The VasoStat™ Hemostasis Device is indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or lower leg, including radial artery catheterization, pedal or tibial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

Device Description

VasoStatTM Hemostasis Device is a device that is adhered to the patient's skin directly over a percutaneous vascular puncture site and allows the application of adjustable compression to the puncture site to achieve hemostasis. The device is composed of a flexible thermoplastic base that has the ability to conform to the patient's anatomy (e.g. lower arm, upper arm, foot) and is secured to the skin with biocompatible adhesive pads. A plunger component passes through the base, applies targeted pressure to the puncture site through a ratcheting mechanism, and can be adjusted with one hand to apply the appropriate pressure necessary to promote hemostasis. VasoStat has the ability to vary the amount of pressure applied to the puncture site to promote hemostasis while minimizing the risk of thrombosis. The device design and materials ensure that the product is comfortable for the patient to wear while their puncture site stops bleeding. Once hemostasis is achieved (in approximately 15 to 45 minutes), the device is easily removed and discarded.

AI/ML Overview

The provided text describes a medical device called the "VasoStat™ Hemostasis Device" and its clearance through a 510(k) premarket notification. The document primarily focuses on establishing substantial equivalence to predicate devices for expanded indications for use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, prescriptive manner for the device's performance in a clinical study. Instead, the performance testing section mentions that the previous 510(k) (K123041) established the device's performance, and the current submission "leveraged" that data for the new indications. For the expanded indication (transpedal access), a retrospective evaluation was conducted, focusing on the device's ability to achieve hemostasis and low complication rates.

Based on the "Performance Testing" section and the "Summary of Substantial Equivalence," the implicit performance criteria are tied to effective hemostasis and low complication rates, demonstrated through retrospective evaluation for the new indication.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to achieve hemostasis following transpedal catheterization	Capable of achieving hemostasis following transpedal catheterization
Low rates of pseudo-aneurysm following transpedal catheterization	Low rates of pseudo-aneurysm
Low rates of access site occlusion following transpedal catheterization	Low rates of access site occlusion

2. Sample size used for the test set and the data provenance:

Sample Size: Three hundred fourteen (314) patients.
Data Provenance: The study was a retrospective evaluation. The country of origin is not explicitly stated. The patients underwent "transpedal access for peripheral vascular disease intervention."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth for the retrospective evaluation. The assessment of hemostasis, pseudo-aneurysm, and access site occlusion would typically be made by medical professionals, but this detail is not given.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not specify any adjudication method used for the retrospective evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This device is a hemostasis device (a physical medical device), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable and was not performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

As stated above, this is a physical medical device, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the retrospective evaluation, the ground truth was based on clinical outcomes data observed in patients post-procedure, specifically:

Achievement of hemostasis.
Occurrence of pseudo-aneurysm.
Occurrence of access site occlusion.

This data would have been recorded as part of routine clinical practice.

8. The sample size for the training set:

The document refers to a retrospective evaluation for the expanded indications, not a training set in the context of machine learning. The device itself is a physical medical device, not an algorithm that requires training. The performance data from the 314 patients effectively serves as the "test set" for the expanded indications.

9. How the ground truth for the training set was established:

As there is no "training set" in the machine learning sense for this physical device, this question is not applicable. The device's design and previous clearance (K123041) would have been based on established medical and engineering principles, and prior performance data.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a triple-stranded helix, resembling a stylized bird in flight. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.

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

January 06, 2016

Forge Medical, Inc. c/o Mason Diamond, DDS Texel Fortis, LLC 150 Levinberg Lane Wayne, NJ 07470

Re: K153259

Trade/Device Name: VasoStat™ Hemostasis Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: November 7, 2015 Received: November 10, 2015

Dear Dr. Diamond:

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 device-related 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.

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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" (21CFR 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. Hillebrand

