AMBUVAC

K971548 · Kinetic Concepts, Inc. · OMP · May 22, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971548
• Device Name: AMBUVAC
• Applicant: Kinetic Concepts, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ambulatory V.A.C. device is indicated for patients who whould benefit from a suction device, particularly as the device use may promote wound healing, including for patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.

Device Story

Ambulatory V.A.C. is a portable, battery-powered suction pump for wound therapy. Device applies continuous or intermittent negative pressure to wounds via a disposable collection canister and multi-lumen tubing. System includes a pump housing, vacuum pump, control system, and sterile disposables (canister with hydrophobic filter, wound dressing pad, adhesive film). Operated by clinicians or patients; pump carried in a pouch or placed on a surface. User selects therapy parameters (pressure, mode) via LCD and keypad. Microprocessor monitors negative pressure; provides feedback and alarms for canister full, dressing leak, or low battery. Output is negative pressure at the wound site, facilitating fluid drainage and wound healing. Device stores previous settings for continuity of care.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design comparisons to the predicate device.

Technological Characteristics

Powered suction pump; oil-less diaphragm pump mechanism. Materials: translucent plastic canister, USP Class VI flexible tubing, polyurethane/PVA foam dressing, plastic adhesive drape. Energy: battery or low voltage adapter. Dimensions: 15cm x 11cm x 6cm; weight ~500g. Features: microprocessor control, LCD/keypad interface, 0.2 micron hydrophobic filter, negative pressure feedback loop. Sterilization: sterile single-use disposables.

Indications for Use

Indicated for patients requiring vacuum-assisted wound drainage and removal of infectious material or fluids to promote healing. Contraindicated for fistulas (excluding blind/incomplete), necrotic tissue (including bone osteomyelitis), and skin cancer.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• V.A.C. Plus (K945062)

Reference Devices

• CARE E-VAC (Aeros Instruments)

Submission Summary (Full Text)

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## 510 (k) Summary K971548

| I. Name of Device: | Ambulatory V.A.C |
|-------------------------------|--------------------------------------------|
| II. Classification Name: | Powered Suction Pump (per 21 CFR 878.4780) |
| | MAY 22 1997 |
| III. Substantial Equivalence: | V.A.C. Plus, 510(k) No. 945062 |

#### IV. Device Description:

The Ambulatory V.A.C. is a portable suction device that can be powered by a separate battery pack or a low voltage power adapter. When activated, it applies continuous or intermittent negative pressure to a wound, promoting wound healing and drainage of fluids and/or infectious materials from the wound into a disposable collection canister.

The Ambulatory V.A.C. consists of a small housing that contains a vacuum pump and control system with a containment chamber for a disposable wound fluid collection canister, and sterile, single-use disposables. Accessories included in the Ambulatory V.A.C. system are separate battery packs, a battery charger, an optional modem and a carrying belt and pouch. The disposables consists of the wound fluid collection canister with an integral hydrophobic filter and an attached length of multi-lumen tubing, a wound dressing pad, and an overlying adhesive film that adheres to the skin surrounding the wound.

The Ambulatory V.A.C. pump housing comprises of a compact plastic molding that weighs approximately 500 grams and measures 15 cm x 11 cm x 6 cm. When in use, the pump can be placed inside the pouch and carried on the belt or, when the patient is stationary, the pump can be placed on a table or flat surface.

The pump is turned ON by applying power either by the battery pack or the low voltage adapter. An LCD and membrane keypad on the top of the unit becomes active when power is applied. Operating parameters are selected using the LCD and keypad. The LCD is also used during operation to display the current negative pressure being applied and any alam condition messages.

The Ambulatory V.A.C. automatically stores the operating parameters from the previous therapy session. When the Ambulatory V.A.C. unit is initialized, the LCD displays the phrase "NEW PATIENT" at the top the display with "NO" and "YES" beneath it. "NO" is displayed over the left-arrow key and "YES" is displayed over the right-arrow key. Both arrow keys are located directly below the LCD. If the left-arrow key is pressed, for NO, the phrase "Will operate at previous settings" is displayed on the LCD. The operating parameters for the current therapy session remain as they were for the previous session. The THERAPY ON/OFF key, located to the left of the LCD, is then pressed to begin therapy.

