(344 days)
Not Found
No
The summary describes a standard blood pressure and glucose monitor using established measurement methods (oscillometric for blood pressure, quantitative measurement of glucose in whole blood). There is no mention of AI, ML, or any advanced algorithms beyond basic data storage and display.
No
The device is described as a monitor for quantitative measurement of glucose, blood pressure, and pulse rate, and as an aid to monitor the effectiveness of diabetes control. It does not actively treat or intervene to alleviate a disease or condition, which would make it a therapeutic device.
Yes
The device is explicitly stated to be an "aid to monitor the effectiveness of diabetes control" and performs "quantitative measurement of glucose in whole blood taken from the fingertip". It also measures systolic and diastolic blood pressure and pulse rate, all of which provide information for diagnosis or monitoring of a medical condition.
No
The device description explicitly states it consists of a meter with wrist cuff and test strips, and the blood pressure part employs a wrist cuff and the oscillometric method of measurement. These are hardware components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "Testing is done outside the body (In Vitro diagnostic use)." and "Glucose testing is done outside the body (In Vitro diabetes mellitus, or in clinical settings by healthcare professionals."
- Nature of Glucose Measurement: The device measures glucose in whole blood taken from various sites. This process of analyzing a biological sample outside the body to diagnose or monitor a condition is the definition of an in vitro diagnostic test.
While the device also measures blood pressure, which is a physiological measurement taken on the body (in vivo), the glucose monitoring component definitively classifies it as an IVD.
N/A
Intended Use / Indications for Use
The Duo-Max Blood pressure and Glucose Monitor, Model HMF-100 consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric metric method of measurement.
The Blood pressure and glucose monitor. Duo-Max™ consists of a meter with wrist cuff and glucose test strips. The glucose test system is intended for use in the quantitative measurement of glucose in capillary whole blood taken from the fingertip, dorsal hand, ventral palm, upper arm, forearm, calf and thigh. Glucose testing is done outside the body (In Vitro diabetes mellitus, or in clinical settings by healthcare professionals. Glucose testing system is not to be used for the diagnosis or screening of diabetes. It is not intended for use on neonates. Also the blood pressure test system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillomentric metric method of measurement.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX, DXN
Device Description
HuBDIC's Duo- Max Blood Pressure and Glucose Monitor System, Model HMF-100 combines the function of a blood pressure meter and a blood glucose monitoring system in one unit. Supplies with the meter are test strips, lancets, Lancing device, storage case, batteries and log book.
HMF-100 adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface pane has power switch, timer switch, memory switch for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 180 most recent measurement results.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fingertip, dorsal hand, ventral palm, upper arm, forearm, calf and thigh (for glucose measurement); wrist (for blood pressure measurement)
Indicated Patient Age Range
The glucose test system is not intended for use on neonates. The blood pressure test system measures systolic and diastolic blood pressure and pulse rate from adult's wrist.
Intended User / Care Setting
at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 including ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements.
The Blood Pressure and Glucose Monitor, Model HMF-100 tested and met all relevant requirements of the aforementioned tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
0
510(k) Summary
EXHIBIT #1
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: January 11, 2008
FEB 1 3 2009
1. Submitter:
| Name: | HuBDIC Co., Ltd.
195-42, Anyang 7-dong, Manan-gu, Anyang-si,
Gyeonggi-do, Korea |
|----------|---------------------------------------------------------------------------------------|
| Contact: | In-Young An
Phone +82-31-441-8671
Fax +82-31-442-4994 |
2. Device:
| Proprietary Name: | Duo-Max Blood Pressure and Glucose Monitor, Model
HMF-100 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Pressure Monitor, Blood Glucose Monitor,
Blood glucose test strip and quality control material
System, test, blood glucose, over the counter |
| Classification Name: | Glucose oxidase, glucose
Single (specified) analyte controls |
| Classification: | 21 CFR 862.1345 |
| Product Code: | NBW, CGA, JJX, DXN |
3. Predicate Device:
Blood Glucose and Blood Pressure Monitor System, Model BGP-100 Sein Electronics Co., Ltd K052108 Infopia Glucolab™ Blood Glucose Monitoring System K051285
4. Description:
HuBDIC's Duo- Max Blood Pressure and Glucose Monitor System, Model HMF-100 combines the function of a blood pressure meter and a blood glucose monitoring system in one unit. Supplies with the meter are test strips, lancets, Lancing device, storage case, batteries and log book.
HMF-100 adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface pane has power switch, timer switch, memory switch for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 180 most recent measurement results.
HuBDIC Co., Ltd.
1
5. Indications for use:
The Duo-Max Blood pressure and Glucose Monitor, Model HMF-100 consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric metric method of measurement.
6. Comparison of Technological Characteristics with Predicate:
The Duo-Max Blood Pressure and Glucose Monitor, Model HMF-100 has the same general design and performance characteristics as the predicate device from Sein. The main difference is the physical size, shape and weight as seen below:
| ltem | Duo-Max Blood Pressure and Glucose
Monitor, model HMF-100 | Sein, Blood Glucose and Blood Pressure
Monitor System, Model BGP-100 |
|-------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|
| Pulse Rate | 20 ~ 199 pulse/min | 40 ~ 199 pulse/min |
| Number of
Readings stored
in Memory | 180 times (Blood Pressure Part)
270 times (Blood Glucose Part) | 60 times (Blood Pressure Part)
150 times (Blood Glucose Part) |
| Dimension | 64(W) x 84(W) x 31(H)(mm) | 62(W) x 83(W) x 33(H)(mm) |
| Weight | 163g | 192g |
7. Performance Data:
In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards including ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements.
The Blood Pressure and Glucose Monitor, Model HMF-100 tested and met all relevant requirements of the aforementioned tests.
8. Conclusion:
We have demonstrated that the Blood Pressure and Glucose Monitor, Model HMF-100 is as safe and effective as the predicate devices based on our performance testing results as well as with the risk analysis supplied with this submission.
This submitter concludes that the Blood Pressure and Glucose Monitor, Model HMF-100 is therefore substantially equivalent to the predicate devices.
HuBDIC Co., Ltd.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" on the first line, "Health" on the second line, and "Service" on the third line. The text is black against a white background.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
HuBDIC Co. Ltd. c/o Maria Griffin, MDI Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021
FEB 1 3 2009
Re: K080636
Trade Name: Duo-Max Blood Pressure and Glucose Monitor, Model HMF-100 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA, DXN, JJX Dated: January 30, 2009 Received: February 2, 2009
Dear Ms. Griffin:
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 sect additional commis . Enisting major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CEA), Econo 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page - 2
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 nuïnber. (800) 638-2041 or (301) 443-6597 or at its Internet address - http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
4
Indication for Use
:
上一篇:
510(k) Number (if known): K080636
Device Name: Blood Pressure and Glucose Monitor, Duo-Max™ (Model HMF-100)
Indication For Use:
2013
The Blood pressure and glucose monitor. Duo-Max™ consists of a meter with wrist cuff and glucose test strips. The glucose test system is intended for use in the quantitative measurement of glucose in capillary whole blood taken from the fingertip, dorsal hand, ventral palm, upper arm, forearm, calf and thigh. Glucose testing is done outside the body (In Vitro diabetes mellitus, or in clinical settings by healthcare professionals. Glucose testing system is not to be used for the diagnosis or screening of diabetes. It is not intended for use on neonates. Also the blood pressure test system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillomentric metric method of measurement.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use_v (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)
Carol C. Benson
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety .. .
510(k) K080636