(90 days)
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.
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 provided text describes a 510(k) submission for a medical device, the "Attachable Cath Lab Hemostasis Valve." However, it does not detail a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/CADe devices, which would involve metrics like sensitivity, specificity, or AUC, established through a rigorous ground truth determination process.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and functional testing. The "acceptance criteria" here are essentially the performance specifications, and the "study" is the non-clinical functional testing performed.
Here's an analysis based on the information provided:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance (Functional Testing Results) |
|---|---|
| Pressure Withstand: 7 PSI | Device met product specifications (implied: achieved 7 PSI) |
| Vacuum Withstand: 0.47 in-Hg | Device met product specifications (implied: achieved 0.47 in-Hg) |
| Guidewire Insertion Test | Device met product specifications |
| Dilator Insertion Test | Device met product specifications |
| Sidearm Tubing to Hub Pull Force Test | Device met product specifications |
| Spinlock Collar Adapter Pull Test | Device met product specifications |
| Biocompatibility | Demonstrated through predicate devices with identical raw materials and package configuration |
| Sterilization | Adopted into existing ethylene oxide sterilization cycle for a predicate device |
| Packaging Shelf Life | Demonstrated through predicate submissions |
-
Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of units tested. The functional testing states it was performed on "4-year aged product," implying a set of devices and potentially new devices.
- Data Provenance: The functional testing was conducted by Galt Medical Corp. on their own manufactured devices. The text does not specify the country of origin of the data beyond being from the manufacturer's internal testing. It is prospective in the sense that the testing was performed for this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable in the context of this device and submission type. The "ground truth" for these functional tests is the defined engineering specification (e.g., 7 PSI pressure withstand). The tests themselves are designed to objectively measure whether the device meets these specifications, not to interpret complex medical data requiring expert consensus.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as the tests are objective functional measurements against engineering specifications, not subjective interpretations requiring adjudication.
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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
- This is not applicable because the device is a physical medical instrument (hemostasis valve), not an AI/CADe system.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable as the device is not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical functional tests is derived from engineering specifications and established performance standards relevant to the function of such a valve (e.g., ability to withstand a certain pressure, secure insertion of guidewires, pull force thresholds). For biocompatibility and sterilization, the ground truth refers to meeting pre-defined biological safety standards and sterility assurance levels.
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The sample size for the training set
- This is not applicable as the device is a physical medical instrument and does not involve AI or machine learning models that require a training set.
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How the ground truth for the training set was established
- This is not applicable as there is no training set for this type of device.
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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
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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
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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
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| Application Date: | September 01, 2015 |
|---|---|
| Application Type: | Traditional 510(k) |
| Applicant Information | Galt Medical Corporation2220 Merritt Dr.Garland, TX 75041Phone: 214-778-1306Fax: 972-271-4706 |
| Official Contact: | David DerrickDirector of Quality and Regulatory AffairsGalt Medical Corporation2220 Merritt Dr.Garland, TX 75041Phone: 214-778-1306Fax: 972-271-4706dderrick@galtmedical.com |
| Device Name: | Attachable Cath Lab Hemostasis Valve |
| Device Model Number: | TBD |
| Classification Name: | Cardiopulmonary bypass adaptor, Stopcock, Manifold, orFitting (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 Medical2220 Merritt DriveGarland, TX 75041Phone: 214-778-5177Fax: 972-271-4706 |
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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 MedicalAttachable CathLab HemostasisValve | Merit Medical IN-LINE Hemostasis(K990975) | Galt Medical CathLab Introducer(K043525) | Galt Medical VTIValved Tearaway(K140028 ) |
| 510(k)Number | N/A | K112398 | K043525 | K140028 |
| DeviceClassification | 870.4290 | 870.4290 | 870.1340 | 870.1340 |
| ProductCode | DTL | DTL | DYB | DYB |
| Intended use | Intended tominimize bloodloss during theintroduction ofcatheters,guidewires andother intravasculardevices into thevasculature | Intended tominimize bloodloss during theintroduction ofcatheters,guidewires andother intravasculardevices into thevasculature | The seathintroducer systemis indicated for usein percutaneousprocedures tointroducecatheters andother intravasculardevices into thevasculature. | These introducersare used for thepercutaneousintroduction ofdiagnostic ortherapeuticdevices, such ascatheters andpacing leads intothe vasculature. |
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| Subject device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| Design | The Galt AttachableCath Lab HemostasisValve assemblyconsists of a moldedhub with anintegratedhemostasis valve,sideport tubing with3 way stopcock. | The Merit MedicalIN-LINE HemostasisValve assemblyconsists of a moldedhub with anintegratedhemostasis valve,sideport tubing with3 way stopcock. | Cath Lab introducerhas a moldedhub/sheath withintegratedhemostasis valve,and side port tubingwith stopcock. Thedevice includes alocking dilator toassist in the insertionof the device intothe vascular system. | The VTI valvedtearaway introducerhas a moldedhub/sheath withintegratedhemostasis valve,and side port tubingwith stopcock. Thedevice includes alocking dilator toassist in the insertionof the device intothe vascular system |
| Color | White or GreenColored hub andcap with clearsideport tubingand stopcock | White Colored hubwith clear sideporttubing andstopcock | White Coloredhub, color codedcap with clearsideport tubingand stopcock | Color coded hub,clear cap withclear sideporttubing andstopcock |
| Shape | Round hub withspinlock collar | Round hub withspinlock collar | Cylindrical cannulawith round hub | Cylindrical cannulawith winged hub |
| Sizes | Accepts up to 8Fdevice | Accepts up to 8Fdevice | 6cm, to120cmlengths, sizes 4F -9F | 13cm, and 23cmlengths, sizes 6F -16F |
| Pressurewithstand | 7 PSI | 7 PSI | 7 PSI | 6.1 PSI |
| VacuumWithstand | 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.
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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
§ 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.