The CUFF-ABLE PLUS™ 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 single patient use disposable device and is available in child and adult sizes.

Device Description

The device comprises a soft fabric with an integral bladder that is wrapped around a patient's limb and secured by a hook and loop closure. One or two tubes extend from the bladder and are connected to a non-invasive blood pressurement system. The blood pressure cuffs contain no latex. Sizes will include child through adult. The device is treated with and antimicrobial agent that helps prevent bacterial growth, mildew and odors. Each unit is packaged in a polyfilm bag.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CUFF-ABLE PLUS™ blood pressure cuff. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.

Therefore, many of the requested elements are not applicable or cannot be extracted from the given information. The information primarily concerns physical and functional equivalence of a medical device (blood pressure cuff).

Below is an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Attributes based on ANSI/AAMI SP-9, 1994 Standard)	Reported Device Performance (CUFF-ABLE PLUS™ vs. CUFF-ABLE®)
Cuff Closure Performance	Equivalent performance
Pressure Capacity Performance	Equivalent performance
Repeated Inflations Performance	Equivalent performance
Hook Seal Strengths	Equivalent performance
Fabric Seal Strengths	Equivalent performance
Flange Seal Strengths	Equivalent performance
Seal Burst	Equivalent performance

Study Details:

The study conducted was a comparative functional and environmental testing of the CUFF-ABLE PLUS™ against its predicate device, the CUFF-ABLE®, single-use blood pressure cuff.

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

Sample Size: The document does not specify the exact sample size used for the functional and environmental testing. It only states that "The CUFF-ABLE PLUS™ blood pressure cuff was compared to the CUFF-ABLE®, single use blood pressure cuff."
Data Provenance: Not applicable. The testing appears to be laboratory-based functional and physical performance testing of the device itself, not involving patient data or clinical retrospective/prospective studies.

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

This is not applicable to the type of testing described (functional and physical performance of a blood pressure cuff). Ground truth in this context would likely be established by engineering specifications and objective measurements against standards, not expert adjudication of diagnostic outcomes.

4. Adjudication Method for the Test Set

Not applicable. The testing was objective measurement against an industry standard (ANSI/AAMI SP-9, 1994) and comparison to a predicate device, not subjective interpretation 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. The device is a traditional blood pressure cuff, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a traditional blood pressure cuff, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the functional and environmental testing was based on objective physical and functional measurements against the ANSI/AAMI SP-9, 1994 Standard and direct comparison to the performance characteristics of the predicate device (CUFF-ABLE® blood pressure cuff).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Z-99 THU 12:17 PM VITAL SIGNS

FAX NC. 9737904150

Premarket Notification 510(k) Section 2 - Summary

CUFFABLE PLUS™

SEP 1 1999
K990412

	510(k) SUMMARY
	As required by Section 807.92 (c)
Company Name:	Vital Signs, Inc20 Campus RoadTotowa, New Jersey
Telephone Number:	(973) 790-1330EXT 356
Fax Number:	(973) 790-4150
Official Contact:	Anthony P. MartinoV.P. Quality Assurance and Regulatory Affairs
Date:	August 12, 1999
Proprietary or Trade Name:	CUFF-ABLE PLUS™
Common/Usual Name:	Blood Pressure Cuff
Classification Name:	Non-Automated Sphygmomanometers(per CFR 870.1120)
Predicate Device:	PyMaH Corp., Pregaged® Cuff with AntimicrobialTreatment - K884421Vital Signs, Inc., CUFF-ABLE® (BiomedicalDynamics- K911213)

Device Description:

The device comprises a soft fabric with an integral bladder that is wrapped around form the The device comprises in sole libers and loop closure. One or two tubes extend from the bladder and are connected to a non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes will include child through adult. The device blood pressure currs contain no litem of the helps prevent bacterial growth, mildew and odors. Each unit is packaged in a polyfilm bag.

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Premarket Notification 510(k) Section 3 - Introduction and General Information CUFF-ABLE PLUS

Introduction:

Vital Signs Inc., intends to market the CUFF-ABLE PLUS™ blood pressure cuff. The CUFF-ABLE PLUS™ blood pressure cuff is a disposable, single patient use device with an antimicrobial treatment used for indirect measurement of blood pressure. The CUFF-ABLE PLUS™ blood pressure cuff is of the same material and construction as the CUFF-ABLE®, single use blood pressure cuff currently manufactured by Vital Signs MN, Inc. and cleared under (Biomedical Dynamics) K911213 with the addition of an antimicrobial agent. The antimicrobial properties will inhibit the growth of bacteria and fungi.

Device Description:

Intended Use:

Cautions:

Federal Law restricts this device to sale or on order of physician. If irritation should occur, discontinue use.

Summary of Functional and Environmental Testing:

The CUFF-ABLE PLUS™ blood pressure cuff was compared to the CUFF-ABLE®, single use blood pressure cuff to confirm that its functional and physical performance characteristics were equivalent. The ANSI/AAMI SP-9, 1994 Standard was used in part to select the key performance attributes to measure. The cuffs were equivalent in performance in regards to Cuff Closure, Pressure Capacity and Repeated Inflations. Testing included, but was not limited to hook, fabric and flange seal strengths, seal burst

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized depiction of an eagle with three lines representing its wings, symbolizing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

SEP 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Anthony Martino Vice President Quality Assurance and Requlatory Affairs Vital Signs, Inc. 20 Campus Road Totowa, NJ 07512

Re : K990412 CUFF-ABLE PLUS™ Requlatory Class: II (Two) Product Code: 74 DXQ Dated: June 9, 1999 Received: June 10, 1999

Dear Mr. Martino:

ﺬﺣ

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, Drug, 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, qood 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 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 Please note: this response to your premarket Federal Register. 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 requlations.

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Page 2 - Mr. Anthony 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,

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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ATTACHMENT 1

INDICATION FOR USE STATEMENT

510(k) Number:

K990412

Device Name:

CUFF-ABLE PLUS™

Indications for Usc:

Bera E. Semperle

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

K990412 510(k) Number _

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr CFR 801.109)

or Over-the-counter use

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).