(27 days)
Not Found
No
The description focuses on automated mechanical and chemical processes for glucose measurement, with no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No.
The device is a blood glucose monitoring system, used for measuring glucose levels, which aids in monitoring the effectiveness of diabetes control. It does not exert a therapeutic effect on the body.
Yes
The device is intended for the quantitative measurement of glucose in blood samples, which is a diagnostic measurement. Although it explicitly states it should not be used for the diagnosis of diabetes, it is used as an "aid to monitor the effectiveness of diabetes control," which is a diagnostic purpose to track the disease and adjust treatment.
No
The device description clearly outlines hardware components including a meter with a photometer, a Bluetooth module, and cartridges containing test strips and lancing mechanisms. While software is mentioned for V&V, the core functionality relies on physical components for blood glucose measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The POGO Automatic Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
- Definition of IVD: An in vitro diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device analyzes a blood sample to measure glucose levels.
- Purpose: The device is used to measure glucose in a blood sample outside the body to aid in monitoring diabetes control. This aligns with the purpose of an IVD.
N/A
Intended Use / Indications for Use
The POGO Automatic Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The POGO Automatic Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).
POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Product codes
NBW
Device Description
The POGO BGMS is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The system includes multiple glucose-oxidase-based dry-reagent test strips housed in a cartridge and a photometer to read the glucose-dependent color change from the in-use strip. The meter uses calibration information from a barcode on the disposable cartridge to convert the reflectance information into a plasma-equivalent glucose value. A Bluetooth Low Energy (BLE) module in the meter allows the user to authorize the POGO meter to send data wirelessly, securely, and automatically after each test to specified electronic computing devices.
The POGO BGMS automates finger lancing, blood sample collection and placement onto the test strip, and calculation of the blood glucose result, and so requires significantly fewer steps than existing BGMSs to obtain a glucose result. The POGO BGMS accomplishes this via a 10-test cartridge where each foil-sealed test includes a hollow lancet, spring, and test strip. The user does not need a separate lancing device since the lancing mechanism is built into individual test cells of the cartridge. The blood sample is drawn into the test through capillary action and the meter, by monitoring the time and degree of blood spreading on the reagent pad, can detect when the test is under-filled and allow the user a limited amount of time to add blood to the test trip to obtain a glucose result rather than an error. Additionally, used tests are retained within the cartridge for added user convenience.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertips
Indicated Patient Age Range
Adults and adolescents (13 and up)
Intended User / Care Setting
People with diabetes at home for self testing.
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)
Multiple nonclinical tests were identified via risk assessment activities as requirements to demonstrate comparable safety and effectiveness between the predicate and subject devices. The subject device achieved a "Pass" result for all of those tests, namely:
-
- Performance tests conducted to demonstrate that items modified or replaced from the predicate device met the performance specifications established for those components;
-
- Mechanical, Environmental, and Electrical safety tests appropriate for SMBG devices;
-
- Cleaning and Disinfection efficacy and robustness challenges on raw materials and the assembled device;
-
- Software V&V:
-
- Bluetooth wireless proximity and coexistence testing; and
-
- Labeling readability.
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
§ 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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June 14, 2018
Intuitv Medical, Inc. % Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010
Re: K181316
Trade/Device Name: POGO Automatic Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: May 17, 2018 Received: May 18, 2018
Dear Cindy Domecus:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181316
Device Name
POGO Automatic Blood Glucose Monitoring System
Indications for Use (Describe)
The POGO Automatic Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The POGO Automatic Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).
POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Intuity Medical. The logo consists of a stylized "i" inside a circle, followed by the word "intuity" in a bold, sans-serif font. Below the word "intuity" is the word "MEDICAL" in a smaller, lighter font. To the right of the word "intuity" is the phrase "Simplifying Diabetes" in a light, sans-serif font.
