The AugEase™ is a foot actuated augmentation device intended to rapidly inflate and deflate an air bladder cuff generating static, tourniquet pressure to limbs of patients undergoing vascular testing. It is indicated as an accessory to an ultrasound imaging machine with or without Doppler which may be used for:

Distal augmentations
Proximal augmentations
Reflux measurements of specific venous valves
Vein Mapping
Locating suitable distal vessel for bypass

Device Description

The AugEase™ is a foot actuated augmentation device intended to be used during a vascular ultrasound exam of the extremity. It consists of a foot actuated pneumatic device that is used to rapidly inflate and deflate an air bladder cuff that has been placed around the patient limb at the appropriate location. Quickly inflating and deflating the placed cuff creates a waveform image that is captured by the ultrasound machine and used in the diagnosis of a variety of conditions.

AI/ML Overview

The provided 510(k) summary for the AugEase™ device primarily focuses on demonstrating substantial equivalence to a predicate device (VenaPulse Model VP-25) based on technical characteristics and intended use. It does not present a study with specific acceptance criteria and detailed device performance metrics in the way a clinical study or a standalone AI algorithm performance study would.

Instead, the submission relies on non-clinical tests to ensure the device's safety and fundamental functional equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative way to compare against a clinical or AI-driven outcome. Instead, it lists technical characteristics for comparison against the predicate device. The implicit acceptance criterion is that the AugEase™ device's characteristics are similar enough to the predicate device to ensure similar performance and safety.

Feature	Acceptance Criteria (Implicit: Similar to Predicate)	Reported AugEase™ Performance
Intended Use	Match predicate's indications for use	Matches predicate's indications for use
Technological Characteristics		1. MANUAL2. PNEUMATIC3. 0.8L MAXIMUM VOLUME4. RAPID INFLATION CUFF5. LARGE DIAMETER HOSE
Mode of Operation	Rapid inflation and deflation, foot actuated	Rapid inflation and deflation, Foot actuated
Inflation/Deflation Rise/Fall Time	Approximately 300 milliseconds (predicate)	0.5 seconds
Pressure Range	0-240 mmHg	0-240 mm/Hg
Safety Feature	Alarm (predicate)	1. Check Valve 1.0 psi2. 300mm/Hg Gauge
Instructions for Use	Yes	Yes
Non-sterile	Yes	Yes

The document also lists several "Product Validation Testing" items, which are non-clinical safety/material tests rather than performance-based acceptance criteria related to efficacy. These include:

Burst pressure
Materials testing
Cytotoxicity Test
Sensitization Test
Irritation and Intracutaneous Reactivity Test
Tensile Strength Test
Method of attachment (Velcro or straps)
Seal Strength Comparison
Cuff Leak Testing

The reported performance for these tests is that they were "Product Validation Testing," implying that results met internal specifications, but no numerical results or acceptance thresholds are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a medical device (a foot-actuated augmentation device) and its 510(k) submission for substantial equivalence. It does not involve a "test set" in the context of an AI/algorithm study or a clinical trial with patient data. The validation is based on engineering and materials testing, as listed under "Product Validation Testing." There is no mention of patient data, clinical images, or any form of "test set" in the context of data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this is not a study involving diagnostic interpretation or comparison of an algorithm's output against human experts, there is no "ground truth" established by experts in this context. The evaluation is against engineering specifications and comparison to a predicate device's technical characteristics.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in the context of an AI/clinical study.

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 augmentation device, not an AI or imaging diagnostic tool that would be evaluated with MRMC studies or human reader improvement metrics.

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

Not applicable. This device is a physical, non-AI medical device. There is no algorithm to evaluate in standalone mode.

7. The Type of Ground Truth Used

For the physical and functional tests listed (e.g., burst pressure, seal strength, inflation/deflation time), the "ground truth" would be established by engineering specifications and validated testing methods. For the purpose of substantial equivalence, the "ground truth" is also the characteristics and performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve a "training set" as it is for a physical device, not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned.

Summary

{0}------------------------------------------------

510(k) Summary 807.92(c)

OCT 2 6 2010

SPONSOR Company Name:

AUGDVT LLC

Company Address

723 South Casino Center Blvd., 2nd Floor Las Vegas, NV 89101-6716

807.92(a)(1)

Telephone: Fax:

760-744-2882 760-744-2993

Contact Person:

Jeffrey Michaels

Summary Preparation Date: September 14, 2010

DEVICE NAME

807.92(a)(2) Trade Name: AugEase™ Common/Usual Name: Vascular augmentation device Classification Name: Sleeve, Limb, Compressible Regulation Number: 870.8500 Product Code: JOW Device Class: ll Panel: Cardiovascular

PREDICATE DEVICE

Legally Marketed Equivalent Device Company ACI Medical, Inc.

