(329 days)
No
The summary describes a standard blood glucose and blood pressure monitoring device using established measurement techniques (capillary blood for glucose, inflatable cuff for blood pressure). There are no mentions of AI, ML, image processing, or any other indicators of advanced algorithmic processing beyond basic signal analysis for blood pressure and electrochemical analysis for glucose.
No.
The device is intended for measurement and monitoring, not for providing therapy or treatment.
No
The intended use explicitly states, "The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates."
No
The device description explicitly states the kit consists of a meter, test strips, control solutions, and a lancet device, all of which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood." This is a classic definition of an in vitro diagnostic test, as it involves analyzing a biological sample (blood) outside of the body to obtain diagnostic information (glucose levels).
- Device Description: The device description includes components like "test strips" and "control solutions," which are integral to in vitro diagnostic testing for glucose measurement.
- Exclusion of Diagnosis/Screening: While it's not for the diagnosis or screening of diabetes, it is intended as an aid in monitoring the effectiveness of a diabetes control program. This monitoring is based on the results of the in vitro glucose measurement.
The blood pressure measurement function is a separate function of the device and is not an IVD. However, the device as a whole includes an IVD component (the blood glucose meter).
N/A
Intended Use / Indications for Use
ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The alternative site testing in the systems can be used only during steady-state blood glucose conditions.
The system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. For ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter, the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.31"- 8.66".
The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, DXN
Device Description
The kit of ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter consist of four main products: the meter features both the blood glucose and blood pressure measurement functions, test strips, control solutions (cleared under K012430), and the lancet device (cleared under K833344). These products have been designed and tested to work together as a system to produce accurate blood glucose test results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Glucose measurement: finger, palm, forearm, upper-arm, calf, thigh.
Blood pressure measurement: wrist.
Indicated Patient Age Range
The device is not to be used for testing on neonates.
Intended User / Care Setting
healthcare professionals and people with diabetes mellitus at home
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)
Software verification and validation testing confirmed that the performance, safety and effectiveness of ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter met acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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. Section 10. 510(k) Summary
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The Assigned 510(k) number is: K092875
- Submitter's Identification:
TaiDoc Technology Corporation
3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan Correspondence:
Debra Liang
Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1198 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw
Prepared Date: September 14, 2009 .
- Device name:
Proprietary name: TD-3227 Dual Blood Pressure/Blood Glucose Meter. Regulatory information:
Regulation section: 21 CFR § 862.1345, Glucose Test System 21 CFR §870.1130, Noninvasive blood pressure measurement system Classification: Class II (Glucose Test System)
Class II (Blood Pressure Measurement System)
Product Code: NBW, System, Test, Blood Glucose, Over The Counter
CGA, Glucose Oxidase, Glucose
DXN, System, Measurement, Blood-Pressure, Non-Invasive Panel: 75, Clinical Chemistry - Glucose Test System
- Cardiovascular - Blood Pressure Measurement System
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3. Intended Use:
ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The alternative site testing in the systems can be used only during steady-state blood glucose conditions. The system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. For ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter. the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.31"- 8.66". The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates.
-
- Device Description:
The kit of ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter consist of four main products: the meter features both the blood glucose and blood pressure measurement functions, test strips, control solutions (cleared under K012430), and the lancet device (cleared under K833344). These products have been designed and tested to work together as a system to produce accurate blood glucose test results.
- Device Description:
- Substantial Equivalence Information: Predicate device name:
Clever Chek TD-3217 Blood Glucose plus Blood Pressure Monitoring System. Predicate K number: K062800 Comparison with predicate:
The modified ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter has the following similarities to the predicate device:
□ same operating principle,
[ same fundamental scientific technology,
[ incorporate the same basic circuit design,
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2
O incorporate the same materials.
□ same shelf life
O packaged using the same materials, and
O Manufactured by the same process.
The modifications encompass:
[] A modification in the software of the meter
□ Modification in the physical appearance
O Expansion of cuff size
[] Labeling change due to the software modification
- Test Principle:
For blood glucose, the detection and measurement is by an electrochemical biosensor technology using glucose oxidase.
For blood pressure, the measurement is by using oscillometric, non-invasive blood pressure (systolic, diastolic and mean arterial pressure) measuring technology.
7. Performance Characteristics:
Software verification and validation testing confirmed that the performance, safety and effectiveness of ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter met acceptance criteria.
8. Conclusion:
Based on the information provided in this submission. ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter is substantially equivalent to the predicate Clever Clever Chek TD-3217 Blood Glucose plus Blood Pressure Monitoring Systems.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver-Spring - MD-20993-0002
TaiDoc Technology Coporation C/O Debra Liang 6F, No. 127, Wugong 2nd Rd. Wugu Township, Taipei, Taipei County, Taiwan 248
AUG 1 3 2010
Re: K092875
Trade/Device Name: Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, NBW, DXN Dated: July 23, 2010 Received: July 26, 2010
Dear Ms. Liang:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.
4
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CFC
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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AUG 1 3 2010
Attachment 6. Indications for Use
Indications for Use
510(k) Number: K092875
Device Name: ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter
Indications for Use:
ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The alternative site testing in the systems can be used only during steady-state blood glucose conditions.
The system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. For ECHO TD-3227 Dual Blood Pressure/Blood Glucose Meter, the blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.31"- 8.66".
The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates.
| Prescription Use | |
|---|---|
| (21 CFR Part 801 Subpart D) |
Over the Counter Use And/Or X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)
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