GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR by GOCANNING TECHNOLOGY LTD.

The provided text describes the GOCANNING GLS-700 e-Pulse Analysis Monitor, a non-invasive blood pressure monitor, and its 510(k) submission. However, the document does not contain the detailed acceptance criteria, the specific study conducted to prove the device meets these criteria, or most of the requested information regarding the study design.

The document primarily focuses on the device's substantial equivalence to a predicate device (Rossmax Automatic Blood Pressure Monitor K021225) based on intended use, technological characteristics, and conformance to applicable standards (EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2). It mentions "bench testing" and "clinical testing" were supplied without providing any details about these studies.

Here's a breakdown of the available information and the requested details that are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text	Not specified in the provided text
Conformance to EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1, IEC 60601-1-2 requirements (for operating specification, Safety & EMC)	The device conforms to these requirements. (No specific performance data is provided, only a statement of conformance.)

Missing Information: Detailed acceptance criteria, such as specific blood pressure measurement accuracy ranges (e.g., mean difference and standard deviation compared to a reference method), and the actual measured performance values from the clinical study are not present.

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "clinical testing."

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
(For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference measurement method, like auscultatory measurement with a mercury sphygmomanometer, not usually "experts" in the sense of radiologists, etc.)

4. Adjudication method for the test set:

Adjudication Method: Not specified.

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:

This device is a non-invasive blood pressure monitor, not an AI-powered image analysis or diagnostic tool involving "human readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device.

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

This directly relates to the device's function as an automatic blood pressure monitor. The device is standalone in its measurement capability, meaning its algorithm provides the blood pressure and pulse rate readings without human interpretation of raw data. The "clinical testing" mentioned would assess this standalone performance against a reference standard. However, the details of this testing are not provided.

7. The type of ground truth used:

Type of Ground Truth: Not specified. For blood pressure monitors, the ground truth is typically established using a validated reference method (e.g., auscultatory method with a mercury sphygmomanometer) by trained observers.

8. The sample size for the training set:

This device is not explicitly described as employing a machine learning or AI algorithm that requires a "training set" in the common sense for medical imaging or complex diagnostic tasks. While the internal algorithms for signal processing and blood pressure determination are developed, the document does not refer to a "training set" in the context of such algorithms. If it does use machine learning, the training set size is not specified.

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

How Ground Truth was Established: Not applicable/Not specified, as a training set is not explicitly mentioned for this device type in the provided text.

Summary of what is known from the provided text:

Device Name: GOCANNING GLS-700 e-Pulse Analysis Monitor
Intended Use: Measures human's Systolic, Diastolic blood pressure, and pulse rate, and is intended for adult of age 18 and above for over-the-counter use.
Predicate Device: Rossmax Automatic Blood Pressure Monitor (K021225)
Performance Claim: The device conforms to EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1, and IEC 60601-1-2 requirements.
Proof: "Bench testing" and "clinical testing" were supplied to demonstrate substantial equivalence and that any technological differences do not raise new questions of safety or effectiveness.

Key Missing Information for a comprehensive answer: The specific details of the "clinical testing" and the "bench testing," including methodologies, acceptance criteria, raw performance data, sample sizes, and how ground truth was established, are entirely absent from this 510(k) summary. These details would typically be found in the full 510(k) submission and associated test reports.

