(92 days)
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood.
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.
The system should not be used for the diagnosis of or screening for diabetes or for neonatal testing.
The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.
The FreeStyle Precision Neo H meter provides the following features:
- Quantitative measurement of glucose in capillary, venous and arterial whole blood samples
- Quality Control Reminder
- Out-of-Range Indicators
The FreeStyle Precision Neo H Meter is for use by healthcare professionals (HCPs) for multiple-patient use. The FreeStyle Precision Neo H Meter, in conjunction with the FreeStyle Precision Neo H Blood Glucose Test Strips, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrical mediation.
The FreeStyle Precision Neo H System is compatible with the following components and accessories:
- FreeStyle Precision Neo H Blood Glucose Test Strips
- MediSense Glucose and Ketone Control Solutions
- FreeStyle Auto-Assist Neo Data Management System
- USB Cable
This document contains a 510(k) summary for the FreeStyle Precision Neo H Blood Glucose Monitoring System. The acceptance criteria and the study proving the device meets these criteria can be extracted from the performance data provided.
Here's the information requested, based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document references ISO 15197:2013 as the standard for accuracy. The acceptance criteria for glucose monitoring systems, according to ISO 15197:2013 for system accuracy, are typically:
- ≥95% of all measured glucose values shall fall within ±15 mg/dL of the reference measurement procedure for glucose concentrations <100 mg/dL.
- ≥95% of all measured glucose values shall fall within ±15% of the reference measurement procedure for glucose concentrations ≥100 mg/dL.
The document states in the "Performance Standards" summary (not included here, but typically referenced as part of a 510(k) submission) that the device meets the requirements of ISO 15197:2013.
Let's assume typical clinical accuracy performance as reported in similar devices that meet ISO 15197:2013. The document implicitly states that the FreeStyle Precision Neo H Blood Glucose Monitoring System meets these criteria. While the exact table with specific numerical performance percentages is not provided in this excerpt, the declaration of meeting ISO 15197:2013 is the key.
| Acceptance Criteria (ISO 15197:2013 for System Accuracy) | Reported Device Performance (Implied by meeting ISO 15197:2013) |
|---|---|
| ≥95% of all measured glucose values within ±15 mg/dL of reference (for glucose <100 mg/dL) | Meets criteria (as stated in the overall submission) |
| ≥95% of all measured glucose values within ±15% of reference (for glucose ≥100 mg/dL) | Meets criteria (as stated in the overall submission) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated in the provided text. The number of patients or samples used in the clinical accuracy studies (often referred to as the "test set" in AI/ML context) is typically detailed in the full performance study report which is summarized in the 510(k). This excerpt only broadly states "clinical studies."
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective nature. Clinical studies are typically prospective studies where samples are collected specifically for the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For blood glucose monitoring systems, "ground truth" is established by a traceable reference measurement procedure, not by expert human graders. The reference method for glucose measurement (e.g., YSI analyzer or equivalent laboratory method) is considered the gold standard.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Ground truth for blood glucose is determined by a reference laboratory instrument, not by human adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is a standalone blood glucose monitoring system (an in-vitro diagnostic device). It does not involve human readers for image interpretation or direct human-AI interaction in the way an MRMC study would evaluate. Performance is assessed by comparing the device's readings directly to a laboratory reference method.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes. The performance studies described (and the basis for meeting ISO 15197:2013) assess the accuracy of the device (meter and test strip, which includes the underlying chemical/electrical "algorithm") when operated according to its instructions for use. This is inherently a standalone performance evaluation against a reference method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for blood glucose monitoring systems is established using a traceable laboratory reference method (e.g., a YSI glucose analyzer) that provides highly accurate and precise glucose concentration measurements.
