(12 days)
The TM-2430/31 Ambulatory Blood Pressure Monitors are designed to monitor systolic and diastolic blood pressure, and pulse rate of adults who are eighteen (18) years and older using the oscillometric method.
Not Found
The provided text is a 510(k) premarket notification approval letter for the A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure Monitors. This document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a clinical study report or a more technical submission.
Therefore, I cannot directly extract the detailed information requested in the prompt. The document explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This implies that the device's performance was compared to a predicate device, but the specifics of that comparison, including acceptance criteria and study details, are not present in this regulatory letter.
Based on the provided text, the following information is either not present or cannot be determined:
- A table of acceptance criteria and the reported device performance: Not available. The letter only states that the device is "substantially equivalent" to a predicate, not specific performance metrics or acceptance criteria for those metrics.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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 device is an ambulatory blood pressure monitor, not an AI-powered diagnostic imaging tool, so MRMC studies in this context are irrelevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated, but as a blood pressure monitor, its "standalone" performance is its core function. No algorithm-only performance in the context of interpretation is mentioned.
- The type of ground truth used: Not available. For a blood pressure monitor, the "ground truth" would typically refer to a validated reference method for blood pressure measurement, but this is not detailed in the letter.
- The sample size for the training set: Not applicable and not available. As an oscillometric blood pressure monitor, it uses a physiological algorithm rather than a machine learning "training set" in the conventional sense.
- How the ground truth for the training set was established: Not applicable and not available.
Information that can be inferred or is directly stated (but does not fulfill the core request):
- Indications for Use: The TM-2430/31 Ambulatory Blood Pressure Monitors are designed to monitor systolic and diastolic blood pressure, and pulse rate of adults who are eighteen (18) years and older using the oscillometric method.
- Regulatory Class: Class II (Two)
- Product Code: 74 DXN
- Device Type: Ambulatory Blood Pressure Monitors
To answer the questions posed, the relevant document would be the detailed 510(k) submission itself or a clinical validation report, which would describe the testing protocols and results against recognized standards (e.g., AAMI, BHS protocol for blood pressure monitors) that define acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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SEP 1 19999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A&D Medical Division c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Meeting, PA 19462
Re: K992808 A&D Medical TM-2430 and TM 2431 Ambulatory Blood Pressure Monitors Requlatory Class: II (Two) Product Code: 74 DXN Dated: Auqust 19, 1999 Received: Auqust 20, 1999
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. 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.
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Page 2 - Mr. Robert Mosenkis
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) 594-4648. 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Aug-31-99 08:28A A&D Service
K 992808 510(k) Number (if known): __
Device Name: IM-2430 and TM-2431 Ambulatory Blood Pressure Monitors
Or
Indications for Use:
The models TM-2430 and TM-2431 will be referred to as TM-2430/31 except where specific differences occur. The TM-2430/31 Ambulatory Blood Pressure Monitors are designed to monitor systolic and diastolic blood pressure, and pulse rate of adults who are eighteen (18) years and older using the oscillometric method.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ ਮ Over-The-Counter Use
(Optional Format 1-2-96)
Sue K. Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_ 14992808
§ 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).