(93 days)
The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals for multiple patient use in a professional healthcare setting for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. It is not for use on capillary blood specimens. It Is intended to provide plasma equivalent results to laboratory methods.
The Nova StatStrip Lactate Hospital Meter System has the same fundamental scientific technology and intended use as the currently marketed Nova StatStrip Lactate Hospital Meter System (K100602). Both the Nova StatStrip Lactate Hospital Meter System and the proposed Nova StatStrip Lactate Hospital Meter System are hand held devices with similar intended use to quantitatively measure the lactate levels in whole blood. The principle of operation is the same for the proposed and predicate device. Each utilizes a test strip that is inserted into a meter for results within 13 seconds.
The provided document describes the Nova StatStrip Lactate Hospital Meter System. Here's an analysis of its acceptance criteria and the study that proves whether the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the primary acceptance criterion is substantial equivalence to the predicate device (K100602 - Nova StatStrip Lactate Hospital Meter System) in terms of intended use, technological characteristics, and performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | Conclusion: "Results of laboratory and clinical testing demonstrate that the performance of the Nova StatStrip Lactate Hospital Meter System has the same intended uses, with similar technological characteristics and and can produce results that are substantially equivalent to results obtained on the predicate device. The system performs as intended and raises no new safety or effectiveness issues."Specific Performance Characteristics Compared to Predicate (K100602):- Measuring Range: Proposed: 0.3 - 20.0 mmol/L (Predicate: 0.7 - 20.0 mmol/L). The proposed device has a wider lower detection limit, implying an improvement rather than just equivalence. This suggests the proposed device meets or exceeds the predicate's range.- Operating Principle: Electromechanical Biosensor, Lactate oxidase (LOD) - "Same"- Intended Use: "Same"- Sample Type: Whole Blood - "Same"- Sample Size: 0.6 uL - "Same"- Sample Application: Capillary Draw - "Same"- Handheld Meter? Yes - "Same"- Meter Calibration: Automatic - "Same"- Data Storage: 1000 Patient Tests, 200 QC Tests, 4000 Operators - "Same"- Test Time: 13 Seconds - "Same"- Weight: 360 grams - "Same"Overall: The performance studies confirmed that the blood lactate results from the proposed system were "substantially equivalent to the current methods for blood lactate measurements" and to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific sample size (i.e., number of patient samples or data points) used for the definitive performance testing. It generally refers to "laboratory and clinical testing."
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It just mentions "Laboratory testing was performed" and "clinical testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. For a lactate monitor, the ground truth would typically be established by a reference laboratory method, not necessarily by "experts" in the sense of human readers interpreting images or data.
4. Adjudication Method for the Test Set
This information is not applicable as the device is an in vitro diagnostic test determining lactate levels, not an AI system interpreting complex data that requires expert adjudication. The "ground truth" would be the result from a reference laboratory method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or interpretation tasks, not for continuous measurement devices like a lactate meter.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, effectively. The performance studies described are inherently "standalone" in the context of an automated measuring device. The device itself performs the measurement, and its results are compared against reference methods. While a human operates the device, the core performance being evaluated is the device's accuracy in measuring lactate independent of human interpretation bias. The statement "The laboratory studies demonstrated that the blood lactate results from the Nova StatStrip Lactate Hospital Meter System were substantially equivalent to the current methods for blood lactate measurements" supports this.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Nova StatStrip Lactate Hospital Meter System was based on "current methods for blood lactate measurements," implying reference laboratory methods. The intended use explicitly states, "It Is intended to provide plasma equivalent results to laboratory methods."
8. The Sample Size for the Training Set
This information is not provided in the document. For an in vitro diagnostic device like this, there isn't typically a "training set" in the machine learning sense. The device's calibration and analytical performance are established through development and validation, not through learning from a specific training data set by the end-user.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the machine learning context is not applicable, the concept of establishing ground truth for it is also not relevant here. Device development and calibration would involve comparing the device's measurements against established reference methods, but this is part of the engineering and verification process for the device itself, not a separate "training set" of data.
