(83 days)
The DynaPulse 5200A Pathway is indicated for trained medical professionals to operate on patients at clinical settings to collect and measure blood pressure and pulse rate information. In addition, the DynaPulse DPS200A Pathway is indicated for patients at home who are capable and willing to selfadministrate this device upon prescription of their healthcare provider. The DP5200A monitor must be connected to an IBM PC-compatible computer that is concurrently running DP5200A Pathway PC Software. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Noninvasive blood pressure measurement system.
This looks like an FDA 510(k) clearance letter for the DynaPulse 5200A Pathway Blood Pressure Monitor System, rather than a detailed study report with acceptance criteria and performance metrics. Therefore, much of the requested information regarding detailed study results, sample sizes, expert qualifications, and ground truth establishment is not present in this document.
However, I can extract the following relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of specific acceptance criteria or reported device performance metrics (e.g., accuracy, precision) as would be found in a study report. The letter confirms substantial equivalence to a predicate device, implying that its performance is considered acceptable based on comparison to that predicate, but the specific metrics are not detailed here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the FDA clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the FDA clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the FDA clearance letter.
5. 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
This device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool for which an MRMC study or "human improvement with AI" would be relevant. Therefore, this question does not apply to the device described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a non-invasive blood pressure monitor that requires a human to operate it and an IBM PC-compatible computer running specific software. It is not an "algorithm-only" device. The Indications for Use state, "Clinical judgment and experience are required to check and interpret the information delivered." This implies active human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "ground truth" used for testing the blood pressure monitor. For blood pressure devices, the typical ground truth in validation studies involves comparison against a reference standard (e.g., invasive arterial line measurements or a highly calibrated manual sphygmomanometer reading) performed by trained observers, following established protocols (e.g., AAMI, ISO standards).
8. The sample size for the training set
This information is not provided in the FDA clearance letter. The device itself is a measurement device, not a machine learning model that typically relies on a "training set" in the same way.
9. How the ground truth for the training set was established
This information is not provided, and again, the concept of a "training set" and "ground truth establishment" in this context is generally for machine learning algorithms, which is not the primary nature of this blood pressure monitor.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, bold line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2002
Mr. Robert Duffy Director of Product Development Pulse Metric, Inc. 11777 Sorrento Valley Road San Diego, CA 92121
Re: K013478
Trade Name: DynaPulse 5200A Pathway Blood Pressure Monitor System Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system. Regulatory Class: II (two) Product Code: DXN Dated: December 23, 2001 Received: January 2, 2002
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,
Dak Tille
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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DynaPulse 5200A Pathway Non-Invasive Blood Pressure Monitor - K013478 - response 12/23/01
Indications for Use Statement
(U)ST-bod and Drug Administration Center for Devices and Radio Celler line
510(k) Number: K013478
Device Name: DynaPulse 5200A Pathway Non-Invasive Blood Pressure Monitor
Indications for Use:
The DynaPulse 5200A Pathway is indicated for trained medical professionals to operate on patients at clinical settings to collect and measure blood pressure and pulse rate information. In addition, the DynaPulse DPS200A Pathway is indicated for patients at home who are capable and willing to selfadministrate this device upon prescription of their healthcare provider. The DP5200A monitor must be connected to an IBM PC-compatible computer that is concurrently running DP5200A Pathway PC Software. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
| Concurrence Of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use レ | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter-Use (Optional Format 1-2-96)
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510(k) Number
story Devicer
Pulse Metric Confidential
Page 3
§ 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).