AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) by AVITA CORPORATION

The device is noninvasive and provide systolic, diastolic blood pressure and pulse rate(heart rate) measurements by using an inflating cuff which is wrapped around the wrist. All values can be read out in one LCD panel. The device is indicated for use by people over 15 years old in home use.

Device Description

AVITA BPM1 Series Wrist Type Blood Pressure Meter is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AVITA BPM1 Series Wrist Type Blood Pressure Meter:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly suggests that the device's performance needs to be "statistically and clinically acceptable" when compared to an auscultatory method. It also states adherence to several standards.

Acceptance Criteria Category	Specific Criteria (Implicit/Standard-based)	Reported Device Performance
Accuracy/Performance	Clinical repeatability acceptable (compared to auscultatory method)	Demonstrated clinical repeatability that is "statistically and clinically acceptable."
Operating Specifications	Conformance to applicable standards	Conforms to EN-1060-1, EN-1060-3, ANSI/AAMI SP-10.
Safety	Conformance to applicable standards	Conforms to IEC 60601-1.
EMC (Electromagnetic Compatibility)	Conformance to applicable standards	Conforms to IEC 60601-1-2.
Substantial Equivalence	Similar intended use & technological characteristics to predicate. No new questions of safety/effectiveness.	Demonstrated substantial equivalence to HL-168D Wrist Blood Pressure Monitor (K012310) with no new questions of safety or effectiveness.

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It is referred to as a "comparison study" and "clinical testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the ground truth was established by an auscultatory method, which is a direct measurement standard, not an expert consensus for image interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as it was a direct comparison study to a standard measurement method (auscultatory), not an expert interpretation scenario requiring adjudication.
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. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance study effectively evaluates the device in a standalone manner, as it functions automatically to measure blood pressure and rate. The comparison is between the device's reading and the auscultatory method.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was the auscultatory method, which is considered a traditional gold standard for blood pressure measurement.
The sample size for the training set:
- Not applicable. This device is a measurement instrument, not an AI/machine learning model that requires a training set in the conventional sense. Its function is based on established oscillometric principles.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an AI/ML model for this device. Its design and validation rely on engineering principles and comparison to established measurement methods.

Summary

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510(K) SUMMARY

MAY 23 2003

(030230

1 of 2

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

...

1.0	Submitter's Name:	AVITA Corp
	Address:	9F, No. 78, Sec. 1, Kwang-Fu Rd., San-Chung, Taipei County,Taiwan, R.O.C.
	Phone:	001-886-2-85121568
	Fax:	001-886-2-85121347
	Contact:	Mr. Geo Lin, General Manager
2.0	Device Name:	AVITA BPM1Series (Wrist Type) Blood Pressure Meter (or Monitor)Model No.: BPM1XY
		► The first Character (blank, 0-9 or A-Z )is for the minorchange revision of device (The Minor change meaningdevice change that do not affect the conformity test result ofEMC & Safety, ie. IEC 60601-1 and IEC 60601-1-2 )► The second Character (blank, 0-9 or A-Z ) is for the color ofthe housing(for example Wellex Blood Pressure Monitor # BPM101, is forthe first revision of device design and the present version of color &artwork)
3.0	Classification:	Class II
4.0	Predicate Device:	AVITA BPM1 Series Wrist Type Blood Pressure Monitor hassimilar general design with HL-168D Wrist Blood PressureMonitor(K012310) marketed by Health & Life Co., Ltd..
5.0	Device Description:	AVITA BPM1 Series Wrist Type Blood Pressure Meter isdesigned to measure the systolic and diastolic blood pressure, andpulse rate(heart of an individual).
6.0	Intended Use:	AVITA BPM1 Series Wrist Type Blood Pressure Meter isintended to measure the systolic and diastolic blood pressure, andpulse rate(heart rate) by using an inflating cuff which is wrappedaround the wrist. The Device is indicated for use by people over 15years old in home use.

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7.0 Performance Summary:

In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements. A comparison study with device that use auscultatory method was performed to validate the performance of the AVITA BPM1 Series Wrist Type Blood Pressure Meter. The comparison study demonstrated that the clinical repeatability of AVITA BPM1 Series Wrist Type Blood Pressure Meter is statistically and clinically acceptable.

8. Conclusions:

The AVITA BPM1 Series Wrist Type Blood Pressure Meter have the same intended use and similar technological characteristics as HL-168D Wrist Blood Pressure Monitor(K012310) marketed by Health & Life Co., Ltd.. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the AVITA BPM1 Series Wrist Type Blood Pressure Meter is substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, with a bird-like wing extending from the head of the first profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2003

AViTA Corporation c/o Ms. Jennifer Reich 3892 South America West Trail Flaggstaff. AZ 86001

Re: K030230

Trade Name: AViTA BPM 1 Series (Wrist type) Blood Pressure Meter (or Monitor) Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive blood measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: April 7, 2003 Received: April 18, 2003

Dear Ms. Reich:

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.

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

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Page 2 - Ms. Jennifer Reich

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 (OS) 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 (301) 594-4646. 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/dsma/dsmamain.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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K030230

Page _________________________________________________________________________________________________________________________________________________________________________

510 (k) NUMBER (IF KNOWN): K032230

AVITA BPM1 Series Wrist Type Blood Pressure Meter DEVICE NAME: AVITA Corp.

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use(Per 21 CFR 801.109)
(Division Sign-Off)Division of Cardiovascular Devices
Over-The-Counter(Optional Format)	X
510(k) Number	K030230

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).