OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM

K073656 · Hypermed, Inc. · MUD · Jan 25, 2008 · Cardiovascular

Device Facts

• Record ID: K073656
• Device Name: OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM
• Applicant: Hypermed, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Jan 25, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

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.

Device Story

OxyVu™-1 is a non-invasive hyperspectral imaging system used by healthcare professionals in clinical settings to assess superficial tissue oxygenation. The system captures hyperspectral imaging cubes of a scanned surface using a broadband illuminator, camera, and spectral filter. It performs spectral analysis at each point in the 2D scanned area to calculate approximate values for oxygen saturation (HT-Sat), oxyhemoglobin (HT-Oxy), and deoxyhemoglobin (HT-Deoxy). The system outputs these measurements as numeric values and 2D color-coded maps displayed on a monitor. A single-use check pad is used for instrument calibration, and a target is used for image registration and focusing. By visualizing tissue oxygenation, the device assists clinicians in evaluating patients with potential circulatory compromise, supporting clinical decision-making regarding tissue perfusion.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, intended use, and performance specifications consistent with the predicate device. Bench testing was performed to validate the modified sensor illumination and measurement algorithm.

Technological Characteristics

Hyperspectral imaging system consisting of a console (CPU, monitor, printer), imaging head (broadband illuminator, camera, spectral filter), and accessories (check pads, targets). Performs spectral analysis at specific light wavelengths. Complies with IEC 60601-1, IEC 60601-1-1, and IEC 60601-1-2.

Indications for Use

Indicated for patients with potential circulatory compromise to determine oxygenation levels in superficial tissues. Intended for use by healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• OxyVu™-1 Hyperspectral Tissue Oxygenation Measurement System (K061848)

Submission Summary (Full Text)

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# 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: [phone]

### Device name and classification

| Proprietary Name: | OxyVu™-1 Hyperspectral Tissue Oxygenation<br>Measurement 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

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

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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 saturation<br>Oxyhemoglobin level<br>Deoxyhemoglobin level | Oxygen saturation<br>Oxyhemoglobin level<br>Deoxyhemoglobin level |
| Method of<br>Measurement | Spectral analysis at specific wavelengths of light returned from target tissue. | Spectral analysis at specific wavelengths of light returned from target tissue. |
| Output Display | Numeric<br>Two-dimensional color map of approximate tissue oxygenation | Numeric<br>Two-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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Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

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 [phone]. 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 [phone] or [phone] 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:

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.

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