(185 days)
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to be 7"-15".
noninvasive blood pressure measurement system
This is a 510(k) premarket notification for a blood pressure monitor, not a study report for a medical device that uses AI or image analysis. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance in the context of AI or expert evaluation is not present in the provided text.
The document describes the FDA's clearance of the Mytech Happy Life Blood Pressure Monitor (Models HPL-300 and HPL-300A) as substantially equivalent to a legally marketed predicate device. The core of this clearance is based on the device meeting the requirements for a noninvasive blood pressure measurement system as defined in 21 CFR 870.1130.
Here's what can be extracted and inferred, with explanations for what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Regulation) | Reported Device Performance (Inferred from Clearance) |
|---|---|
| Compliance with 21 CFR 870.1130 (Noninvasive Blood Pressure Measurement System) | Device meets regulatory requirements for its classification. |
| Measurement of systolic and diastolic blood pressure, and pulse rate. | Device is intended for this purpose with an arm cuff. |
| Intended for adult individuals over age 18. | Stated indication for use. |
| Cuff circumference 7"-15". | Stated limitation for use. |
| Performance substantially equivalent to a legally marketed predicate device. | Found to be substantially equivalent by FDA. |
| Good manufacturing practices (21 CFR Part 820) | Assumed compliance for market clearance. |
| Labeling requirements (21 CFR Part 801) | Assumed compliance for market clearance. |
| Annual registration and listing (21 CFR Part 807) | Assumed compliance for market clearance. |
Explanation: The document does not provide specific numerical acceptance criteria (e.g., accuracy +/- X mmHg) or a detailed summary of device performance (e.g., mean difference, standard deviation compared to a reference method). These would typically be found in a detailed test report submitted as part of the 510(k) application, but are not included in the FDA's clearance letter itself. The "reported device performance" in this context is the FDA's determination of substantial equivalence based on the provided data in the 510(k) submission.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the provided text.
- Data provenance: Not specified in the provided text. It is common for these devices to undergo clinical validation studies (e.g., according to ISO 81060-2 or similar standards), which would involve prospective data collection from human subjects. However, the document does not detail this.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. This type of information is relevant for devices involving subjective interpretation, such as image analysis. For a blood pressure monitor, ground truth is typically established by using a highly accurate reference method (e.g., invasive arterial blood pressure measurement or auscultation by trained observers using a mercury sphygmomanometer) performed by trained technicians or medical professionals, not necessarily "experts" in the context of interpretation. The document does not detail the specific methodology for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used when there's subjective interpretation by multiple readers (e.g., radiologists) and a disagreement resolution process is needed. For a blood pressure monitor, the measurements are objective, and while there might be multiple measurements or different observers for the reference method, "adjudication" in this sense is not typically used.
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
- No. This is not relevant for a blood pressure monitor. MRMC studies are specific to diagnostic devices where human readers interpret medical images or data, and AI assistance might augment their performance. This device is a standalone measurement system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, effectively. A blood pressure monitor operates as a standalone device. While a human initiates the measurement and reads the display, the core function (blood pressure measurement) is performed algorithmically by the device itself without human interpretation influencing the measurement outcome. The performance assessment would focus on the accuracy of the device's measurements against a reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Most likely a reference blood pressure measurement method. For blood pressure monitors, the ground truth is typically established using a highly accurate, often invasive or a validated auscultatory method (e.g., mercury sphygmomanometer with trained observers), against which the device's readings are compared. The document does not specify which method was used.
8. The sample size for the training set
- Not applicable / Not specified. The provided document does not mention a training set, as modern AI/machine learning models are not typically involved in the fundamental operation of this type of traditional blood pressure monitor. If the device uses adaptive algorithms, those might be "trained" or calibrated, but the document does not provide details.
9. How the ground truth for the training set was established
- Not applicable / Not specified. As there's no mention of a traditional "training set" in the context of AI/ML, this information is not available.
In summary, the provided FDA clearance letter focuses on regulatory compliance and substantial equivalence for a non-AI medical device. It does not contain the detailed study design, performance results, or expert evaluation specifics that would be present in a study report for an AI-powered diagnostic device.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2003
Mytech Technology Co., Ltd. c/o Ms. Shu Chen Cheng ROC Chinese-European Industrial Research Society CEIRS 2064 Tamarin Drive Columbus, OH 43235
Re: K030221
Trade Name: Mytech Happy Life Blood Pressure Monitor, Model HPL-300 and HPL-300A Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: April 26, 2003 Received: April 30, 2003
Dear Ms. Cheng:
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 - Ms. Shu Chen Cheng
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 (OS) 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely vours.
VQa Til
Drew D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MYTECH TECHNOLOGY CO., LTD.
5F.6, Alley 2, Lane 222, Lien Cheng Road, Chung Ho City, Taipei Hsien, 235, Taiwan, ROC Telephone: 886-2-2247 4816 Fax: 886-2-2247 7024 Email: sale(@mytech.com.tw
Applicant: Mytech Technology Co., Ltd.,
03022 510(k) Number ( if known): ___________________________________________________________________________________________________________________________________________________
Device Name: MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR, HPL300, HPL300A
● Indications for use:
The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to be 7"-15".
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE )
Concurrence of CDRH, office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030221
Prescription Use _**_ OR Over-The-Counter-Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
§ 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).