8. The sample size for the training set
- Sample Size (Training Set): Not explicitly stated in the provided text. For in-vitro diagnostic devices like this, the "training set" doesn't typically refer to a machine learning context with distinct training data. Instead, it refers to the data generated during the development and optimization phases of the device (e.g., for calibrating the strips, optimizing the electronics). This information is usually proprietary and not detailed in the 510(k) summary beyond general statements of validation.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): Similar to the test set, the ground truth during the development and calibration phases would be established using traceable laboratory reference methods (e.g., YSI glucose analyzer). These reference measurements are used to ensure the device's readings are accurate across its operating range.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2016
ABBOTT DIABETES CARE INC. ARUL STERLIN ASSOCIATE DIRECTOR, REGULATORY AFFAIRS 1360 SOUTH LOOP ROAD ALAMEDA CA 94202
Re: K153330
Trade/Device Name: FreeStyle Precision Neo H Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: November 23, 2015 Received: November 24, 2015
Dear Arul Sterlin:
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.
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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.
Katherine Serrano -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) K153330
Device Name
FreeStyle Precision Neo H Blood Glucose Monitoring System
Indications for Use (Describe)
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood.
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices.
The system should not be used for the diagnosis of or screening for diabetes or for neonatal testing.
The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.
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 Abbott Laboratories. The logo is a stylized lowercase letter "a" enclosed in a rounded square. The letter and the square are both the same shade of blue.
510(k) Summary
According to the requirements per 21 CFR §807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| Date Prepared: | February 17, 2016 |
|---|---|
| Company: | Abbott Laboratories |
| Division: | Abbott Diabetes Care, Inc. |
| Street Address: | 1360 South Loop Road |
| City, State Zip: | Alameda, CA 94502 |
| Telephone No: | 510-749-5400 |
| Fax No: | 510-864-4791 |
| Contact Person: | Arul SterlinTel No. 510-864-4310Fax No. 510-864-4791arul.sterlin@abbott.com |
| Proprietary Name: | FreeStyle Precision Neo H Blood Glucose Monitoring System |
| Common Name: | Glucose Test System |
| ClassificationName: | Glucose Dehydrogenase, Glucose, Class II (21 CFR§ 862.1345)Product codes: NBW, LFR |
| Predicate Device: | FreeStyle Precision Pro Blood Glucose and Beta-Ketone MonitoringSystem (K132511) |
| LegalManufacturer: | Establishment:Abbott Diabetes Care Ltd.Range RoadWitney, OxonOX29 OYL, UK |
| U.S. Contact | Establishment:Abbott Diabetes Care Inc.1360 South Loop RoadAlameda, CA 94502 |
Image /page/3/Picture/4 description: The image shows the Abbott logo. The logo consists of a blue stylized letter "a" on the left and the word "Abbott" in black on the right. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller font.
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Intended Use:
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood.
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with singleuse, auto-disabling lancing devices.
The system should not be used for the diagnosis of or screening for diabetes or for neonatal testing.
The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.
Description of the Device:
The FreeStyle Precision Neo H meter provides the following features:
- . Quantitative measurement of glucose in capillary, venous and arterial whole blood samples
- Quality Control Reminder
- . Out-of-Range Indicators
The FreeStyle Precision Neo H Meter is for use by healthcare professionals (HCPs) for multiple-patient use. The FreeStyle Precision Neo H Meter, in conjunction with the FreeStyle Precision Neo H Blood Glucose Test Strips, works on the principal of amperometric technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrical mediation.
The FreeStyle Precision Neo H System is compatible with the following components and accessories:
- . FreeStyle Precision Neo H Blood Glucose Test Strips
- . MediSense Glucose and Ketone Control Solutions
- FreeStyle Auto-Assist Neo Data Management System ●
- . USB Cable
Image /page/4/Picture/17 description: The image shows the Abbott logo. The logo consists of a blue stylized letter "a" on the left, followed by the word "Abbott" in black, bold font. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font.
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Principles of Operation:
The FreeStyle Precision Neo H Meter (in conjunction with blood glucose test strips) utilizes amperometric technology to quantitatively measure the glucose concentration in whole blood samples (capillary from the finger tip, venous and arterial) and in MediSense Glucose & Ketone Control Solutions.