510(k) Summary, K181316
510(k) Owner
Robb Hesley Senior VP Corporate Development Intuity Medical, Inc. 3500 West Warren Avenue Fremont, CA 94538 (510) 946-8861 (phone) (510) 897-0603 (fax) robb.hesley@intuitymedical.com
Submission Correspondent
Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC Regulatory Consultant to Intuity Medical, Inc. Office: 650-343-4813 Fax: 650-343-7822 DomecusConsulting@comcast.net
Date Summary Prepared
June 11, 2018
Device Name and Classification
| Trade Name | POGO® Automatic™ Blood
Glucose Monitoring System |
|----------------|-----------------------------------------------------|
| Common Name | Glucose Test System |
| Classification | Class II |
| Regulations | 21 CFR 862.1345 |
| Product Codes | NBW |
| Panel | Clinical Chemistry |
Predicate Device
The predicate device for the POGO Automatic Blood Glucose Monitoring System (POGO BGMS) is the earlier version of the system cleared under K162203 on April 6, 2017.
4
Device Description
The POGO BGMS is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip. The system includes multiple glucose-oxidase-based dry-reagent test strips housed in a cartridge and a photometer to read the glucose-dependent color change from the in-use strip. The meter uses calibration information from a barcode on the disposable cartridge to convert the reflectance information into a plasma-equivalent glucose value. A Bluetooth Low Energy (BLE) module in the meter allows the user to authorize the POGO meter to send data wirelessly, securely, and automatically after each test to specified electronic computing devices.
The POGO BGMS automates finger lancing, blood sample collection and placement onto the test strip, and calculation of the blood glucose result, and so requires significantly fewer steps than existing BGMSs to obtain a glucose result. The POGO BGMS accomplishes this via a 10-test cartridge where each foil-sealed test includes a hollow lancet, spring, and test strip. The user does not need a separate lancing device since the lancing mechanism is built into individual test cells of the cartridge. The blood sample is drawn into the test through capillary action and the meter, by monitoring the time and degree of blood spreading on the reagent pad, can detect when the test is under-filled and allow the user a limited amount of time to add blood to the test trip to obtain a glucose result rather than an error. Additionally, used tests are retained within the cartridge for added user convenience.
Indications for Use
The POGO Automatic Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The POGO Automatic Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).
POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
5
| POGO BGMS | POGO BGMS K162203 | |
|---|---|---|
| Characteristic | Subject Device | Predicate Device |
| Intended Use | Quantitative measurement of blood glucose | Same |
| Indications For Use | The POGO Automatic Blood Glucose | |
| Monitoring System is intended to be used | ||
| for the quantitative measurement of | ||
| glucose (sugar) in fresh capillary whole | ||
| blood samples drawn from the fingertips. | ||
| The POGO Automatic Blood Glucose | ||
| Monitoring System is intended to be used | ||
| by a single person and should not be | ||
| shared. | ||
| The POGO Automatic Blood Glucose | ||
| Monitoring System is intended for self | ||
| testing outside the body (in vitro diagnostic | ||
| use) by people with diabetes at home as an | ||
| aid to monitor the effectiveness of diabetes | ||
| control. The POGO Automatic Blood | ||
| Glucose Monitoring System should not be | ||
| used for the diagnosis of or screening of | ||
| diabetes or for neonatal use. The POGO | ||
| Automatic Blood Glucose Monitoring | ||
| System is indicated for use in adults and | ||
| adolescents (13 and up). | ||
| POGO Automatic Test Cartridges are for | ||
| use with the POGO Automatic Meter to | ||
| quantitatively measure glucose (sugar) in | ||
| fresh capillary whole blood samples drawn | ||
| from the fingertips. | Same | |
| Rx/OTC | OTC | Same |
| Classification | ||
| Regulation | 862.1345 | Same |
| Product Codes | NBW | Same |
| Product Design | Battery-powered handheld meter | Same |
| Delivery of Blood to | ||
| Reagent Pad via | ||
| Capillary Action | Yes | Same |
| Automatic Blood | ||
| Sample Collection | Yes | Same |
