The Sensa-Cuff Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

Device Description

The device comprises tubing attached to an 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 non-invasive blood pressure measurement system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Sensa-Cuff Blood Pressure Cuff". The focus of the document is on establishing substantial equivalence to a predicate device, the Critikon DURA-CUF®, rather than a standalone clinical study proving performance against specific acceptance criteria with detailed statistical analysis.

Therefore, many of the requested details about a "study that proves the device meets the acceptance criteria" (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not present in the provided document, as it is a regulatory submission for a Class II medical device based on substantial equivalence.

However, I can extract the acceptance criteria related to general device characteristics and the study performed for comparison.

Here's the information that can be extracted or reasonably inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device and adherence to relevant standards. The "reported device performance" is essentially that the Sensa-Cuff is comparable to the predicate for these features.

Feature / Acceptance Criteria	Predicate Device (DURA-CUF®) Report	Sensa-Cuff Report
Intended Use	Indirect measurement of blood pressure	Indirect measurement of blood pressure
Patient Populations	Adults/pediatrics	Adults/pediatrics
Material	Cuff Substrate: Polyurethane coated nylon woven cloth; Tubing: SE-BS Thermoplastic elastomer; Hook: Molded Nylon; Loop: Nylon	Cuff material: Woven nylon; Film (bladder): Ethylene vinyl acetate copolymer (EVA); Tubing: PVC; Ribbon: Textured polyester; Hook: Molded Nylon; Loop: nylon
Tube Configuration	1 and 2 tube	1 and 2 tube
Sizes (Ranges in cm) (Conforms to AHA bladder size recommendations)	Infant (8-13); Child (12-19); Small Adult (17-25); Adult (23-33); Large Adult (31-40); Thigh (38-50)	Infant (8-13); Child (12-19); Small Adult (17-25); Adult (23-33); Large Adult (31-40); Thigh (38-50)
Repeated Inflations	10,000 inflations	10,000 inflations
Hook and Loop Closures	3,000 hook and loop closures	3,000 hook and loop closures
Compliance with Standards	(Implied by predicate's market clearance)	Tested according to: SP-9 Nonautomated Sphygmomanometer, BS EN 1060 Non-Invasive Sphygmomanometers, ISO 10993 Biological Evaluation of Medical Devices

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes design validation testing according to specified standards (SP-9, BS EN 1060, ISO 10993) and a comparison to a predicate device. It does not describe a clinical "test set" in the context of a diagnostic algorithm or predictive model. The testing refers to physical and performance characteristics of the cuff itself, likely using laboratory methods.
Sample Size: Not explicitly stated for specific tests, but would involve a sufficient number of cuffs or materials to confirm adherence to the mentioned standards and physical properties.
Data Provenance: Not specified, but likely laboratory-based testing rather than clinical patient data. The manufacturer is GE Medical Systems Information Technologies, based in Tampa, FL, USA, so testing would likely be performed in the US or by accredited labs.
Retrospective/Prospective: Not applicable in the context of device characteristic testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the document is about a blood pressure cuff and its physical/performance characteristics, not a diagnostic algorithm requiring expert "ground truth" for a test set. The "ground truth" for the device's performance would be the objective measurements obtained during testing against the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept typically applies to discrepancies in expert readings for diagnostic images or complex clinical data, which is not the subject of this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document is for a medical device (blood pressure cuff), not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers assisting with AI is not relevant and was not performed.

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

Not applicable. The Sensa-Cuff is a passive accessory; it does not contain an algorithm or operate as a standalone diagnostic system in the way this question implies. Its function is to interface with a non-invasive blood pressure measurement system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is adherence to recognized national and international standards for sphygmomanometers (SP-9, BS EN 1060) and biological evaluation of medical devices (ISO 10993), as well as the established physical and performance characteristics of the predicate device (Critikon DURA-CUF®). No clinical "ground truth" from pathology or outcomes data is mentioned or relevant for this type of device submission.

8. The sample size for the training set

Not applicable. The Sensa-Cuff is a physical accessory and does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. The letters are black, and the circle is also black with white accents around the edges.

AUG 1 3 2002

GE Medical Systems Information Technologies

General Electric Company 4502 Woodland Corporate Blvd., Tampa, FL 33614 813 887-2000

SUMMARY OF SAFETY AND EFFECTIVENESS June 24, 2002

Sensa-Cuff

A. Submitter

GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard Tampa, FL 33614

B. Company Contact

Primary: Melissa Robinson, Regulatory Affairs Specialist Phone: 813-887-2133 Fax: 813-887-2552

Secondary:

Tom English, Global QA/RA Phone: 813-887-2107 Fax: 813-887-2413

C. Device Name

Trade Name: Common Name: Classification/Product Code: Sensa-Cuff Blood Pressure Cuff DXQ-870.1120

D. Predicate/Legally Marketed Devices

DURA-CUF®-Preamendment Critikon Company, LLC

E. Device Description

F. Intended Use

The Sensa-Cuff Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

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G. Testing
The Sensa-Cuff Blood Pressure Cuffs were tested according to the applicable sections of the following standards:
•SP-9 Nonautomated Sphygmomanometer
•BS EN 1060 Non-Invasive Sphygmomanometers
•ISO 10993 Biological Evaluation of Medical Devices

H. Comparison to the Predicate Device

COMPARISON OF THE Critikon Sensa-Cuff to the Critikon DURA-CUF®
Features	DURA-CUF®	Sensa-CUFF
Intended Use	Indirect measurement of blood pressure	Indirect measurement of blood pressure
Patient Populations	Adults/pediatrics	Adults/pediatrics
Material	Cuff Substrate: Polyurethanecoated nylon woven clothTubing: SE-BS ThermoplasticelastomerHook: Molded NylonLoop: Nylon	Cuff material: Woven nylonFilm (bladder): Ethylene vinylacetate copolymer (EVA)Tubing: PVCRibbon: Textured polyesterHook: Molded NylonLoop: nylon
Tube Configuration	1 and 2 tube	1 and 2 tube
Sizes(Ranges in cm)	Conform to AHA bladder sizerecommendations• Infant (8-13)• Child (12-19)• Small Adult (17-25)• Adult (23-33)• Large Adult (31-40)• Thigh (38-50)	Conform to AHA bladder sizerecommendations• Infant (8-13)• Child (12-19)• Small Adult (17-25)• Adult (23-33)• Large Adult (31-40)• Thigh (38-50)
Repeated Inflations	10,000 inflations3,000 hook and loop closures	10,000 inflations3,000 hook and loop closures

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2002

GE Medical Systems Information Technologies c/o Mr. Jeff D. Rongero Project Engineer Underwriters Laboratories Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K022482

Trade Name: Sensa-Cuff Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: July 26, 2002 Received: July 29, 2002

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Jeff D. Rongero

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.

Elisa Diaz for

Bram D. Zuckerman, M. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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June 24, 2002

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510(K) Number (if known): _ K 022482

Device Name: Sensa-Cuff 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)

Prescription Use X

(Per 21 CFR 801.109)

Over-The Counter Use

Olish for Bru Zuchn
(Division Sign-Off)
Division of Cardiovascular
8/14/02

nd Respiratory De

510(k) Number

(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).