COWBOY XV

K981311 · Kci New Technologies, Inc. · JOW · Apr 23, 1999 · Cardiovascular

Device Facts

• Record ID: K981311
• Device Name: COWBOY XV
• Applicant: Kci New Technologies, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cowboy XV is designed to enhance blood circulation in the venules and arterioles in the lower extremities. The Cowboy XV Is designed to only patients with diabetic ulcers of the lower extremities. patients with diabone of flow to: - treat and assist healing of cutaneous ulceration (wounds). - . reduce wound healing time. . - reduce wound neamig in thiosed flow). - enhance afterial enclaims of blood flow). . - prevent vonsarimental pressures. . - reduce edoma (swelling). . - reduce edema (Swoning). reduce post-operative pain and swelling. . - reduce post-operative pain and swelling. reduce the post-operative pain and swelling. The second of the subscribesis (DVT) (blood clots in deep veins). reduce the need for anticoagulant medications (includes in deep veins). prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins). Thrombosis Thrombosis (DVT) (blood c . - .

Device Story

Cowboy XV is an intermittent pneumatic compression device for home use by patients. It consists of a reusable pump unit connected via tubing to single-patient use inflatable foot wraps. The pump inflates wraps to mimic physiological actions of walking, enhancing blood circulation in venules and arterioles of lower extremities. The device is software-driven and microprocessor-controlled; it monitors pressure in wraps and adjusts inflation/deflation cycles. If target pressure is not maintained, the system triggers visual and audio alarms. Healthcare providers prescribe the device to assist in wound healing, reduce edema, and prevent DVT. Patients benefit from improved blood flow, which may prolong time before or prevent amputation.

Clinical Evidence

No clinical data provided; bench testing only. The device is designed to meet UL 1431 standards for electrical safety.

Technological Characteristics

Intermittent pneumatic compression device; electrically operated (115V AC, 60Hz). Components: reusable pump unit (Prism CM-200 material shell, 12"x10.5"x7", 11 lbs) and single-patient use inflatable foot wraps. Microprocessor-controlled pressure monitoring and inflation cycles (min 20s intervals, max 180 mmHg pressure). Connectivity: standalone. Power: 16-foot hospital-grade cord. Leakage: <100 microamperes.

Indications for Use

Indicated for patients with diabetic and/or arterial ulcers of the lower extremities requiring increased blood flow to treat/heal cutaneous ulcers, reduce healing time, enhance arterial circulation, prevent venous stasis, reduce compartmental pressures, reduce edema, reduce post-operative pain/swelling, reduce need for anticoagulants, and prevent DVT. Contraindicated in patients with congestive heart failure or suspected pre-existing DVT.

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

• Cowboy X (a.k.a. PlexiPulse® Acute Care Unit) (K944567)

Submission Summary (Full Text)

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4/23/99

K981311

# 510(k) Summary

(21 CFR 807.92c.)

### APPLICANT [As Required by 21 CFR 807.92 a(1)]

Applicant:

KCi New Technologies, Inc. (NuTech) (NoTCon)
Establishment Registration No. 1648561

Intermittent, External Pneumatic Compression

Address:

Telephone Number:

210-255-4450 fax Judith Harbour

April 8, 1998

Cowboy XV

Device

(subject to change)

Compressible Limb Sleeve

(per 21 CFR section 870.5800)

210-255-4468

Regulatory Affairs

8023 Vantage Dr.

San Antonio, TX 78230-4726

Company Contact:

Date:

# DEVICE NAME [As Required by 21 CFR 807.92 a (2)]

Proprietary Name:

Common Name:

Classification Name:

# CLASSIFICATION OF DEVICE [As Required by 21 CFR 807.87(c)]

Review Panel:

Classification:

Product Code:

# MANUFACTURING FACILITY [As Required by 21 CFR 807.87(h)]

Kinetic Concepts, Inc. 4958 Stout Dr. San Antonio, TX 78219 Cardiovascular

Class II

74JOW

210-662-9191 210-662-0215 fax

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# IDENTIFICATION OF PREDICATE DEVICE [As Required by 21 CFR 807.92 a(3)]

The predicate device to which substantial equivalence is being claimed is Cowboy X
The predication of Canate Care Unit), olso manufactured for NuTech by KCI. The The predicate device to which substantial equivalence for NuTech by KCI. The
(a.k.a. PlexiPulse® Acute Care Unit), also manufactured for NuTech by KCI. The (a.k.a. PlexiPulse® Acute Care Unit), also manufacturer nor Norvoor of Corporation of See at
PlexiPulse® Acute Care Unit is the hospital version of Cowboy XV and has at PlexiPulse® Acute Care Unit is the hospital version of Councy of Chiles and Care Unites and Chiles
hospitals for approximately 6 years. The PlexiPulse® Acute Care Uncreased hospitals for approximately 6 years. The PlexiPulse= Acule Ouro Univers
compression device used for non-ambulatory, resting patients who require increased blood flow in the calf and foot.

