← Product Code [NBW](/productcode/NBW) · K181316

# POGO Automatic Blood Glucose Monitoring System (K181316)

_Intuity Medical, Inc. · NBW · Jun 14, 2018 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K181316

## Device Facts

- **Applicant:** Intuity Medical, Inc.
- **Product Code:** [NBW](/productcode/NBW.md)
- **Decision Date:** Jun 14, 2018
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1345
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## 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.

## Device Story

POGO Automatic Blood Glucose Monitoring System; home-use blood glucose meter; measures glucose in capillary whole blood. Modification adds Bluetooth Low Energy (BLE) connectivity; pixelated display screen; graphical UI elements/alerts; speaker (replacing buzzer); slip-resistant back label; updated display lens coating. Device operates via automated lancing and glucose measurement; data transmitted via BLE to external devices. Intended for patient self-monitoring; aids in diabetes management by providing real-time glucose readings. Cleaning/disinfection validated for 730 cycles using Clorox Germicidal Wipes.

## 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.

## Regulatory 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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# **SPECIAL 510(k): Device Modification**
**OIR Decision Summary**

**To:** THE FILE

**RE:** DOCUMENT NUMBER k181316

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.)

**POGO Automatic Blood Glucose Monitoring System (k162203)**

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**.

This change was for the following items:

a. Addition of Bluetooth Low Energy capability
b. Addition of a pixelated display screen
c. Changed protective hard coat finish for the display lens
d. Addition of graphical elements, settings and alerts to the display
e. Changed from a buzzer to a speaker
f. Changed silicone rubber "feet" on back of meter to a slip resistant label on the back of meter
g. Updated the labeling

4. **Comparison Information** (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and specifications.

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
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

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.

The POGO Automatic Blood Glucose Monitoring System is intended for single patient home use. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial laboratory testing services demonstrating complete inactivation of

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hepatitis B Virus (HBV) with Clorox Germicidal Wipe (EPA Reg. No: 67619-12). The sponsor also conducted robustness studies and demonstrated that there was no change in performance or in the external materials of the meter after 730 cleaning and disinfection cycles representing 3 years of single patient use. Each robustness cycle tested consisted of one pre-clean wipe and one disinfecting wipe. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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**Source:** [https://fda-staging.innolitics.com/device/K181316](https://fda-staging.innolitics.com/device/K181316)

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