(198 days)
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No
The description focuses on standard oscillometric blood pressure measurement and preprogrammed sequential measurements, with no mention of AI or ML terms or functionalities.
No
The device is described as measuring blood pressure and pulse rate for monitoring purposes, not for treating or preventing a condition.
Yes
The device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly states it is a hardware device that measures blood pressure using an upper arm cuff and the oscillometric method, with software used for programming.
Based on the provided information, the Meditech ABPM-04 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device function: The Meditech ABPM-04 measures blood pressure and pulse rate directly from the patient's upper arm using a cuff and the oscillometric method. It does not analyze any specimens taken from the body.
- Intended Use: The intended use describes measuring blood pressure and pulse rate in adult patients under ambulatory circumstances. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the Meditech ABPM-04 falls under the category of a non-IVD medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
The Meditech ABPM-04 device automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
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
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Indicated Patient Age Range
adult patients
Intended User / Care Setting
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is surrounded by a circular border containing the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2005
MEDITECH KFT. c/o Mr. Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187 ISRAEL
Re: K051149
Trade Name: Meditech ABPM-04 Ambulatory 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: May 4, 2005 Received: May 4, 2005
Dear Mr. Arazy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 -- Mr. Benny Arazy
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) 276-0120. 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,
Blimimton for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
8.3 Indications for Use
510(k) Number (if known): Not applicable
Device Name: Noninvasive Blood Pressure Measurement System, Meditech ABPM-04
Indications for Use:
The Meditech ABPM-04 device automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
Image /page/2/Picture/5 description: The image shows a logo with the word "Modtech" in a stylized font at the top left. To the right of the word is a grid of nine circles, with eight of them filled in black and one in the bottom right corner left white. The logo appears to be for a technology-related company or product.
Meditech Kit, - Orvosi F 1191 Budapest, Ulloi ut . Adoszára: 10397880-
Prescription Use
・・・
AND / OR
Over-the-Counter Use
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
Srilanka
General Manager (Name & Signature)
4-12-05
Date
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Brammer
Page 1 of 1
on sign-om Islon of Cardiovascular Devic 510(k) Number 15/140
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