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If the right-arrow key is pressed for YES, indicating a new patient, the phrase "USING DEFAULTS" is displayed on the LCD. The user must specify whether default or user-selected parameters are to be used for the current therapy session. To use default parameters and begin operation, the THERAPY ON/OFF key is pressed and the unit will operate at default settings of 125mmHg with continuous therapy. To specify new parameters, the SELECT OPTIONS key, located to the right of the LCD, is pressed. The LCD displays the words "VAC TARGET =" followed by a number representing the current vacuum pressure setting. Pressing the right-arrow key increases the current setting in 25mmHg increments, while pressing the left-arrow key When the desired vacuum pressure is displayed, the decreases it in 25mmHg increments. SELECT OPTIONS key is again pressed to save the setting.

The LCD next displays a choice of two operation modes: 1) continuous and 2) intermittent. The word "CONTIN." appears over the left-arrow key and the word "INTERMIT." appears over the right-arrow key. The currently selected mode flashes on and off. To select continuous mode (if it is not already the currently selected mode), the user presses the left-arrow key and then the THERAPY ON/OFF key, to begin operation. If the continuous mode is already selected, the user simply presses the THERAPY ON/OFF key. To select the intermittent mode (if it is not already the currently selected mode), the user presses the right-arrow key and then the THERAPY ON/OFF key to being operation of therapy ON for 5 minutes and OFF for 2 minutes. The Ambulatory V.A.C. runs continuously until the THERAPY ON/OFF key is again pressed.

The Ambulatory V.A.C. pump has the following Alarm functions:

- · Canister Full
- · Dressing Leak
- · Battery Low

Each alarm condition is accompanied by an appropriate LCD message and an audible alarm that can be silenced by correcting the condition or pressing the therapy button.

#### SINGLE USE DISPOSABLES

- · wound fluid collection canister (50 ml) with integral filter and attached multilumen tube ( flexible medical tubing, meets USP Class VI criteria)
- polyurethane foam pad .
- plastic adhesive overlay .
- · Flexible tube to dressing connector

The wound fluid collection canister is a disposable chamber made of translucent plastic used for receiving fluids emitted from a wound. The canister includes a plastic cap that firmly locates the canister inside the pump housing. The canister is also graduated to allow the user to easily view and measure the volume of wound fluids within the canister.

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510(k) Summary Ambulatory V.A.C. Date Prepared: April 24, 1997

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The collection canister has two parts which locate on spigots inside the pump housing. One spigot is used for applying a vacuum down the central bore of the multilumen tube. The other spigot locates in the second port which in turn is connected to the outer lumen of the tube and is used for sensing negative pressure at the wound site. A 0.2 micron hydrophobic membrane filter is mounted over the canister outlet. Fluid is drawn up through the central bore of the tube and into the canister. When the canister becomes full, the face of the filter is occluded and the negative pressure is reduced at the wound site which triggers the canister full alarm.

The disposable wound pad is fabricated from either polyurethane or PVA foam. In order for wound fluids to be communicated into the canister, the pad must be secured over the wound. This is accomplished by applying a plastic adhesive drape over the wound pad that gently adheres to the skin surrounding the wound. With the wound area sealed, vacuum pressure is transmitted to the wound when the suction pump is activated.

#### INDICATIONS FOR USE

The Ambulatory V.A.C. is a compact, portable device indicated for patients who would benefit from a suction device, particularly as the device use may promote wound healing, including for patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.

## CONTRAINDICATIONS

The Ambulatory V.A.C. suction device is contraindicated for the following types of wounds:

- · Fistulas, excluding blind or incomplete fistulas,
- · Presence of necrotic tissue (including bone osteomyelitis),
- · Skin Cancer.

