(205 days)
Not Found
No
The description mentions a "microcomputer" and "simple calculation" using the oscillometric method, which is a standard technique for blood pressure measurement and does not inherently involve AI/ML. There is no mention of AI, ML, or related terms in the document.
No
The device is a noninvasive blood pressure measurement system intended to measure blood pressure and pulse rate, not to treat a disease or condition.
No
Explanation: The device is described as a "blood pressure monitor" that "measures the systolic and diastolic blood pressures and pulse rate." While it provides information about the user's health state, its primary function is measurement, not the diagnosis of a disease or condition. Diagnostic devices typically involve interpreting data to identify the presence or absence of a disease.
No
The device description explicitly states it is a "noninvasive blood pressure measurement system" that uses an "inflatable cuff" wrapped around the wrist and the "Oscillometric method" to measure blood pressure. These are hardware components and a physical measurement method, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Amluck automatic digital wrist blood pressure monitor measures blood pressure and pulse rate by applying a cuff to the wrist and using the oscillometric method. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
The description clearly states it's a "noninvasive blood pressure measurement system" and that it measures blood pressure "at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist." This aligns with the definition of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Amluck automatic digital wrist blood pressure monitor, Model AK-3000 / AK-4000, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
AMLUCK AK-3000 / AK-4000 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
over age 18
Intended User / Care Setting
adult individual, at home
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)
ELECTRIC SAFETY and EMC test reports:
General safety: EN 60601-1:1990+A1+A2+A11+A12+A13 - PASS
EMC conformity: EN 60601-1-2: 1993 - PASS
WOVEN COTTON SHEETING:
JIS L 1096 6.39.1.2 Method B 2, certified by SGS UK Ltd.
PERFORMANCE & CLINICAL TEST:
AAMI / ANSI SP10
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.
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.
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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
AMLUCK Enterprises Co. Ltd.
No. 41, Ching Hsiang St., Tu-Cheng, Taipei, Taiwan, ROC 236 Fax: 886-2-22695115 Telephone: 886-2-226955555 Email: amluck@ms7.hinet.net
KO12796
MAR 1 4 2002
"510(k) Summary"
Submitter's Name: AMLUCK ENTERPRISES CO. LTD.
No. 41, Ching Hsiang St., Tu-Cheng, Taipei, Address: Taiwan, ROC 236
Telephone: 886-2-22695555
886-2-22695115 FAX:
Mr. THOMAS CHEN Contact Person:
Date Summary 12/15/2001 Prepared:
AMLUCK BLOOD PRESSURE Proprietary Name: MONITOR AK-3000 / AK-4000
BLOOD PRESSURE MONITOR Common Name:
NON-INVASIVE BLOOD-PRESSURE Classification Name: MEASUREMENT SYSTEM
( per 21CFR section 870.1130)
Device Class: Class II (performance standards)
Specialty: CARDIOVASCULAR
Product code: DXN
WRIST MICROLIFE WATCH BLOOD Legally Marketed PRESSURE MONITOR, MODEL BP-3BU1 ( Predicate ) Device : 510(k) No: K001182
1
Description of the new device:
AMLUCK AK-3000 / AK-4000 uses the Oscillometric method to measure the blood The Oscillometric method is adopted clinically to measure the blood pressure pressure. It is not needed to use the stethoscope, as in the traditional measuring method, recently. to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Technological Characteristics of our new device compared to the predicate device:
The technological characteristics of AMLUCK AK-3000 / AK-4000 are substantially equivalent to MICROLIFE BP 3BU1. AMLUCK AK-3000 / AK-4000 is of generally the same form and intended to be used in the same manner as the substantially equivalent products, MICROLIFE BP 3BU1.
2
Email: amluck(@ms7.hinet.net
Test Summary:
ELECTRIC SAFETY and EMC test reports, 1.
| General safety | EN 60601-1:1990+A1+A2+A11+A12+A13 | PASS |
|---|---|---|
| EMC conformity | EN 60601-1-2: 1993 | PASS |
WOVEN COTTON SHEETING 2.
JIS L 1096 6.39.1.2 Method B 2, certified by SGS UK Ltd.
PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10
Amluck Enterprises Co. Ltd. believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate product and other products currently in distribution.
Thomas Chen
Submitter, 01/11/2002 General Manager AMLUCK ENTERPRISES CO., LTD.
E
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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 stylized eagle with three stripes forming its wing, positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2002
Amluck Enterprises Co., Ltd. c/o Dr. Yang, Tien-Hsing ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City Taiwan, ROC
Re: K012796
Trade Name: Amluck Automatic Digital Wrist Blood Pressure Monitor AK-3000/AK-4000 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: January 11, 2002 Received: January 15, 2002
Dear Dr. Yang:
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 - Dr. Yang, Tien-Hsing
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
N. Dala Miller
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular And Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AMLUCK Enterprises Co. Ltd. No. 41, Ching Hsiang St., Tu-Cheng, Taipei, Taiwan, ROC 236 Telephone: 886-2-226955555 Fax: 886-2-22695115 Email: amluck@ms7.hinet.net
| Applicant: | AMLUCK ENTERPRISES CO., LTD. |
|---|---|
| 510(k) Number (if known): | TBA K012796 |
| Device Name: | AMLUCK AUTOMATIC DIGITAL WRIST BLOOD PRESSURE |
| MONITOR AK-3000 / AK-4000 |
. Indications for use:
The Amluck automatic digital wrist blood pressure monitor, Model AK-3000 / AK-4000, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".
( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, office of Device Evaluation (ODE )
Division of Cardiovascular & Respiratory Devices
510(k) Number K012796
Prescription Use __ OR
( Per 21 CFR 801.109 )
Over - The - Counter - Use_ \
( Optional Format 1-2-96 )