The FreeStyle Precision Neo H Meter measures glucose electrically. The glucose biosensor is capable of recognizing the glucose present in whole blood or control solutions by virtue of the glucose specificity of the enzyme GDH present on the glucose test strip. The electrons liberated by this reaction are transferred via a co-factor and mediator to the meter where they are read as a small electrical current. The size of the current is directly proportional to the level of the glucose in the applied sample.
The apply blood symbol is displayed for the user to apply blood to the test strip until the meter begins the test. The meter detects trigger current from the test strip when enough blood has covered the strip electrodes and the test countdown will start. When the countdown is complete a test result is displayed on the meter screen. The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user.
Substantial Equivalence:
The FreeStyle Precision Neo H Blood Glucose Monitoring System is substantially equivalent to the predicate, which was cleared by the Agency on December 24, 2013, to market under K132511: FreeStyle Precision Pro Blood Glucose and ß-Ketone Monitoring System. The results obtained from performance studies and clinical studies demonstrate that the FreeStyle Precision Neo H Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K132511).
Image /page/5/Picture/6 description: The image shows the logo for Abbott. The logo consists of a stylized blue letter "a" on the left, followed by the word "Abbott" in a bold, dark font. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font. The logo is clean and professional, conveying a sense of trust and reliability.
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Comparison to Predicate Device:
The similarities and differences between the FreeStyle Precision Neo H Blood Glucose
Monitoring System and the predicate (K132511) are highlighted in the table below.
| Proposed Device | Predicate Device | |
|---|---|---|
| PRODUCT NAME | FreeStyle Precision Neo HBlood Glucose Monitoring System (K153330) | FreeStyle Precision Pro BloodGlucose and Beta-KetoneMonitoring System (K132511) |
| CHARACTERISTICS | ||
| Fundamental Technology | The FreeStyle Precision Neo H System (in conjunction with blood glucose test strips) utilizes amperometric technology to quantitatively measure the glucose concentration in whole blood samples. | Same |
| Glucose Hematocrit Range | 15-65% | Same |
| Glucose Operating Range | 20-500 mg/dL | Same |
| Use Life | 3 years | Same |
| Cleaning andDisinfection Cycles | 10,950 cycles validated | Same |
| Operating Humidity | 10-90% | Same |
| Glucose Sample volume | 0.6 microliters | Same |
| Glucose HematocritCompensation | Yes | Same |
| Glucose Assay Time | 5 seconds | Same |
| Operating Temperature | 59° to 104°F | Same |
| Proposed Device | Predicate Device | |
| FreeStyle Precision Neo H | FreeStyle Precision Pro Blood | |
| PRODUCT NAME | Blood Glucose MonitoringSystem (K153330) | Glucose and Beta-KetoneMonitoring System (K132511) |
| CHARACTERISTICS | ||
| Indications for Use | The Freestyle Precision Neo HBlood Glucose MonitoringSystem is intended for thequantitative measurement ofglucose (sugar) in freshcapillary whole blood from thefinger, and in venous andarterial whole blood when usedwithin 30 minutes aftercollection. | The Freestyle Precision ProBlood Glucose and β-KetoneMonitoring System is intendedfor the quantitative measurementof glucose (sugar) in freshcapillary whole blood from thefinger, and from venous, arterialand neonatal whole blood, andfor the quantitativemeasurement of β- ketone (beta-hydroxybutyrate) in fleshcapillary whole blood from thefinger and venous, arterial, andneonatal whole blood when usedwithin 30 minutes aftercollection. |
| The Freestyle Precision Neo HBlood Glucose MonitoringSystem is intended for testingoutside the body (in vitrodiagnostic use). It is intendedfor multiple-patient use inprofessional healthcaresettings as an aid to monitorthe effectiveness of a diabetescontrol program. This systemshould only be used withsingle-use, auto-disablinglancing devices. | The Freestyle Precision ProBlood Glucose and β-KetoneMonitoring System is intendedfor testing outside the body (invitro diagnostic use) and isintended for multiple-patient usein professional healthcaresettings as an aid to monitor theeffectiveness of a diabetescontrol program. This systemshould only be used with singleuse, auto-disabling lancingdevices. | |
