(64 days)
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No
The provided 510(k) summary does not mention AI, ML, or any related technologies. The description focuses on standard blood pressure monitoring functions.
No.
The device is used to collect and measure blood pressure, pulse rate, and pressure waveform information, which are diagnostic/monitoring functions, not therapeutic.
Yes
The device is indicated for collecting and measuring blood pressure, pulse rate, and pressure waveform information, which are physiological parameters used to assess a patient's health status. While it doesn't explicitly state "diagnosis," the collection of such physiological data by medical professionals in clinical settings for medical purposes inherently points towards its use in identifying or monitoring medical conditions, thus serving a diagnostic function.
No
The summary describes a device that collects and measures blood pressure, pulse rate, and pressure waveform information, including ambulatory monitoring. This functionality typically requires hardware components (like a cuff and sensor) to interact with the patient and acquire physiological data. The lack of a device description and the nature of the measurements strongly suggest it is not software-only.
Based on the provided information, the DynaPulse 5000A Mini (ABP) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "collect and measure blood pressure, pulse rate and pressure waveform information" by operating "on a patient". This describes a device that interacts directly with a living patient to obtain physiological measurements.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices that are used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. The DynaPulse 5000A Mini does not appear to be used for analyzing such specimens.
The description points to a device used for in vivo measurements (measurements taken within a living organism), specifically blood pressure monitoring.
N/A
Intended Use / Indications 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.
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
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Intended User / Care Setting
trained medical professionals / clinical settings
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).
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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 |
|---|---|
| --------------- | --------- |