The 510(k) number for Cowboy X is: K944567

# DEVICE DESCRIPTION DEVICE DESOrty 21 CFR 807.92 a(4)]

#### General

General
The Cowboy XV pump is connected through tubing to a foot wrap(s). When inflated, these The Cowboy XV pump is connected through tubling, thus helping to open up the wraps mimic the normal physiological actions of walent, this and circulation in the venules and atterioles in the lower extremines in the proventing
improved blood flow means a greater chance of prolonging the time before or preventing
im improved bioos putation as their wounds heal.

Cowboy XV functions as an intermittent pneumatic compression device that enhances
and interest and interest the Regions XV is not a life-supporting or life-sustaining Cowboy XV functions as an intermittent pheumans confire or life-sustaining
lower extremity blood circulation. Cowboy XV is not a life-sustaining lower extremity blood circulation. Cowboy XV is not a fine sterile device.
device. Cowboy XV is not an implant (short-term or long-term), nor is it a sterile device. device. Cowboy XV is not an implant (snot to nong ton ;) (1431), software-driven.
Cowboy XV is an electrically-operated (designed to meet UL 1431), softwares ( Cowboy XV is an electrically-operated (designed to the home in the morised
prescription device, which is used in the home environment. Cowboy XV is comprised prescription device, which is used in the nome environimes onlient use inflatable
of two major components – the reusable pump unit and a single-patient use inflatable
s a of two major components – the reusable pump ank and a component as a
foot wrap. Neither component contains a drug nor biological product as a subcomponent.

Cowboy XV uses a 16 foot hospital grade power cord to supply a voltage of 115 volts AC at
and a Cowboy XV uses a 16 foot nospilal grant consumption of 0.33 amperes and a
a frequency of 60 Hz with a maximum current consumption of 0.33 ampersource a frequency of 60 Hz with a maximum current on or eroto and the source. An
maximum electrical leakage of less than 100 microamperes from its powers source. An maximum electrical leakage of less than Too microamported how no your unde by 7"
exterior shell made of Prism CM-200 material, measuring 12" long by 10 % " wide by 7" exterior shell made of i nom on. Lowboy XV 11 pound unit.

The compressor inflates one or more of the wraps in minimum intervals of 20 seconds at a
nd the compressor in the 120 seconds of 15 mmHg\ The compressor immates one of there than 180 mmHg (± 15 mmHg).

The unit features a microprocessor that controls the unit's operation. The frequency and The unit features a microprocessor that control the compression, are all preset
intensity of the compressions, as well as the compressions. The microprocessor intensity of the compressions, as well as the curroressor. The microprocessor also
values which are monitored and controlled by the microprocessor also values which are monitored and controlled by the wrap(s), adjusting the in and out has detection capabilities to monitor the pressure in the will be results of the summer of

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for any reason the target pressure cannot be maintained, the microprocessor alarm for any reason the target pressure cannot be maintained, the mark capabilities are built
capabilities will activate both visual and audio alarms. These alarm capabilities ar capabilities will activate both neads and daily unit malfunction situations, should they ever occur.

The non-sterile inflatable foot wraps are for single-patient use only. Each wrap is I he non-sterife innatable loot wape and for easy of the veins of the foot. The foot. The foot wrage designed to if around and compress the lost as worked by around the foot. The foot wrap is
loop fasteners are used to hold the foot wrap comfortably around the foot. This ai loop lastellers are used to notation the the treat then be inflated by Cowboy XV. This air NI -welded to oroate an as a seessure against the body.

# STATEMENT OF INTENDED USE

[As Required by 21 CFR 807.92 a(5)]

## Patient Population

Cowboy XV is intended for patients with diabetic and arterial ulcers of the lower extremities.

## Indications

Cowboy XV is designed to enhance blood circulation in the venules and arterioles in the lower extremities of patients with diabetic and/or arterial ulcers.

