AUGEASE VASCULAR AUGMENTATION DEVICE

K101355 · Augdvt, LLC · JOW · Oct 26, 2010 · Cardiovascular

Device Facts

• Record ID: K101355
• Device Name: AUGEASE VASCULAR AUGMENTATION DEVICE
• Applicant: Augdvt, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Oct 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2

Intended Use

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

Device Story

AugEase™ is a foot-actuated pneumatic device used during vascular ultrasound exams. Operator (physician or technician) uses foot pedal to rapidly inflate/deflate air bladder cuff placed on patient limb. Rapid pressure changes create waveform images captured by ultrasound machine. Output assists clinicians in diagnosing venous conditions, mapping veins, and identifying bypass vessels. Device is non-electric, manual, and portable; provides static tourniquet pressure (0-240 mmHg). Benefits include improved visualization of vascular flow and valve function during diagnostic imaging.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical bench testing including burst pressure, materials testing (cytotoxicity, sensitization, irritation, intracutaneous reactivity), tensile strength, seal strength, and cuff leak testing.

Technological Characteristics

Manual, foot-actuated pneumatic device. Max volume 0.8L. Pressure range 0-240 mmHg. Features check valve (1.0 psi) and 300 mmHg gauge. Non-sterile. Rapid inflation/deflation cuff with large diameter hose. No software or electronic components.

Indications for Use

Indicated for patients undergoing vascular testing requiring limb augmentation or vein mapping. Used as an accessory to ultrasound imaging machines for distal/proximal augmentations, venous valve reflux measurements, and locating vessels for bypass.

Regulatory Classification

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.

Predicate Devices

• Venapulse Models VP-25 & VP-50 (K903894)

Submission Summary (Full Text)

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## 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.

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K101355 pg 2 of 4

## DEVICE INTENDED USE

## 807.92(a)(5)

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 .

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 use<br>and claims | The AugEase™ is a foot actuated<br>augmentation device intended to<br>rapidly inflate and deflate an air<br>bladder cuff generating static,<br>tourniquet pressure to limbs of<br>patients undergoing vascular<br>testing. It is indicated as an<br>accessory to an ultrasound<br>imaging machine with or without<br>Doppler which may be used for: | VenaPulse® Model VP-25<br>generates static, tourniquet<br>pressure to limbs of patients<br>undergoing vascular testing. The<br>tourniquet pressure is reached<br>very rapidly and the tourniquet<br>cuff is deflated very rapidly with<br>approximately 300 millisecond<br>rise and fall times. Inflation and<br>deflation are controlled with a<br>foot switch or with a manual<br>switch. The pressure is regulated<br>between 0 and 240mmHg. There<br>are safety alarms to ensure safe<br>operation. |
| | Distal augmentations Proximal augmentations Reflux measurements of<br>specific venous valves Vein Mapping Locating suitable distal<br>vessel for bypass | Indications For Use: Distal augmentations Proximal augmentations Vein mapping Locating suitable distal<br>vessel for bypass Quantification of venous |
| | Caution: Federal (USA) law<br>restricts this device to sale by or<br>on the order of a physician. | |

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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 |
| Technological<br>characteristics | 1. MANUAL<br>2. PNEUMATIC<br>3. 0.8L MAXIMUM VOLUME<br>4. RAPID INFLATION CUFF<br>5. LARGE DIAMETER HOSE | 1. ELECTRIC<br>2. COMPUTER AUTOMATION<br>3. PNEUMATIC<br>4. UNKNOWN MAXIMUM VOLUME<br>5. RAPID INFLATION CUFF<br>6. LARGE DIAMETER HOSE |
| Mode of<br>operation | Rapid inflation and deflation<br>Foot actuated | Rapid inflation and deflation<br>Foot switch/manual switch |
| Inflation/deflation rise and fall<br>time | 0.5 seconds | 300 millisecond |
| Pressure | 0-240mm/Hg | 0-240mmHg |
| Safety feature | 1. Check Valve 1.0 psi<br>2. 300mm/Hg Gauge | 1. Alarm |
| Instructions for<br>use | 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;

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## 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

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## 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.

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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 [phone] or [phone] 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

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# Indications for Use Form

#### Indications for Use

510(k) Number (if known): K101355

OCT 2 6 2010

Device Name: AugEase™

Indications for Use:

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 .

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)

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(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

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