(14 days)
K# 040002
Not Found
No
The description explicitly states the use of the "oscillometric method," a well-established, non-AI/ML technique for blood pressure measurement. There are no mentions of AI, ML, or related concepts in the document.
No.
The device is intended for measurement and monitoring, not for treating or preventing a disease or condition.
Yes
The device measures blood pressure and pulse rate, which are physiological parameters used to assess the health status of an individual, thereby aiding in diagnosis or monitoring of medical conditions.
No
The device description explicitly mentions an "inflatable cuff" and an "electronic semiconductor sensor," indicating the presence of hardware components beyond just software.
Based on the provided information, the AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The AMPLIFE Wrist Watch Blood Pressure Monitor measures blood pressure and pulse rate directly from the individual's wrist using a non-invasive technique (an inflatable cuff). It does not analyze any bodily fluids or tissues.
The description clearly states it's a non-invasive device that measures physiological parameters directly from the body. This falls under the category of in vivo diagnostic devices or simply medical devices used for monitoring physiological signs, rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of intendou to ividual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 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 Wrist. 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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the AMPLIFE Automatic Wrist Watch Blood Pressure Monitor, Model M600 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 ದ.
- Reliability Test Vibrating Testing e.
- سن EMC Test
- IEC 60601-1 Safety Test g.
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer OE Automatic Blood Pressure Monitor, Model our conclusion that the Allant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed:
We have performed the clinical test on AMPLIFE Wrist Watch Blood Pressure Monitor according to "Gillied. In summarizes clinical testing performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Microlife Automatic Wrist Watch Blood Pressure Monitor, Model BP3AX1, K# 040002.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 5l0(k) number is:
Submitter's Identification: 1.
AMPLIFE Corporation 10F, No. 69, Sec. 3, Hue Jung Rd Taichung, Taiwan, R.O.C
Date Summary Prepared: January 25, 2005
Contact: Mr. Laurence Yang Tel: 0422587766 Fax: 0422587558
2. Name of the Device:
AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600
Common Name or Classification Name:
Wrist Watch Blood Pressure Monitor / Auto-Inflation Oscillometric Digital Blood Pressure Monitor
3. Predicate Device Information:
The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 is substantially equivalent to the Microlife Automatic Wrist Watch Blood Pressure Monitor, Model BP3AX1, K# 040002.
4. Device Description:
The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 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 Wrist. 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
1
define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method".
Intended Use: 5.
The AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of intendou to ividual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist.
Comparison to Predicate Devices: 6.
The AMPLIFE Wrist Watch Automatic Blood Pressure Monitor, Model M600 and the predicate device are identical in functionality and performance with the difference being the external shape of the devices, and PCB layout of the devices, performance specifications, ergonomics of the user interface, dimensional specifications, display mode and memory function, which do not make any effects on the performance of the device. The blood pressure measurements algorithm and its fundamental scientific technology are identical to the predicate device.
Both devices use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. A wrist watch cuff is inflated automatically; deflate rate is controlled but a factory set bleed valve and the deflation pressures are transferred via tubing to a sensor in both units.
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 Wrist Watch Blood Pressure Monitor, Model M600 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 ದ.
2
- Reliability Test Vibrating Testing e.
- سن EMC Test
- IEC 60601-1 Safety Test g.
None of the testing demonstrated any design characteristics that violated the None of the Reviewer Guidance or resulted in any safety hazards. It was requirements of the Reviewer OE Automatic Blood Pressure Monitor, Model our conclusion that the Allant requirements of the aforementioned tests.
(050413
p 3/3
Discussion of Clinical Tests Performed: 8.
We have performed the clinical test on AMPLIFE Wrist Watch Blood Pressure We have performed the olinical toa and Analysis ANSI/AAMI - SP-10 Standard, Monitor according to "Gillied. In summarizes clinical testing performed.
Conclusions: 9.
We have demonstrated that the AMPLIFE Automatic Wrist Watch Blood Pressure Monitor, Model M600, is as safe and effective as the predicate, the Microlife Automatic Blood Pressure Monitor, Model BP3AX1, based on electrical, mechanical and environmental testing results as well as the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification November 1900 Drame Standard, Standard, SP10-1992 testing results.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines representing the body and head. The symbol is black, and the background is white.
Public Health Service
MAR 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AMPLIFE Corporation c/o Mr. Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548
Re: K050413
R020113
Trade Name: AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: February 17, 2004 Received: February 18, 2005
Dear Mr.Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device w chave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conniner co may no may 2011 de nees mat have been require approval of a premarket approval application (PMA). and cosmotic receive, market the device, subject to the general controls provisions of the Act. The r ou may, arovisions of the Act include requirements for annual registration, listing of general only is profiteturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither 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.
4
Page 2 -- Mr. Ned Devine
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a believe complies with other requirements of the Act
that FDA has made a determination that your device complies with of act that FDA has made a decemmanon that your as were were were would be and the said the sed ligit or any Federal statutes and regulations daminders but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with an the Act s requirements, merceive reading practice requirements as set CFK Part 807); labeling (21 CFR Part 607); god ations (21 CFR Part 820); and if applicable, the electronic (21 CFR) 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Dections on device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your douice to Jegal I his letter will anow you to begin maneting your antial equivalence of your device to a legally premarket nother in the PDA midning of backanian vipen 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 If you desire specific advice for your device of variable of the regulation entitled, the regulation entitled, contact the Office of Comphalled as (21 mg 11 mart 807.97). You may obtain "Misbranding by relefence to premation is nother the Act from the Division of Small other geleral miormational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, machadonal and Comsailters http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Vainer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K050413
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Exhibit B
of ___________________________________________________________________________________________________________________________________________________________________________ Page _ 1
KOSO413 510(k) Number (if known): __
Device Name: AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600
Indications For Use:
The AMPLIFE Wrist Watch Blood Pressure Monitor, Model M600 is a device The AMPLIFE Whist Watch Diood Fressure and pulse rate and pulse rate of
intended to measure the systolic and diastolic blood pressure and pulse rate of intended to measure the systolic and diactorie brood province in which an inflatable cuff is wrapped around the wrist.
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)
Duna R. Varner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko504 13