(47 days)
Not Found
No
The document describes a standard blood glucose monitoring system and a data management application. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on glucose measurement, data logging, and data transfer.
No.
The device measures blood glucose levels and manages data for monitoring diabetes, but it does not directly treat or provide therapy for the condition.
No
The "Intended Use / Indications for Use" section explicitly states, "The iBGStar™ Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes..."
No
The device description clearly states that the iBGStar Blood Glucose Monitoring System consists of a meter, test strips, and control solution, which are hardware components. While the iBGStar Diabetes Manager Application is a software accessory, the overall system is not software-only.
Yes, the iBGStar™ Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The iBGStar™ 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."
N/A
Intended Use / Indications for Use
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels from fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be shared. The iBGStar™ 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 iBGStar™ Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
Device Description
The iBGStar Blood Glucose Monitoring System (BGMS) consists of:
- iBGStar Blood Glucose Meter .
- . BGStar Test Strips
- BGStar Control Solution .
The iBGStar. Diabetes Manager Application (DMA) is an optional software accessory for the iBGStar Blood Glucose Monitoring System. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the DMA installed on an iPhone or iPod touch from the iBGStar meter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palms (at the base of the thumb), or forearms.
Indicated Patient Age Range
Not intended for use with neonates.
Intended User / Care Setting
Home Use by a single patient
email to an individual's healthcare professional
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)
Disinfection Study: Per pre-submission Q120016 (See Attachment 2 of original submission), FDA recommended that disinfection and robustness testing be performed on the new components. Disinfection testing on the surface materials of the iPhone 5, iPod touch 5, Apple Lightning to 30-pin Adapter, and Apple Lightning to 30-pin Adapter (0.2m) cable was performed by an outside lab. The results with PDI® Super Sani-Cloth® Germicidal Disposable Wipes with EPA number 9480-4 demonstrated complete inactivation of live virus (see Attachments 3 and 4 of original submission). Robustness testing was performed with the iPhone 5, iPod touch 5th generation, Lightning to 30-pin Adapter, and Lightning to 30-pin Adapter (0.2m) cable using the PDI® Super Sani-Cloth® Germicidal Disposable Wipes with EPA number 9480-4. The results demonstrate there was no change in performance or material of the tested devices at the conclusion of the disinfection and robustness testing which consisted of 260 cleaning/disinfection cycles designed to simulate 5 years of use (see Attachments 5,6 and 7 of original submission).
Verification and Validation: Verification and validation protocols were successfully executed to validate the use of the Apple Lightning to 30-pin Adapter and the Apple Lightning to 30-pin Adapter (0.2m) cable with the iBGStar DMA. Results demonstrate substantial equivalence to the predicate system.
Human Factors Study: A human factors study (see Attachments 8 and 9 of original submission) was conducted to evaluate the ability of users to connect and transfer readings from the iBGStar DMA via the new Apple Lightning to 30-pin Adapter and the Apple Lightning to 30-pin Adapter (0.2m) cable. Results demonstrate substantial equivalence to the predicate system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
AgaMatrix.
AgaMatrix, Inc. · 7C Raymond Avenue · Salem, NH 03079 USA
510(k) Summary
K 130535
This summary of 510k) substantial equivalence is being submitted in accordance with the requirements of 21 CFR 807.92.
| Prepared: | March 28, 2013 |
|---|---|
| Submitter: | AgaMatrix, Inc. |
| Address: | 7C Raymond Ave. |
| Salem, NH 03079 | |
| Phone: (603) 328-6000 | |
| Contact: | William H. McGrail |
| Executive Director of Regulatory & Clinical Affairs | |
| wmcgrail@agamatrix.com | |
| Phone: 603-328-6051 | |
| Fax: 603-836-4025 | |
| Device Name: | Trade/Proprietary Name: iBGStar Blood Glucose Monitoring System |
| Common Name: Glucose Test System |
Product Name: iBGStar Diabetes Manager Application
Common Name: Diabetes Management Software |
Device Classification:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW - system, test, blood | |||
| glucose, over the counter | Class II | 21 CFR 862.1345 | 75, Clinical Chemistry |
| JQP - Calculator/data processing | |||
| module for clinical use. | Class I | 21 CFR 862.2100 | 75, Clinical Chemistry |
Predicate Device:
iBGStar Blood Glucose Monitoring System, iBGStar Diabetes Manager Application, 510(k) K103544
AgaMatrix, Inc. 7C Raymond Avenue TEL FAX WEB Salem, New Hampshire 03079 USA +1 (603) 328 6000 +1 (617) 588 0430 www.agamatrix.com
1
Image /page/1/Picture/0 description: The image shows the word "AgaMatrix" in a stylized font. The word is written in black ink, and there is a curved line underneath the "Aga" portion of the word. Above the "Matrix" portion of the word, there is a series of dots that form an arc.
· 7C Raymond Avenue · Salem, NH 03079 USA
Device Description:
The iBGStar Blood Glucose Monitoring System (BGMS) consists of:
- iBGStar Blood Glucose Meter .
