diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical assembly consisting of a molded hub, integrated hemostasis valve, sideport tubing, and stopcock. It is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature." This describes a device used in vivo (within the body) during a medical procedure, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
Device Description: The description details a mechanical device with a valve, tubing, and stopcock, designed for use in a Cath Lab setting. This aligns with a surgical or interventional device, not a diagnostic test.
Anatomical Site: The device is used in the "vasculature," which is within the body.
Performance Studies: The performance studies described are functional tests related to the mechanical integrity and performance of the device during insertion and use, not studies evaluating the accuracy or reliability of a diagnostic measurement.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and mechanical, not diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.

Product codes (comma separated list FDA assigned to the subject device)

DTL

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vasculature

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)

Functional testing on 4 year aged product was conducted to verify that the Attachable Cath Lab Hemostasis Valve met product specifications. Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:

. Pressure Leak Test
Vacuum Leak Test .
. Guidewire Insertion Test
. Dilator Insertion Test
Sidearm Tubing to Hub Pull Force Test
. Spinlock Collar Adapter Pull Test
Additionally the Attachable Cath Lab Hemostasis Valve was adopted into the existing ethylene oxide sterilization cycle for the Galt Cath Lab Introducer Sheath cleared under K043525.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Merit Medical IN-LINE Hemostasis Valve (K990975), Galt Medical Cath Lab Introducer Sheath (K043525), Galt VTI® Valved Tearaway Introducer Sheath (K112398)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 02, 2015

Galt Medical Corp. David Derrick Director Of Quality And Regulatory Affairs 2220 Merritt Dr. Garland, Texas 75041

Re: K152528

Trade/Device Name: Attachable Cath Lab Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, Or Fitting Regulatory Class: Class II Product Code: DTL Dated: September 1, 2015 Received: September 3, 2015

Dear David Derrick:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrenner

for

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

Enclosure

INDICATIONS FOR USE

510(K) number (if known): K152528

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.

Prescription Use_ X (Per 21 CFR 801 Subpart D) OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _ 1

Application Date:	September 01, 2015
Application Type:	Traditional 510(k)
Applicant Information	Galt Medical Corporation
2220 Merritt Dr.
Garland, TX 75041
Phone: 214-778-1306
Fax: 972-271-4706
Official Contact:	David Derrick
Director of Quality and Regulatory Affairs
Galt Medical Corporation
2220 Merritt Dr.
Garland, TX 75041
Phone: 214-778-1306
Fax: 972-271-4706
dderrick@galtmedical.com
Device Name:	Attachable Cath Lab Hemostasis Valve
Device Model Number:	TBD
Classification Name:	Cardiopulmonary bypass adaptor, Stopcock, Manifold, or
Fitting (DTL),
21 CFR 870.4290
Device Classification:	Class II (Cardiovascular)
Predicate Device:	Merit Medical IN-LINE Hemostasis Valve (K990975)
Galt Medical Cath Lab Introducer Sheath (K043525)
Galt VTI® Valved Tearaway Introducer Sheath (K112398)
Manufacturer:	Galt Medical
2220 Merritt Drive
Garland, TX 75041
Phone: 214-778-5177
Fax: 972-271-4706

Intended Use: The Attachable Cath Lab Hemostasis Valve is indicated to minimize blood loss during the introduction of catheters, guidewires and other intravascular devices into the vasculature.

Device Description: The Galt Medical Attachable Cath Lab Hemostasis Valve assembly consists of a molded hub with an integrated hemostasis valve, sideport tubing with 3 way stopcock. The design of the Attachable Cath Lab Hemostasis Valve is derived directly from the current line of Galt Medical Cath Lab Introducer Sheath (K043525). The subject and predicate device are both have an integrated hemostasis valve, and side port tubing with stopcock.

The Galt Cath Lab Introducer (K043525) has been previously determined to be substantially equivalent. In this submission, Galt Medical Corp will establish that the subject device Attachable Cath Lab Hemostasis is substantially equivalent to the current marketed devices; Merit Medical IN-LINE Hemostasis Valve, Galt Cath Lab Introducer Sheath and Galt VTI Valved Tearaway Introducer.

Comparison of Technological Characteristics: The Attachable Cath Lab Hemostasis Valve is substantially equivalent to the unmodified predicate in construction, materials, and device performance.

