(270 days)
The KD-622 Fully 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 8.6614 inches to 13.78 inches.
KD-622 Fully Automatic Electronic 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, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint 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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, presented in the requested format:
The provided text for K030358, the KD-622 Fully Automatic Electronic Blood Pressure Monitor, is a 510(k) summary and FDA clearance letter. It primarily describes the device, its intended use, and claims substantial equivalence to a predicate device. While it mentions "Clinical Tests" and "accuracy requirements of ANSI/AAMISP10-1992", it does not provide detailed information about the acceptance criteria or the study methodology, sample sizes, expert qualifications, or ground truth establishment for that study.
Therefore, most of the requested information cannot be extracted directly from the provided text.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/AAMI SP10-1992 Accuracy requirements for non-invasive sphygmomanometers (This standard defines accuracy requirements for both systolic and diastolic blood pressure measurements) | "The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The clinical tests were performed to comply with ANSI/AAMI SP10-1992. The submitter is a Chinese company, so the tests were likely conducted in China, but this is not explicitly stated. It is standard for these types of studies to be prospective, but this is not confirmed in the text.
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)
- Number of Experts: Not specified in the provided document.
- Qualifications of Experts: Not specified in the provided document. For blood pressure monitors, "experts" typically refers to trained observers following a standardized protocol (e.g., using a reference sphygmomanometer) as outlined by standards like ANSI/AAMI SP10.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified in the provided document. ANSI/AAMI SP10 typically involves a comparison against a reference method by independent observers, with predefined criteria for acceptable differences between readings.
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
- MRMC Comparative Effectiveness Study: Not applicable. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Yes, as the device is an automatic blood pressure monitor, its performance is considered standalone. The "Clinical Tests" mentioned assess its ability to accurately measure blood pressure on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for blood pressure measurement studies typically involves simultaneous measurements by trained observers using a highly accurate, calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer) following a standardized protocol as outlined in ANSI/AAMI SP10. The readings from the reference device are considered the "true" blood pressure against which the device under test is compared.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. As a traditional medical device (non-AI/ML), there isn't a "training set" in the machine learning sense. The device is based on established oscillometric principles and calibrated during manufacturing. The "clinical tests" are for validation, not training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable for the reasons stated above (non-AI/ML device).
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page 4
OCT 3 1 2003
510(k) Summarv
ldentification of the submitter:
| Submitter: | Kodon (Tianjin) Electronic & Electrical ApparatusCo., LTDNo 31, Changjiang Road, Nankai District, Tianjin,P.R. China, 300193 |
|---|---|
| Telephone number: | 86-22-27470070 |
| Fax number: | 86-22-27371293 |
| Contact: | Liu Yi |
| Date of Application: | 01/28/2003 |
Identification of the product:
| Device proprietary Name: KD-622 Fully Automatic Electronic Blood PressureMonitor |
|---|
| Common name: Noninvasive blood pressure measurementsystems |
| Classification name: Noninvasive blood pressure measurement systemClass II per 21 CFR 870.1130 |
Marketed Devices to which equivalence is claimed:
| Device | manufacture | 510(k) number |
|---|---|---|
| HEM-757 | OMRON HEALTHCARE, INC. | K001670 |
Device description:
KD-622 Fully Automatic Electronic 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, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint 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.
Intended use:
KD-622 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 anyone each time, except infants and
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unconscious people, with the air 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 KD-622 Fully Automatic Electronic Blood Pressure Monitor utilizes Oscilliometric measurement method, with an electronic interface module and a silicon integrate pressure sensor and a air 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.
Clinical Tests:
Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.
Non-clinical Tests:
the non-clinical tests coincide following standards, including All Electromagnetic Compatibility test.
IEC601-1 (1988)
Medical electrical equipment----Part 1:General requirements for safety IEC601-1 (1988)
Amendment 2
IEC 60602-2-30: 1995
Medical electrical equipment-part2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. GB9706.1-1995 ISO 1833-1977
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
Kondon (Tianjin) Electronic & Electrical Apparatus Co., Ltd. c/o Mr. Liu Yi President, Board of Directors No. 31, Changjian Road Tianjin CHINA 300193
Re: K030358
Trade Name: KD-622 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1300 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 22, 2003 Received: September 22, 2003
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, FDA may 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 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 yours,
Dna Heuskin 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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Page 2
Statement of Indications for Use
| Applicant: | Kondon (Tianjin) Electronic & Electrical Apparatus Co., LTD |
|---|---|
| 510(k) number: | K030358 |
| Device name: | KD-622 Fully Automatic Electronic Blood Pressure Monitor |
Indications for use:
The KD-622 Fully 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 8.6614 inches to 13.78 inches.
Dia Heenhe
(Division Sign-Off)
Division of Cardio
510(k) Number K02
§ 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).