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) K153259

Device Name VasoStat™ Hemostasis Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Name:	Forge Medical, Inc
Submitter Address:	791 West Broad Street, Suite 102Bethlehem, PA 18018
Phone Number:Fax Number:	215-605-3225866-244-8988
Contact Person:	Mason Diamond, DDSTexel Fortis, LLC150 Levinberg LaneWayne, NJ 07470Phone: 508-333-0108Fax: 973-305-0213
Date Prepared:	10 December, 2015
Device Trade Name:	VasoStatTM Hemostasis Device
Common Name	Vascular compression device
Classification NameNumber andProduct Code:	Vascular clamp870.4450DXC
Predicate Devices:	VasoStatTM Hemostasis Device (Forge Medical): K123041RadARTM Vascular Compression Assist Devices (AdvancedVascular Dynamics): K142122
Device Description	VasoStatTM Hemostasis Device is a device that is adhered to thepatient's skin directly over a percutaneous vascular puncture siteand allows the application of adjustable compression to thepuncture site to achieve hemostasis. The device is composed ofa flexible thermoplastic base that has the ability to conform to thepatient's anatomy (e.g. lower arm, upper arm, foot) and is securedto the skin with biocompatible adhesive pads. A plungercomponent passes through the base, applies targeted pressure tothe puncture site through a ratcheting mechanism, and can beadjusted with one hand to apply the appropriate pressurenecessary to promote hemostasis. VasoStat has the ability to varythe amount of pressure applied to the puncture site to promotehemostasis while minimizing the risk of thrombosis. The device
Submitter:Forge Medical, Inc.	VasoStat™ Hemostasis DevicePremarket Notification: Traditional 510(k)
	design and materials ensure that the product is comfortable forthe patient to wear while their puncture site stops bleeding. Oncehemostasis is achieved (in approximately 15 to 45 minutes), thedevice is easily removed and discarded.
Statement ofIndications for Use	The VasoStat™ Hemostasis Device is indicated for use bymedical professionals to promote hemostasis following acatheterization or other puncture into a blood vessel in a patient'sarm or lower leg, including radial artery catheterization, pedal ortibial artery catheterization, arterial or venous line removal,hemodialysis, and in patients on anticoagulation therapy.
Summary ofTechnologicalCharacteristics	The VasoStat™ Hemostasis Device is designed to provide localcompression to the puncture site into a blood vessel of the arm orlower leg, including arterial sheath placement and dialysis shuntaccess. The degree of pressure is designed to stop bleedingwithout causing vessel thrombosis. The VasoStat™ HemostasisDevice is the same as that previously cleared by the FDA(K123041), and functions in the same way. Though different indesign, the VasoStat™ Hemostasis Device provides sufficientcompression to stop bleeding in pedal arterial catheterizationssimilar to the RadAR™ Vascular Compression Assist Devices,which also utilize compression to stop bleeding (K142122).
PerformanceTesting	Since this submission applies to the VasoStat™ HemostasisDevice to revise the indications for use without any changes todevice design, the benchtop and animal testing reported inK123041 has been leveraged to demonstrate that the submitteddevice is appropriate for the new indications for use. Similarly,biocompatibility for this device has already been established perISO-10993 (K123041).Furthermore, the VasoStat™ Hemostasis Device wasretrospectively evaluated in three-hundred fourteen (314) patientsfollowing transpedal access for peripheral vascular diseaseintervention. The analysis concluded that the VasoStat™Hemostasis Device was capable of achieving hemostasisfollowing transpedal catheterization with low rates of pseudo-aneurysm and access site occlusion.
SubstantialEquivalence	The VasoStat™ Hemostasis Device is Substantially Equivalent topredicate VasoStat™ Hemostasis Device (K123041), with respectto technical and design features. The Indications for Use andMode of Action is Substantively Equivalent to the RadAR™Vascular Compression Assist Devices (K142122).
Conclusion	The information discussed above demonstrates that theVasoStat™ Hemostasis Device is substantially equivalent to thepredicate device.

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Summary of Substantial Equivalence

Feature	VasoStat™ HemostasisDevice	VasoStat™ HemostasisDevice	RadAR™ VascularCompression AssistDevices
510(k) Number	K153259	K123041	K142122
Class	II	II	II
Classification	Vascular clamp	Vascular clamp	Vascular clamp
Regulation	870.4450	870.4450	870.4450
Product Code(s)	DXC	DXC	DXC
Indications forUse	...indicated for use bymedical professionals topromote hemostasisfollowing a catheterizationor other puncture into ablood vessel in a patient'sarm or lower leg, includingradial arterycatheterization, pedal ortibial artery catheterization,arterial or venous lineremoval, hemodialysis, andin patients onanticoagulation therapy.	...indicated for use bymedical professionals topromote hemostasisfollowing a catheterizationor other puncture into ablood vessel in a patient'sarm, including radial arterycatheterization, arterial orvenous line removal,hemodialysis, and inpatients on anticoagulationtherapy.	...indicated for use bymedical professionals topromote hemostasisfollowing a catheterizationor other puncture into ablood vessel in a patient'sarm or leg, including radialbrachial, dorsalis, pedis, ortibial blood vessels, arterialor venous line or sheathremoval, hemodialysis, andin patients onanticoagulation therapy.
Mode of Action	Compression	Compression	Compression
Composition	Same a predicate	MoldedPolypropylene/Polyethylene Foam/Acrylic Adhesive	Not available
Biocompatibility	Established biocompatiblematerials	ISO 10993 - Part 5ISO 10993 - Part 10	Established biocompatiblematerials

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).