(102 days)
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is for use by medical rofessionals 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 ann. The cuff circumference is imited to 22cm-48cm(be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one).
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622. KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is 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, which cuff circumference is limited to 22cm-48cm (be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one), the device can analyze the signals promotly and display the test results.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Arm Electronic Blood Pressure Monitor:
The document provides a 510(k) summary for the Andon Health Co., Ltd. Arm Electronic Blood Pressure Monitor. It asserts substantial equivalence to previously marketed devices and references compliance with certain standards for performance and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Standard: ANSI/AAMI SP-10 standard | Device meets ANSI/AAMI SP-10 standard |
| Safety Standard: EN60601-1 Medical electrical equipment Part 1: General requirements for safety | Device meets EN60601-1 |
| EMC Standard: EN60601-1-2 Electromagnetic Compatibility | Device meets EN60601-1-2 |
| Intended Use: For use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time. | Device intended for this use and functions, as evidenced by compliance with performance standards. |
| Cuff Circumference: Limited to 22cm-48cm (comprised of 3 cuffs: 22-30cm, 30-42cm, 42-48cm) | Device supports this range with specified cuffs. |
| Cuff Pressure Range: 0-300mmHg (for KD-322, KD-622 and KD-575) | Device functions within this range. |
| Humidity (Operational): <90% | Device functions within this limit. |
| Temperature (Storage): -20-55°C | Device can be stored within this range. |
| Humidity (Storage): <95% | Device can be stored within this limit. |
Missing Information: The document states the device meets the ANSI/AAMI SP-10 standard, which would contain specific numerical criteria for accuracy (e.g., mean difference and standard deviation between device readings and a reference method). However, these specific numerical performance results (e.g., mean difference in systolic/diastolic readings, standard deviation) are not explicitly reported in this summary. The summary only generally states compliance with the standard.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the given document. The summary states that "Arm Electronic Blood Pressure Monitor ... meets the following standards: ANSI/AAMI SP-10 standard," which implies a clinical validation study was performed according to that standard. However, the details of that study, including sample size and data provenance, are absent from this 510(k) summary.
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. For blood pressure monitors, the "ground truth" (reference measurements) for validation studies compliant with standards like ANSI/AAMI SP-10 typically involves a team of trained observers (e.g., physicians or nurses) taking auscultatory measurements using a mercury sphygmomanometer or validated oscillometric device, blinded to the device's readings. However, the specific number and qualifications of these experts are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided in the given document. In BP monitor validation studies, discrepancies between observers' readings (if multiple observers are used) usually follow a specific adjudication protocol, but this is not detailed here.
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
This is not applicable to this device. The Arm Electronic Blood Pressure Monitor is a standalone measurement device, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed (and would not be relevant).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is a standalone device. The entire validation described by its compliance with the ANSI/AAMI SP-10 standard is a standalone performance assessment of the device's algorithm and hardware against reference measurements. There is no "human-in-the-loop" interaction for interpreting the device's main output (blood pressure and pulse rate readings).
7. The Type of Ground Truth Used
The ground truth used for compliance with the ANSI/AAMI SP-10 standard would typically be concurrent auscultatory measurements taken by trained observers using a reference sphygmomanometer, specifically a mercury sphygmomanometer or another validated reference oscillometric device. These measurements are considered the "expert consensus" reference for blood pressure validation. The document states compliance with this standard, implying this type of ground truth was used.
8. The Sample Size for the Training Set
This information is not provided in the given document. For a traditional medical device like a blood pressure monitor, the "training set" doesn't typically refer to a large dataset for machine learning algorithms. Instead, it refers to data used during the development and calibration of the oscillometric algorithm. The specific size or nature of this data is not disclosed here.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the given document. Similar to question 8, the "ground truth" for the development/calibration of the oscillometric algorithm would involve comparing the evolving device's readings against established reference methods, likely auscultatory measurements. However, the specifics of this process are not described in the 510(k) summary.
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天 津 九 安 医 疗 电 子 股 份 有 限 公 司
Andon Health Co., Ltd.
地址:天津市南开区雅安道金平路 10号华侨创业大厦 7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, NanKai District, Tianjin, China 郎纷(P.C.): 300190 传(Fax): 86-22-6052 6162 E-mail: andon@public.tpt.tj.cn ttt:1(Tel): 86-22-6052 6161
510(k) Summary
ldentification of the submitter:
| Submitter: | Andon Health Co., Ltd. |
|---|---|
| No 31, Changjiang Road, Nankai District, Tianjin, | |
| P.R. China, 300193 | |
| Telephone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 11/10/08 |
Identification of the product:
| Device proprietary Name: | Arm Electronic Blood Pressure Monitor |
|---|---|
| Common name: | Noninvasive blood pressure measurement systems |
| 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 |
|---|---|---|
| KD-322 | Andon Health Co., Ltd | K052676 |
| KD-622 | Andon Health Co., Ltd | K030358 |
| KD-525E | Andon Health Co., Ltd | K070395 |
| KD-575 | Andon Health Co., Ltd | K042418 |
| KD-593 | Andon Health Co., Ltd | K070828 |
| KD-595 | Andon Health Co., Ltd | K070828 |
| KD-596 | Andon Health Co., Ltd | K070828 |
| KD-598 | Andon Health Co., Ltd | K070828 |
Device description:
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622. KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is 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
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083395
天 津 九 安 医 疗 电 子 股 份 有 限 公 司 Andon Health Co., Ltd.