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nova
biomedical
JAN - 5 2012
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510(k) Summary
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| 510(K) Owner: | Nova Biomedical Corporation |
|---|---|
| Registration Number: | 1219029 |
| Address: | 200 Prospect St.Waltham, MA 02454 USA |
| Phone: | 781-894-0800 |
| Fax Number: | 784-891-4806 |
| Contact Person: | Paul W. MacDonald |
| Date Prepared: | 30 Sept 2011 |
| Proprietary Name: | Nova StatStrip Lactate Hospital Meter System |
| Common Or Usual Name: | Lactate Monitor |
| Classification Name: | System, Test, Lactate |
| Product Codes: | KHP, JJX |
| Predicate Device: | K100602 - Nova StatStrip Lactate Hospital Meter System |
| Device Description: | Nova StatStrip Lactate Hospital Meter System |
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Nova Biornedical, 200 Prospect Street, Waltham, MA 02454-9141 U.S.A. Tel: 781-894-0800 www.novabiomedical.com
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| Intended Use: | Indications for Use:The Nova StatStrip Lactate Hospital Meter System is intended for in vitrodiagnostic use by healthcare professionals for multiple patient use in aprofessional healthcare setting for clinical and for point-of-care usage forthe quantitative determination of Lactate (Lac) in fresh venous and arterialwhole blood specimens as an aid to evaluate the acid-base status ofpatients suspected of having lactic acidosis. It is not for use on capillaryblood specimens. It Is intended to provide plasma equivalent results tolaboratory methods. |
|---|---|
| Summary ofTechnologicalCharacteristics: | The Nova StatStrip Lactate Hospital Meter System has the samefundamental scientific technology and intended use as the currentlymarketed Nova StatStrip Lactate Hospital Meter System (K100602).Both the Nova StatStrip Lactate Hospital Meter System and the proposedNova StatStrip Lactate Hospital Meter System are hand held devices withsimilar intended use to quantitatively measure the lactate levels in wholeblood. The principle of operation is the same for the proposed andpredicate device. Each utilizes a test strip that is inserted into a meter forresults within 13 seconds. |
| Comparison toPredicateDevices: | The proposed Nova StatStrip Lactate Hospital Meter System uses the samefundamental scientific technology, similar specifications, and has the sameintended use as the predicate Nova StatStrip Lactate Hospital MeterSystem (K100602). |
| PerformanceStudies: | Laboratory testing was performed on the proposed Nova StatStrip LactateHospital Meter System. The laboratory studies demonstrated that the bloodlactate results from the Nova StatStrip Lactate Hospital Meter System weresubstantially equivalent to the current methods for blood lactatemeasurements. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that the performanceof the Nova StatStrip Lactate Hospital Meter System has the same intendeduses, with similar technological characteristics and can produce results thatare substantially equivalent to results obtained on the predicate device. Thesystem performs as intended and raises no new safety or effectivenessissues. |
ので、その他のお気になる。
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| Characteristic | Predicate | Proposed |
|---|---|---|
| K100602 - Nova StatStrip LactateHospital Meter System | Nova StatStrip LactateHospital Meter System | |
| Measuring Range | 0.7 - 20.0 mmol/L | 0.3 - 20.0 mmol/L |
| Operating Principle | Electromechanical BiosensorLactate oxidase (LOD) | Same |
| Intended Use | Indications for Use:The Nova StatStrip Lactate HospitalMeter System is intended for invitro diagnostic use by healthcareprofessionals for multiple patientuse in a professional healthcaresetting for clinical and for point-of-care usage for the quantitativedetermination of Lactate (Lac) infresh venous and arterial wholeblood specimens as an aid toevaluate the acid-base status ofpatients suspected of having lacticacidosis. It is not for use oncapillary blood specimens. It isintended to provide plasmaequivalent results to laboratorymethods. | Same |
| Sample type | Whole Blood | Same |
| Sample size | 0.6 uL | Same |
| Sample application | Capillary Draw | Same |
| Handheld meter? | Yes | Same |
| Meter Calibration | Automatic | Same |
| Data storage | 1000 Patient Tests200 QC Tests4000 Operators | Same |
| Test Time | 13 Seconds | Same |
| Weight | 360 grams | Same |
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Comparison of Predicate Devices and Proposed device
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Nova Biomedical Corporation c/o Paul W. MacDonald Chief Quality & Regulatory Affairs Officer 200 Prospect St. Waltham, MA 02454, USA
JAN - 5 2012
Re: K112955 Trade/Device Name: Nova StatStrip Lactate Hospital Meter System Regulation Number: 21 CFR 862.1450 Regulation Names: Lactic Acid Test System Regulatory Class: Class I, meets limitations of exemptions per 21 CFR 862.9 (c)(9) Product Code: KHP, JJX Dated: December 7, 2011 Received: December 9, 2011
Dear Mr. MacDonald:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
z
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Nova StatStrip Lactate Hospital Meter System
Indications for Use:
Meter.
Meter:
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Test Strips:
Test Strips:
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Hospital Meter for quantitative determination of lacted in fresh venous and the Hospital Meter for quantitative determination of actions. The performance characteristics of the
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device for lact the one for tapillary specimens have not been other device for lactate measurements on capillary specifically outside the body in vitro diagnostic use only).
Control and Linearity Solutions:
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Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 601 Subpair D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (O(VD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112955
Page 1 of
§ 862.1450 Lactic acid test system.
(a)
Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.