(35 days)
The ACON Automatic Blood Pressure Monitor is a fully automatic blood pressure monitor that measures systolic blood pressure (SYS), diastolic blood pressure (DIA) and pulse rate (P). It is intended to be sold over-the-counter for home use.
The ACON Automatic Blood Pressure Monitor (BPM) Kit consists of an oscillometer assembly that measures blood pressure oscillometrically. This BPM comes with a standard & a large arm cuff. The BPM is powered by either four AA batteries or an optional AC adapter. Before measuring, the user fits the end of the cuff through a D-ring and secures it by the Velcro strap around the upper arm. The position of the arm cuff should be leveled with user's heart. Once fastened, the user turns on the BPM to initiate a self-checking program. The cuff is automatically inflated by the pump only when the BPM passes the self-check and the "Err" sign is not shown on the monitor. While inflating, the monitor displays upward numbers and arrows to signify that the cuff is slowly inflating. After reaching the appropriate level, the pumping action stops and the monitor displays downward numbers and arrows to signify that the cuff is slowly deflating. During this time, a heart-shaped icon also appears on the right hand side of the monitor together with the beeping sounds, indicating the heart rate is also being measured. Once the monitoring has completed, the LCD screen displays the following measurements from top to bottom: systolic blood pressure (SYS), diastolic blood pressure (DIA), and pulse rate (P) to the user.
Here's an analysis of the provided text regarding the ACON™ Automatic Blood Pressure Monitor Kit's acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the Accuracy specifications listed under "Technological Characteristics," and the study aims to show equivalence to a predicate device and a mercury sphygmomanometer.
| Acceptance Criteria (from "Accuracy" specification) | Reported Device Performance (from "Consumer studies" section) |
|---|---|
| Blood Pressure (SYS and DIA): ± 3 mmHg (0.40kPa) | Comparison to OMRON: "mean deviation and standard deviation between the ACON and OMRON Blood Pressure Monitors..." (Specific numerical values for mean deviation and standard deviation are not provided in the summary.) |
| Pulse Rate (P): ± 5 % | Comparison to OMRON: "...and between the ACON Blood Pressure Monitor and a Mercury Sphygmomanometer per ACON consumer study protocol for Blood Pressure Monitor are compared. Study results indicate that the non-professional, inexperienced lay persons were able to obtain comparable blood pressure and pulse rate readings when using the ACON™ Automatic Blood Pressure Monitor Kit and a legally marketed OMRON automatic Blood Pressure Monitor..." (Specific numerical values for mean deviation and standard deviation are not provided in the summary.) |
Note: While the "Technological Characteristics" section defines the desired accuracy, the "Discussion of Clinical Tests Performed" section discusses a "consumer study" indicating "comparable" readings, but does not provide the specific numerical mean deviation and standard deviation values from this study that would directly demonstrate compliance with the ± 3 mmHg and ± 5% pulse accuracy acceptance criteria. The summary only states that the study results indicate comparable readings.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the number of participants in the "consumer studies." It only states "Consumer studies were conducted..." and mentions "the participated lay persons."
- Data Provenance: The document does not explicitly state the country of origin. It refers to the ACON Laboratories, Inc. as being in San Diego, California, USA, but does not confirm if the study participants were exclusively from the US. The study is described as prospective, as it involved "consumer studies" where "lay persons were able to obtain comparable blood pressure and pulse rate readings."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the consumer study. Instead, it compares the ACON device's readings against:
- A legally marketed OMRON automatic Blood Pressure Monitor, Model #HEM-711AC (predicate device).
- A Mercury Sphygmomanometer.
The Mercury Sphygmomanometer would serve as the clinical reference standard, traditionally considered the "gold standard" for blood pressure measurement, often operated by trained personnel, though the document does not elaborate on who operated it in this specific consumer study.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The study directly compares readings from the ACON device to the OMRON device and a mercury sphygmomanometer. It focuses on the "mean deviation and standard deviation" between these measurements, implying a direct comparison rather than an adjudication process of ambiguous results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study involved "non-professional, inexperienced lay persons" using the device, but it wasn't a study to assess how human readers (interpreters of diagnostic images, for example) improve with AI assistance. This device is a measurement tool, not an interpretive AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary clinical validation described is a standalone performance study. The "consumer studies" evaluated the ACON Automatic Blood Pressure Monitor Kit's ability to measure blood pressure and pulse rate independently, and then compared these measurements to established reference methods (OMRON monitor and mercury sphygmomanometer). The "human-in-the-loop" aspect here refers to the user operating the device for measurement, not interpreting an AI's output.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by:
- Readings from a legally marketed OMRON automatic Blood Pressure Monitor, Model #HEM-711AC (K930798), which itself has been cleared as substantially equivalent.