- . BGStar Test Strips
- BGStar Control Solution .
The iBGStar. Diabetes Manager Application (DMA) is an optional software accessory for the iBGStar Blood Glucose Monitoring System. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the DMA installed on an iPhone or iPod touch from the iBGStar meter.
Labeling and Intended Use:
The iBGStar BGMS Owner's guide has been edited to include instructions on how to connect the meter to a device with the Lightning adapter. The iBGStar BGMS carton has been updated to include a statement that the meter will work with the iPhone 5 and iPod touch 5th generation when using the Lightning adapter.
Intended Use
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be shared. The iBGStar™ 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 iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The iBGStar Diabetes Manager Application is intended for use in the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Technological Characteristics:
There were no changes to the fundamental scientific technology.
| AgaMatrix, Inc. 7C Raymond Avenue |
|---|
| Salem, New Hampshire 03079 USA |
+1 (603) 328 6000
+1 (617) 588 0430
ww.agamatrix.com
2
Image /page/2/Picture/0 description: The image shows the word "AgaMatrix." in a stylized font. The word is in bold black letters. There is a curved line under the "Aga" portion of the word, and a series of dots above the "trix" portion of the word.
AgaMatrix, Inc. · 7C Raymond Avenue · Salem. NH 03079 USA
Comparison to Predicate:
Blood Glucose Monitoring System (meter, strips, controls)
There have been no modifications to the iBGStar BGMS to allow it to operate with the iPhone 5 and iPod touch 5th generation. The Meter, Test Strips and Control Solution are identical to the previously cleared system. The iBGStar BGMS has the all the same technological and performance characteristics as the predicate. There were minor modifications to the labeling for the iBGStar BGMS to clarify the use of the meter with the iPhone 5 and iPod touch 5th generation. The table below illustrates the same intended use and characteristics between the predicate device and the candidate device (no differences between predicate and candidate).
| Similarities | ||
|---|---|---|
| Characteristic | iBGStar BGMS (predicate) | iBGStar BGMS (candidate) |
| Indications for Use | Blood Glucose Monitoring | Same |
| Intended Use | Home Use | Same |
| Calibration | No coding required | Same |
| Test Principle/Enzyme | Glucose Oxidase | Same |
| Control Levels | Two levels | Same |
| System Characteristics | Operating Temp, Test Time, Test Range, Sample Size, Test strips, Control Solution | Same |
| Backlight | No | Same |
| Number of results stored | 300 | Same |
| Power Source | Polymer lithium-ion rechargeable batteries | Same |
| Optional Software accessory | iBGStar Diabetes Manager Application | Same |
| Differences | ||
| None |
| AgaMatrix, Inc. 7C Raymond Avenue
Salem, New Hampshire 03079 USA | TEL
+1 (603) 328 6000 | FAX
+1 (617) 588 0430 | WEB
www.agamatrix.com |
| --------------------------------------------------------------------- | -------------------------- | -------------------------- | -------------------------- |
|---|
3
Image /page/3/Picture/0 description: The image shows the word "AgaMatrix." in a stylized font. There is a curved line under the "Aga" portion of the word. There are also a series of dots above the "Matrix" portion of the word.
AgaMatrix, Inc. · 7C Raymond Avenue · Salem, NH 03079 USA
Diabetes Manager Application
The iBGStar DMA has the same intended use as the previously cleared system. The iBGStar DMA has the all the same technological and performance characteristics as the predicate. There is no modification to the labeling for the iBGStar DMA. To transfer glucose readings from the iBGStar meter to the iBGStar DMA which has been downloaded on Apple's new iPhone 5 and/or iPod touch 500 generation, an Apple Lightning to 30-pin Adapter or the Apple Lightning to 30-pin Adapter (0.2m) is required The table below lists the similarities and differences between candidate and predicate device.
| Similarities | |||
|---|---|---|---|
| Characteristic | iBGStar Diabetes Manager App | ||
| (predicate) | |||
| to | |||
| iPhone 3G,3GS,4, 4S | |||
| iPod touch 2,3,4 | iBGStar Diabetes Manager | ||
| App (candidate) | |||
| to | |||
| iPhone 5 and iPod touch 5 | |||
| Indications for | |||
| Use | Download glucose readings to a data | ||
| management system to aid in the | |||
| effective management of diabetes. | Same | ||
| Intended Use | Home Use | Same | |
| Management | |||
| Tools | Logbook and Trend Charts | Same | |
| Upload To | Device compatible with the iPhone | ||
| Operating System platform | Same | ||
| Differences | |||
| Characteristic | iBGStar Diabetes Manager App | ||
| (predicate) | |||
| to | |||
| iPhone 3G,3GS,4, 4S | |||
| iPod touch 2,3,4 | iBGStar Diabetes Manager | ||
| App (candidate) | |||
| to | |||
| iPhone 5 and iPod touch 5 | |||
| Transfer of | |||
| Glucose Readings | No connector needed | ||
| (see Figure 1) | Apple Lightning to 30-pin | ||
| Adapter | |||
| (see Figure 2) | |||
| or | |||
| Apple Lightning to 30-pin | |||
| Adapter (0.2m) cable | |||
| (see Figure 3) |
| AgaMatrix. Inc. 7C Raymond Avenue | TEL | FAX | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
WEB |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Salem, New Hampshire 03079 USA
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | +1 (603) 328 6000 | +1 (617) 588 0430 | www.agamatrix.com |
4
Figure 1: iPhone to iBGStar-no connector
Image /page/4/Picture/2 description: The image shows a close-up of a device, possibly an iPod or similar gadget, displaying a screen with health-related information. The screen indicates a reading of '147 mg/dL', which is likely a blood sugar level. The date displayed on the screen is 'Monday, January 10, 2011, 9:30 AM', and the context is labeled as 'Post Breakfast'.