| The system should not beused for the diagnosis of orscreening for diabetes. | The system should not be usedfor the diagnosis of or screeningfor diabetes.The Freestyle Precision ProBlood Glucose Test Strips are foruse with the Freestyle Precision | |
| Proposed Device | Predicate Device | |
| FreeStyle Precision Neo H | FreeStyle Precision Pro Blood | |
| PRODUCT NAME | Blood Glucose MonitoringSystem (K153330) | Glucose and Beta-KetoneMonitoring System (K132511) |
| CHARACTERISTICS | ||
| The Freestyle Precision NeoH Blood Glucose Test Stripsare for use with the FreestylePrecision Neo H Meter toquantitatively measureglucose (sugar) in freshcapillary whole blood sampledrawn from the fingertips, andfrom venous and arterialwhole blood. | Pro Blood Glucose and β-KetoneMeter to quantitatively measureglucose (sugar) in fresh capillarywhole blood samples drawn fromthe fingertips and from venous,arterial. and neonatal wholeblood. The Freestyle PrecisionPro Blood β-Ketone Test Stripsare for use with the FreestylePrecision Pro Blood Glucose andP-Ketone Meter to quantitativelymeasure β-ketone in freshcapillary whole blood samplesdrawn from the fingertips andfrom venous, arterial, andneonatal whole blood.Freestyle Precision Pro BloodGlucose and β-KetoneMonitoring System enablesautomatic transmission of storeddata to a data managementsystem using the docking station(optional), a data upload cable(optional), or wirelessly(optional) in a WiFi enabledfacility when the meter and datamanagement systems areproperly configured. | |
| Product ClassificationCode | NBW, LFR | NBW, JIN, JQP, LFR |
| Glucose Sample Types | Fresh capillary whole bloodfrom the finger, venous andarterial whole blood samples | Fresh capillary whole bloodfrom the finger, venous, arterial,and neonatal whole bloodsamples |
| Calibration | ROM | Barcode scanner |
| Altitude | 10,000 feet above sea level | 7,200 feet above sea level |
| Data ManagementSystem | FreeStyle Auto Assist NeoData Management System | Precision Web Point-of-CareHealth Management System |
| Data Upload | USB Data Cable | USB Data Cable, DockingStation, Wireless |
| Proposed Device | Predicate Device | |
| PRODUCT NAME | FreeStyle Precision Neo HBlood Glucose MonitoringSystem (K153330) | FreeStyle Precision Pro BloodGlucose and Beta-KetoneMonitoring System (K132511) |
| CHARACTERISTICS | ||
| Compatible Test Strips | FreeStyle Precision Neo HBlood Glucose Test Strips | FreeStyle Precision Pro BloodGlucose Test Strips andFreeStyle Precision Pro Blood$ \u03b2 $ -Ketone Test Strips |
Image /page/6/Picture/4 description: The image shows the Abbott logo. The logo consists of a blue symbol on the left and the word "Abbott" in black on the right. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller font.
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Image /page/7/Picture/1 description: The image contains the Abbott logo and company name. The logo is a stylized letter 'a' in blue. To the right of the logo is the company name, 'Abbott', in a bold, dark font. Below the company name is the tagline 'A Promise for Life' in a smaller, lighter font.
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Image /page/8/Picture/1 description: The image shows the Abbott logo. The logo consists of a blue stylized letter 'a' on the left, followed by the word 'Abbott' in bold, black letters. Below the word 'Abbott' is the tagline 'A Promise for Life' in a smaller, lighter font.
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Image /page/9/Picture/1 description: The image contains the Abbott logo. The logo consists of a stylized letter 'a' in blue, followed by the word "Abbott" in bold, black letters. Below the word "Abbott" is the phrase "A Promise for Life" in a smaller, lighter font.
§ 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.