POGO Automatic Blood Glucose Monitoring System

K181316 · Intuity Medical, Inc. · NBW · Jun 14, 2018 · Clinical Chemistry

Device Facts

• Record ID: K181316
• Device Name: POGO Automatic Blood Glucose Monitoring System
• Applicant: Intuity Medical, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 14, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended 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.

Device Story

POGO Automatic Blood Glucose Monitoring System (BGMS) is a handheld, battery-powered device for home use by patients with diabetes. System integrates lancing, blood collection, and glucose measurement into a single 10-test cartridge. Input: fresh capillary whole blood from fingertip. Operation: hollow lancet in cartridge punctures skin; blood drawn via capillary action onto glucose-oxidase-based dry-reagent pad. Photometer measures color change; meter converts reflectance to plasma-equivalent glucose value using barcode calibration. Device detects under-filled pads, allowing re-application within 15 seconds. Output: quantitative blood glucose result displayed on screen; data transmitted via Bluetooth Low Energy (BLE) to external computing devices. Benefits: automates lancing/sampling, reducing steps for patient; improves convenience; aids diabetes control monitoring.

Clinical Evidence

Bench testing only. Performance verified through mechanical, environmental, and electrical safety testing; cleaning/disinfection efficacy; software V&V; Bluetooth wireless proximity/coexistence testing; and labeling readability. No clinical data presented.

Technological Characteristics

Handheld, battery-powered photometer. Glucose-oxidase-based dry-reagent test strips in 10-test cartridges. Photometric detection (LED). Measurement range: 20-500 mg/dL. Hematocrit range: 20-60%. Connectivity: Bluetooth Low Energy (BLE). User interface: pixelated display, speaker. Integrated lancing mechanism.

Indications for Use

Indicated for adults and adolescents (13+) with diabetes for home self-monitoring of blood glucose levels. Not for diabetes diagnosis, screening, or neonatal use.

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

• POGO Automatic Blood Glucose Monitoring System (k162203)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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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 [phone] (phone) [phone] (fax) [e-mail]

#### 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: [phone] [e-mail]

#### Date Summary Prepared

June 11, 2018

## Device Name and Classification

| Trade Name | POGO® Automatic™ Blood<br>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.

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## 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.

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| | 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<br>Monitoring System is intended to be used<br>for the quantitative measurement of<br>glucose (sugar) in fresh capillary whole<br>blood samples drawn from the fingertips.<br>The POGO Automatic Blood Glucose<br>Monitoring System is intended to be used<br>by a single person and should not be<br>shared.<br>The POGO Automatic Blood Glucose<br>Monitoring System is intended for self<br>testing outside the body (in vitro diagnostic<br>use) by people with diabetes at home as an<br>aid to monitor the effectiveness of diabetes<br>control. The POGO Automatic Blood<br>Glucose Monitoring System should not be<br>used for the diagnosis of or screening of<br>diabetes or for neonatal use. The POGO<br>Automatic Blood Glucose Monitoring<br>System is indicated for use in adults and<br>adolescents (13 and up).<br>POGO Automatic Test Cartridges are for<br>use with the POGO Automatic Meter to<br>quantitatively measure glucose (sugar) in<br>fresh capillary whole blood samples drawn<br>from the fingertips. | Same |
| Rx/OTC | OTC | Same |
| Classification<br>Regulation | 862.1345 | Same |
| Product Codes | NBW | Same |
| Product Design | Battery-powered handheld meter | Same |
| Delivery of Blood to<br>Reagent Pad via<br>Capillary Action | Yes | Same |
| Automatic Blood<br>Sample Collection | Yes | Same |
| Detects Under-filled<br>Reagent Pad | Yes | Same |
| Characteristic | POGO BGMS | POGO BGMS k162203 |
| | Subject Device | Predicate Device |
| Allows Blood<br>Reapplication<br>to Complete Test | Yes, provides glucose result or error code<br>after blood addition to under-filled strip | Same |
| Time period allowed<br>for patient to add<br>more blood when<br>reagent pad is under-<br>filled | 15 seconds | Same |
| Time period allowed<br>for patient to apply<br>blood when blood does<br>not reach reagent pad | 90 seconds | Same |
| Meter enforces limits<br>on strip exposure? | Yes, device design prevents strip use after<br>5 minute exposure (open cell time window) | Same |
| Patient able to re-use<br>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<br>Cartridge | Same |
| Measurement<br>Range | 20 - 500 mg/dL | Same |
| Minimum<br>Sample Size | 0.25 µL | Same |
| Monitor Memory | 500 results | Same |
| Operating<br>Temperature Range | 50 to 104° F | Same |
| Principle of Operation | Glucose is oxidized by the enzyme glucose<br>oxidase and electrons are transferred to<br>form the intermediate hydrogen peroxide.<br>Horseradish peroxidase catalyzes the<br>transfer of electrons between hydrogen<br>peroxide and precursor dye molecules to<br>form a blue oxidation product, the<br>concentration of which is proportional to<br>the concentration of glucose in the sample.<br>The amount of color formed is read by a<br>photometer in the meter. | Same |

# Comparison to Predicate Device -- POGO BGMS

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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:

- 1. Performance tests conducted to demonstrate that items modified or replaced from the predicate device met the performance specifications established for those components;
- 2. Mechanical, Environmental, and Electrical safety tests appropriate for SMBG devices;
- 3. Cleaning and Disinfection efficacy and robustness challenges on raw materials and the assembled device;
- 4. Software V&V:
- 5. Bluetooth wireless proximity and coexistence testing; and
- 6. 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.