The OmniCorder BioScan System is thermal camera based imaging device intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is for adjunctive diagnostic screening for detection of breast cancer or other uses. This device is intended for use by qualified healthcare personnel trained in its use.

Device Description

The OmniCorder BioScan System is an infrared camera device which provides the capability for imaging and recording of thermal data radiating from adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings; and in the home. It is a prescription device intended for use only by health care professionals.

AI/ML Overview

The provided text (K990416) is a 510(k) summary for the OmniCorder BioScan System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove that the device meets specific performance acceptance criteria.

The 510(k) process is typically for devices that are "substantially equivalent" to already marketed devices, and often does not require new clinical studies for performance metrics if equivalence can be established through design, materials, and intended use.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them is not explicitly present in the provided 510(k) summary. The document focuses on comparing its features to predicate devices.

Here's a breakdown of why each point cannot be fully addressed with the provided text:

A table of acceptance criteria and the reported device performance: This information is not present. The document highlights "Operational Principles" and "Indications and Contraindications" as being the "same" as predicate devices, and that the device "complies with" CSA and UL standards. This is not a table of specific measurable acceptance criteria and reported performance values.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or study data is described. The 510(k) is a comparison document, not a study report.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No ground truth establishment is described for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method is described.
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: No MRMC study is mentioned. The device is an infrared camera system, not an AI-assisted diagnostic tool as described in the prompt's context (e.g., "human readers improve with AI").
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The BioScan System uses "CPU/Custom Algorithms" for data processing, but the 510(k) does not describe a standalone performance study. Its use is described as being "by qualified healthcare personnel trained in its use," suggesting human-in-the-loop interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
The sample size for the training set: No training set is mentioned as this device predates the common usage of "training set" in the context of deep learning algorithms for medical devices as it is understood today. The "Custom Algorithms" would likely refer to image processing algorithms rather than machine learning models requiring extensive training data.
How the ground truth for the training set was established: Not applicable, as no training set is described.

In summary, the provided 510(k) K990416 document for the OmniCorder BioScan System is a substantial equivalence submission. It does not contain information about specific performance acceptance criteria or a study designed to prove the device meets those criteria. Instead, it argues for equivalence based on similar intended use, operational principles, design, and adherence to general safety standards (CSA, UL).

Summary

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K990416

DEC 2 3 1999

510(k) Summary

Date of Summary Preparation:

January 29, 1999

Manufactures Contact Person:

Mark Fauci President Tel. (516)-444-6499 Fax. (516)-444-8825 OmniCorder Technologies, Inc. 25 East Loop Road Stony Brook, NY 11790

Trade Name: OmniCorder BioScan System

Classification Classification Number, Class, Classification Name. Reference:

Classification Name	Class.No.	Class	21CFR §
Telethermographic System	IYM/LHQ	I	884.2980

Special Controls: There are no regulatory standards or special controls applicable for this device.

Indications for Use: The OmniCorder BioScan System is thermal camera based imaging device intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal.

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The device is for adjunctive diagnostic screening for detection of breast cancer or other uses. This device is intended for use by qualified healthcare personnel trained in its use.

Device Description: The OmniCorder BioScan System is an infrared camera device which provides the capability for imaging and recording of thermal data radiating from adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings; and in the home. It is a prescription device intended for use only by health care professionals.

The captured energy is processed by software to produce digital output values of the thermal energy captured by the camera's thermal sensors.

The following accessories are available for use with the device:

1. Computer Processing Unit (Pentium II Workstation)
1. Color Monitor
1. Color Printer
1. Tripod Stand

The device and its accessories are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution.

Substantially Equivalent Commercially Available Devices: OmniCorder BioScan System is substantially equivalent to the following commercially available predicate devices with respect to indications for use, device design, materials, and method of manufacture.

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Substantial Equivalence Comparison: The : OmniCorder BioScan System is similar to commercially available devices with respect to intended use, material, design and operational principles as follows:

Inframetrics, Inc., Inframetrics Infracam-Med ~ (K982327)

Bales Scientific, Inc., BSI Model Tip ~ (K897191)

JEOL Model #JTG-500M ~ (K823041)

DCATS by Dorex Inc. ~ (K812799)

1. Operational Principles: The basic operational principles of the OmniCorder BioScan System and the predicate devices measure and record, without touching the patient's skin, self-emanating infrared radiation to reveal temperature variations. The parameters that are measured and displayed are generally the same as those for the predicate devices.
1. Indications and Contraindications: Relative indications and contraindications for the OmniCorder BioScan System and commercially available devices for similar intended uses are the same.

Assessment of non-clinical performance data for equivalence: Currently there are no FDA standards for this device. However, the OmniCorder BioScan System complies with:

CSA Standard C22.2, No. 125-1984, Electromedical Equipment

UL544 09/1985, Underwriters Laboratories Standard for Medical and Dental Equipment

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Conclusion: In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, OmniCorder Technologies concludes that the new device, the OmniCorder BioScan System, is safe, effective and substantially equivalent to the predicate device as described herein.

Feature	BioScanSystem	InfraCam-Med(K982327)	BSI Model TIP(K897191)	Jeol Model#JTG-500M(K823041)	DCATS(K812799)
Intended Use	Visualization/documentationof temperaturepatterns andchanges	Visualization/documentationof temperaturepatterns andchanges	Visualization/documentationof temperaturepatterns andchanges	Visualization/documentationof temperaturepatterns andchanges	Visualization/documentationof temperaturepatterns andchanges
Method ofDataCollection	Non-contactPassive InfraredEmissions	Non-contactPassive InfraredEmissions	Non-contactPassive InfraredEmissions	Non-contactPassive InfraredEmissions	Non-contactPassive InfraredEmissions
CollectionInstrument	InfraredCamera	InfraredCamera	InfraredCamera	InfraredCamera	InfraredCamera
DataProcessing	CPU/CustomAlgorithms	CPU/CustomAlgorithms	CPU/CustomAlgorithms	CPU/CustomAlgorithms	CPU/CustomAlgorithms
Storage	Hard Disk	PCM/CIA card	Hard disk	Video tape	Hard disk
DetectorType	Focal PlaneArray	Focal PlaneArray	Single Detector	Single Detector	Single Detector
Display	Monitor/TVPrinter	Monitor/TVPrinter	Monitor/TVPrinter	Monitor/TVPrinter	Monitor/TVPrinter
Userinterface	Keyboard,Mouse,On-systemcontrols	On-systemcontrols	Keyboard,Mouse,On-systemcontrols	Keyboard,On-systemcontrols	Keyboard,On-systemcontrols

Table 1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1999

Mark Fauci OmniCorder Technologies, Inc. 25 East Loop Road Stony Brook, New York 11790 Re:

K990416 OmniCorder BioScan System Dated: September 18, 1999 Received: September 29, 1999 Regulatory Class: I 21 CFR 884.2980/Procode: 90 LHQ

Dear Mr. Fauci:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any oblication you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also. please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K990416

Device Name : OmniCorder BioScan System

Indications for Use:

The OmniCorder BioScan System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult, pediatric and neonatal. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting the blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 884.2980 Telethermographic system.

(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.