(17 days)
BP Pro is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).
The BP Pro Blood Pressure Monitor is a fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm. It employs the Oscillometric Principle.
The provided text is a 510(k) summary for the BP Pro Blood Pressure Monitor. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on identical technological characteristics.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The text explicitly states: "The BP Pro Blood Pressure Monitor is identical to the predicate I.E.M. device except for its name, hence it should raise no new questions of safety and effectiveness. This submitter concludes that the BP Pro Blood Pressure Monitor is therefore substantially equivalent to the predicate device." This indicates that the approval is based on equivalence, not a new performance study.
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510(k) Summary
DEC 2 3 2005
| Submitter's Name: | Card Guard Scientific Survival Ltd., |
|---|---|
| Address | 2 Pekeris St. P.O.B. 527 Rehovot 76100, Israel |
| Phone: | 972-8-9484019 |
| Fax: | 972-8-9484005 |
| E-mail: | galex@cardguard.com |
| Contact: | Alex Gonorovsky, RA Manager |
| Date of Summary: | |
| Trade Name: | Blood Pressure Monitor |
| Classification: | Noninvasive Blood Pressure Measurement SystemProduct Code: DXNRegulation Number: 21 CFR 870.1130Class: II |
| Predicate Devices: | K041313 Stabil-O-Graph, Blood Pressure Monitor by I.E.M. |
| Device Description: | The BP Pro Blood Pressure Monitor is a fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm. It employs the Oscillometric Principle. |
| Intended Use: | The BP Pro Blood Pressure Monitor is intended to be used by adults at home to measure blood pressure (systolic and diastolic) and pulse rate from the upper arm. |
| TechnologicalCharacteristics: | The BP Pro Blood Pressure Monitor is identical to the predicate I.E.M. device except for its name, hence it should raise no new questions of safety and effectiveness. This submitter concludes that the BP Pro Blood Pressure Monitor is therefore substantially equivalent to the predicate device. |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2005
Card Guard Scientific Survival, Ltd. c/o Mr. Alex Gonorovsky Manager, Regulatory Affairs 2 Pefris St. P.O.B. 527 Rehovot 76100 ISRAEL
Re: K053395
Trade Name: BP Pro Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 14, 2005 Received: November 16, 2005
Dear Mr. Gonorovsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave acterially marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). alle Costience Act (11ct) that do novice, subject to the general controls provisions of the Act. The f ou may, increfore, market the device, becycer coursements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA), it If your device is classified (500 a0070) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FD may be subject to sach addrenal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. publish further announce of a substantial equivalence determination does not mean i lease oe actives and I Drivination that your device complies with other requirements of the Act
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Page 2 – Mr. Alex Gonorovsky
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that YDA 3 issualted of a backed complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that FDA has made a determination administered by other Federal agencies. You must or any Federal statutes and regulations damindiers of of not limited to: registration and listing (21 comply with an the Act 3 requirements, mercess, and manufacturing practice requirements as set a CFR Part 807); labeling (21 CFR Part 001); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1960 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decions of 1 over device as described in your Section 510(k) I his letter will anow you to begin mankeling your use of your device of your device to a legally premarket notification. The PDA midning of baction 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 If you desire specific advice for Jour 2011 276-0120. Also, please note the regulation entitled, Colliact the Office of Complanes at (210) = if = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Misbranding by reference to premainsonsbilities under the Act from the Division of Small other gelleral informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Adam Fenton
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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Indications for Use
510(k) Number (if known): Device Name: BP Pro Blood Pressure Monitor
Indications for Use:
BP Pro is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aiil Rente For. Brian Zuckerman M.D
(Division Sign-Off)
ivision of Cardiovascular Devices
KOS3395 510(k) Number_
Page I of 1
(Posted November 13, 2003)
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).