(62 days)
The Liberty™ Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use in the home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.
The Liberty™ Blood Glucose Monitoring System consists of the following elements: test strips; a battery operated, portable, compact meter; and a control solution.
Instrument Operating Principle: photometric
Reagent Test Principle: glucose oxydase
The Liberty™ System is based on photometric biosensor technology. The test strip is first inserted into the meter and the meter is switched on by pressing the "ON" button. A code number will appear on the display that should match the code on the vial of strips. An icon showing a flashing drop near the end of a test strip will appear on the display to prompt the user to apply a drop of blood. When a drop of blood is applied to the top of the strip at the mesh-filled target area, it flows into the membrane and starts the measurement. This is indicated on the display by a moving bar. After approximately 30 seconds, a glucose reading is displayed on the meter. The reading is stored in the meter memory with a date and time.
The Liberty™ System uses a photometric test strip that includes glucose oxidase to generate a color reaction that is proportional to the concentration of glucose in the sample.
I am sorry, but the provided text does not contain sufficient detail to fully address all parts of your request regarding acceptance criteria and a study proving device performance as it pertains to AI/ML devices. The document seems to be a 510(k) summary for a blood glucose monitoring system, and the information provided is typical for such a submission for a non-AI/ML device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance characteristics for the Liberty™ System and compares them to a predicate device (Accu-Chek Simplicity). Since this is not an AI/ML device, the acceptance criteria are not explicitly stated in terms of model performance metrics (like sensitivity, specificity, AUC). Instead, the performance is reported as correlation and precision data against a laboratory reference method.
| Characteristic | Acceptance Criteria (Implied by Predicate & Study Results) | Reported Liberty™ System Performance |
|---|---|---|
| Capillary Blood Study vs. YSI/HemoCue | Correlation coefficient, linear regression, and range comparable to predicate device. | Linear regression: Y = 0.930, Correlation coefficient = 0.941, Range = 35 - 470 mg/dL |
| Consumer Study vs. Lab Reference | Correlation coefficient, linear regression, and range comparable to predicate device. | Linear regression: y = 0.872, Correlation coefficient = 0.921, Range = 28 to 390 mg/dL |
| Precision (Within-run) | CV < 1% for control solution, high correlation for blood samples, and > 99% in "A" region (likely Clarke Error Grid Zone A). | Control solution: Mean 163 mg/dl, sd 11.3, CV < 1%. Blood: R=0.994 / 0.995 for 2 lots, > 99% in "A" region. |
Note: The "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device, which met FDA requirements. The specific numeric thresholds for acceptance are not explicitly listed but are demonstrated through the provided results being comparable to or better than the predicate for the given metrics.
2. Sample Size for the Test Set and Data Provenance:
- Capillary blood study: N = 116 patients
- Consumer study: N = 116 different patients
- Provenance: The document does not explicitly state the country of origin. It indicates it's a "clinical study" and "consumer study," which implies prospective data collection, but this is not explicitly stated. It does not mention retrospective data.
3. Number of Experts and Qualifications for Ground Truth:
This information is typically not relevant or included for blood glucose monitoring systems. The "ground truth" for glucose measurements is established by a highly accurate laboratory reference method (Yellow Springs Instrument (YSI) and HemoCue), not by human expert consensus or radiologists.
4. Adjudication Method for the Test Set:
Not applicable for this type of device. Glucose measurement is an objective quantitative biochemical reading, not a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a standalone diagnostic device, not an AI-assisted interpretation system for human readers.
6. Standalone Performance Study:
Yes, a standalone study was conducted. The performance data presented in the table (Capillary blood study and Consumer study) represents the performance of the Liberty™ System (algorithm/device only) against a laboratory reference method.
7. Type of Ground Truth Used:
The ground truth used was a laboratory reference method, specifically the Yellow Springs Instrument (YSI) and HemoCue, which are highly accurate established methods for measuring glucose in blood.
8. Sample Size for the Training Set:
The document does not mention a "training set" in the context of machine learning. For traditional medical devices like this, the device's development involves engineering and calibration, not an AI training set. Performance is evaluated through analytical and clinical studies on defined sample sizes.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the AI/ML sense, this question is not applicable. The device relies on photometric biosensor technology and glucose oxidase chemistry, not a trained AI model.
