(115 days)
Not Found
No
The summary describes a standard blood pressure monitor and does not mention any AI or ML capabilities.
No
A therapeutic device is used for treatment. This device is solely for measurement and monitoring of vital signs, not for treating any condition.
Yes
The device measures blood pressure and pulse rate, which are physiological parameters used to assess a person's health status. While it doesn't explicitly state "diagnosis," measuring these parameters for "e-Pulse Analysis" falls under the broad category of providing physiological data relevant for diagnosis. The predicate device is also a blood pressure monitor, which is a diagnostic tool.
No
The device description explicitly states it is designed to "measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual)," and the performance studies reference standards for physical devices (EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1, IEC 60601-1-2). This strongly indicates the device includes hardware components for measurement, not just software for analysis.
Based on the provided information, the GLS-700 e-Pulse Analysis Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside the body.
- GLS-700 Function: The GLS-700 measures blood pressure and pulse rate directly from the human body using a cuff. This is a non-invasive measurement performed on the body, not on a specimen taken from the body.
- Intended Use: The intended use clearly states it measures "human's Systolic, Diastolic blood pressure and pulse rate," which are physiological parameters measured directly from the individual.
Therefore, the GLS-700 falls under the category of a non-invasive medical device used for monitoring physiological signs, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DXN
Device Description
GOCANNING GLS-700 e-Pulse Analysis Monitor is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult of age 18 and above.
Intended User / Care Setting
Over-The-Counter Use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Pressure | |
| Monitor(K021225) marketed by ROSSMAX INTERNATIONAL LTD. | ||
| 5.0 Device Description: GOCANNING GLS-700 e-Pulse Analysis Monitor is designed to | ||
| measure the systolic and diastolic blood pressure, and pulse rate(heart | ||
| of an individual). | ||
| 6.0 Intended Use: | GOCANNING GLS-700 e-Pulse Analysis Monitor is intended to | |
| measure human's Systolic, Diastolic blood pressure and pulse rate. All | ||
| values can be read out in one LCD DISPLAY. | ||
| 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. | ||
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.
1
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.
2
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
3
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
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