地址:天津市南开区雅安道金平路 10号华侨创业大厦7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, Ya An Road, NanKai District, Tianjin, China 邮编(P.C.): 300190 传真(Fax): 86-22-6052 6162 【!】(Tel): 86-22-6052 6161 E-mail: andon@public.tpt.ti.cn
with an electronic interface module. Buckling a cuff around the left upper arm, which cuff circumference is limited to 22cm-48cm (be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one), the device can analyze the signals promotly and display the test results.
Intended use:
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E. KD-593. KD-595. KD-596, KD-598) is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual, which is same as predicated device.
Summary comparing technological characteristics with predicate device:
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-675, KD-525E, KD-593, KD-595, KD-596, KD-598) has the same principle with predicated device, which utilizes Oscilliometric measurement method to monitor the blood pressure and the result can be shown on the LCD. The modifications that were made are:
(1): Cuff size change into 22cm-48cm from 22cm-30cm.
(2): The Environmental parameters are changed.
The operational range for humidity (<90%) and the storage range for temperature ( - 20-55°C) and for humidity (<95%) of the modified device are all changed from the predict device.
(3): The Cuff Pressure Range change into 0-300mmHg from 20-300 mmHg (only for KD-322, KD-622 and KD-575).
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K083395 $ 3/3
天 津 九 安 医 疗 电 子 股 份 有 限 公 司
Andon Health Co., Ltd. 地址:天津市南开区雅安道金平路 10 号华侨创业大厦 7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, Ya An Road, NanKai District, Tianjin. China 邮编(P.C.) 300190 传真(Fax): 86-22-6052 6162 电话(Tel): 86-22-6052 6161 E-mail: andon@public.tpt.tj.cn
Please find the following tabulated comparison supporting that the proposed device is substantially equivalent to the predicated device.
| FDA file reference number | Predicated Devices |
|---|---|
| Technological Characteristics | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Identical |
| Sterility | Not Applicable |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Not Applicable |
| Energy used and/or delivered | Identical |
| Where used | Similar |
| Standards met | Identical |
| Electrical safety | Identical |
Device testing:
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) meets the following standards:
- · ANSI/AAMI SP-10 standard
- EN60601-1 Medical electrical equipment Part 1: General requirements for safety
- · EN60601-1-2 Electromagnetic Compatibility
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2009
Andon Health Co. Ltd. c/o Ms. Liu Yi No. 31, Changjiang Road, Nankai District Tianjin, P.R. China 300193
Re: K083395
Trade Name: Arm Electronic Blood Pressure Monitor, Models KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596 and KD-598
Regulation Number: 21 CFR 870.1130
Regulation Name: Noninvasive Blood Pressure Measurement System
Regulatory Class: Class II (two)
Product Code: DXN
Dated: February 4, 2009
Received: February 9, 2009
Dear Ms. 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. Ilsting 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 - Ms. 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" (21 CFR 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 vours.
Mark Teller
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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天 津 九 安 医 疗 电 子 股 份 有 限 公 司
Andon Health Co., Ltd.
地址:天津市南开区雅安道金平路 10号华侨创业大厦 7楼 Add: 7th floor Hua Qiao Chuang Ye Plaza, No. 10 JinPing Road, Ya An Road, NanKai District, Tianjin, China 邮编(P.C.): 300190 传真(Fax):86-22-60526162 E-mail: andon@public.tpt.tj.cn 山语(Tel): 86-22-6052 6161
Statement of Indications for Use
510(k) Number :
083375
Applicant:
Andon Health Co., Ltd
Device name:
Arm Electronic Blood Pressure Monitor Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598
indications for use:
Arm Electronic Blood Pressure Monitor (Models: KD-322, KD-622, KD-575, KD-525E, KD-593, KD-595, KD-596, KD-598) is for use by medical rofessionals 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 ann. The cuff circumference is imited to 22cm-48cm(be comprised of 3 cuffs, 22cm-30cm, 30cm-42cm, 42cm-48cm, select one).
Prescription use Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
YES
.
.
.
.
.
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.
(Please Do Not WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| -- | -------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K083395 |
§ 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).