	Subject device	Predicate Device	Predicate Device	Predicate Device
Mfr. /
Product	Galt Medical
Attachable Cath
Lab Hemostasis
Valve	Merit Medical IN-
LINE Hemostasis
(K990975)	Galt Medical Cath
Lab Introducer
(K043525)	Galt Medical VTI
Valved Tearaway
(K140028 )
510(k)
Number	N/A	K112398	K043525	K140028
Device
Classification	870.4290	870.4290	870.1340	870.1340
Product
Code	DTL	DTL	DYB	DYB
Intended use	Intended to
minimize blood
loss during the
introduction of
catheters,
guidewires and
other intravascular
devices into the
vasculature	Intended to
minimize blood
loss during the
introduction of
catheters,
guidewires and
other intravascular
devices into the
vasculature	The seath
introducer system
is indicated for use
in percutaneous
procedures to
introduce
catheters and
other intravascular
devices into the
vasculature.	These introducers
are used for the
percutaneous
introduction of
diagnostic or
therapeutic
devices, such as
catheters and
pacing leads into
the vasculature.

	Subject device	Predicate Device	Predicate Device	Predicate Device
Design	The Galt Attachable
Cath Lab Hemostasis
Valve assembly
consists of a molded
hub with an
integrated
hemostasis valve,
sideport tubing with
3 way stopcock.	The Merit Medical
IN-LINE Hemostasis
Valve assembly
consists of a molded
hub with an
integrated
hemostasis valve,
sideport tubing with
3 way stopcock.	Cath Lab introducer
has a molded
hub/sheath with
integrated
hemostasis valve,
and side port tubing
with stopcock. The
device includes a
locking dilator to
assist in the insertion
of the device into
the vascular system.	The VTI valved
tearaway introducer
has a molded
hub/sheath with
integrated
hemostasis valve,
and side port tubing
with stopcock. The
device includes a
locking dilator to
assist in the insertion
of the device into
the vascular system
Color	White or Green
Colored hub and
cap with clear
sideport tubing
and stopcock	White Colored hub
with clear sideport
tubing and
stopcock	White Colored
hub, color coded
cap with clear
sideport tubing
and stopcock	Color coded hub,
clear cap with
clear sideport
tubing and
stopcock
Shape	Round hub with
spinlock collar	Round hub with
spinlock collar	Cylindrical cannula
with round hub	Cylindrical cannula
with winged hub
Sizes	Accepts up to 8F
device	Accepts up to 8F
device	6cm, to120cm
lengths, sizes 4F -
9F	13cm, and 23cm
lengths, sizes 6F -
16F
Pressure
withstand	7 PSI	7 PSI	7 PSI	6.1 PSI
Vacuum
Withstand	0.47in-Hg	0.47in-Hg	0.47in-Hg	0.47in-Hg
Dilator Lock	N/A	N/A	Dilator is retained	Dilator is retained

Use Type: The Galt Attachable Cath Lab Hemostasis Valve is a single patient use, disposable device.

Summary of Non-Clinical Data Submitted: Functional testing on 4 year aged product was conducted to verify that the Attachable Cath Lab Hemostasis Valve met product specifications. Testing was conducted according to protocols based on international standards and Galt Medical requirements. Functional Testing included the following:

. Pressure Leak Test
Vacuum Leak Test .
. Guidewire Insertion Test
. Dilator Insertion Test
Sidearm Tubing to Hub Pull Force Test
. Spinlock Collar Adapter Pull Test

Additionally the Attachable Cath Lab Hemostasis Valve was adopted into the existing ethylene oxide sterilization cycle for the Galt Cath Lab Introducer Sheath cleared under K043525.

Biocompatibility testing was provided in Galt Cath Lab Introducer Sheath submission K043525 and for the optional valve - Galt VTI Valved Tearaway Introducer submission K140028. The devices tested included identical raw materials and package configuration and materials utilized in the Galt Attachable Cath Lab Hemostasis Valve and Galt VTI Valved Tearaway Introducer.

Packaging shelf life testing was provided in the predicate submissions.

Conclusion: It will be shown in this 510(k) submission that the differences between the Galt Attachable Cath Lab Hemostasis Valve and the predicate device do not raise any questions regarding safety and effectiveness. The Galt Attachable Cath Lab Hemostasis Valve as designed and manufactured is determined to be substantially equivalent to the referenced predicate device.

End of Section