(35 days)
The AMPLIFE Upper Arm Blood Pressure Monitor, Model M100, is a device intended to measure the systolic and diastolic blood pressure 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 AMPLIFE Upper Arm Automatic Blood Pressure Monitor, Model M100 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
This 510(k) summary provides limited information regarding the clinical study.
Here's a breakdown of the available information and areas where details are missing or unclear based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI SP-10 Standard) | Reported Device Performance (from AMPLIFE Study) |
|---|---|
| Not explicitly detailed in the provided text. The document states the clinical test was performed according to "Clinical Data and Analysis ANSI/AAMI -- SP-10 Standard, Section 4.4.2". This standard outlines accuracy requirements for blood pressure monitors. | Not explicitly stated in the provided text. The document concludes: "We have demonstrated that the AMPLIFE Automatic Blood Pressure Monitor, Model M100, is as safe and effective as the predicate, the Microlife Automatic Model Mr. Co, re Monitor, Model BP-2BHO, based on electrical, mechanical and environmental testing results as well as... the ANSI/AAMI Voluntary Standard, SP10-1992 testing results." This implies the device met the criteria of the standard, but the specific performance metrics (e.g., mean difference, standard deviation) are not provided. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified. The document only states "We have performed the clinical test on AMPLIFE Upper Arm Blood Pressure".
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications: Not specified. For blood pressure monitors, ground truth is typically established by trained observers using a mercury sphygmomanometer or validated reference device. The qualifications of these observers (e.g., trained technicians, physicians) are not mentioned.
4. Adjudication Method for the Test Set
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is not typically relevant for a standalone blood pressure monitor, which measures a physiological parameter directly rather than requiring human interpretation of complex images or data.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance assessment was effectively done. The AMPLIFE Upper Arm Blood Pressure Monitor is a standalone device that measures blood pressure using an "oscillometric method" algorithm without human intervention in the measurement process itself. The clinical test described refers to the performance of this device in making those measurements.
7. Type of Ground Truth Used
- Ground Truth: The document states the clinical test was performed according to the "ANSI/AAMI -- SP-10 Standard, Section 4.4.2". This standard typically requires comparison of the device's measurements against a reference method, such as direct intra-arterial measurement or, more commonly for non-invasive devices, simultaneous auscultatory measurements performed by trained observers using a validated reference device (e.g., mercury sphygmomanometer). While not explicitly stated, it is implied that a reference method was used to establish the ground truth.
8. Sample Size for the Training Set
- Not applicable/Not specified. For a traditional blood pressure monitor using the oscillometric method, the "algorithm" is based on established physiological principles and signal processing, rather than a machine learning model that requires a separate "training set" in the common sense. The algorithm parameters might be refined or calibrated, but this isn't typically referred to as "training" in the same way as for AI/ML algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified for the reasons stated above.
In summary:
The provided 510(k) summary indicates that a clinical test was performed in accordance with the ANSI/AAMI SP-10 Standard, which is the relevant standard for validating the accuracy of automated sphygmomanometers. However, the summary lacks specific details regarding the clinical study's methodology, such as the exact acceptance criteria, the number of subjects (sample size), the ground truth measurement details, or the specific performance results (e.g., mean differences and standard deviations) that demonstrated compliance with the standard. It only provides a general statement that the device met the requirements of the standard.
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K04-3550
P1/3
JAN 2 7 2005
EXHIBIT # 1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
1. Submitter's Identification:
AMPLIFE Corporation 10F, No. 69, Sec. 3, Hue Jung Rd Taichung, Taiwan, R.O.C
Date Summary Prepared: November 29, 2004
Contact: Mr. Laurence Yang Tel: 0422587766 Fax: 0422587558
2. Name of the Device:
AMPLIFE Upper Arm Blood Pressure Monitor, Model M100
Common Name or Classification:
Non-Invasive Blood Pressure Measurement System
3. Predicate Device Information:
The AMPLIFE Upper Arm Automatic Blood Pressure Monitor, Model M100 is substantially equivalent to the Microlife Automatic Blood Pressure Monitor, Model BP-2BHO, K# 970211.
4. Device Description:
The AMPLIFE Upper Arm Automatic Blood Pressure Monitor, Model M100 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating
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pulse rate, which is a well - known technique in the market called the "oscillometric method".
Intended Use: 5.
The AMPLIFE Upper Arm Blood Pressure Monitor, Model M100 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Comparison to Predicate Devices: e.
Both the subject and predicate devices use the well known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. For the subject device, the cuff is inflated to a suitable pressure automatically without the need to pre-set the inflation pressure value by hand, as is the case with the predicate device; deflate rate is controlled, but a factory set bleed valve and the deflation pressures are transferred via tubing to a sensor in both units. The subject device, Model M100, uses a semiconductor pressure sensor instead of a capacitive pressure sensor (predicate device) to translate the pressure variations to electrical signals that can be interpreted by an integrating circuit. Once the reading is determined, each unit operates the linear valve to release the pressure to zero. In addition, the subject device has the added clock function which is not included in the predicate device.
Unlike the predicate device, the subject device, Model M100, uses a piezoresistive pressure sensor to detect alternation of cuff pressure.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the AMPLIFE Automatic Blood Pressure Monitor, Model M100 in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.
The following testing was conducted:
- General Functions Test a.
- Reliability Test Operation Conditions b.
- Reliability Test Drop Testing C.
- Reliability Test Storage ರು.
- Reliability Test Vibrating Testing e.
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- f. EMC Test
- IEC 60601-1 Safety Test ப் ப
None of the testing demonstrated any design characteristics that violated the Norte of the Reviewer Guidance or resulted in any safety hazards. It was requirements of the Ronomatic Blood Pressure Monitor, Monitor, Model our ocholder. that relevant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed: 8.
We have performed the clinical test on AMPLIFE Upper Arm Blood Pressure We have portormou the "Clinical Data and Analysis ANSI/AAMI -- SP-10 Standard, Section 4.4.2" which outlines and summarizes clinical testing performed.
Conclusions: ு.
We have demonstrated that the AMPLIFE Automatic Blood Pressure Monitor, Model M100, is as safe and effective as the predicate, the Microlife Automatic Model Mr. Co, re Monitor, Model BP-2BHO, based on electrical, mechanical and environmental testing results as well as the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", and, the ANSI/AAMI Voluntary Standard, SP10-1992 testing results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2005
AMPLIFE Corporation c/o Mr. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 43548
Re: K043550
Trade Name: AMPLIFE Upper Arm Blood Pressure Monitor, Model M100 Regulation Number: 21 CFR 870.1130 Regulation Name: Blood Pressure Monitor Regulatory Class: Class II Product Code: DXN Dated: January 14, 2005 Received: January 18, 2005
Dear Mr. Devine:
ﻏﻴ
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. Ned Devine
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 (240) 276-0120 Also, please note the regulation entitled, "Misbranding bv 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,
Blinima 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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Exhibit B
Page _ 1
K043550 510(k) Number (if known):
Device Name: AMPLIFE Upper Arm Blood Pressure Monitor, Model M100
Indications For Use:
The AMPLIFE Upper Arm Blood Pressure Monitor, Model M100, is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use X (21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Z.H. HERRMANN, JR.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number U Cardiovascular Devices
510(k) Number U 510(k) Number K 0 4 న
§ 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).