GSIBP BLOOD PRESSURE CUFF

K012553 · Globalshop, Inc. · DXQ · Aug 17, 2001 · Cardiovascular

Device Facts

• Record ID: K012553
• Device Name: GSIBP BLOOD PRESSURE CUFF
• Applicant: Globalshop, Inc.
• Product Code: DXQ · Cardiovascular
• Decision Date: Aug 17, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The GSIBP blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is nonsterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.

Device Story

GSIBP blood pressure cuff; reusable multi-patient device; used with non-invasive blood pressure measurement systems. Comprised of inflatable latex bladder with stitched nylon or cotton cover; secured to patient limb via hook and loop (Velcro) closure. Tubing connects to measurement system; available in child through large adult sizes. Operated by trained personnel in clinical settings. Device facilitates indirect blood pressure measurement; output provided by connected measurement system; aids clinical decision-making regarding patient cardiovascular status.

Clinical Evidence

Bench testing only. Performance compared to ADCUFF predicate using ANSI/AAMI SP9-1994 standards. Evaluated cuff closure, pressure capacity, and repeated inflation durability (10,000 cycles). Results demonstrated functional and physical equivalence.

Technological Characteristics

Reusable blood pressure cuff; latex bladder; nylon or cotton cover; hook and loop (Velcro) closure. 1 or 2 tube configuration. Pressure range 0-300 mmHg. Non-sterile. Complies with ANSI/AAMI SP9-1994 standards for performance.

Indications for Use

Indicated for child through large adult patients requiring non-invasive blood pressure measurement. Used by trained personnel in conjunction with blood pressure measurement systems.

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

• ADCUFFTM (K962655)

Submission Summary (Full Text)

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# AUG 1 7 2001

KO12553 p.1/2

## SECTION 2: 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________

DATE OF SUBMISSION: SUBMITTER:

July 31, 2001

Mr. Gary C. Bauman Globalshop Inc. 1156 East Ridgewood Ave. Ridgewood NJ 07450 TELEPHONE: [phone] FAX: [phone]

## ESTABLISHMENT

REGISTRATION NO: 2249861

OFFICIAL CONTACT: GARY C. BAUMAN GLOBALSHOP INC. PO BOX 1211 1156 EAST RIDGEWOOD AVE. NJ 07450 TELEPHONE: [phone] FAX: [phone]

#### TRADE NAME: GSIBP CUFF

BLOOD PRESSURE CUFF COMMON/USUAL NAME:

CLASSIFICATION CUFF, BLOOD PRESSURE (CFR 870.1120) NAME:

CLASSIFICATION CARDIOVASCULAR PANEL:

ADCUFFTM PREDICATE DEVICE: AMERICAN DIAGNOSTIC CORP. (K962655)

### INTENDED USE

The GSIBP blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is nonsterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.

> Page 5 of 39 Globalshop Inc.

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K012553 p.2/2

## SECTION 3: DEVICE DESCRIPTION

The device is comprised of one or two tubes attached to an inflatable latex bladder, which is covered with a stitched nylon or cotton cover. The device is wrapped around a patient's limb and secured by a hook and loop closure. The tubing connects to a non-invasive blood pressure measurement system. Sizes will include child through large adult. Each cuff will be packaged in a polyethylene bag.

## COMPARISON WITH PREDICATE DEVICE

| ITEM | GSIBP BLOOD PRESSURE<br>CUFF | ADCUFFTM (K962655) |
|----------------------------|-------------------------------------------|----------------------------------------------|
| INTENDED USE | INDIRECT MEASUREMENT OF<br>BLOOD PRESSURE | INDIRECT<br>MEASUREMENT OF<br>BLOOD PRESSURE |
| ANATOMICAL<br>SITES OF USE | UPPER ARM | UPPER ARM |
| INTENDED<br>POPULATION | CHILD – LARGE ADULT | NEWBORN – LARGE<br>ADULT |
| LABELING | SEE SECTION 5A | SEE SECTION 9A |
| OUTER<br>MATERIAL | NYLON FABRIC OR COTTON | NYLON FABRIC OR<br>COTTON |
| BLADDER<br>MATERIAL | LATEX | LATEX |
| CUFF CLOSURE | VELCRO | VELCRO |
| PRESSURE<br>LIMITS | 0 – 300 mmHg | 0 – 300 mmHg |
| USABLE LIFE | 10,000 INFLATION | 10,000 INFLATION |
| NUMBER OF<br>TUBES | 1 and 2 | 1 and 2 |

### PERFORMANCE DATA

The GSIBP blood pressure cuff was compared to the ADCUFF™ blood pressure cuff to confirm its functional and physical performance characteristics were equivalent. The AAMI SP9: 1994 standard was used to select the relevant performance attributes to measure. The cuffs were equivalent in performance in regards to Cuff Closure, Pressure Capacity and Repeated Inflations as required under the SP9 standard.

## CONCLUSION

In accordance with the FDA 21CFR807 and based on the information provided in this premarket notification, Globalshop Inc. concludes that the GSIBP cuff is safe, effective and substantially equivalent to the ADCUFF predicate device as described herein and meets the relevant requirements of ANSI/AAMI SP9-1994.

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AUG 1 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globalshop, Inc. c/o Mr. Ned Devine Entala, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548

Re: K012553

Trade Name: GSIBP Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulatory Class: Class II (two) Product Code: 78 DXQ Dated: July 31, 2001 Received: August 8, 2001

Dear Mr. Devine:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section 510(x) nevice is substantially equivalent (for the indications for use above and we nave determined the actived predicate devices marketed in interstate commerce stated in the enclosure) to legally markets of the Medical Device Amendments, or to devices that provision in the reasonee with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general omanufacturing 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 (1 charks rippt vary of they of 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 mspotions, and regulation may result in regulatory action. In addition, FDA may publish comply with also Crill regular in the Federal Register. Please note: this

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## Page 2 - Mr. Ned Devine

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Oak Teh

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE SECTION 5B:

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: GSIBP BLOOD PRESSURE CUFF

INDICATIONS FOR USE

Personnel properly trained in the use of blood pressurement devices use the GSIBP blood pressure cuff in conjunction with non-invasive blood pressure measurement systems. The device is non-sterile and is intended as a reusable multipatient device. It is available in child through large adult sizes.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Keh
**Division of Cardiovascular & Respiratory Devices**
**510(k) Number** K012553

Prescription Use (Per zi CFK 801.109)

Globalshop Inc.