(90 days)
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No
The summary describes a standard blood pressure monitor with automatic measurement and LCD output, with no mention of AI, ML, or related concepts.
No
The device measures blood pressure and pulse rate, which are diagnostic functions, not therapeutic ones. It does not provide any treatment or therapy.
Yes
The device measures objective physiological parameters (blood pressure and pulse rate), which are used to assess a person's health status, aligning with the definition of a diagnostic device.
No
The description explicitly states the device "automatically measures human's Systolic, Diastolic blood pressure and pulse rate, and output in one LCD Panel." This indicates the presence of hardware components for measurement and display, which is inconsistent with a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description states the device "automatically measures human's Systolic, Diastolic blood pressure and pulse rate". This is a direct measurement of physiological parameters within the body, not an analysis of a sample taken from the body.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
All five models automatically measures human's Systolic, Diastolic blood pressure and Pulse rates, and display the result out in one LCD Panel. The intended use of Models PH168A, PH168E and PH168W is for age 16 and above. The intended use for the Models PHC888JA and PH888HA is for adult patients whose arm circumstance is between 24-32cm (approx. 8.7" to 12.6").
Product codes
DXN
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Arm
Indicated Patient Age Range
The intended use of Models PH168A, PH168E and PH168W is for age 16 and above. The intended use for the Models PHC888JA and PH888HA is for adult patients.
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
SEP 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Proton Health Care Ltd. c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight Inc. 13 Red Fox Lane Littleton, CO 80127
Re: K051565
No1200
Trade Name: Proton Digital Blood Pressure Monitor Models PH168A, PH168W, ade Name: Trees and Proton Blood Pressure Monitor Model PHC888JA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 31, 2005 Received: September 1, 2005
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to comments provision to May 20, 1976, the excordance with the provisions of the Federal Food, DNIg, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allo Cosmetic Act (Act) that do not require app to the general controls provisions of the Act. The I ou may, merciole, market the act include requirements for annual registration, listing of general controls provision 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 If your device is crassified (see above) this. Existing major regulations affecting your device can thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Coursements concerning your device in the Federal Register.
1
Page 2 - Mr. Kevin Walls, RAC
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 (QS) 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 (240) 276-0295. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bismimar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use 510(k) Number (if known): Kul S-15-6 ك
Device Names:
-
- Proton Digital Blood Pressure Monitor, Model PH168A
- Proton Digital Blood Pressure Monitor, Model PH168E 2.
- Proton Digital Blood Pressure Monitor, Model PH168W က
-
- Proton Blood Pressure Monitor, Model PHC888JA
- Proton Digital Blood Pressure Monitor, Model PH888HA 5.
Indications for Use:
All five models automatically measures human's Systolic, Diastolic blood pressure and All five models adtomatically measures haman's Cyclers, and out in one LCD Panel.
The intended use of Models PH168A, PH168E and PH168W is for age 16 and above.
The intended use for the Models PHC888JA and PH888HA is for adult patients whose The Interioed ass for the ween 24-32cm (approx. 8.7" to 12.6").
.
Over-The-Counter Use _ × Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hemmer
(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
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