(244 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 or interpretation.
No.
The device is a diagnostic tool used to monitor blood glucose levels, aiding in the management of diabetes, rather than directly treating a condition.
Yes.
The device measures glucose levels to aid in monitoring the effectiveness of diabetes control, which is a diagnostic purpose.
No
The device description explicitly states that the system includes hardware components such as a meter with a photometer, test strips housed in a cartridge, and a built-in lancing mechanism.
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)..."
- Nature of the Test: The device measures glucose in a biological sample (blood) outside the body. This is the core definition of an in vitro diagnostic test.
- Device Description: The description details the use of "glucose-oxidase-based dry-reagent test strips" and a "photometer to read the glucose-dependent color change," which are components of an in vitro diagnostic assay.
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 (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The POGO Automatic Blood Glucose Monitoring System (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.
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. Control solutions are available to confirm correct system performance.
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
single person, self testing, at home
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)
-
Study Type: Nonclinical Data
-
Sample Size: 60 POGO BGMS whole blood results
-
Key Results: All data were within ±15% bias to the plasma YSI reference results.
-
Study Type: Clinical Lay User Evaluation (initial study for Reapplication feature)
-
Sample Size: 285 subjects with diabetes, from a total of four cartridge lots.
-
Key Results:
- 100% of POGO BGMS self-test glucose results were within ±15 mg/dL of the reference YSI results at a glucose concentration of 75mg/dL) or 10 mg/dL (for glucose 75mg/dL) or 10 mg/dL (for glucose
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2017
INTUITY MEDICAL, INC. C/O CINDY DOMECUS, R.A.C. PRINCIPAL, DOMECUS CONSULTING SERVICES, LLC 1171 BARROILHET DRIVE HILLSBOROUGH, CA 94010
Re: K162203
Trade/Device Name: POGO Automatic Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. CGA Dated: February 28, 2017 Received: March 1, 2017
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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) K162203
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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3
Image /page/3/Picture/0 description: The image shows the logo for Intuity Medical. The logo features a stylized "i" inside a circle, followed by the word "intuity" in a sans-serif font. Below "intuity" is the word "MEDICAL" in a smaller font. To the right of "intuity" is the phrase "Simplifying Diabetes".
510(k) Summary
1 510(k) Owner
| Owner: | Intuity Medical, Inc. |
|---|---|
| Address: | 526 Almanor Avenue |
| Sunnyvale, CA 94085 | |
| Phone: | (408) 530-1700 x275 |
| Fax: | (408) 530-1717 |
| Contact: | Robb Hesley |
2 Submission Correspondent:
Cindy Domecus, R.A.C. (US & EU) Principal, Domecus Consulting Services LLC (650) 343-4813
3 Date Summary Prepared: February 28, 2017
4 Device name - trade name and common 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, CGA |
| Panel | Clinical Chemistry |
5 Identification of the legally marketed predicate device
The POGO® Automatic™ Blood Glucose Monitoring System is substantially equivalent to the Contour Next EZ Blood Glucose Monitoring System (Bayer HealthCare LLC, Mishawaka, IN), cleared under K130265 on June 23, 2014.
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6 Device Description
The POGO Automatic Blood Glucose Monitoring System (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.
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. Control solutions are available to confirm correct system performance.
7 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
| Characteristic | POGO BGMS | Contour Next EZ
K130265 |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The Contour Next EZ blood
glucose monitoring system is
an over the counter (OTC)
device utilized for self-testing
by persons with diabetes at
home for the quantitative
measurement of glucose in
whole blood, is for single-
patient use only, and should
not be shared. The Contour
Next EZ blood glucose
monitoring system is indicated
for use with fresh fingertip
capillary whole blood samples.
The clinical utility of this
device is to aid in monitoring
the effectiveness of your
diabetes control program. The
Contour Next EZ blood
glucose monitoring system is
not intended for use for the
diagnosis of or screening for
diabetes mellitus and is not
intended for use on neonates.