| Detects Under-filled | ||
| Reagent Pad | Yes | Same |
| Characteristic | POGO BGMS | POGO BGMS K162203 |
| Subject Device | Predicate Device | |
| Allows Blood | ||
| Reapplication | ||
| to Complete Test | Yes, provides glucose result or error code | |
| after blood addition to under-filled strip | Same | |
| Time period allowed | ||
| for patient to add | ||
| more blood when | ||
| reagent pad is under- | ||
| filled | 15 seconds | Same |
| Time period allowed | ||
| for patient to apply | ||
| blood when blood does | ||
| not reach reagent pad | 90 seconds | Same |
| Meter enforces limits | ||
| on strip exposure? | Yes, device design prevents strip use after | |
| 5 minute exposure (open cell time window) | Same | |
| Patient able to re-use | ||
| lancet? | No, device design prevents re-use | Same |
| Cal Coding | Automated | Same |
| Detection Method | Photometric (LED) | Same |
| Enzyme | Glucose oxidase | Same |
| Hematocrit Range | 20% to 60% | Same |
| Humidity Range | 10% to 90% RH | Same |
| Lancing Device | Integrated in Meter with Strip/Lancet in | |
| Cartridge | Same | |
| Measurement | ||
| Range | 20 - 500 mg/dL | Same |
| Minimum | ||
| Sample Size | 0.25 µL | Same |
| Monitor Memory | 500 results | Same |
| Operating | ||
| Temperature Range | 50 to 104° F | Same |
| Principle of Operation | Glucose is oxidized by the enzyme glucose | |
| oxidase and electrons are transferred to | ||
| form the intermediate hydrogen peroxide. | ||
| Horseradish peroxidase catalyzes the | ||
| transfer of electrons between hydrogen | ||
| peroxide and precursor dye molecules to | ||
| form a blue oxidation product, the | ||
| concentration of which is proportional to | ||
| the concentration of glucose in the sample. | ||
| The amount of color formed is read by a | ||
| photometer in the meter. | Same |
Comparison to Predicate Device -- POGO BGMS
6
7
The subject modifications for the POGO BGMS do not affect any of the above attributes that were included in the substantial equivalence section of the predicate device and relied upon for the substantial equivalence finding for the predicate device, K162203. Similarities between the between the subject and predicate POGO BGMS include:
- Same fundamental technological characteristics. The following remain unchanged: blood ● sampling and blood glucose measurement, use of the same cartridge (which contains the reagent system used to measure blood glucose), technology and procedure to acquire a blood sample and monitor the color development on the reagent pad and the algorithm to calculate a glucose value from the reaction at the reagent pad
- Same intended use and indications for use
Differences between the subject and predicate POGO BGMS include:
- the addition of BLE capability,
- a pixelated versus a segmented display screen,
- a new hard coat material on the display lens,
- addition of graphical elements, settings, and alerts to the display, ●
- a speaker versus a piezo annunciator, and ●
- a replacement of rubber feet on the bottom of the device for one large slip-resistant label. .
The modifications do not alter fundamental technologies or principles of operation of the POGO BGMS.
Summary of Nonclinical Performance Data
Multiple nonclinical tests were identified via risk assessment activities as requirements to demonstrate comparable safety and effectiveness between the predicate and subject devices. The subject device achieved a "Pass" result for all of those tests, namely:
-
- Performance tests conducted to demonstrate that items modified or replaced from the predicate device met the performance specifications established for those components;
-
- Mechanical, Environmental, and Electrical safety tests appropriate for SMBG devices;
-
- Cleaning and Disinfection efficacy and robustness challenges on raw materials and the assembled device;
-
- Software V&V:
-
- Bluetooth wireless proximity and coexistence testing; and
-
- Labeling readability.
Conclusion
Results from the nonclinical testing using the modified POGO BGMS demonstrate that it is substantially equivalent to the predicate device. The modifications to the POGO BGMS do not raise different questions of safety and effectiveness and the testing performed to evaluate the modifications confirms that the modified device is as safe and effective and is substantially equivalent to the predicate device.