Who is the manufacturer of Attachable Cath Lab Hemostasis Valve?

Galt Medical Corp. filed the 510(k) submission for Attachable Cath Lab Hemostasis Valve (K152528).

What is the FDA product code for Attachable Cath Lab Hemostasis Valve?

DTL. It is classified under 21 CFR 870.4290 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Attachable Cath Lab Hemostasis Valve?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Attachable Cath Lab Hemostasis Valve?

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

Who can help prepare an FDA 510(k) submission like Attachable Cath Lab Hemostasis Valve?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Attachable Cath Lab Hemostasis Valve

K152528 · Galt Medical Corp. · DTL · Dec 2, 2015 · Cardiovascular

Device Facts

Record ID	K152528
Device Name	Attachable Cath Lab Hemostasis Valve
Applicant	Galt Medical Corp.
Product Code	DTL · Cardiovascular
Decision Date	Dec 2, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4290
Device Class	Class 2

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 Story

Device is a single-patient-use, disposable hemostasis valve assembly; consists of a molded hub with integrated valve, sideport tubing, and 3-way stopcock. Used in clinical settings (cath lab) by physicians or trained clinical staff during intravascular procedures. Device attaches to existing introducer systems to provide a seal around inserted catheters or guidewires. Function is to minimize blood loss during device exchange or insertion. Output is a physical seal; healthcare providers observe blood loss reduction directly. Benefits include maintenance of hemostasis during complex vascular interventions.

Clinical Evidence

Bench testing only. No clinical data provided. Functional testing included pressure leak, vacuum leak, guidewire insertion, dilator insertion, sidearm tubing to hub pull force, and spinlock collar adapter pull tests. Biocompatibility and shelf-life testing were leveraged from predicate device submissions (K043525 and K140028) based on identical raw materials and packaging.

Technological Characteristics

Molded hub with integrated hemostasis valve, sideport tubing, and 3-way stopcock. Accepts up to 8F devices. Pressure withstand: 7 PSI; Vacuum withstand: 0.47 in-Hg. Sterilization: Ethylene oxide (EO) cycle adopted from K043525. Materials identical to predicate devices.

Indications for Use

Indicated for patients undergoing percutaneous procedures requiring the introduction of catheters, guidewires, and other intravascular devices into the vasculature, where minimization of blood loss is required.

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

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

Reference Devices

Galt Medical VTI Valved Tearaway Introducer (K140028)

Related Devices

K052459 — 6248VAL ADJUSTABLE VALVE · Medtronic Vascular · Jan 11, 2006
K990975 — IN-LINE HEMOSTASIS VALVE · Merit Medical Systems, Inc. · Mar 15, 2000
K131124 — COLIGN · Jilin Coronado Medical , Ltd. · Aug 28, 2013
K072556 — HEMOSTASIS VALVE · Merit Medical Systems, Inc. · Nov 20, 2007
K172453 — WATCHDOG Hemostasis Valve Kit · Boston Scientific Corporation · Nov 9, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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 {3}------------------------------------------------ | 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 | {4}------------------------------------------------ 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. | {5}------------------------------------------------ | | 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. {6}------------------------------------------------ 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