The CRITIKON Soft Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The device is non-sterile and semidisposable (may be single-patient use or optional limited reuse). It is available in neonatal, pediatric and adult sizes. The device is not designed, sold, or intended for use except as indicated.

Device Description

The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a noninvasive blood pressure measurement system.

The device is available in the following configurations:

five neonatal and eight pediatric and adult sizes t
single and dual cuff tubing, connectors, adapters and bulb/valve . assemblies available for use with a variety of manual and automated sphygmomanometers

AI/ML Overview

The provided text describes the 510(k) summary for the CRITIKON Soft Blood Pressure Cuff, focusing on its substantial equivalence to previously marketed devices. The document details the device's description, technological characteristics, and performance testing, but it does not contain specific acceptance criteria or an explicit study proving the device meets those criteria in the format requested.

The information primarily focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway than proving performance against specific acceptance criteria for a novel device.

However, based on the provided text, here's an attempt to extract and infer information relevant to your request, acknowledging that explicit "acceptance criteria" and a detailed "study" demonstrating adherence to those criteria are not fully present for areas like accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Biocompatibility: Device materials are safe for patient contact.	Bench and laboratory testing was conducted to demonstrate performance. (Specific results not detailed, but testing implies meeting safety standards.)
Reprocessing Validation: Instructions for reprocessing ensure the device remains safe and effective for limited reuse.	Validated according to a formal protocol (052496), comprising sound scientific principles and laboratory procedure. Conceptually based on AAMI TIR No. 12-1994.
Repeated Inflations: Device maintains integrity and function over repeated inflation cycles (for limited reuse).	Bench and laboratory testing was conducted to demonstrate performance. (Specific number of inflations or failure rate not detailed, but implies meeting durability standards.)
Blood Pressure Measurement Accuracy: (Inferred from device function, but not explicitly stated as an acceptance criterion for the cuff itself)	The cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The document does not provide data on the accuracy of blood pressure readings using this cuff, as that is typically evaluated for the measurement system as a whole. The substantial equivalence argument implies it performs similarly to predicate cuffs.

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

The document mentions "Bench and laboratory testing" but does not specify sample sizes for these tests (e.g., number of cuffs tested for biocompatibility, reprocessing, or repeated inflations). It also does not discuss data provenance in terms of country of origin or whether it was retrospective or prospective, as these tests are product performance evaluations rather than clinical data collection.

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

This information is not provided in the document. The tests performed are engineering/laboratory tests (biocompatibility, reprocessing validation, repeated inflations) rather than clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This is not applicable and not provided. The tests described are objective, laboratory-based performance tests, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted or described for this device. This type of study is typically used for diagnostic devices where human readers interpret images or data, and AI assistance might improve their performance. The CRITIKON Soft Blood Pressure Cuff is a physical medical accessory.

6. Standalone (Algorithm Only) Performance

A standalone performance study was not conducted or described. This device is a physical accessory and does not involve an algorithm.

7. Type of Ground Truth Used

For the described tests:

Biocompatibility: Ground truth is established by recognized standards and laboratory protocols for material safety.
Reprocessing Validation: Ground truth is established by adherence to a formal protocol (052496) conceptually based on AAMI TIR No. 12-1994, which details acceptable microbiological and material integrity outcomes after reprocessing cycles.
Repeated Inflations: Ground truth is established by engineering specifications for durability and functional performance over a specified number of inflation cycles (though specific details are not provided).

8. Sample Size for the Training Set

This is not applicable and not provided. The CRITIKON Soft Blood Pressure Cuff is a hardware medical device and does not involve a "training set" in the context of machine learning.

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

This is not applicable and not provided. As mentioned, there is no training set for this type of device.

Summary

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1974080

MAY 1 8 1998

510(k) Summary
-----------------------

Date	October 27, 1997
Contact	Darlene T. KorabSr. Project ManagerRegulatory AffairsJohnson & Johnson Medical, Inc.4110 George RoadTampa, FL 33634Telephone: 813-887-2663Telefax: 813-887-2263E Mail: dkorab@crtus.jnj.com
Device Name	CRITIKON* Soft Blood Pressure CuffThe subject of this premarket notification is a modification of the currentlymarketed Johnson & Johnson Medical, Inc. CRITIKON Soft Blood PressureCuff (formerly DISPOSA-CUF* Soft Blood Pressure Cuff).
Common Name	Blood Pressure Cuff
Classification	The classification name, 21 Code of Federal Regulations (CFR) Part andParagraph number, product code and classification of the CRITIKON SoftBlood Pressure Cuff follow. The tier categorization based on the list (January27, 1994) distributed by the Office of Device Evaluation is also included.

