(142 days)
Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.
Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-30cm.
Fully Automatic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy requirements of ANSI/AAMI SP10-2002 | The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions that "Clinical tests were performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focused on the device's accuracy against a standard (ANSI/AAMI SP10-2002), not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The clinical tests were performed to assess the "Fully Automatic Electronic Blood Pressure Monitor" against the accuracy requirements of ANSI/AAMI SP10-2002. This implies an evaluation of the device's algorithmic performance in measuring blood pressure and pulse rate without human-in-the-loop adjustments during the measurement.
7. Type of Ground Truth Used
The ground truth used was the accuracy requirements of ANSI/AAMI SP10-2002. This standard defines the acceptable error limits for non-invasive blood pressure measurement devices.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. Given the context of a 510(k) for a blood pressure monitor, the "training set" concept (as understood in machine learning) might not be directly applicable in the same way. The device's underlying algorithm is likely developed based on established oscillometric principles rather than being "trained" on a large dataset in the modern AI sense.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how ground truth for a training set was established. (See the explanation in point 8 regarding the applicability of the "training set" concept here). The device's accuracy is evaluated against a pre-defined industry standard.
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510(k) Summary
AUG 1 5 2007
Identification of the submitter:
Kodon (Tianjin) Electronic & Electrical Apparatus Submitter: Co., LTD No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-6052 8012 Telephone number: 86-22-6052 6162 Fax number: Contact: Liu Yi Date of Application: 07/02/07
Identification of the product:
| Trade Name: | Fully Automatic Electronic Blood Pressure Monitor,Models: KD-593, KD-595, KD-596, KD-598 |
|---|---|
| Common name: | Noninvasive blood pressure measurement systems |
| Classification name: | Noninvasive blood pressure measurement systemClass per 21 CFR 870.1130 |
Marketed Devices to which equivalence is claimed:
| Device | manufacture | 510(k) | number |
|---|---|---|---|
| KD-622 | Kodon (Tianjin) Electronic and ElectricalApparatus Co., Ltd. | K030358 |
Device description:
Fully Automatic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.
Intended use:
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Image /page/1/Picture/0 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The first line reads 'K070828', with the 'K' being a letter and the rest being numerical digits. Below this, there's another line that reads 'p. 212', where 'p' is a lowercase letter followed by a period, and '212' is a three-digit number.
Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.
Comparison of technological characteristics of new device to predicate devices:
The design of Fully Automatic Measurement Electronic Blood Pressure Monitor utilizes Oscilliometric measurement method, with an electronic interface module and a silicon integrate pressure sensor and a cuff automatically inflated and released by an internal pump over the left upper arm to obtain blood pressure signals in the same manner as the predicate device.
In addition, we adopt a new technological method in developing the device so that it has a series of new functions, such as blood pressure level classification and date and time displayed in large screen.
Clinical Tests:
Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-2002.
Non-clinical Tests:
non-clinical tests coincide the following standards, including All Electromagnetic Compatibility test. Product Safety test and Biocompatibility test.
EN60601-1-2 72001
Medical electrical equipment----Part 1-2:General requirements for safety ٦ Collateral standards: Electromagnetic compatibility; Requirements and test. IEC60601-1: 1998+A1:1991+A2:1995
Medical electrical equipment --- Part 1: General requirements for basic safety and essential performance
ISO 10993-5
Biological evaluation of medical device --- part 5: Test for in vitro cytotoxicity. ISO 10993-10
Biological evaluation of medical device --- part 10: Tests for irritation and delayed type hypersensitivity.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2007
Kodon (Tianjin) Electronic & Electrical Apparatus, Co. c/o Mr. Liu Yi No. 31, Changjiang Road, Nankai District Tianjin, China 300193
Re: K070828
Trade Name: Fully Automatic Electronic Blood Pressure Monitor, Models KD-593, KD-595, KD-596, KD-598 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: Not provided Received: July 6, 2007
Dear Mr. Yi:
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, U.A.mav publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Liu Yi
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B/Bumimo 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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Statement of Indications for Use
K070828 510(k) Number: -
Kodon (Tianjin) Electronic & Electrical Apparatus Co. LTD Applicant:
Device name: Eully Automatic Electronic Blood Pressure Monitor Models: KD-593, KD-595, KD-596, KD-598
Indications for use:
Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-30cm.
Prescription use _ _ _ _ _____________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use YES (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B/Kummema
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ision Sign-Off)
Dision of Cardiovascular Devices
510(k) Number ka70828
§ 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).