### PRECAUTIONS

- · Patients on anticoagulant, or difficult hemostatis
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510(k) Summary Ambulatory V.A.C. Prepared by: J. Harbour Kinetic Concepts, Inc. P.O. Box 659508 San Antonio, TX 78265

Date Prepared: April 24, 1997

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| DESCRIPTION | Pump unit carried on belt with<br>separate battery pack | Hand carry, portable pump unit |
|---------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------|
| WEIGHT | 1.1 pounds | 10 pounds |
| POWER | Battery powered or low voltage<br>adapter, 115V/60Hz | 115V/60Hz |
| THERAPY SETTINGS | Range 0-125mmHg | Range 0-125mmHg |
| CONTINUOUS AND<br>INTERMITTENT<br>THERAPY SETTING | Custom settings range from 30<br>secs. to 10 min. for ON/OFF<br>times | Custom settings range from 30<br>secs. to 10 min for ON/OFF<br>times |
| EXHAUST FILTER | YES | YES |
| SETTINGS LOCKOUT | YES | YES |
| PUMP TYPE | Oil-less Diaphragm | Oil-less Diaphragm |
| CANISTER CAPACITY | 50 ml | 300 ml |
| MICROPROCESSOR<br>CONTROL | YES | YES |
| NEGATIVE PRESSURE<br>FEEDBACK | YES | YES |
| | | |

## DIFFERENCES BETWEEN CURRENT AND PREDICATED DEVICE

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510(k) Summary Ambulatory V.A.C. Prepared by: J. Harbour Kinetic Concepts, Inc. P.O. Box 659508 San Antonio, TX 78265 Date Prepared: April 24, 1997

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# Ambulatory V.A.C. SPECIFICATIONS COMPARISON CHART

| | AmbuVAC | VACPLUS | CARE E-VAC |
|------------------------------|---------------------------------------|---------------------------------------|--------------------|
| MANUFACTURER/<br>DISTRIBUTOR | Kinetic Concepts, Inc. | Kinetic Concepts, Inc. | Aeros Instruments |
| MAX. PRESSURE | | 380mm/15" Hg | 550mm/22" Hg |
| INDICATOR | Gauge | Gauge | Gauge |
| WEIGHT | 2 lbs | 10 lbs | 9.7 lbs |
| FREE AIR<br>DISPLACEMENT | 2 liters/min | 9 liters/min | 27 liters/min |
| CYCLE | Intermittent and<br>Continuous Option | Intermittent and<br>Continuous Option | Continous |
| VACUUM<br>VARIABILITY | Yes, Manual | Yes, Manual | Yes, Manual |
| TIME METER | Yes | Yes | No |
| EXHAUST<br>FILTER | Yes | Yes | Unavailable |
| PUMP TYPE | Oil-less Diaphragm | Oil-less Diaphragm | Oil-less Diaphragm |
| POWER | 115V/60Hz | 115V/60Hz | 110V/60Hz |
| DIMENSIONS | 6"Wx4.3"Hx3"D | 11"Wx12"Hx7"D | 19"Wx11.5"Hx16.5"D |
| IN-TAKE HOSE | 0.25" ID | 0.25" ID | Unavailable |
| ILLUMINATED<br>POWER SWITCH | Yes | Yes | Yes |

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510(k) Summary Ambulatory V.A.C. Prepared by: J. Harbour Kinetic Concepts, Inc. P.O. Box 659508 San Antonio, TX 78265 Date Prepared: April 24, 1997

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in all caps and is evenly spaced around the circle.

Public Health Service

APR - 7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KCI USA, Inc. % Ms. Christy Oviatt 6203 Farinon Drive San Antonio, Texas 78230

Re: K971548

Trade/Device Name: AmbuVAC Device Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: April 24, 1997 Received: April 28, 1997

Dear Ms. Oviatt:

This letter corrects our substantially equivalent letter of May 22, 1997.

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 (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.

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

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Page 2 - Ms. Christy Oviatt

limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

for Rob Romer

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page / of /

510(k) Number (if known): K971548

Device Name: Ambulatory V.A.C.

Indications For Use:

・しと

The Ambulatory V.A.C. device is indicated for patients who whould benefit from a suction device, particularly as the device use may promote wound healing, including for patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.

NOTE: The Indications for Use of the Ambulatory V.A.C. are identical to the predicate device, VAC PLUS, 510(k)945062.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K971548 |

Prescription Use (Per 21 CFR 801. 109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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