(122 days)
HemoNIR is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methernoglobin and carboxyhemoglobin.
HemoNIR is a small, portable, battery-powered system using rechargeable batteries to measure total hemoglobin, methemoglobin and carboxyhemoglobin using spectroscopic technology. The system uses inexpensive disposable sample tabs and requires no sample preparation or reagents. Samples are introduced into the HemoNIR, JM by using sample tabs. The sample tab well is filled with approximately 10uL of sample and is then inserted into the sample slot of the HemoNIR, "10 unit. The unit automatically starts-up and runs its built-in self-test before performing the measurements. After less than 30 seconds from sample insertion, results will be displayed on the built-in LCD.
Here's an analysis of the provided text regarding the HemoNIRLab™ device, focusing on acceptance criteria and supporting studies:
It's important to note that the provided text is a 510(k) summary from 2005, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and exhaustive study results in the same way a modern medical device submission or academic paper might. Therefore, some information requested will not be explicitly present.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state numerical acceptance criteria for performance metrics like accuracy, precision, or linearity. Instead, it broadly states that "These studies demonstrated that the HemoNIRLab™ performs in accordance with its specifications." It does, however, mention the types of studies conducted and implies that the performance was found to be acceptable relative to a predicate device.
| Performance Characteristic | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Accuracy (Method Comparison) | Not explicitly stated. Implied to be comparable to or within acceptable limits of commercial system. | A "method comparison study was performed with the HemoNIR,™ and a commercially available system." |
| Linearity | Not explicitly stated. Implied to be within specifications. | "Linearity... studies were also conducted using the HemoNIR." |
| Precision | Not explicitly stated. Implied to be within specifications. | "...precision... studies were also conducted using the HemoNIR." |
| Interference | Not explicitly stated. Implied to be within specifications. | "...interference studies were also conducted using the HemoNIR." |
| Electrical Safety | Compliance with IEC 61010-1, IEC 61010-2-101. | "found to be in compliance with applicable requirements of IEC 61010-1, IEC 61010-2-101." |
| Electromagnetic Compatibility (EMC) | Compliance with FCC 47 CFR part 15, EN 61326. | "found to be in compliance with applicable requirements of FCC 47 CFR part 15, and EN 61326." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size for any of the performance studies (method comparison, linearity, precision, interference).
- Data Provenance: Not specified within the provided text. It's unclear if the data was retrospective or prospective, or the country of origin of the samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not present in the document. The HemoNIRLab™ is an in vitro diagnostic device measuring objective biochemical parameters (hemoglobin, methemoglobin, carboxyhemoglobin). Its ground truth would be established by reference methods or instruments, not by expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable for a device measuring objective biochemical parameters. The "ground truth" would be the result from a reference laboratory method or a predicate device. There is no mention of adjudication in the context of human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study (MRMC) is typically relevant for interpretative diagnostic devices where human readers provide diagnoses (e.g., radiology AI). The HemoNIRLab™ is an analytical device that provides quantitative measurements.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, effectively. The performance testing described (method comparison, linearity, precision, interference) inherently evaluates the device (including its "algorithm" if it uses one for spectroscopic analysis) in a standalone manner, comparing its output directly to a reference or predicate method. The device is intended to provide quantitative measurements and does not involve human interpretation as part of its primary function where AI assistance would be relevant for "human-in-the-loop" scenarios.
7. The Type of Ground Truth Used
The ground truth for the performance studies was implicitly established by:
- Reference Devices/Methods: The "commercially available system" used in the method comparison study served as the reference for accuracy. For linearity, precision, and interference studies, the ground truth would typically be established using carefully prepared samples with known concentrations or by comparison to established laboratory reference methods. The predicate devices (OSM3 Hemoximeter, AVOXimeter 4000) also served as benchmarks for substantial equivalence.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI models. Given that this submission is from 2005 and describes a spectroscopic device, it's highly likely that any internal calibration or "learning" parameters would be determined through a combination of physics-based models, empirical calibration using physical standards, and possibly statistical regression on specific sample sets, rather than a "training set" in the modern AI sense. The size of any such calibration set is not specified.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the modern AI sense of "training set ground truth." If internal calibration or model development involved empirical data, the "ground truth" for those samples would be established by highly accurate laboratory reference methods (e.g., hemoximetry, spectrophotometry) using carefully prepared samples with known characteristics. However, the document does not provide details on this.
