The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is non-sterile and reusable.

Device Description

The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs consists of an integrated inflatable cuff bladder manufactured from Urethane coated nylon. The cuff is closed with a hook and loop fastening system (Loop with vinyl backing and Vinyl Hook). The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are reusable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC, ABS or Nylon) for use with most monitoring systems.
Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are available in the following configurations:
Six sizes (Child, Sm. Adult, Adult, Adult Long, Large Adult, Thigh)
Single Tube configuration with 6 types of connectors
Double Tube configuration with 2 types of connectors

AI/ML Overview

The provided text describes the SURGI-CUF® REUSABLE Blood Pressure Cuffs, but it does not contain information about acceptance criteria, reported device performance, or a study involving AI or human readers. The document is a 510(k) summary for a medical device regulatory submission, focusing on establishing substantial equivalence to predicate devices primarily through physical characteristics and adherence to recognized standards for safety and effectiveness.

Therefore, I cannot fulfill your request for the specific details outlined, as those are not present in the provided text.

Here's what I can extract based on the information available:

1. A table of acceptance criteria and the reported device performance

Not available in the provided text. The document states that performance was demonstrated per AAMI SP10:2002 and AAMI / ANSI / ISO 10993-1:2003(E) but does not list specific acceptance criteria or performance metrics.

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

Not available in the provided text. The document mentions "Bench and laboratory testing" but does not provide details on sample sizes or data provenance.

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)

Not applicable/Not available in the provided text. This type of information is relevant for studies involving diagnostic interpretation (e.g., imaging devices, AI algorithms), which is not the subject of this document.

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

Not applicable/Not available in the provided text. See point 3.

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 such study was done. This document is for a blood pressure cuff and does not involve AI or human reader performance.

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

Not applicable/Not available in the provided text. This document is for a physical medical device (blood pressure cuff), not an algorithm.

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

Not applicable/Not available in the provided text. The performance was demonstrated against technical standards for blood pressure cuffs and biological evaluation, not against clinical ground truth in the manner of diagnostic algorithms.

8. The sample size for the training set

Not applicable/Not available in the provided text. This device does not involve a training set as it is not an AI-driven system.

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

Not applicable/Not available in the provided text. See point 8.

Study described (bench and laboratory testing):
The substantial equivalence of the SURGI-CUF® REUSABLE Blood Pressure Cuffs was demonstrated through "Bench and laboratory testing" to conform to the following standards:

AAMI SP10:2002, Manual, electronic or automated sphygmomanometers: This standard would address the performance characteristics of the blood pressure cuff itself, likely including aspects like accuracy of pressure transmission, durability, and functional integrity.
AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices — Part 1: Evaluation and testing User Validation: This standard relates to the biocompatibility of the materials used in the device when in contact with the patient, ensuring it does not cause adverse biological reactions.

The document emphasizes that the device has "the same intended use and general construction" as its predicate devices, suggesting that the primary evidence for substantial equivalence relies on design similarity and compliance with recognized safety and performance standards for this type of device, rather than extensive clinical efficacy studies comparing it to a "ground truth" using complex metrics.

Summary

{0}------------------------------------------------

K061962
p 1/2

Attachment 3

510(k) Summary

Date:	April 19, 2006
Submitter:	Ethox International, Inc.251 Seneca StreetBuffalo, New York USA 14204-2088Tel: 716-842-4000Fax: 716-842-4040
	JUL 25 2006
	John Riggi, VP of Quality Assurance & Regulatory Affairsriggi@ethoxint.com
Device Name:	SURGI-CUF® REUSABLE Blood Pressure Cuffs
Common/ Usual Name:	Blood Pressure Cuff
Product Code/ Classification:	DXQ / 21CFR870.1120
Intended Use:	Indirect measurement of blood pressure
Indications for Use:	The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is non-sterile and reusable.
Device Description:	The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs consists of an integrated inflatable cuff bladder manufactured from Urethane coated nylon. The cuff is closed with a hook and loop fastening system (Loop with vinyl backing and Vinyl Hook). The Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are reusable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC, ABS or Nylon) for use with most monitoring systems.Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are available in the following configurations:Six sizes (Child, Sm. Adult, Adult, Adult Long, Large Adult, Thigh)Single Tube configuration with 6 types of connectorsDouble Tube configuration with 2 types of connectors

{1}------------------------------------------------

Predicate

Devices:

The SURGI-CUF® REUSABLE Blood Pressure Cuff is substantially equivalent to the following predicate devices:

K022482; Sensa-Cuff; GE Medical Systems Information Technologies

Preamendent; CRITIKON DURA-CUF®; Critikon Company, LLC.

K040286, SURGI-CUF®; Ethox Corporation

The SURGI-CUR® REUSABLE Blood Pressure Cuff has the same intended use and general construction as the predicate devices. All four devices contain a bladder and hook & look fastening system. The SURGI-CUF® REUSABLE and DURA-CUF® arc made of the same material. The SURGI-CUF® REUSABLE and SURGI-CUF® are available in the same sizes.

Performance:

Bench and laboratory testing to demonstrate safety and effectiveness per:

AAMI SP10:2002, Manual, electronic or automated sphygmomanometers
AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing User Validation

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.

JUL 25 2006

Ethox International, Inc. c/o Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Service NA, Inc. 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087

Re: K061962

Trade Name: SURGI-CUF® REUSABLE Blood Pressure Cuffs Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: July 11, 2006 Received: July 12, 2006

Dear Mr. Devine:

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.

{3}------------------------------------------------

Page 2 - Mr. Neil E. Devine, Jr.

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 (OS) 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Zukerman, MD

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

Enclosure

{4}------------------------------------------------

K061962

Attachment 2

Statement of Indications for Use

Device Name: SURGI-CUF® REUSABLE Blood Pressure Cuffs

Indications for Use: The SURGI-CUF® REUSABLE Blood Pressure Cuff is a bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure. The device is nonsterile and reusable.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Brimmin

(Division Sign-Off) Division of Cardlovascular Dovices 510(k) Number K/ v/962

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).