HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1

K061848 · Hypermed, Inc. · MUD · Nov 8, 2006 · Cardiovascular

Device Facts

• Record ID: K061848
• Device Name: HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
• Applicant: Hypermed, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Nov 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended 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 OxyVu-1 system displays two-dimensional color-coded 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 hyperspectral imaging system for non-invasive assessment of superficial tissue oxygenation. Input: hyperspectral imaging cube collected via instrument head (broadband illuminator, camera, spectral filter). Processing: spectral analysis at each point in a 2D scanned area to calculate oxygen saturation (HT-Sat), oxyhemoglobin (HT-Oxy), and deoxyhemoglobin (HT-Deoxy) levels. Output: 2D color-coded map of tissue oxygenation and numeric measurements for selected regions. Used in clinical settings by healthcare professionals. System includes console (cart, electronics, CPU, monitor) and instrument head with support arm. Check pads and targets used for calibration and image registration. Output assists clinicians in evaluating tissue perfusion and circulatory status, potentially aiding in the management of patients with circulatory compromise.

Clinical Evidence

The document mentions that substantial equivalence is supported by comparable results in clinical testing, but does not provide specific study design, sample sizes, or quantitative performance metrics (e.g., sensitivity, specificity, AUC).

Technological Characteristics

System utilizes hyperspectral imaging technology. Components: console (CPU, monitor, electronics), hyperspectral instrument head (broadband illuminator, camera, spectral filter), and single-use check pads/targets. Performs spectral analysis at specific wavelengths to derive HT-Sat, HT-Oxy, and HT-Deoxy. Output is 2D color-coded image and numeric data. Connectivity includes keyboard/pointing device interface. No specific material standards or software architecture details provided.

Indications for Use

Indicated for determining oxygenation levels in superficial tissues for patients with potential circulatory compromise.

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

• Inspectra Tissue Spectrometer System, Model 325 (K053618, K042020, K023933, K012759)

Submission Summary (Full Text)

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NOV - 8 2006

510(k) Summary OxyVu-1 Hyperspectral Tissue Oxygenation Measurement System (June 28, 2006)

### Submittal information:

Post-approval contact: Jenny Freeman, MD, President, Hypermed, Inc. Hypermed, Inc. 305 Second Avenue Suite B Waltham, MA 02451

Phone: [phone]

510(k) prepared by Chas Burr, President, Chas Burr Q/R Systems, Inc. Phone: [phone] Fax: [phone]

### Device name and classification

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

## Substantial Equivalence

The Oxy Vu-1 system is substantially equivalent to the Inspectra Tissue Spectrometer System, Model 325 manufactured by Hutchinson Technology, Inc. The Inspectra system was cleared in 510(k)'s K053618, K042020, K023933, and K012759.

### Device Description

The OxyVu-1 system is based on hyperspectral imaging technology. The

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technology performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. For the OxyVu-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 instrument head with support arm: broadband illuminator, . camera and spectral filter for collecting hyperspectral imaging cube.
- Single use OxyVu Check Pads and Targets: The OxyVu 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 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 OxyVu-1 system displays two-dimensional color-coded 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.

### Comparison with the Predicate Device

| | OxyVu-1 | Inspectra Model 325 |
|--------------------------|---------------------------------------------------------------------------------|---------------------|
| Measures | Oxygen saturation<br>Oxyhemoglobin level<br>Deoxyhemoglobin level | Oxygen saturation |
| Method of<br>Measurement | Spectral analysis at specific wavelengths of light returned from target tissue. | |
| Output Display | Numeric<br>Two-dimensional color map of<br>approximate tissue oxygenation | Numeric |

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# Similarities and Differences

Oth devices use spectral analysis to determine oxygenation levels in near-surface tissues. The Clyckly, I systems Both devices use spectral analysis to decomment on the hemoglobin. The OxyVu-l system a display numeric values of the approximate oxygen and deoxyhemoglobin levels necessary for the oxygen saturation calculation.

The hyperspectral scanning method used by the OxyVu-1 system provides two-dimensional mapping of color-coded oxygenation levels.

# Basis of Substantial Equivalence

Based on equivalent intended uses and technologies and on comparable results in clinical testing, the Oxy Vu-1 Hyperspectral Tissue Oxygenation Measurement System is substantially equivalent to the Inspectra Model 325 Tissue Spectrometer System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2006

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

Re: K061848

Trade Name: Oxy Vu-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System Regulation Number: 21 CFR 870.2700 Regulation Name: Tissue saturation oximeter Regulatory Class: Class II Product Code: MUD Dated: October 11, 2006 Received: October 13, 2006

Dear Mr. Burr:

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 cither 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 the Code of 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,

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): __ 対応 Kole1048

Device Name: OxyVu-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 OxyVu-1 system displays two-dimensional color-coded 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 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 OF NEEDED)

Concurrence of CDRH/Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K061848

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