- Readings from a Mercury Sphygmomanometer, which is generally considered the clinical "gold standard" for blood pressure measurement.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This type of device (an oscillometric blood pressure monitor) typically relies on established algorithms and physical principles for measurement rather than requiring a machine learning "training set" in the common sense for AI algorithms. The "Laboratory Testing" section implies internal verification and calibration, which might align with traditional engineering validation, but not an AI training process.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a traditional machine learning "training set" for an AI algorithm, there's no information on how a ground truth for such a set was established. The device operates based on oscillometric principles, and its internal algorithms would have been developed and validated through engineering design and testing, likely against established pressure and pulse rate references during development and internal calibration.
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5. 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 K060925.
MAY - 9 pons
Submitter's Identification:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel .: 858-535-2030 Fax: 858-535-2038
Date Prepared: March 31, 2006
Contact Person:
Edward Tung, Ph.D. V.P., Regulatory Affairs
Proprietary Name of the Device:
ACONTM Automatic Blood Pressure Monitor Kit
Common Name:
System, Measurement, Blood-Pressure, Non-Invasive
Classification Name:
Class II §870.1130 Noninvasive Blood Pressure Measurement System (To be manufactured and marketed for consumer home use)
Predicate Device:
OMRON Automatic Blood Pressure Monitor, Model # HEM-711AC OMRON Healthcare, Inc., located at 300 Lakeview Parkway, Vernon Hills, IL 60061, USA. 510(k) Number: K930798
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Description:
The ACON Automatic Blood Pressure Monitor (BPM) Kit consists of an oscillometer assembly that measures blood pressure oscillometrically. This BPM comes with a standard & a large arm cuff. The BPM is powered by either four AA batteries or an optional AC adapter. Before measuring, the user fits the end of the cuff through a D-ring and secures it by the Velcro strap around the upper arm. The position of the arm cuff should be leveled with user's heart. Once fastened, the user turns on the BPM to initiate a self-checking program. The cuff is automatically inflated by the pump only when the BPM passes the self-check and the "Err" sign is not shown on the monitor. While inflating, the monitor displays upward numbers and arrows to signify that the cuff is slowly inflating. After reaching the appropriate level, the pumping action stops and the monitor displays downward numbers and arrows to signify that the cuff is slowly deflating. During this time, a heart-shaped icon also appears on the right hand side of the monitor together with the beeping sounds, indicating the heart rate is also being measured. Once the monitoring has completed, the LCD screen displays the following measurements from top to bottom: systolic blood pressure (SYS), diastolic blood pressure (DIA), and pulse rate (P) to the user.
Intended Use:
The ACON Automatic Blood Pressure Monitor is a fully automatic blood pressure monitor that measures systolic blood pressure, diastolic blood pressure and pulse rate. It is intended to be sold over-the-counter for home use.
