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, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

Device Description

The VasoStat™ Hemostasis Device is an ergonomic, simple 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, etc.) and is secured to the skin with biocompatible, hypoallergenic 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

Here's a breakdown of the acceptance criteria and study information for the VasoStat™ Hemostasis Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in a pass/fail format. Instead, it demonstrates substantial equivalence by comparing the VasoStat™ Hemostasis Device's performance, particularly hemostasis time, to a legally marketed predicate device. The primary performance metric mentioned is time to hemostasis.

1. Table of Acceptance Criteria and Reported Device Performance

None explicitly stated as quantifiable acceptance criteria in the document. However, the study aimed to show performance comparable to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance (VasoStat™)	Predicate Device Performance (Terumo TR Band)
Achieve hemostasis	Achieved hemostasis	Achieved hemostasis
Time to hemostasis (comparable to predicate)	Approximately 5.8 minutes (average)	Approximately 5.8 minutes (average)
Biocompatibility	Non-cytotoxic, non-reactive, non-sensitizing	N/A (Established biocompatible materials for RaDAR, ISO 10993 for TR Band)

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

Sample Size: Not explicitly stated as a number of animals. The study was conducted on a "domestic swine model."
Data Provenance: Prospective (in vivo assessment), animal model (domestic swine). The country of origin is not specified but is implicitly assumed to be within the US, given the submission to the FDA.

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

Not applicable. The study involved a direct measurement of hemostasis time in an animal model, not expert evaluation of images or clinical outcomes that would require ground truth establishment by multiple experts.

4. Adjudication method for the test set

Not applicable. This was an in vivo animal study measuring the time to hemostasis, not a study requiring adjudication of expert interpretations.

5. 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

Not applicable. This device is a physical hemostasis device, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this study was the observed time to achieve hemostasis in the swine model, directly measured by the investigators of the study. This aligns with outcomes data (i.e., the clinical outcome of stopping bleeding).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As noted in #8, there is no training set for a physical medical device.

Summary

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Submitter: Forge Medical, Inc.

VasoStat™ Hemostasis Device Premarket Notification: Traditional 510(k)

MAY 2 9 2013

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K123041

510(k) Summary

Submitter Name:	Forge Medical, Inc
Submitter Address:	8516 Parkwood LanePhiladelphia, PA 19128
Phone Number:	877-466-0109
Fax Number:	866-244-8988
Contact Person:	Mason Diamond, DDSTexel Fortis, LLC150 Levinberg LaneWayne, NJ 07470Phone: 508-333-0108Fax: 973-305-0213
Date Prepared:	30 April, 2013
Device Trade Name:	VasoStat™ Hemostasis Device
Common Name	Vascular compression device
Classification Name	Vascular clamp
Number andProduct Code:	870.4450DXC
Predicate Devices:	RaDAR Vascular Compression Device (Advanced VascularDynamics) (DXC): K092503TR Band (Terumo) (DXC): K070423VasoStat™ Hemostasis Device (Forge Medical) (NOO): DeviceListing (D147574)
Device Description	The VasoStat™ Hemostasis Device is an ergonomic, simpledevice that is adhered to the patient's skin directly over apercutaneous vascular puncture site and allows the application ofadjustable compression to the puncture site to achievehemostasis. The device is composed of a flexible thermoplastic

base that has the ability to conform to the patient's anatomy (e.g.

Section 5.0: 510(k) Summary

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lower arm, upper arm, etc.) and is secured to the skin with biocompatible, hypoallergenic 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.

Statement of Indication for Use 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, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

Summary of Technological Characteristics The VasoStat™ Hemostasis Device is designed to provide local compression to the puncture sites of a dialysis access shunt of a dialysis patient. The device applies uniform pressure to the sites of needle puncture along the dialysis access shunt until hemostasis is achieved. The degree of pressure is designed to stop bleeding without causing blood clots.

A domestic swine model was utilized for in vivo assessment of the VasoStat™ Hemostasis Device in comparison to the Terumo TR Band (predicate device). Vascular sheaths were created in the femoral arteries and veins, and in the jugular veins. The sheaths were removed and either a VasoStat™ Hemostasis Device or a Terumo TR Band placed. Both devices achieved hemostasis in the approximately 5.8 minutes (average). These results demonstrate that the VasoStat™ Hemostasis Device and the predicate device are substantially equivalent.

Biocompatibility testing (per ISO 10993) performed on the device demonstrated, that the VasoStat Hemostasis Device is safe for the indications of use, and was found to be non-cytotoxic, nonreactive and non-sensitizing by ISO Cytotoxicity, ISO Intracutaneous Reactivity and ISO Buehler Sensitization testing, respectively.

The VasoStat™ Hemostasis Device is substantially equivalent to the predicates. RaDAR Vascular Compression Device (K092503), the TR Band (K070423), and the VasoStat™ Hemostasis Device (D147574), with respect to technical and design features. The submitted device poses no new questions about safety or effectiveness as compared to the predicate devices.

Substantial Equivalence

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Submitter:Forge Medical, Inc.	VasoStat™ Hemostasis DevicePremarket Notification: Traditional 510(k)
Conclusion	The information discussed above and presented in the followingtable demonstrates that the VasoStat™ Hemostasis Device issubstantially equivalent to the predicate devices.
Declarations	• This summary includes only information that is also covered inthe body of the 510(k).• This summary does not contain any unsubstantiated labelingclaims.• This summary does not contain any raw data, i.e., containsonly summary data.

o This summary does not contain any trade secret or confidential commercial, information.

o This summary does not contain any patient identification information.

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Submitter:
Forge Medical, Inc.

ummary of Substantial Equivalen

Feature	VasoStat™ Hemostasis Device	RaDAR Vascular Compression Device	TR Band	VasoStat™ Hemostasis Device
510(k) Number	K123041	K092503	K070423	D147574
Class	II	II	II	I (Exempt)
Classification	Vascular clamp	Vascular clamp	Vascular clamp	Clamp, Dialysis arm
Regulation	870.4450	870.4450	870.4450	876.5540
Product Code(s)	DXC	DXC	DXC	NOO
Indications for Use	...indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.	...indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.	...is a compression device to assist hemostasis of the radial artery after a transradial procedure.	...to temporarily apply puncture site compression and, aid in obtaining puncture site hemostasis, following the removal of dialysis needles.
Mode of Action	Compression	Compression	Compression	Compression
In Vivo Performance	Hemostatic	Not Tested	Hemostatic	Hemostatic
Composition	MoldedPolypropylene/Polyethylene Foam/Acrylic Adhesive	Not Available	Plastic	MoldedPolypropylene/Polyethylene Foam/Acrylic Adhesive
Biocompatibility	ISO 10993- Part 5ISO 10993- Part 10	Established biocompatible materials	ISO 10993- Part 5ISO 10993- Part 10	ISO 10993- Part 5ISO 10993 - Part 10

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

May 29, 2013

Forge Medical, Inc! c/o Mr. Mason Diamond 150 Levinberg Lane Wayne, NJ 07470

Re: K123041

Trade/Device Name: VasoStat Hemostasis Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: April 10, 2013 Received: April 12, 2013

Dear Mr. Mason 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-interstatecommerce 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

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Page 2 - Mr. Mason Diamond

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Bram D. Zackerman -S

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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Submitter: Forge Medical, Inc.

VasoStat™ Hemostasis Device Premarket Notification: Traditional 510(k)

Indications for Use

510(k) Number (if known): K123041

Device Name: VasoStat™ Hemostasis Device

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) · AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 4.0

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).