The OxyVu™-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:

. oxygen saturation (HT-Sat),
oxyhemoglobin level (HT-Oxy), and .
deoxyhemoglobin (HT-Deoxy) level .
in superficial tissue. The Oxy Vu™-1 system displays two-dimensional colorcoded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.

The OxyVu™-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Device Description

The OxyVu™-1 system is based on hyperspectral imaging technology. The technology performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. For the Oxy Vu™-1 system, the spectral analysis determines in superficial tissues approximate values of oxygen saturation (HT-Sat), oxyhemoglobin levels (HToxy), and deoxyhemoglobin levels (HT-deoxy). The OxyVu™-1 system displays the tissue oxygenation in a two-dimensional, color-coded image.

The system consists of:

System console: cart, system electronics, CPU, monitor, keyboard, pointing . device and printer.
Hyperspectral imaging instrument head with support arm: broadband . illuminator, camera and spectral filter for collecting hyperspectral imaging cube.
Single use Oxy VuTM Check Pads and Targets: The Oxy VuTM Check Pad is . used to perform an instrument check prior to patient measurements. The OxyVu™ Target is placed within the intended field of view and is used as a fiduciary mark for image registration and for focusing.

AI/ML Overview

This document is a 510(k) summary for the OxyVu™-1 Hyperspectral Tissue Oxygenation Measurement System. It describes a Special 510(k) submission, meaning the device is essentially the same as a previously cleared predicate device (K061848), with changes focused on improving robustness rather than fundamental accuracy. Therefore, the document explicitly states that the "changes increase robustness of operation, but not fundamental accuracy of results."

Given this context, the document does not report any new acceptance criteria or new studies proving the device meets those criteria. Instead, it relies on the substantial equivalence to the predicate device, which would have established such criteria and studies previously. The current submission's "Basis of Substantial Equivalence" states: "Based on virtually the same methods of validation, the OxyVu™-1 Hyperspectral Tissue Oxygenation Measurement System as modified is substantially equivalent to the OxyVu™-1 cleared in 510(k) K061848."

Therefore, I cannot directly provide the requested information from this document. However, I can infer the implied acceptance criteria for this Special 510(k) would be maintaining the performance and safety characteristics of the predicate device.

Here's an analysis based on the provided document, addressing what it does and does not state in relation to your request:

1. A table of acceptance criteria and the reported device performance

Not provided in this document. This Special 510(k) explicitly states that the changes "increase robustness of operation, but not fundamental accuracy of results." It relies on the validation methods of the predicate device (K061848). Therefore, no new performance criteria or new reported performance data is presented here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in this document. Since it's a Special 510(k) focused on robustness improvements rather than a new device or significant accuracy changes, no new test set details are presented.

3. 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)

Not provided in this document. As with the test set itself, details on ground truth establishment are not discussed in this Special 510(k).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in this document.

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

Not applicable / not provided. The device is a "Hyperspectral Tissue Oxygenation Measurement System" that provides objective measurements (oxygen saturation, oxyhemoglobin, deoxyhemoglobin). It is not an AI-assisted diagnostic tool for human readers, nor does it present data that would typically involve a multi-reader multi-case study for comparative effectiveness with human interpretation in the context of improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Implied, but details not provided. The device is described as "reporting approximate values" and displaying "color-coded images of tissue oxygenation." This suggests a standalone algorithm generating these outputs. However, no specific study details are provided in this document. The original 510(k) (K061848) would have contained such standalone performance data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided in this document. The nature of "tissue oxygenation" measurements often involves comparison to established physiological measurements or phantoms, but this document does not specify the ground truth methodology.

8. The sample size for the training set

Not provided in this document.

9. How the ground truth for the training set was established

Not provided in this document.

In summary: This 510(k) submission is for a modified version of an already cleared device, focusing on "robustness of operation" rather than fundamental accuracy. Therefore, it explicitly avoids re-presenting clinical performance data or acceptance criteria, instead relying on the substantial equivalence to the predicate device (K061848) and its prior validation. To find the details requested, one would need to refer to the original 510(k) submission for the predicate device, K061848.