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| FEB 1 9 2002 | K0141 | |
|---|---|---|
| E. | 510(k) SUMMARY | |
| Introduction | According to the requirements of 21 CFR 807.92, the following information providessufficient detail to understand the basis for a determination of substantial equivalence | |
| Submittername, address,contact | Polymedica Corporation11 State StreetWoburn, MA 01801, USA(781)-933-2020Contact Person: Patricia Collins | |
| Device name | Date prepared: 12/04/01Proprietary name: Liberty™ Blood Glucose Monitoring SystemCommon name: whole blood glucose test systemClassification name: Glucose Test System (21 CFR 862.1345) | |
| Predicate device | We claim substantial equivalence to the Accu-check Simplicity System marketed byRoche Diagnostics, 510(k) # K993829 | |
| Devicedescription | The Liberty™ Blood Glucose Monitoring System consists of the following elements:test strips; a battery operated, portable, compact meter; and a control solution. | |
| Instrument Operating Principle: photometricReagent Test Principle: glucose oxydase | ||
| The Liberty™ System is based on photometric biosensor technology. The test strip isfirst inserted into the meter and the meter is switched on by pressing the "ON"button. A code number will appear on the display that should match the code on thevial of strips. An icon showing a flashing drop near the end of a test strip will appearon the display to prompt the user to apply a drop of blood. When a drop of blood isapplied to the top of the strip at the mesh-filled target area, it flows into themembrane and starts the measurement. This is indicated on the display by a movingbar. After approximately 30 seconds, a glucose reading is displayed on the meter. Thereading is stored in the meter memory with a date and time. | ||
| The Liberty™ System uses a photometric test strip that includes glucose oxidase togenerate a color reaction that is proportional to the concentration of glucose in thesample. | ||
| Intended use | The Liberty™ Blood Glucose System is intended for the quantitative measurement ofglucose in fresh capillary whole blood. Testing is done outside the body ( in vitrodiagnostic use). It is indicated for use in the home by persons with diabetes as an aidto monitor the effectiveness of diabetes control. | |
| Comparison toPredicate Device | The Liberty™ Blood Glucose System is substantially equivalent to the Accu-chekSimplicity System marketed by Roche Diagnostics, 510(k) K993829 |
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| SE Comparison Table, Technological Characteristics | Liberty™ System | Accu-Chek Simplicity | |
|---|---|---|---|
| CHARACTERISTIC | Pre-market Notification | K014167 | K993829 |
| CHARACTERISTIC | Marketed by | Polymedica Corporation | Roche Diagnostics |
| CHARACTERISTIC | Type of Meter | Portable, battery operated, blood glucose meter | same |
| CHARACTERISTIC | Glucose Measurement Technology (test strip) | Glucose oxidase chemistry; colorimetric, reflectance detection technology | same |
| CHARACTERISTIC | Intended Use | Quantitative determination of glucose in bloodhome use, self test blood glucose monitoring by diabetics | same |
| CHARACTERISTIC | Reference | Whole blood referenced | Plasma calibrated |
| CHARACTERISTIC | Sample Type | Capillary whole blood | same |
| CHARACTERISTIC | Sample Application | Apply blood to test strip | same |
| CHARACTERISTIC | Hematocrit range | 35%-55% | 30%-60% |
| CHARACTERISTIC | Control Solution(s) | Normal control solution, aqueous-based polymer emulsion | Normal control solution, aqueous buffered solution |