The Contour Next test strips
are intended for self-testing by
persons with diabetes for the
quantitative measurement of
glucose in whole blood
samples from 20 to 600
mg/dL. |
| Rx/OTC | OTC | Same |
| Characteristic | POGO BGMS | Contour Next EZ
K130265 |
| Classification
Regulation | 862.1345 | Same |
| Product Codes | NBW, CGA | NBW, LFR |
| Product Design | Battery-powered handheld
meter | Same |
| Delivery of Blood to
Reagent Pad via
Capillary Action | Yes | Same |
| Automatic Blood
Sample Collection | Yes | No |
| Detects Under-filled
Reagent Pad | Yes | Same |
| 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 | 20 seconds |
| Time period allowed
for patient to apply
blood when blood
does not reach
reagent pad | 90 seconds | 180 seconds |
| Meter enforces limits
on strip exposure? | Yes, device design prevents
strip use after 5 minute
exposure (open cell time
window) | No, device design does not
prevent strip re-insertion
unless blood or serious
mishandling is detected |
| Patient able to re-use
lancet? | No, device design prevents
re-use | Yes, device design does not
prevent re-use |
| Cal Coding | Automated | Same |
| Detection Method | Photometric (LED) | Electrochemical |
| Enzyme | Glucose oxidase | Glucose dehydrogenase |
| Hematocrit Range | 20% to 60% | 15% to 65% |
| Humidity Range | 10% to 90% RH | 10% to 93% RH |
| Characteristic | POGO BGMS | Contour Next EZ K130265 |
| Lancing Device | Integrated in Meter with
Strip/Lancet in Cartridge | Separate from Meter |
| Measurement Range | 20 - 500 mg/dL | 20 - 600 mg/dL |
| Minimum Sample Size | 0.25 µL | 0.6 µL |
| Monitor Memory | 500 results | 480 results |
| Operating Temperature Range | 50 to 104° F | 41 to 113° F |
| 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. | Glucose is oxidized by the
enzyme glucose
dehydrogenase-FAD and
electrons are transferred to
form a reduced mediator
intermediate. The reduced
mediator transfers electrons to
an electrode to produce an
electric current, which is
proportional to the
concentration of glucose in the
sample. The current is read by
a potentiometer in the meter. |
Technological Characteristics Comparison 8
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7
Comparison of Intended Use
POGO BGMS and the listed predicate device have the same intended use; namely, the quantitative measurement of blood glucose. Both devices use fingerstick capillary whole blood as the sample. Both devices are for single-patient use in the home.
Comparison of Technological Characteristics
The technology used in the POGO BGMS is similar to that used in the predicate device. Similar elements include: a capillary channel to automate blood delivery from the fingerstick wound to the reagent section of the test strip, a means to detect when an insufficient amount of blood has been applied to the test strip, and the ability to add blood to an in-process test until either the meter has sufficient sample or the time allowed to add blood has expired. The test strips are all dry-reagent chemistries specific for glucose in samples of whole blood delivered via capillary action.
8
Differences between the POGO BGMS and the predicate device include: a different enzyme in the test strip (glucose oxidase in POGO BGMS and glucose dehydrogenase in the predicate), a different signal transduction system (photometric in POGO BGMS, electrochemical in predicate), a new, sterile, single-use and auto-disabling lancet is provided with every test in the POGO BGMS versus user-controlled lancet replacement or re-use in the predicate, smaller minimum sample volume in POGO BGMS (0.25 uL versus 0.6 uL in the predicate), and an automatic storage of used test strips and lancets within the cartridge for POGO BGMS versus user-required disposal of at least the test strip after every test in the predicate. The POGO BGMS also prevents use of a test strip that has been exposed to the environment for more than five minutes (open cell time window), whereas the predicate device has no means to measure strip exposure time and does not prevent strip re-insertion until the strip contains blood or has been seriously degraded by moisture.
9 Brief Discussion of Nonclinical Data
The software change that is the subject of this 510(k) was validated.
In accordance with FDA's Guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, issued in October, 2016, IMI obtained 60 POGO BGMS whole blood results via intermittent sampling at nominal glucose levels from 60 to 225 mg/dL. All data were within ±15% bias to the plasma YSI reference results.
10 Brief Description of Clinical Data
In support of the Reapplication feature of the POGO BGMS. Intuity Medical, Inc. (IMI) has conducted three clinical studies. The initial study was a multi-site Clinical Lay User Evaluation where some of the system accuracy data was from users who completed the test using Reapplication. The two subsequent studies focused on collecting additional data specifically from the system in the Reapplication Mode using native fingerstick capillary whole blood samples.
In the Clinical Lay User Evaluation, self-test data from 285 subjects with diabetes, from a total of four cartridge lots, were evaluated for accuracy versus plasma from a fingerstick sample analyzed on a YSI. A total of 100% of POGO BGMS self-test glucose results were within ±15 mg/dL of the reference YSI results at a glucose concentration of 75mg/dL) or 10 mg/dL (for glucose