(37 days)
To measure of systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.
Full Auto Wrist Digital Blood Pressure Monitor, SE-312
Based on the provided text, the document is a 510(k) clearance letter for the "Full Auto Wrist Digital Blood Pressure Monitor, SE-312" (K012054). This type of document from the FDA primarily focuses on establishing "substantial equivalence" to a predicate device, rather than requiring a detailed study demonstrating device performance against specific acceptance criteria for this particular device.
Therefore, most of the requested information regarding acceptance criteria and performance studies is not present in these documents. The 510(k) process typically relies on comparisons to already-cleared devices to demonstrate safety and effectiveness.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics for this specific device. The entire 510(k) process implies acceptance if substantial equivalence to a legally marketed predicate device is demonstrated for the stated indications for use.
- Reported Device Performance: Not explicitly enumerated in a performance table in these documents. The clearance is based on the comparison to a predicate device, assuming similar performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe a specific test set or clinical study for this device's performance.
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)
- Not applicable. No test set or ground truth establishment process is described for this device in these documents.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is described.
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 device is a blood pressure monitor, not an AI-assisted diagnostic tool. An MRMC study is not relevant here and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical diagnostic monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for this device. The concept of "ground truth" as used for AI/diagnostic algorithms doesn't apply directly to a blood pressure monitor submission in this context. Substantial equivalence relies on comparing the device's design and operating principle to a predicate, and potentially some basic performance data if presented, but not typically a complex ground truth dataset.
8. The sample size for the training set
- Not applicable. This isn't an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This isn't an AI/machine learning device that requires a training set or ground truth for it.
In summary: The provided 510(k) documents grant clearance based on substantial equivalence to a predicate device. They do not contain the details of a de novo clinical study with explicit acceptance criteria and performance data for the "Full Auto Wrist Digital Blood Pressure Monitor, SE-312." Such detailed performance studies are typically found in the 510(k) submission itself (which is not provided) and would compare the device's accuracy against a recognized standard (e.g., AAMI, BHS protocol for blood pressure devices).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2001
Sein Electronics Co., Ltd. c/o Ms. Molly Bettger Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas. WA 98607-8542
Re: K012054
Trade Name: Full Auto Wrist Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulatory Class: Class II (two) Product Code: DXN Dated: July 27, 2001 Received: July 27, 2001
Dear Ms. Bettger:
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 895. A substantially equivalent determination assumes compliance with 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 Federal Register. Please note: this
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Page 2 - Ms. Molly Bettger
response to your premarket 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.
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) 594-4646. Additionally, for questions on the promotion and advertising of your device, (1) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Kark Till
James E. Dillard I 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
| 510(k) Number (if known): | KO12054 |
|---|---|
| Device Name: | Full Auto Wrist Digital Blood Pressure Monitor, SE-312 |
| Indications for Use: | To measure of systolic and diastolic blood pressure andpulse rates of adults using wrist cuff and oscillometricmethod. |
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dan Till
Division of Cardiovascular & Respiratory Devices
510(k) Number K012054
Prescription Use _ (Per 21 CFR 801.109) or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
the state of the state of the status and the subject of
§ 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).