The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.

Device Description

The Arm BPM is designed to measure the systolic, and pulse rate (heart rate) of an individual. The device consists of an inflatable cuff that is wrapped around the upper arm and held in place with Velcro™, a Dot-matrix LCD display, a semiconductor sensor, an internal air pump, a battery power or ac/dc power source, and keys for operation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the K-jump Arm Blood Pressure Monitor, Model KP-7600 series:

Based on the provided snippets, the 510(k) submission for the K-jump Arm Blood Pressure Monitor, Model KP-7600 series, relies on conformity to established standards rather than a specific clinical study with detailed results for this particular device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Blood Pressure Measurement Devices (based on ANSI/AAMI SP10:2002)

Metric/Standard	Acceptance Criteria (ANSI/AAMI SP10:2002)	Reported Device Performance (KP-7600 series)
Blood Pressure Accuracy	Mean difference (algorithm vs. reference): ≤ ± 5 mmHg	The device complies with ANSI/AAMI SP10:2002. Specific mean difference or standard deviation values for this device are not explicitly reported in the provided text.
	Standard deviation of differences (algorithm vs. reference): ≤ 8 mmHg
Electrical Safety	Compliance with IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety)	The device complies with IEC 60601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2001 (Medical Electrical Equipment - EMC)	The device complies with IEC 60601-1-2:2001.

Note: The provided text explicitly states that "This Arm BPM also complies with the electrical safety standards 60601-1 Medical Electrical Equipment- Part 1: General Requirements For Safety & 60601-1-2:2001 Medical Electrical Equipment- Part 1-2: General Requirements For Safety- Collateral Standard: Electromagnetic Compatibility-Requirements and Tests." and "In addition to the conformity standards, ANSI/AAMI SP10:2002 Manual, Electronic or Automated Sphygmomanometers, of the predicate device." While it states compliance, it does not provide the specific performance data (e.g., mean difference and standard deviation of differences for BP measurements) for the KP-7600 series against the ANSI/AAMI SP10:2002 criteria. It's implied that because it complies, it meets these thresholds.

2. Sample size used for the test set and the data provenance

The provided text does not explicitly state the sample size used for a test set for the KP-7600 series' blood pressure accuracy.
The data provenance (country of origin, retrospective/prospective) is also not specified for any performance study directly related to the KP-7600 series. The submission primarily references compliance with standards. It's possible that an internal verification was performed, but details are not included here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The provided text does not provide information on the number or qualifications of experts used to establish ground truth. Since the submission relies on compliance with a standard (ANSI/AAMI SP10), the ground truth for such a standard is typically established by trained technicians following a specific protocol using auscultatory reference measurements performed by multiple observers, not necessarily "experts" in the clinical sense specified (e.g., radiologists, which are irrelevant for BP monitors).

4. Adjudication method for the test set

The provided text does not specify an adjudication method. For ANSI/AAMI SP10 compliance, the standard outlines specific consensus methods for obtaining reference blood pressure values, often involving simultaneous auscultation by multiple trained observers.

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

No, an MRMC comparative effectiveness study was not done or reported. This type of study is not relevant for a standalone blood pressure monitor, which is a measurement device, not an AI-assisted diagnostic tool for interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, implicitly. The device is a "Blood Pressure Monitor," which functions as a standalone algorithm-only device in terms of generating the blood pressure measurement. Its performance is evaluated against a reference standard (e.g., auscultation). The direct measurement by the device (algorithm only) is what is assessed against the ANSI/AAMI SP10 standard.

7. The type of ground truth used

The ground truth used for verifying blood pressure accuracy in relation to the ANSI/AAMI SP10 standard is typically auscultatory reference measurements performed by trained observers. This involves a gold standard method where human observers listen for Korotkoff sounds to determine systolic and diastolic blood pressure.

8. The sample size for the training set

The provided text does not mention a training set sample size. Digital blood pressure monitors like this typically do not have a "training set" in the machine learning sense. Their algorithms are developed based on physiological principles and validated against reference methods. If iterative algorithm refinement occurred, the data used for that is not disclosed as a "training set" here.

9. How the ground truth for the training set was established

As there is no explicit mention of a "training set" for the KP-7600 series in the machine learning context, the method for establishing its ground truth is not applicable/not provided. The device's algorithm development and validation would rely on established medical knowledge and comparisons to reference methods (like auscultation) as outlined in standards like ANSI/AAMI SP10.

Summary

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510(k) Summary

Kobi
pi/
nd Date Prepared

K-jump's Arm Blood Pressure Monitor, Model KP-7600 series. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Daniel Tseng K-jump Health Co., Ltd

No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, Taiwan Phone: +886 2 2299 1378 Facsimile: +885 2 2299 1386 Date Prepared: June 16, 2006

AUG 1 4 2006

Name of Device and Name/Address of Sponsor

Arm Blood Pressure Monitor, Model KP-7600 series K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, Taiwan Phone: +886 2 2299 1378 Facsimile: +886 2 2299 1386 Contact person: Danny Wanq Email: danny.wang@kjump.com.tw

Common or Usual Name:	Blood Pressure Monitor
Classification Name:	System, Measurement, Blood Pressure, Non-invasive
Predicate Device:	K-jump Health Co., Ltd. Arm Blood Pressure MonitorModels KP-6821A & KP-6822A series

Intended Use

The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use in adults.

Technological Characteristics

Performance Data

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K061760
P2/2

In addition to the conformity standards, ANSI/AAMI SP10:2002 Manual, Electronic or Automated Sphygmomanometers, of the predicate device. This Arm BPM also complies with the electrical safety standards 60601-1 Medical Electrical Equipment- Part 1: General Requirements For Safety & 60601-1-2:2001 Medical Electrical Equipment- Part 1-2: General Requirements For Safety- Collateral Standard: Electromagnetic Compatibility-Requirements and Tests.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2006

K-Jump Health Co., Ltd. c/o Mr. Danny Wang Quality Representative No. 56 Wu Kung 5th Rd., Taipei Hsien, Taiwan 248

Re: · K061760

Trade/Device Name: Arm Blood Pressure Monitor, Model KP-7600 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 21, 2006 Received: August 1, 2006

Dear Mr. Wang:

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. Danny Wang

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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K061760

Indications for Use Statement

510(k) Number (if known):

Device Name:

Arm Blood Pressure Monitor model KP-7600 series

Indications for Use:

The Arm BPM is intended to measure the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the arm. The device is indicated for use in adults.

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The Counter Use OR (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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K061760

Regulation Number and Section

§ 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).