| CHARACTERISTIC | Operating temperature range | 59 - 95F (15 - 35C) | 50 - 104F (10 to 40C) |
| CHARACTERISTIC | Operating humidity range | Less than 80% | same |
| CHARACTERISTIC | Dimensions | 9.8 cm x 5 cm x 1.9 cm | 10 cm x 5.5c m x 1.7 cm |
| CHARACTERISTIC | Weight | 2.1 ounces with battery | 2.03 ounces without battery |
| CHARACTERISTIC | Display | Liquid Crystal display | same |
| CHARACTERISTIC | Results Presentation | Liquid Crystal display | same |
| CHARACTERISTIC | Memory Capabilities | 250 tests with time and date | 30 test results with time and date |
| CHARACTERISTIC | Test Start | Turn on meter, insert strip, then application of blood sample | same |
| CHARACTERISTIC | Liberty™ System | Accu-Chek Simplicity | |
| Test Time | 20-30 seconds | 25 to 30 seconds | |
| Power Source | Single 3-volt lithium battery | 2 lithium batteries DuracellD11/3N or4 button batteries Varta: V13GUcar: A76 Panasonic LR44,Toshiba G13 | |
| Battery Life | 1 year of routine usage | same | |
| Meter coding procedure | Enter lot-specific code numberfrom test strip bottle into meter | Code chip provided with eachcarton of test strips | |
| Measurement Range | 30-500 mg/dL (1.6 - 27 mmol/L) | 10-600 mg/dL | |
| Qualified Test Strip | Device-specific test strip | same | |
| Qualified Control Solution | One glucose control solution | same | |
| Accuracy Check Device | Meter automatically self-calibrates when new strip isinserted | same | |
| Test strip storage conditions | 15-30C (59-86F) | 36 to 86F (2 to 30C) | |
| Quality control procedure | Tests should be run with controlsolutions whenever new vial oftest strips is opened or anunusual blood test result isobtained | same | |
| Labeling instructions regardingresponse to unusual results | Run a quality control test, if theresult is outside the acceptableQC range, contact customerservice. If results are within theacceptable range, review propertesting procedure and repeatblood glucose test with a newtest strip | same | |
| Labeling instructions regardingexpected results | The normal fasting adult bloodglucose range for a non-diabeticis 70 - 105 mg/dL. One to twohours after meals, normal bloodglucose levels should be lessthan 140 mg/dL. Physician willdetermine range that isappropriate for the patients | same | |
| Warnings and precautions | For in vitro diagnostic use | same | |
| Reagent stability | 16 months | 24 months | |
| Liberty™ System | Accu-Chek Simplicity | ||
| CHARACTERISTICReagent composition | Test strips: | Test strips: | |
| min at time ofmanufacture0.016 mg Chromogen2.3 IU Glucose oxidase,1.0 IU Peroxidase | qty/cm2(minimum at time of manufacture)Glucose-dye-0.4 IUoxidoreductaseBis-(2-hydroxyethyl)-(4-hydroxaminocyclohexa-2,5-dienylidene)-ammonium chloride19.3 ug2,18-Phospho-328 ugmolybdic acid0.3 l mgStabilizer4.4 mgNonreactive substances | ||
| Control Solution: | Control solution: | ||
| 0.2% sodium benzoate10% hydrophilic synthoticpolymer0.1% Ponceau red0.1% glucose | GlucoseOxypyrionGermallPhosphate Buffer Solution |
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and the comments of the comments of
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buslazioal Chazaoteristics
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The non-clinical and clinical studies carried out on the Liberty™ System and the The non-clinical and clinical Simplicity) demonstrate that the system is substantially
predicate device (Accu-Chek Simplicity) demonstrate that the intended use. predicate device (Accu-Chek Simplicity) demonstaller in its intended use.
equivalent to the predicate device and is safe and effective for its intended use.