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K05 00/4
MAY - 5 2005
510(k) Summary for HemoNIRLab™
SPONSOR 1.
NIR Diagnostics Inc. 44 Crawford Crescent Campbellville, Ontario, L0P 1B0 Canada
Contact Person: Ashwani Kaushal, Vice President, Engineering 905-854-5727 Telephone:
Date Prepared: December 30, 2004
DEVICE NAME 2.
| Proprietary Name: | HemoNIRLabTM |
|---|---|
| Common/Usual Name: | Whole Blood Hemoglobin Assays |
| Classification Name: | Oximeter to Measure Hemoglobin |
PREDICATE DEVICES 3.
DEVICE DESCRIPTION 4.
HemoNIR ... "M is a small, portable, battery-powered system using rechargeable batteries to measure total hemoglobin, methemoglobin and carboxyhemoglobin using spectroscopic technology. The system uses inexpensive disposable sample tabs and requires no sample preparation or reagents.
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Samples are introduced into the HemoNIR, JM by using sample tabs. The sample tab well is filled with approximately 10uL of sample and is then inserted into the sample slot of the HemoNIR, "10 unit. The unit automatically starts-up and runs its built-in self-test before performing the measurements. After less than 30 seconds from sample insertion, results will be displayed on the built-in LCD.
ડ. INTENDED ÜSE
HemoNIR, "TM is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methemoglobin and carboxyhemoglobin.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The HemoNIR , TM and the cited predicate devices are all intended for the measurement of total hemoglobin, methemoglobin quantitative and carboxyhemoglobin in samples of anticoagulated whole blood. No sample preparation or reagents are required for either the HemoNIR, M or the AVOXimeter 4000, whereas the OSM3 Hemoximeter requires ultrasonic hemolyzation and use of reagents.
Another similarity is that all three devices utilize a spectroscopic measurement method. For the HemoNIR , "M continuous wavelengths are used while the OSM3 Hemoximeter and AVOXimeter 4000 use six and five wavelengths, respectively. The HemoNIR _ TM is also more compact than the cited predicate devices.
PERFORMANCE TESTING 7.
Electrical Testing
The HemoNIR, "M underwent electrical safety testing and electromagnetic compatibility testing and was found to be in compliance with applicable requirements of IEC 61010-1, IEC 61010-2-101, FCC 47 CFR part 15, and EN 61326.
Performance Testing
Studies were conducted to evaluate the performance characteristics of the HemoNIR, "M. A method comparison study was performed with the HemoNIR, "M and a commercially available system. Linearity, precision and interference studies were also conducted using the HemoNIR These studies demonstrated that the HemoNIRLabTM performs in accordance with its specifications.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
NIR Diagnostics, Inc. c/o Ms. Cynthia A. Sinclair, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
MAY - 5 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
K050014 Re:
Trade/Device Name: NIR Diagnostics Inc., HemoNIR120 TM Regulation Number: 21 CFR § 862.7500 Regulation Name: Oximeter to measure hemoglobin Regulatory Class: II Product Code: JKS, GLY ﭘﯿ Dated: April 14, 2005 Received: April 18, 2005
Dear Ms. Sinclair:
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 either class II (Special Controls) or class III (PMA), 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); 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PK Director Division of Immunology and Hematology 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: HemoNIRLaoTM
Indications for Use:
HemoNIR is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methernoglobin and carboxyhemoglobin.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Joceline Bautista
Division Sign-Off
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050014
§ 864.7500 Whole blood hemoglobin assays.
(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.