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.

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.

AI/ML Overview

The provided text describes a medical device called the "Duo-Max Blood Pressure and Glucose Monitor, Model HMF-100" and its 510(k) submission. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested.

The document primarily focuses on:

Device Description: What the device is and its components.
Intended Use: For whom and how the device is to be used (blood pressure and glucose monitoring).
Comparison to Predicate Device: Highlighting similarities and minor physical differences (dimensions, weight, memory capacity) with an existing device (Sein BGP-100).
Standards Conformance: Stating that the device "conforms to applicable standards including ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements" and "met all relevant requirements of the aforementioned tests." This implies that the device achieved performance in line with these standards, but the specific numerical acceptance criteria or test results are not provided in this summary.
Conclusion of Substantial Equivalence: The manufacturer's assertion that the device is as safe and effective as predicate devices.
FDA Clearance Letter: Confirming the FDA's decision that the device is substantially equivalent.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Metric / Parameter	Acceptance Criteria (as per standards)	Reported Device Performance
Blood Pressure	Conforms to ANSI/AAMI SP-10 standards	"met all relevant requirements"
Blood Glucose	Conforms to unspecified standards related to glucose monitoring	"met all relevant requirements"
Safety & EMC	Conforms to IEC 60601-1 and IEC 60601-1-2	"met all relevant requirements"

Explanation: The document states the device "conforms to applicable standards including ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements" and "met all relevant requirements of the aforementioned tests." However, it does not explicitly list the numerical acceptance criteria from these standards or provide the specific numerical results of the device's performance against those criteria. It only makes a general statement of compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The summary mentions "performance testing results" but does not detail the sample size (number of participants or measurements), the nature of the study (retrospective or prospective), or the data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. For a blood pressure and glucose monitor, the ground truth is typically established by comparing the device readings to a reference method (e.g., a clinically validated sphygmomanometer for BP, or a laboratory analyzer for glucose). This does not involve human expert consensus in the same way as image interpretation. The document does not describe how ground truth was established, beyond implying comparison to reference methods as part of standardized testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., medical image interpretation by multiple readers). For an objective measurement device like this, ground truth is established by a reference method, not by expert adjudication.

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

Not applicable. This device is a direct measurement tool (blood pressure and glucose monitor), not an AI-powered diagnostic imaging tool that assists human readers. Therefore, an MRMC study or AI assistance is not relevant to this product.

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

Not applicable for "algorithm only" in the typical sense. The device itself is a standalone system for measurement. The performance described "met all relevant requirements of the aforementioned tests," implying that the device was tested as a complete system (hardware and internal algorithms) without human intervention in the measurement process itself. However, it's not an "algorithm only" study in the context of AI models.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Implicitly Reference Methods. For blood pressure, the ground truth would typically be established using a carefully calibrated and validated reference sphygmomanometer (e.g., mercury or an oscillometric device that has passed a higher level of validation). For blood glucose, the ground truth would be established by laboratory-grade glucose analyzers. The document does not explicitly state this, but it is standard practice for validating such devices.

8. The sample size for the training set

Not applicable / Not provided. As this is a traditional medical device for objective measurement (not an AI/machine learning model in the usual sense that requires a "training set"), the concept of a training set as understood in AI development does not apply here. The device's internal algorithms for measurement are likely developed through engineering and calibration, not statistical training on a dataset.

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

Not applicable / Not provided. See explanation for question 8.

Summary

{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 AnPhone +82-31-441-8671Fax +82-31-442-4994

2. Device:

Proprietary Name:	Duo-Max Blood Pressure and Glucose Monitor, ModelHMF-100
Common Name:	Blood Pressure Monitor, Blood Glucose Monitor,Blood glucose test strip and quality control materialSystem, test, blood glucose, over the counter
Classification Name:	Glucose oxidase, glucoseSingle (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 Co., Ltd.

{1}------------------------------------------------

5. Indications for use:

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 GlucoseMonitor, model HMF-100	Sein, Blood Glucose and Blood PressureMonitor System, Model BGP-100
Pulse Rate	20 ~ 199 pulse/min	40 ~ 199 pulse/min
Number ofReadings storedin 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).

{3}------------------------------------------------

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

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

Regulation Number and Section

§ 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.