(55 days)
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD PANEL.
One or two readings will not provide a true indication of your normal blood Ghe of the is very important to take regular, daily measurements and to keep prood. I would be and home. (Try to measure your blood pressure at the same time each day for consistency). In partnership with your doctor, an accurate record of your blood pressure over a period of time can be a valuable aid in diagnosing and preventing potential health problems.
Not Found
This 510(k) summary does not contain the detailed study information needed to fully answer all aspects of the request. The document is primarily a clearance letter from the FDA, confirming substantial equivalence to a predicate device, rather than a full study report.
Here's an analysis of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and reported device performance:
This information is not provided in the given document. The FDA clearance letter typically summarizes the finding of substantial equivalence but does not detail the specific performance metrics or acceptance criteria used by the manufacturer in their submission.
2. Sample size used for the test set and the data provenance:
This information is not provided in the given document. The document is a regulatory clearance letter, not a clinical study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given document.
4. Adjudication method for the test set:
This information is not provided in the given document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
This information is not provided in the given document. This type of study is more common for diagnostic imaging devices, whereas this device is a blood pressure monitor.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device described is a "Full Automatic (NIBP) Blood Pressure Monitor," which by its nature operates standalone to measure blood pressure. The "algorithm" here refers to the internal processing of the oscillometric method to derive blood pressure and heart rate. However, the document does not provide details of a specific standalone study or its performance metrics.
7. The type of ground truth used:
Given the device measures blood pressure, the ground truth would typically be reference blood pressure measurements obtained from a validated method (e.g., auscultatory method with a mercury sphygmomanometer) as per established standards for blood pressure device validation (e.g., ANSI/AAMI/ISO 81060-2). However, the document does not explicitly state the type of ground truth used in the manufacturer's testing.
8. The sample size for the training set:
This information is not provided in the given document. As the device likely uses an established oscillometric algorithm, there might not be a "training set" in the machine learning sense for its core function, but rather a validation against a reference standard. If machine learning were involved, the document does not elaborate.
9. How the ground truth for the training set was established:
This information is not provided in the given document.
In summary, the provided document is an FDA clearance letter for a blood pressure monitor. It confirms that the device was deemed "substantially equivalent" to predicate devices, meaning it has similar indications for use and safety/effectiveness profiles. However, it does not include the detailed technical or clinical study data (such as acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics) that would have been part of the manufacturer's 510(k) submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
MAR 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Health and Life Co, Ltd. c/o Mr. Paul Hung Manager, Regulation Department 9F, NO. 186, Jian Yi Road Chung Ho City, Taipei Hsien (235) Taiwan R.O.C.
Re: K050249
K 050249
Trade Name: H&L Full Automatic (NIBP) Blood Pressure Monitor (HL168JP) Regulation Number: 21 CFR 870.1130 Regulation Name: 21 OF R 07071159
Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 21, 2005 Reccived: March 23, 2005
Dear Mr. Hung:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati we have reviewed your Section 910(x) premained in substantially equivalent (for the indications felerenced above and have determined the assessed predicate devices marketed in interstate for use stated in the encrosule) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Drug commerce prior to May 28, 1970, the chaemient auto shown of the Federal Food, Drug, devices that have been reclassified in accordance whiles approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, lighten, diginal You may, merelore, market the devree, salges to the general registration, listing of
general controls provisions of the Act include requirements for annual registration, list general controls provisions of the necesses of the adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (see above) nito entist sure regulations affecting your device can
may be subject to such additional controls. Existing major regulations diDame may be subject to such additional controller Existing may one of the 21, In addition, I'DA may be found in the Code of Peachartergerning your device in the Federal Register.
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Page 2 -- Mr. Paul Hung
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a subscunter oquirements of the Act
that FDA has made a determination that your device Forexal agencies. You must that FDA has made a determination that your develop of er Federal agencies. You must
or any Federal statutes and regulations administered by other registration and listing or any Federal statutes and regulations administed or registration and listing (2)
comply with all the Act's requirements, including, but not treation requirements as set comply with all the Act s requirences, menames our open ice requirements as set
CFR Part 807); labeling (21 CFR Part 801); groom at 200); explicable, the electronic CFR Part 807); labeling (21 CFR Part on ); good manananing manufacelle, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Scetions 35 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your active ap walence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your d premarket notification. The FDA inding of substantial equivation of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs of the may be and and 100 and been the regulation entitled If you desire specific advice for your de need on our of not a Also, please note the regulation entitled, white contact the Office of Complance at (246) 276 of (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to premarket noutheausneder the Act from the Division of Small
other general information on your responsibilities under the Act from www.org.000 other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-demanain html Manufacturers, International and Combanier 14-15-1
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Brimmer for
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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Indications for Use
510(k) Number (if known): K050249
Device Name: H & L Full Automatic (NIBP) Blood Pressure Monitor, HL168 JP
Indications for Use:
Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD PANEL.
One or two readings will not provide a true indication of your normal blood Ghe of the is very important to take regular, daily measurements and to keep prood. I would be and home. (Try to measure your blood pressure at the same time each day for consistency). In partnership with your doctor, an accurate record of your blood pressure over a period of time can be a valuable aid in diagnosing and preventing potential health problems.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blummo
§ 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).