ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER

K092875 · Taidoc Technology Corporation · NBW · Aug 13, 2010 · Clinical Chemistry

Device Facts

• Record ID: K092875
• Device Name: ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Clever Chek TD-3217 Blood Glucose plus Blood Pressure Monitoring System is intended for use in the home or clinical setting for the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, upper arm, calf, and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control programs. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The blood pressure monitoring function is intended for use by adults to measure systolic and diastolic blood pressure and pulse rate.

Device Story

Dual-function meter measuring blood glucose via electrochemical biosensor (glucose oxidase) and blood pressure/pulse via oscillometric wrist cuff. Input: fresh capillary whole blood (glucose) and wrist pressure oscillations (BP). Output: digital display of glucose concentration, systolic/diastolic BP, and pulse rate. Used by patients at home or healthcare professionals in clinics. Aids monitoring of diabetes control programs. Cuff circumference 5.31"-8.66".

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm modifications met predetermined acceptance criteria. Risk analysis conducted using ALARP methodology.

Technological Characteristics

Electrochemical biosensor (glucose oxidase) for glucose; oscillometric technology for BP. Wrist-worn device with inflatable cuff (5.31"-8.66").

Indications for Use

Indicated for quantitative blood glucose measurement (finger/alternative sites) and non-invasive blood pressure/pulse rate monitoring in patients with diabetes mellitus. Intended for home and professional use. Contraindicated for neonates and for diagnosis/screening of diabetes or hypertension.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Clever Chek TD-3217 Blood Glucose plus Blood Pressure Monitoring System (k062800)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k092875

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Clever Chek TD-3217 Blood Glucose plus Blood Pressure Monitoring System, k062800
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. The glucose meter/test strip modifications included design changes (removal of calibration button), coding changes from coded to no code, name change to ECHO TD-3227, software changes corresponding to the coding change and labeling changes for meter, test strips and controls. The blood pressure component modification was an increase in the circumference of the blood pressure cuff from 5.25" to 7.75" to 5.31" to 8.66".
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, analyte, software validation, risk analysis, and validation and verification activities.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis by ALARP.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.