Summary

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JAN 25 . Da

510(k) Summary

OxyVu™-1 Hyperspectral Tissue Oxygenation Measurement System (December 20, 2007)

Submittal information:

Kevin Schomacker, VP of Research and Regulatory Affairs, HyperMed, Inc. HyperMed, Inc. 41 Second Avenue Burlington, MA 01803

Phone: 781-229-5900

Device name and classification

Proprietary Name:	OxyVu™-1 Hyperspectral Tissue OxygenationMeasurement System
Common Name:	Hyperspectral Tissue Oxygenation Measurement System
Classification Name:	Tissue Saturation Oximeter
Classification Panel:	Cardiovascular
CFR Section:	21 CFR 870.2700
Class:	II
Product Code:	MUD

Substantial Equivalence

The OxyVu™-1 system is substantially equivalent to the OxyVu™-1 system cleared in 510(k) K061848.

Device Description

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the tissue oxygenation in a two-dimensional, color-coded image.

The system consists of:

System console: cart, system electronics, CPU, monitor, keyboard, pointing . device and printer.
Hyperspectral imaging instrument head with support arm: broadband . illuminator, camera and spectral filter for collecting hyperspectral imaging cube.
Single use Oxy VuTM Check Pads and Targets: The Oxy VuTM Check Pad is . used to perform an instrument check prior to patient measurements. The OxyVu™ Target is placed within the intended field of view and is used as a fiduciary mark for image registration and for focusing.

Intended Use

The Oxy Vu-1™ Hyperspectral Tissue Oxygenation (HTO) Measurement System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:

oxygen saturation (HT-Sat), .
oxyhemoglobin level (HT-Oxy), and .
deoxyhemoglobin (HT-Deoxy) level .

in superficial tissue. The Oxy Vu™-1 system displays two-dimensional colorcoded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.

The OxyVu™-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

	OxyVu™-1	Predicate OxyVu™-1
Measures	Oxygen saturationOxyhemoglobin levelDeoxyhemoglobin level	Oxygen saturationOxyhemoglobin levelDeoxyhemoglobin level
Method ofMeasurement	Spectral analysis at specific wavelengths of light returned from target tissue.	Spectral analysis at specific wavelengths of light returned from target tissue.
Output Display	NumericTwo-dimensional color map of approximate tissue oxygenation	NumericTwo-dimensional color map of approximate tissue oxygenation

Comparison with the Predicate Device

Similarities and Differences

External, user-observable features are essentially the same. The changes described in the Special 510(k) involve changes in the sensor illumination and in the measurement

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algorithm. Changes increase robustness of operation, but not fundamental accuracy of results.

The intended uses and indications of the modified device, as described in its labeling are the same as the intended uses and indications for the unmodified predicate device.

Basis of Substantial Equivalence

The intended use and the fundamental operating specifications are unchanged. Based on virtually the same methods of validation, the Oxy Vu™-1 Hyperspectral Tissue Oxygenation Measurement System as modified is substantially equivalent to the OxyVu™-1 cleared in 510(k) K061848.

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Standards

Product conformity to IEC 60601-1, IEC 60601-1-1, and IEC 60601-1-2 was documented in the original 510(k), K061848. There is no new or modified statement of conformity in this Special 510(k).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 25 2008

Hypermed, Inc. c/o Mr. Chas Burr Chas Burr Q/R Services, Inc. 11 Mystic Avenue Winchester, MA 01890-2920

Re: K073656

Oxy Vu™-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System Regulation Number: 21 CFR 870.2700 Regulation Name: Tissue Saturation Oximeter Regulatory Class: Class II (two) Product Code: MUD Dated: December 20, 2007 Received: December 26, 2007

Dear Mr. Burr:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to commerce prox to Frid 2011-03-19) in accordance with the provisions of the Federal Food, Drug, de flees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, more rever mains 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to bash af Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Chas Burr

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 Part 801); 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. 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bymima for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Ko 73656

Device Name: Oxy Vu™-1 Hyperspectral Tissue Oxygenation Measurement System

Indications for Use:

. oxygen saturation (HT-Sat),
oxyhemoglobin level (HT-Oxy), and .
deoxyhemoglobin (HT-Deoxy) level .

The OxyVu™-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumima

n Slan-C lvision of Cardiova 510/k) Number

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).