(9 days)
No
The device description and performance studies focus on the physical characteristics and basic function of a blood pressure cuff, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is described as a blood pressure cuff used "in conjunction with non-invasive blood pressure measurement systems." Its function is to facilitate measurement, not to treat a condition. While it is a medical device, it is diagnostic, not therapeutic.
No
The device is a blood pressure cuff, which is a component used in blood pressure measurement systems. While blood pressure measurement can be used for diagnostic purposes, the cuff itself is not a diagnostic device; it is a vital sign measurement device that collects data for a diagnostic system.
No
The device description clearly states it is a blood pressure cuff, which is a physical hardware component. It is not described as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used "in conjunction with non-invasive blood pressure measurement systems." It is a component used externally on the body to facilitate a physiological measurement.
- Device Description: The description details a physical cuff with a bladder and tubing, designed to be wrapped around a limb. This is a mechanical device for applying pressure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would involve testing in vitro (outside of the living body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This blood pressure cuff does not perform such a function.
N/A
Intended Use / Indications for 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.
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.
Product codes
78 DXQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
UPPER ARM
Indicated Patient Age Range
CHILD – LARGE ADULT
Intended User / Care Setting
personnel properly trained
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
CUFF | ADCUFFTM (K962655) |
|----------------------------|-------------------------------------------|----------------------------------------------|
| INTENDED USE | INDIRECT MEASUREMENT OF
BLOOD PRESSURE | INDIRECT
MEASUREMENT OF
BLOOD PRESSURE |
| ANATOMICAL
SITES OF USE | UPPER ARM | UPPER ARM |
| INTENDED
POPULATION | CHILD – LARGE ADULT | NEWBORN – LARGE
ADULT |
| LABELING | SEE SECTION 5A | SEE SECTION 9A |
| OUTER
MATERIAL | NYLON FABRIC OR COTTON | NYLON FABRIC OR
COTTON |
| BLADDER
MATERIAL | LATEX | LATEX |
| CUFF CLOSURE | VELCRO | VELCRO |
| PRESSURE
LIMITS | 0 – 300 mmHg | 0 – 300 mmHg |
| USABLE LIFE | 10,000 INFLATION | 10,000 INFLATION |
| NUMBER OF
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.
2
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
3
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
4
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.