Technological Characteristics:
| Feature | Technical Specification |
|---|---|
| Measurement Area | Upper arm |
| Measurement Technology | Oscillometry |
| Measurement Range | Blood Pressure (SYS and DIA): 30 to 280 mmHg (4.00-37.33kPa);Pulse Rate (P): 40 to 200 beats per minute |
| Accuracy | Blood Pressure (SYS and DIA): ± 3 mmHg (0.40kPa);Pulse Rate (P): ± 5 % |
| Measurement Resolution (DIA/SYS) | 1 mmHg (0.13kPa) |
| Cuff Pressure Display Range | 0-299 mmHg (0-39.86kPa) |
| Inflation Method | Automatic by electric pump |
| Deflation Method | Automatic pressure release valve |
| Rapid Pressure Release Method | Automatic exhaust valve |
| Display | Liquid Crystal Display (LCD) |
| Memory | Automatically stores the last 36 measurements taken |
| Operating Temperature | 50 to 104°F |
| Operating Humidity | 10 to 85% RH |
| Storage Temperature | -4 to 122°F |
| Storage Humidity | 10 to 95% RH |
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| Arm Size and Cuff Circumference | Standard Cuff: for 7"-13" upper arm circumference;Large Cuff: for 13"-18" upper arm circumference |
|---|---|
| Power Source | 4 "AA" 1.5V alkaline (LR6) or equivalent battery;6V 500mA or 600mA output AC Adapter |
| Battery Life | Approximately 300 uses |
| Size | 4.6" (W) x 4.7" (L) x 2.4" (H) |
| Weight | 19.7 oz (with batteries and Standard Cuff)20.3 oz (with batteries and Large Cuff) |
Comparison to Predicate Devices:
The ACON Automatic Blood Pressure Monitor Kit is substantially equivalent to the OMRON Automatic Blood Pressure Monitor, Model #HEM-711AC, K930798.
The blood pressure arm cuffs included in the ACON™ Automatic Blood Pressure Monitor Kit The exactly the same as a FDA-cleared KTJ-20C™ Blood Pressure Cuff (K010686), manufactured by Golden Horse Medical Equipment (WUXI) Co, LTD.
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(k) Submissions for Non-Invasive Blood Pressure (NIBP) Monitor" and "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Compliance to applicable voluntary standards includes ANSI/AAMI SP-10:2002/A1:2003, as well as AAMI 60601-2-30:1999 requirements.
Laboratory Testing:
The performance characteristics of the ACON™ Automatic Blood Pressure Monitor Kit were verified by many tests including pressure accuracy test, pulse accuracy test, repeatability test, operation condition test including temperature, humidity and ambient pressure tests, battery condition test, storage condition test, AC adaptor test, measurement time test, power consumption test, temperature compensation test, software validation test and electromagnetic compatibility and electrical safety test.
Discussion of Clinical Tests Performed:
Consumer studies were conducted using the ACONTM Automatic Blood Pressure Monitor Kit. Consumer study data are presented and the mean deviation and standard deviation between the ACON and OMRON Blood Pressure Monitors and between the ACON Blood Pressure Monitor and a Mercury Sphygmomanometer per ACON consumer study protocol for Blood Pressure Monitor are compared. Study results indicate that the non-professional, inexperienced lay
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persons were able to obtain comparable blood pressure and pulse rate readings when using the ACONTM Automatic Blood Pressure Monitor Kit and a legally marketed OMRON automatic Blood Pressure Monitor, Model #HEM-711AC (K930798). In addition, the participated lay persons also satisfied with the ease of following the "Instructions for Use" section in the Instruction Manual as well as the performance of the BPM.
Conclusion:
The laboratory testing and consumer study results demonstrated that the ACON™ Automatic Blood Pressure Monitor is safe, accurate and easy-to-use. It is also demonstrated that the ACON™ Automatic Blood Pressure Monitor is substantially equivalent to the OMRON Automatic Blood Pressure Monitor, Model #HEM-711AC, currently sold on the U.S. market (K930798).
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS logo, which consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the logo. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2006
ACON Laboratories, Inc. c/o Edward Tung, Ph. D. Vice President, Regulatory Affairs 4108 Sorrento Valley Boulevard San Diego, CA 92121
Re: K060925
Trade Name: ACON Automatic Blood Pressure Monitor Kit (Model OB11-111) and ACON Automatic Blood Pressure Monitor Kit with AC Adapter (Model OB11-112) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: March 31, 2006 Received: April 4, 2006
Dear Dr. Tung:
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 - Edward Tung, Ph. D.
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 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/industry/support/index.html.
Sincerely yours,
Brimmer 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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4. INDICATIONS FOR USE
K060925 510(k) Number (if known):
ACONTM Automatic Blood Pressure Monitor Kit Device Name:
Indications for Use:
The ACON Automatic Blood Pressure Monitor is a fully automatic blood pressure monitor that measures systolic blood pressure (SYS), diastolic blood pressure (DIA) and pulse rate (P). It is intended to be sold over-the-counter for home use.
... ..
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Bimmatuma
on Sign-Off) Tivision of Cardiovascular Devices : 10(k) Number
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§ 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).