Classification Name	21 CFR Section	Product Code	Class	Tier
Blood Pressure Cuff	870.1120	DXQ	II	2

Continued on next page

(12.05

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510(k) Summary, Continued

Predicate Devices

The CRITIKON Soft Blood Pressure Cuff is substantially equivalent to the CRITIKON (formerly DISPOSA-CUF) Soft Blood Pressure Cuff currently marketed by Johnson & Johnson Medical, Inc. The original DISPOSA-CUF Blood Pressure Cuff received market clearance on May 25, 1979 via Crest Medical Equipment 510(k) K790810. The device is virtually the same as the CRITIKON or DISPOSA-CUF Soft Blood Pressure Cuff . The CRITIKON Soft Blood Pressure Cuff is also substantially equivalent to the CUFF-ABLE* Blood Pressure Cuff currently marketed by Vital Signs, Inc. [Biomedical Dynamics 510(k) K911213] and other soft blood pressure cuffs.

Device	Manufacturer	510(k)
CRITIKON (formerlyDISPOSA-CUF) SoftBlood Pressure Cuff	Johnson & JohnsonMedical, Inc.	K790810
SURGI-CUF* Cuff	Ethox Corp.	K883977
CUFF-ABLE Cuff	Vital Signs, Inc.	K911213
Cuff-m* Cuff	Lorin Medical	K921997
Soft Check* Cuff	Statcorp, Inc.	K940214
Safe-Cuff* Cuff	CAS Medical Systems	Unknown

Device Description

The device is available in the following configurations:

five neonatal and eight pediatric and adult sizes t
single and dual cuff tubing, connectors, adapters and bulb/valve . assemblies available for use with a variety of manual and automated sphygmomanometers

Continued on next page

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510(k) Summary, Continued

(Individual of the state of the many of the same of

: 2018-08-08 11:2

Indications	The CRITIKON Soft Blood Pressure Cuff is an accessory used in conjunctionwith non-invasive blood pressure measurement systems. The device is non-sterile and semi-disposable (may be single-patient use or optional limitedreuse). It is available in neonatal, pediatric and adult sizes. The device is notdesigned, sold, or intended for use except as indicated.
TechnologicalCharacteristics	The CRITIKON Soft Blood Pressure Cuff is virtually the same as theCRITIKON or DISPOSA-CUF Soft Blood Pressure Cuff with the exceptionof a modification of the sleeve material to afford greater patient comfort. TheCRITIKON Soft Blood Pressure Cuff is also virtually the same as the CUFF-ABLE Blood Pressure Cuff and other soft blood pressure cuffs. All the abovedevices are available in range of neonatal, pediatric and adult sizes andconfigurations for use with a wide variety of manual and automatedsphygmomanometers.
Performance	Bench and laboratory testing was conducted to demonstrate performance(safety and effectiveness) of the CRITIKON Soft Blood Pressure Cuff:BiocompatibilityValidation of reprocessingRepeated inflations
Conclusions	In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFRPart 807, and based on the information provided in this premarketnotification, Johnson & Johnson Medical concludes that the modified device,the CRITIKON Soft Blood Pressure Cuff, is safe, effective and substantiallyequivalent to the predicate devices as described herein.
OtherInformation	Johnson & Johnson Medical, Inc. will update and include in this summaryany other information deemed reasonably necessary by the FDA.

・

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Johnson Johnson
MEDICAL INC.

October 6, 1997

Critikon, a division of Johnson & Johnson Medical, Inc., certifies that the instructions for reprocessing for CRITIKON™ Soft Blood Pressure Cuffs as available in the Instructions for Use (P/N 714338) have been validated according to a formal protocol (052496), comprising sound scientific principles and laboratory procedure. The protocol is conceptually based on AAMI TIR No. 12-1994, "Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers." A summary of the validation procedure is attached. The protocol and subsequent laboratory report are archived in Critikon Technical File 103-1 under change control. They will be made available for inspection or supplied to FDA upon request.

John P. Clemmons Critikon R&D

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

MAY | 8 1998

Ms. · Darlene T. Korab Johnson & Johnson Medical, Inc. 4110 George Road Tampa, FL 33634

Re : K974080 CRITIKON® Soft Blood Pressure Cuff Regulatory Class: II (two) Product Code: 74 DXQ February 13, 1998 Dated: Received: February 17, 1998

Dear Ms. Korab ':

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 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, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 In addition, FDA may publish further announcements regulatory action. 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 - Ms. Darlene T. Korab

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 requlation (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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,
Thomas A. Gelesh

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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INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known):

Device Name: CRITIKON* Soft Blood Pressure Cuff

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stepe R. Campbell
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

¥ 974080 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use ﺎ، (per 21 CFR 801.109

Over-The Counter Use (Optional Format 1-2-96)

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).