Figure 2: Apple Lightning to 30-pin Adapter
Image /page/4/Picture/4 description: The image shows a smartphone displaying a blood glucose level of 147 mg/dL. The screen indicates that the reading was taken post-lunch on Thursday, January 17, 2013, at 2:11 PM EDT. The phone is connected to a device, possibly a blood glucose meter, via a port at the bottom. The device is attached to the phone.
Figure 3: Apple Lightning to 30-pin Adapter (0.2m) Cable
Image /page/4/Picture/6 description: The image shows a white iPhone connected to a white charger. The phone is displaying the number 147 on the screen. The phone and charger are against a gray wall. The charger is plugged into a black device.
5
Image /page/5/Picture/0 description: The image shows the word "AgaMatrix" in a stylized font. The letters are bold and slightly italicized, with a curved line underneath the "Aga" portion of the word. Above the "Matrix" portion of the word, there is a series of dots that appear to be arranged in an arc. A period is at the end of the word.
AgaMatrix, Inc. · 7C Raymond Avenue · Salem. NH 03079 USA
Assessment of Performance:
Disinfection Study:
Per pre-submission Q120016 (See Attachment 2 of original submission), FDA recommended that disinfection and robustness testing be performed on the new components.
Disinfection testing on the surface materials of the iPhone 5, iPod touch 5, Apple Lightning to 30-pin Adapter, and Apple Lightning to 30-pin Adapter (0.2m) cable was performed by an outside lab. The results with PDI® Super Sani-Cloth® Germicidal Disposable Wipes with EPA number 9480-4 demonstrated complete inactivation of live virus (see Attachments 3 and 4 of original submission).
Robustness testing was performed with the iPhone 5, iPod touch 5th generation, Lightning to 30-pin Adapter, and Lightning to 30-pin Adapter (0.2m) cable using the PDI® Super Sani-Cloth® Germicidal Disposable Wipes with EPA number 9480-4. The results demonstrate there was no change in performance or material of the tested devices at the conclusion of the disinfection and robustness testing which consisted of 260 cleaning/disinfection cycles designed to simulate 5 years of use (see Attachments 5,6 and 7 of original submission).
Verification and Validation:
Verification and validation protocols were successfully executed to validate the use of the Apple Lightning to 30-pin Adapter and the Apple Lightning to 30-pin Adapter (0.2m) cable with the iBGStar DMA. Results demonstrate substantial equivalence to the predicate system.
Human Factors Study:
A human factors study (see Attachments 8 and 9 of original submission) was conducted to evaluate the ability of users to connect and transfer readings from the iBGStar DMA via the new Apple Lightning to 30-pin Adapter and the Apple Lightning to 30-pin Adapter (0.2m) cable. Results demonstrate substantial equivalence to the predicate system.
Conclusion:
The results of the disinfection and robustness testing and the performance assessments demonstrated that the candidate iBGStar Blood Glucose Monitoring System and the iBGStar Diabetes Manager Application using the Lightning to 30-pin Adapter or 30-pin Adapter (0.2m) cable performs in a substantially equivalent manner to that of the predicate. We conclude that the iBGStar Blood Glucose Monitoring system and the iBGStar Diabetes Manager Application are substantially equivalent the predicate devices.
+1 (603) 328 6000
1 (617) 588 0430
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2013
AgaMatrix, Inc. C/O William H. McGrail 7C Raymond Ave SALEM NH 03079
Re: K130535
Trade/Device Name: iBGStar Blood Glucose Monitoring System iBGStar Diabetes Manager Application Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JQP Dated: March 28, 2013 Received: April 02, 2013
Dear Mr. McGrail:
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); 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.
7
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. "Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Carol (Beingson -S för
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
8
Indications for Use Form
510(k) Number (if known): K130535
Device Name: jBGStar Blood Glucose Monitoring System, iBGStar Diabetes Manager Application
Indications for Use:
-The iBGStar™ Blood Glucose Monitoring System
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels from fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be shared. The iBGStar™ 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 iBGStar™ Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The iBGStar Diabetes Manager Application - Home Use
The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Katherine Serrano
Division Sign-Off Office of In Vitro Diagnostic Devices and Radiologic Health
510(k) K130535
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