| SE Comparison Table, Performance Characteristics | ||
|---|---|---|
| CHARACTERISTIC | Liberty™ System | Accu-Chek Simplicity |
| Laboratory method | Yellow Springs Instrument(YSI), HemoCue | YSI |
| Capillary blood study | N = 116 patientsLinear regression:Y = 0.930Correlation coefficient = 0.941Range = 35 - 470 mg/dL | N = 116 patientsLinear regression:Y = 1.02Correlation coefficient = 0.939Range = 74 - 500 mg/dL |
| Consumer study:Studies conducted comparingpatient capillary results with thoseof a whole blood glucoselaboratory reference method | N = 116 different patientslinear regression resultsy = 0.872Correlation coefficient = 0.921Range = 28 to 390 mg/dL | N = 116 different patients linearregression resultsy = 1.02Correlation coefficient = 0.939Range = 74 to 500 mg/dL |
| PrecisionWithin-run precision(N=20 per level) | Control solutionMediumMean 163 mg/dlsd 11,3CV < 1 %BloodRange 25 to 550 mg/dlR=0.994 / 0.995 for 2 lots> 99 % of the 2 lots are in "A"region | BloodRange 35 to 450 mg/dlR=0.996> 93 % is in "A" region |
Table Performance Characteristics on a
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines or strokes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 9 2002
Ms. Patricia Collins Director, Corporate QA PolyMedica Pharmaceuticals, USA., Inc. 11 State Street Woburn, MA 01801
Re: K014167
K014167
Trade/Device Name: Liberty™ Blood Glucose System, Liberty™ Blood Glucose Meter, Liberty - Diood Glucose Strips, Liberty ™ Control Solution Regulation Number: 21 CFR 862.1345; 21 CFR 862.1660 Regulation Name: Glucose test system; Quality Control Materials Regulatory Class: Class II; Class II.; Class I Product Code: NBW; CGA; JJX Dated: December 12, 2001 Received: December 19, 2001
Dear Ms. Collins:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(tr) premained in the the indications felerenced above and nave decembers and are and and and one marketed in interstate for use stated in the enclosate) to regarly manatinent from the Medical Device Amendments, or to commerce prior to May 28, 1970, the characted in accordance with the Federal Food, Drug, devices that have been recassified in accordance with a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. and Cosmetic Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the device, seeject of the more of registration, listing of general controls provisions of the free labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controlls) or class III (PMA), in If your device is classified (secure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such addressions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Regarming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a built other requirements of the Act
that FDA has made a determination that your device complies with other mast that FDA has made a determination administered by other Federal agencies. You must or any Federal statures and regulations damind.co. by not limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: reg comply with an the Act s requirements, mercessed wantics requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing plactically, the electronic CFK Part 807), labeling (21 CFR Part 800); good maxam (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1000 1050 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will anow you to begin marketing your device of your device to a legally marketed notification. The FDA Inding of Substantal equivalities or your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and If you desire specific advice for your do rooms. Includes contact the Office of Compliance at additionally 809.10 for in Vido diaguostic as nother promotion and advertising of your device, (301) 594-4588. Additionally, for questions on as pressed on Are, please note the regulation please contact the Office or Compliation at (30 tr / 01 TFR 807.97). Other general entitled, "Misbranding by telefence to premation in the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained on t information on your responsionnes and its toll-free number (800) 638-2041 or
Manufacturers International and Consumer Assistance at its toll-free demanain html" Manufacturers International and Consumer Prostouries and Consumers of the Marial".
(301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE D.
| Applicant: | Polymedica Pharmaceuticals Inc |
|---|---|
| 510(k) Number (if known): | K014167 |
| Device Name: | Liberty™ Blood Glucose System, Liberty™ Blood GlucoseMeter, Liberty™ Blood Glucose Strips, Liberty™ ControlSolution |
Indications For Use:
Liberty™ Blood Glucose System:
Diberty™ Blood Glucose System is intended for the quantitative The Elocty - Diood Classes th capillary whole blood: Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.
Liberty™ Blood Glucose Meter:
Liberty™ Blood Glucose Meter is intended for use with Liberty™ Blood The Elberty - Brood quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.
Jean
Silom Coffe
(Division Sign-Off)
Division of Clinical Laboni De
510(k) Nurnber 17014107
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use OR
(Optional Format 1-2-96)
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Liberty™ Blood Glucose Strips:
Liberty™ Blood Glucose Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Liberty™ Blood Glucose Meter. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.
Liberty™ Control Solution:
Liberty™ Control Solution is an aqueous glucose solution for use with the Liberty™ Blood Glucose System. It is used as a quality control check to verify the accuracy of the blood glucose test result. The Liberty™ Control Solution is intended for use in the validation of the performance of the Blood Glucose System by providing a test solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Image /page/8/Picture/5 description: The image shows a signature above the text "ision Sign-Off", "vision of Clinica", and "510(k) Number". The number "KC14167" is written next to "510(k) Number". The signature appears to be "Han Coope".
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use V OR
(Optional Format 1-2-96)
§ 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.