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 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.

AI/ML Overview

Here's an analysis of the provided information regarding the CLEEN-ABLE™ Blood Pressure Cuff, structured to address your specific points:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Performance Requirement (Acceptance Criteria)	Test Methodology	Reported Device Performance
Cuff Closure/Construction	ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder	Bench testing conducted and met requirements (implied by conclusion)
Pressure Capacity	ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder	Bench testing conducted and met requirements (implied by conclusion)
Repeated Inflation Testing	ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder	Bench testing conducted and met requirements (implied by conclusion)
Systems Leak Testing	ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder	Bench testing conducted and met requirements (implied by conclusion)
General Safety and Effectiveness	Compliance with relevant standards and predicate device comparison	Device determined to be safe, effective, and substantially equivalent to predicate device (DURA-CUF®)

Note: The document states that bench testing was "conducted to demonstrate performance (safety and effectiveness)" and that the device "meets the appropriate requirements of ANSI/AAMI SP-9." While specific numerical performance values are not provided, the conclusion implies successful adherence to the standard's criteria for these performance aspects.

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

The provided document describes bench testing for performance. This type of testing typically involves physical samples of the device and does not involve human subjects or clinical data in the traditional sense of a "test set" for AI/algorithmic evaluation. Therefore, information about human data provenance (country of origin, retrospective/prospective) and sample size in that context is not applicable. The sample size for the bench tests themselves (e.g., how many cuffs were tested for repeated inflation) is not specified.

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

Not applicable. This device is a physical blood pressure cuff, and its performance was evaluated through bench testing against established engineering standards (ANSI/AAMI SP-9). There was no need for human expert consensus to establish "ground truth" for the performance criteria listed (cuff construction, pressure capacity, inflation cycles, leak testing).

4. Adjudication Method for the Test Set

Not applicable, as the evaluation involved objective engineering tests against a standard, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a blood pressure cuff, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to its evaluation.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established by the ANSI/AAMI SP-9, 1994 Standard for Cuffs with Integral bladder. This standard outlines predefined, objective criteria and test methodologies for evaluating the physical and functional characteristics of blood pressure cuffs.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set."

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

Not applicable. This device is not an AI algorithm.

Summary

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FEB 2 5 2000

K 994044

Section 2 Page 2 - 1

510(k) SUMMARY

Submitter's Name:	Vital Signs, Inc20 Campus RoadTotowa, New Jersey
Official Contact:	Anthony P. MartinoVP Quality Assurance and Regulatory Affairs
Telephone Number:	(973) 790-1330ext. 356
Fax Number:	(973) 790-4150
Date:	November 24, 1999
Proprietary or Trade Name:	CLEEN-ABLE™
Common/Usual Name:	Blood Pressure Cuff
Classification Name:	Cuff, Blood Pressure(Per CFR 870.1120)
Predicate Device:	CRITIKON's DURA-CUF®

Device Description:

Intended Use:

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
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.(b)
Classification. Class II (performance standards).