Product Venapulse Models VP-25 & VP-50

510(k) # K903894

DEVICE DESCRIPTION

807.92(a)(4)

807.92(a)(3)

The AugEase™ is a foot actuated augmentation device intended to be used during a vascular ultrasound exam of the extremity. It consists of a foot actuated pneumatic device that is used to rapidly inflate and deflate an air bladder cuff that has been placed around the patient limb at the appropriate location. Quickly inflating and defler praced cuff creates a waveform image that is captured by the ultrasound machine and used in the diagnosis of a variety of conditions.

{1}------------------------------------------------

K101355 pg 2 of 4

DEVICE INTENDED USE

807.92(a)(5)

Distal augmentations
Proximal augmentations ●
Reflux measurements of specific venous valves ●
. Vein Mapping
Locating suitable distal vessel for bypass .

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

PREDICATE PRODUCT COMPARISON

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

Feature	AUGEASE™ device	VenaPulse Model VP 25
Intended useand claims	The AugEase™ is a foot actuatedaugmentation device intended torapidly inflate and deflate an airbladder cuff generating static,tourniquet pressure to limbs ofpatients undergoing vasculartesting. It is indicated as anaccessory to an ultrasoundimaging machine with or withoutDoppler which may be used for:	VenaPulse® Model VP-25generates static, tourniquetpressure to limbs of patientsundergoing vascular testing. Thetourniquet pressure is reachedvery rapidly and the tourniquetcuff is deflated very rapidly withapproximately 300 millisecondrise and fall times. Inflation anddeflation are controlled with afoot switch or with a manualswitch. The pressure is regulatedbetween 0 and 240mmHg. Thereare safety alarms to ensure safeoperation.
	Distal augmentations Proximal augmentations Reflux measurements ofspecific venous valves Vein Mapping Locating suitable distalvessel for bypass	Indications For Use: Distal augmentations Proximal augmentations Vein mapping Locating suitable distalvessel for bypass Quantification of venous
	Caution: Federal (USA) lawrestricts this device to sale by oron the order of a physician.

{2}------------------------------------------------

K101355 Pg 3 of 4

		flow Reflux measurements of specific venous valves
510(k) Number	K101355	K903894
Classification	Compressible Limb Sleeve	Compressible Limb Sleeve
Product Code	JOW	JOW
Technologicalcharacteristics	1. MANUAL2. PNEUMATIC3. 0.8L MAXIMUM VOLUME4. RAPID INFLATION CUFF5. LARGE DIAMETER HOSE	1. ELECTRIC2. COMPUTER AUTOMATION3. PNEUMATIC4. UNKNOWN MAXIMUM VOLUME5. RAPID INFLATION CUFF6. LARGE DIAMETER HOSE
Mode ofoperation	Rapid inflation and deflationFoot actuated	Rapid inflation and deflationFoot switch/manual switch
Inflation/deflation rise and falltime	0.5 seconds	300 millisecond
Pressure	0-240mm/Hg	0-240mmHg
Safety feature	1. Check Valve 1.0 psi2. 300mm/Hg Gauge	1. Alarm
Instructions foruse	yes	yes
Non-sterile	yes	yes

NONCLINICAL AND CLINICAL TEST

807.92(b)

Product Validation Testing:

II. Burst pressure; .

III. Materials testing;

Cytotoxicity Test; ।

Sensitization Test; י

Irritation and Intracutaneous Reactivity Test -

Tensile Strength Test; ।

IV. Method of attachment (Velcro or straps);

V. Seal Strength Comparison;

VI. Cuff Leak Testing;

{3}------------------------------------------------

SAFETY and EFFECTIVENESS

The AugEase™ Vascular is similar to the predicate device in intended use and mode of operation. The AugEase™ is a manually operated device and does not raise any new issue of safety and effectiveness.

K1013

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

AugDVT LLC c/o Mr. E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114

OCT 2 6 2010

Re: K101355

Trade/Device Name: AugEase™ Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: September 14, 2010 Received: September 14, 2010

Dear Mr. Smith:

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.

{5}------------------------------------------------

Page 2 - Mr. E. J. Smith

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Palmer

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

Enclosure

{6}------------------------------------------------

Indications for Use Form

Indications for Use

510(k) Number (if known): K101355

OCT 2 6 2010

Device Name: AugEase™

Indications for Use:

Distal augmentations .
Proximal augmentations .
Reflux measurements of specific venous valves .
Vein Mapping
Locating suitable distal vessel for bypass .

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

Page __ 1 _ of _ 1

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

DMR. KULNER

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).