SURGI-CUF REUSABLE, RS SERIES

K061962 · Ethox International · DXQ · Jul 25, 2006 · Cardiovascular

Device Facts

• Record ID: K061962
• Device Name: SURGI-CUF REUSABLE, RS SERIES
• Applicant: Ethox International
• Product Code: DXQ · Cardiovascular
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended 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 Story

Reusable, non-sterile blood pressure cuff consisting of an inflatable bladder made of urethane-coated nylon; secured via hook and loop fastening system (vinyl hook/loop with vinyl backing). Device includes PVC tubing with various connectors (PVC, ABS, or Nylon) to interface with standard blood pressure monitoring systems. Available in six sizes ranging from child to thigh. Used in clinical settings to facilitate indirect blood pressure measurement by connecting to external monitoring equipment. Benefits include reusability and compatibility with multiple monitoring platforms.

Clinical Evidence

Bench testing only. Compliance with AAMI SP10:2002 for manual, electronic, or automated sphygmomanometers and AAMI/ANSI/ISO 10993-1:2003 for biological evaluation.

Technological Characteristics

Materials: Urethane-coated nylon bladder, vinyl hook/loop fasteners. Connectivity: PVC tubing with PVC, ABS, or Nylon connectors for external monitoring systems. Sizes: Child, Sm. Adult, Adult, Adult Long, Large Adult, Thigh. Configuration: Single or double tube. Standards: AAMI SP10:2002, ISO 10993-1:2003.

Indications for Use

Indicated for use as a bladder and tube set with blood pressure monitoring systems to determine blood pressure in patients of various sizes (Child, Small Adult, Adult, Adult Long, Large Adult, Thigh).

Regulatory Classification

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.

Predicate Devices

• Sensa-Cuff (K022482)
• CRITIKON DURA-CUF (Preamendent)
• SURGI-CUF (K040286)

Submission Summary (Full Text)

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K061962
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# Attachment 3

## 510(k) Summary

| Date: | April 19, 2006 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Ethox International, Inc.<br>251 Seneca Street<br>Buffalo, New York USA 14204-2088<br>Tel: [phone]<br>Fax: [phone] |
| | JUL 25 2006 |
| | John Riggi, VP of Quality Assurance & Regulatory Affairs<br>[e-mail] |
| 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.<br>Ethox SURGI-CUF® REUSABLE Blood Pressure Cuffs are available in the following configurations:<br><ul><li>Six sizes (Child, Sm. Adult, Adult, Adult Long, Large Adult, Thigh)</li><li>Single Tube configuration with 6 types of connectors</li><li>Double Tube configuration with 2 types of connectors</li></ul> |

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## 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:

б

- 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

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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.

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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 [phone]. 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 [phone] or [phone] 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

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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