CLEEN-ABLE

K994044 · Vital Signs, Inc. · DXQ · Feb 25, 2000 · Cardiovascular

Device Facts

• Record ID: K994044
• Device Name: CLEEN-ABLE
• Applicant: Vital Signs, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Feb 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CLEEN-ABLE™ blood pressure cuff is used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual and automatic sphygmomanometers. The device is non-sterile and is intended as a multi- patient rewable device and is available in infant through adult sizes.

Device Story

CLEEN-ABLE™ is a non-invasive blood pressure cuff consisting of a soft fabric wrap with an integral inflatable bladder and 1 or 2 tubes. It connects to manual or automatic sphygmomanometers to facilitate indirect blood pressure measurement. Used in clinical settings by trained personnel; the device is wrapped around a patient's limb and secured via hook and loop closure. It is a multi-patient, reusable, non-sterile device available in sizes from infant to adult. The cuff functions as a pneumatic interface between the patient and the monitoring system; it does not contain latex.

Clinical Evidence

Bench testing only. Performance demonstrated via compliance with ANSI/AAMI SP-9 (1994) standards for cuffs with integral bladders. Testing included cuff closure/construction, pressure capacity, repeated inflation, and system leak testing.

Technological Characteristics

Materials: Nylon fabric and PVC. Configuration: 1 or 2 tubes, hook and loop closure, integral inflatable bladder. Sizes: Infant through adult. Non-sterile, multi-patient reusable. Complies with ANSI/AAMI SP-9 (1994) standards.

Indications for Use

Indicated for indirect blood pressure measurement in patients ranging from infant to adult sizes. For use by trained personnel with manual or automatic sphygmomanometers.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Predicate Devices

• CRITIKON's DURA-CUF®

Submission Summary (Full Text)

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FEB 2 5 2000

K 994044

Section 2 Page 2 - 1

#### 510(k) SUMMARY

| Submitter's Name: | Vital Signs, Inc<br>20 Campus Road<br>Totowa, New Jersey |
|----------------------------|-------------------------------------------------------------------|
| Official Contact: | Anthony P. Martino<br>VP Quality Assurance and Regulatory Affairs |
| Telephone Number: | [phone]<br>ext. 356 |
| Fax Number: | [phone] |
| Date: | November 24, 1999 |
| Proprietary or Trade Name: | CLEEN-ABLE™ |
| Common/Usual Name: | Blood Pressure Cuff |
| Classification Name: | Cuff, Blood Pressure<br>(Per CFR 870.1120) |
| Predicate Device: | CRITIKON's DURA-CUF® |

#### Device Description:

The device is comprised of one er two tubes attached to a soft fabric with an integral inflatable bladder that is wrapped around a patient's limb and secured by a hook and loop closure. The tubing connects to a non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes will include infant through adult. Each unit is packaged in a polyfilm bag. Connectors, adapters and pump bulb /valve assemblies are available for use with a variety of manual and automatic sphygmomanometers.

#### Intended Use:

.

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The CLEEN-ABLE™ blood pressure cuff is used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual and automatic sphygmomanometers. The device is non-sterile and is intended as a multi- patient rewable device and is available in infant through adult sizes.

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| Item | CLEEN-ABLE™ | DURA-CUF® |
|-----------------------|----------------------------------------|----------------------------------------|
| Intended Use | Indirect measurement of blood pressure | Indirect measurement of blood pressure |
| Prescription Device | Yes | Yes |
| Intended Population | Infant - Adult | Infant - Adult |
| Labeling | Multi-patient use | Multi -patient use |
| Materials | Nylon fabric/PVC | Nylon fabric/PVC or polyurethane |
| Number of tubes | 1 and 2 | 1 and 2 |
| Cleaning Instructions | Provided, same as DURA-CUF® | Provided |

#### Technology Comparison to Predicate Device:

### Summary of Non-Clinical Performance Testing:

Bench testing was conducted to demonstrate performance (safety and effectiveness) of the CLEEN-ABLE™ blood pressure cuff. The key performance requirements and the test methodologies were selected from the ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder. This standard is referred to in the FDA Guidance for Industry document titled "Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1. The cuff performance testing included but was not limited to Cuff Closure/construction, Pressure Capacity and Repeated Inflation testing, and systems leak testing.

## Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Section 807, and based on the information provided in this premarket notification, Vital Signs, Inc. concludes that the CLEEN-ABLE™ Blood Pressure Cuff is safe, effective and substantially equivalent to the predicate device as described herein and meets the appropriate requirements of ANSI/AAMI SP-9.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2000

Mr. Anthony P. Martino VP of Quality Assurance and Regulatory Affairs Vital Signs, Inc. 20 Campus Road Totowa, NJ 07512

Re: K994044 Cleen-Able™ Blood Pressure Cuff Regulatory Class: II (two) Product Code: DXQ Dated: November 24, 1999 Received: November 29, 1999

Dear Mr. Martino:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Anthony P. Martino

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT

510(k) Number:

# Kg94044

Device Name:

CLEEN-ABLE™

## Indications for Use:

1

રજુન

The CLEEN-ABLE™ blood pressure cuff is used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual and automatic sphygmomanometers. The device is non-sterile and is intended as a multi-use device and is available in infant through adult sizes.

Division Sign-Off

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_k 99 4(2)44

Concurrence of CDRH, Office of Device Evaluation (ODE)

134