(64 days)
The DynaPulse 5000A Mini (ABP) is indicated for trained medical rofessionals to operate on a patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information, including ambulatory monitoring.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report or technical documentation that describes acceptance criteria and device performance in detail. Therefore, most of the requested information cannot be extracted directly from this document.
However, I can extract what is implicitly stated about the device and the nature of its clearance:
Implicit Information from the Document:
- Device Name: DynaPulse 5000A Mini (ABP) Blood Pressure Monitor
- Regulation Number & Name: 21 CFR 870.1130, Non-Invasive Blood Pressure Measurement System
- Regulatory Class: Class II
- Product Code: DXN
- Indication for Use: "The DynaPulse 5000A Mini (ABP) is indicated for trained medical professionals to operate on a patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information, including ambulatory monitoring."
- Substantial Equivalence: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This is the core of the 510(k) process, meaning the device performs as safely and effectively as an existing, legally marketed device.
Information NOT available in provided text:
The document does not contain specific details about acceptance criteria, actual performance data, study design (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment. This information would typically be found in the 510(k) submission itself or in separate study reports, not the FDA clearance letter.
Therefore, I cannot populate the table or answer most of the questions based solely on the given text.
Answer based on available information:
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Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not specified in this document. The FDA clearance indicates the device met the criteria for substantial equivalence to a predicate device, which would involve demonstrating similar performance to a device cleared under 21 CFR 870.1130.
- Reported Device Performance: Not specified in this document beyond being "substantially equivalent" to a predicate device.
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Sample sized used for the test set and the data provenance: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
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Adjudication method for the test set: Not specified.
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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, as this is a blood pressure monitor, not an AI diagnostic device for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a "Non-Invasive Blood Pressure Measurement System" and an "ABP Blood Pressure Monitor," implying it's a standalone measurement device rather than an algorithm aiding human interpretation. The 510(k) clearance indicates it functions as intended as described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified. For blood pressure monitors, ground truth typically involves comparison to a recognized reference standard (e.g., intra-arterial measurement or another validated non-invasive method) in clinical studies.
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The sample size for the training set: Not applicable and not specified. This device is not described as an AI/ML product requiring a training set in the conventional sense. Performance validation would involve clinical testing.
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How the ground truth for the training set was established: Not applicable and not specified.
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Image /page/0/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2001
Mr. Robert Duffy Director of Product Development Pulse Metric, Inc. 11777 Sorrento Valley Road San Diego, CA 92121
Re: K013358
Trade Name: DynaPulse 5000A Mini (ABP) Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 12, 2001 Received: November 16, 2001
Dear Mr. Duffy:
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.
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Page 2 - Mr. Robert Duffy
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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Loddy Teell
- Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
(US) Food and Drog Administration's Center Soc. Device | Fand Radio Jogical Health
510(k) Number: K013358
Device Name: DynaPulse 5000A Mini (ABP) Non-Invasive Blood .?ressure Monitor
Indications for Use:
The DynaPulse 5000A Mini (ABP) is indicated for trained medical rofessionals to operate on a patient at clinical settings to collect and measure blood pressure, pulse rate and pressure waveform information, including ambulatory monitoring.
Concurrence Of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | --------------- |
OR
| Over-The-Counter-Use(Optional Format 1-2-96) | |
|---|---|
| -------------------------------------------------- | --------------- |
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | R013358 |
|---|---|
| --------------- | --------- |
§ 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).