Cowboy XV is intended for patient's in the home who would benefit from increased blood flow to:

- treat and assist healing of cutaneous ulceration (wounds). .
- reduce wound healing time. .
- enhance arterial circulation (blood flow). .
- prevent venous stasis (slowing of blood flow). .
- reduce compartmental pressures. ◆
- reduce edema (swelling). .
- reduce post-operative pain and swelling. .
- reduce posicoperative pain and owening.
reduce the need for anticoagulant medications (medications that thin the blood). .
- prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins). .

## Contraindications

Patient conditions for which Cowboy XV is contraindicated include:

- presumptive evidence of congestive heart failure. .
- suspected pre-existing Deep Vein Thrombosis (blood clots in deep veins). .

# Differences in Indications

The indications for Cowboy XV are the same as those for the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles three parallel lines curving upwards, with the bottom of each line ending in a wave-like shape.

4 1999 AUG

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Judith A. Harboour Regulatory Assistant KCI New Technologies, Inc. 8023 Vantage Drive San Antonio, TX 78230

K981311 Re: Cowboy XV Regulatory Class: II (Two) Product Code: 74 JOW Dated: February 16, 1999 Received: February 18, 1999

Dear Ms. Harbour:

This letter corrects our substantially equivalent letter off Inis lecter corrects our band on bean and sees and seeve April 23, 1977, regarming
device. The indication for use form included in the original device. The Indication for about revised to include the patient sabblances for which the device was intended for.

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boose and we have determined the device is the device referenced above and we maintations for use stated in the first in enclosure) to legally marketed predicate devices marketed in enclosure) co regally marketed productions the enactment date of the interstate commerce prior to hap 20, as that have been reclassified in Medical Device Amendments of our active of the Federal Food, articles to the accordance with the presente, market the device, subject to the Act (ACC). Tourmay) corress of the Act. The general controls general controls provisions of equirements for annual registration, provisions of the not in manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special If your device is Crabberroa (see approval) it may be subject to such t hit of class in (Fremazion ispeciality) a frecting your device additional concrols. Enroyang major and can be round in the ecal or resemination assumes compliance co 895. A substancially Cquiralist arequirements, as set forth in the with the Good Handressons - 3
Quality System Regulation (QS) for Medical Devices: General (QS)

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# Page 2 - Ms. Judith A. Harboour

regulation (21 CFR Part 820) and that, through periodic QS regulation (21 Crk Farc 620) and chael of Failure to comply with inspections, FDA Will Verlify Bach assist action. In addition, the che onr regaracter may 2016 (FDA) may publish further announcements . this Food and Drug Adminiberation (Federal Register, Please not affect concerning your device in the ification submission does not affect any response to your premained with sections 531 through 542 of the Act obligation you might information Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to continue marketing your device as a Inis lected will ation you be over the Fores on the FDA finding of described in your 510(x) promantial in a legally marketed predicate substantial equivalence of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific and additionally 809.10 for in vitro regulation (21 Crk rule 601 annual the Office of Compliance at (301) ulaghostic devices , For questions on the promotion and 394-4640. "Addicionally" ac "quinded the Office of Compliance at [phone]. Other general information on your responsibilities [phone]. Ocher general from the Division of Small Manufacturers of under the nay be career [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely, yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory 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): K981311

Device Name: _Cowboy XV

Indications for Use:

If ideatorio to 11.
The Cowboy XV is designed to enhance blood circulation in the venules and arterioles in
the Cowboy of the local the lower extremities. The Cowboy XV Is designed to only
patients with diabetic ulcers of the lower extremities.

patients with diabone of flow to:

- treat and assist healing of cutaneous ulceration (wounds).
- . reduce wound healing time. .
- reduce wound neamig in thiosed flow).
- enhance afterial enclaims of blood flow). .
- prevent vonsarimental pressures. .
- reduce edoma (swelling). .
- reduce edema (Swoning).
reduce post-operative pain and swelling. .
- reduce post-operative pain and swelling.
reduce the post-operative pain and swelling.
The second of the subscribesis (DVT) (blood clots in deep veins). reduce the need for anticoagulant medications (includes in deep veins).
prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins).
Thrombosis Thrombosis (DVT) (blood c .
- .

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Blvinion Sign-Off) (DIVIsion of Cardiovascular, Respiratory, and Neurological Devices Kag 1 311 310(k) Number, Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use_

(Optional Format 1-2-96)

(Per 21 CFR 801.109)