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.

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.

AI/ML Overview

The GSIBP Blood Pressure Cuff was evaluated against the AAMI SP9: 1994 standard to confirm its functional and physical performance characteristics were equivalent to the predicate device, ADCUFF™.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from AAMI SP9: 1994)	Reported Device Performance (GSIBP Blood Pressure Cuff)
Cuff Closure	Equivalent to ADCUFF™
Pressure Capacity	Equivalent to ADCUFF™
Repeated Inflations	Equivalent to ADCUFF™

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the provided text. The document mentions "The cuffs were equivalent in performance," implying a comparative study was performed, but the number of cuffs or trials is not detailed.
Data Provenance: Not explicitly stated. Given that it's a conformity assessment to a standard for a medical device submitted to the FDA, it is highly likely a prospective study was conducted by the manufacturer, or a third-party laboratory. The country of origin of the data is not mentioned, but the submitting company is Globalshop Inc. (USA) and the predicate device is from American Diagnostic Corp. (USA), suggesting a US-centric context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the study involved objective physical performance testing against a standard, not expert interpretation of results that would require ground truth establishment by experts in the typical clinical sense. The "ground truth" here is the adherence to the engineering and performance specifications outlined in the AAMI SP9: 1994 standard.

4. Adjudication method for the test set:

Not applicable. The performance criteria are objective and measurable against the AAMI SP9: 1994 standard, not subjective interpretations requiring adjudication.

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:

Not applicable. This is a comparison of two physical medical devices (blood pressure cuffs) against a technical standard, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used:

The ground truth used was the specifications and performance requirements outlined in the ANSI/AAMI SP9-1994 standard for non-invasive blood pressure measurement devices. The GSIBP cuff was compared to the ADCUFF™ predicate device to confirm equivalence against these criteria.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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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: 201-444-7204 FAX: 201-444-8697

ESTABLISHMENT

REGISTRATION NO: 2249861

OFFICIAL CONTACT: GARY C. BAUMAN GLOBALSHOP INC. PO BOX 1211 1156 EAST RIDGEWOOD AVE. NJ 07450 TELEPHONE: 201-444-7204 FAX: 201-444-8697

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

COMPARISON WITH PREDICATE DEVICE

ITEM	GSIBP BLOOD PRESSURECUFF	ADCUFFTM (K962655)
INTENDED USE	INDIRECT MEASUREMENT OFBLOOD PRESSURE	INDIRECTMEASUREMENT OFBLOOD PRESSURE
ANATOMICALSITES OF USE	UPPER ARM	UPPER ARM
INTENDEDPOPULATION	CHILD – LARGE ADULT	NEWBORN – LARGEADULT
LABELING	SEE SECTION 5A	SEE SECTION 9A
OUTERMATERIAL	NYLON FABRIC OR COTTON	NYLON FABRIC ORCOTTON
BLADDERMATERIAL	LATEX	LATEX
CUFF CLOSURE	VELCRO	VELCRO
PRESSURELIMITS	0 – 300 mmHg	0 – 300 mmHg
USABLE LIFE	10,000 INFLATION	10,000 INFLATION
NUMBER OFTUBES	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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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with the bird figure in the center.

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 (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 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/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

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.

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).