(78 days)
S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, diastolic blood pressure and pulse rate. The cuff circumference is 13.5~22cm for adult individual in a home environment.
Not Found
While the provided text describes the FDA's clearance of the Rossmax S380 and K350 Blood Pressure Monitors (K052727), it does not contain the detailed information required to fulfill your request regarding acceptance criteria and the specific study that proves the device meets those criteria.
The document is a clearance letter, indicating that the device has been deemed "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for market entry, but it does not intrinsically detail the technical performance studies and their specific results that led to this determination.
Here's a breakdown of why I cannot provide the requested information from this document:
- No Acceptance Criteria Table or Reported Performance: The document is a regulatory approval letter, not a performance study report. It does not list specific acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or the actual performance metrics achieved by the device in testing.
- No Information on Sample Size, Data Provenance, Experts, or Adjudication: These details are typically found in the clinical or performance study reports submitted to the FDA, which are not part of this clearance letter.
- No MRMC, Standalone, or Ground Truth Details: The document does not discuss MRMC studies, standalone algorithm performance, or how ground truth was established for any testing.
- No Training Set Information: Similarly, details about the training set size or how its ground truth was established would be in a technical report, not an FDA clearance letter.
To obtain the information you're looking for, you would typically need to:
- Access the full 510(k) submission: Sometimes, the FDA makes portions or summaries of 510(k) submissions publicly available. These often include more detailed information about performance testing.
- Refer to the manufacturer's documentation: The device's official instructions for use or technical specifications would likely contain greater detail on its performance claims and the standards it meets.
- Look for published clinical studies: If the device has been the subject of independent clinical research, those papers would contain the requested methodological details.
In summary, the provided FDA clearance letter K052727 confirms the market approval of the Rossmax S380 and K350 Blood Pressure Monitors but does not contain the specific performance study details, acceptance criteria, or methodological information you requested.
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Public Health Service
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DEC 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rossmax International Ltd. c/o Mr. Tzu-Wei Li Manager Industrial Technology Research Institute Bldg. 16, 321 Kuang Fu Rd. Sec. 2 Hsinchu Taiwan 30042 R.O.C.
Re: K052727
K052727
Trade Name: Rossmax S380 and K350 Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 15, 2005 Received: November 17, 2005
Dear Mr. Li:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematics from stantially equivalent (for the indications for referenced above and nave decimined the aconvents marketed in interstate comments, or to devices that use stated in the enclosure) to legally man color of the Medical Device Amendments, or to devices that prior to May 28, 1976, the enactinent date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Pedication (PMA). You may have been reclassified in accordance with the provisition (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the general Act (Act) that do not require approval of a premainco sprovisions of the Act. The general therefore, market the device, subject to the general semannial registration, listing of devices, good
controls provisions of the Act include requirements for annual regulters controls provisions of the Act merade requirements assust misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo eliner regulations affecting your device can be may be subject to such adultional controls. Existing of the South and States of Financial of found in the Code of Feach in a and in the Federal Register.
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Page 2 – Mr. Tzu-Wei Li
Please be advised that FDA's issuance of a substantial equivalence determination access of the At Please be advised that FDA 's Issualice of a substance of the requirements of the Act or that FDA has made a deletinination that your devices of agencies. You must comply with any Federal Statutes and regulations administered of by but not listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration and lists i all the Act s requirements, menufacturing practice requirements as set forth in the quality [abeling (21 CFR 1 art 801), good manadiation production of the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic prod Systems (QB) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050. control provisious (Sections 551-942 or the 110), device as described in your Section 510(k)
This letter will allow you to begin marketing your device to a loggios to loggi I his letter will anow you to begin maneting your avree quivalence of your everyte your doys premarket nothication. The PDA midning of sactainled of a lovice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your device of your access note the regulation entitled, contact the Office of Compilance at (210) 276 - 3279 Part 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may " Misoraliding of reference to promation in the Act from the Division of Small
general information on your responsibilities under the Act from the Division of Small general information on your responsionates and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the constitudes html Manufacturers, International and Consulter Assistance and Collectivindustry/support/index.html.
Sincerely yours,
Blumman 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):
Device Name: Rossamx S380, K350 Blood Pressure Monitors
Indications For Use:
S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, S380, K.350 are non-invasive blood prossure menters and .5~22cm for adult individual in a home environment.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blossom
510(k) Number
Page 1 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).