Summary

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K043352 510(K) SUMMARY

52 '/

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

.0	Submitter's Name:	Gocanning Technology Ltd.
	Address:	6F-1, No. 188, Sec. 3, Tatung Rd., Hsichih City, Taipei, Taiwan
	Phone:	TEL: 001-886-2-86471618
	Fax:	FAX: 001-886-2-86472653
	Contact:	Mr. TSUNG-Kun Su, General Manager
2.0	Device Name
	Trade Name:	GOCANNING GLS-700 e-Pulse Analysis Monitor
		Model No.: GLS-700
	Common Name:	Non-Invasive Blood Pressure Monitor
		Classification name: System , Measurement , Blood-Pressure , Non-Invasive
3.0	Classification:	Class II
	4.0 Predicate Device:	The predicate device is the Rossmax Automatic Blood PressureMonitor(K021225) marketed by ROSSMAX INTERNATIONAL LTD.
		5.0 Device Description: GOCANNING GLS-700 e-Pulse Analysis Monitor is designed tomeasure the systolic and diastolic blood pressure, and pulse rate(heartof an individual).
	6.0 Intended Use:	GOCANNING GLS-700 e-Pulse Analysis Monitor is intended tomeasure human's Systolic, Diastolic blood pressure and pulse rate. Allvalues can be read out in one LCD DISPLAY.
	7.0 PerformanceSummary:	In terms of operating specification, Safety & EMC requirements, thedevice conforms to applicable standards included EN-1060-1,EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2requirements.

Conclusions: 8.

The GOCANNING GLS-700 e-Pulse Analysis Monitor have the same intended use and similar technological characteristics as Rossmax Automatic Blood Pressure Monitor(K021225) marketed by ROSSMAX INTERNATIONAL LTD. Moreover, bench testing contained in this submission and 'inical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the GOCANNING GLS-700 e-Pulse Analysis Monitor is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle 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 or a bird in flight, composed of three curved lines.

MAR 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gocanning Technology, Ltd. c/o Ms. Jennifer Reich Harvest Consulting Corp. 3892 South America Trail West Flagstaff, AZ 86001

Re: K043352

. Ko+9552
Trade Name: GLS-700 e-Pulse Analysis Monitor Regulation Number: 21 CFR 870.1130 Regulation Number: 21 CFR 0707100
Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: March 10, 2005 Received: March 15, 2005

Dear Ms. Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained is substantially equivalent (for the indications
referenced above and have determined the device merketed in interstate referenced above and nave determined the actives marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Amendments for use stated in the enclosure) to regally manced provide Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1976, the chacmience with the provisions of the Federal Food. Drug, devices that have been recuassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval as the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, merelore, market the devreet, backed in the of
general controls provisions of the Act include requirements for answere misbranding and general controls provisions of the Fret mercial comments of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) in o chair and regulations affecting your device can
may be subject to such additional controls. Title may be subject to such additional controlls. Existing major sogn. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, Inc. And in be found in the Code of Peachar Regening your device in the Federal Register.

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Page 2 -- Ms. Jennifer Reich

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subsidies with other requirements of the Act
that FDA has made a determination that your device aller Feguirements You must that FDA has made a determination and your are your Federal agencies. You must
or any Federal statutes and regulations administered by registration and listing or any Federal statules and regulations daminister of rot limited to: registration and listing (21
comply with all the Act's requirements, including, but not sequirements as comply with all the Act s requirements, moradias wardice requirements as set
CFR Part 807); labeling (21 CFR Part 801); god if annisable, the electronic CFR Part 807); labeling (21 CFK Fall 601); good manatationing production the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, the forth in the quality systems (Q5) regulation (21-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Actibed in your Section 5 product radiation control provisions (Sections 991 - 12 - 2 deciribed in your Section 510(k)
This letter will allow you to begin marketing your device of your douice to a leg This letter will allow you to begin makemig your artist equivalence of your device to a legally premarket notification. The FDA inding of substanted by 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 do not the career note the regulation entitled, the regulation entitled, comaci the Office of Comphance at (21 to tification" (21CFR Part 807.97). You may obtain " Misofanding by relevence to premanse noulities under the Act from the Division of Small other general information on your responsion.com 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,

Mepesmay
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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Indications for Use

K043352_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: GLS-700 e-Pulse Analysis Monitor Gocanning Technology Ltd.

Indications For Use:

GLS-700 e-Pulse Analysis Monitor is used to measure automatically human's Systolic, Diastolic blood pressure and pulse rate.

The intended for use of this over-the-counter device is for adult of age 18 and above.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Noles May

(Division/Sign-Off) /
Division of Cardiovascular Devices
510(k) Number K043352

Page 1 of 1

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).