INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325

K053618 · Hutchinson Technology, Inc. · MUD · Feb 8, 2006 · Cardiovascular

Device Facts

• Record ID: K053618
• Device Name: INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
• Applicant: Hutchinson Technology, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Feb 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is intended for use as a noninvasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). The InSpectra™ Tissue Spectrometer is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

Device Story

InSpectra Tissue Spectrometer System Model 325 provides non-invasive monitoring of percent hemoglobin oxygen saturation (StO2) in skeletal muscle tissue. System components include: monitor (user interface/electronics), optical integrator (patient cable), OptoShield (disposable adhesive patient interface), thermal printer, Optolink RS232 optical converter, and System Check module for calibration. Near-infrared technology measures localized tissue perfusion. Device used in clinical settings by healthcare providers to monitor patients with suspected circulatory compromise. Output displayed on monitor or printed for time-trending; assists clinicians in assessing perfusion status and making clinical decisions regarding patient circulation. Software provided for PC-based data display and storage.

Clinical Evidence

Bench testing only. No clinical data presented. Testing verified device meets or exceeds all predetermined specifications.

Technological Characteristics

Near-infrared spectroscopy; monitor with user interface; optical integrator cable; disposable adhesive OptoShield interface; RS232 optical converter; System Check module for calibration; PC-based software for data display/storage.

Indications for Use

Indicated for patients undergoing circulatory or perfusion examinations of skeletal muscle or patients with suspected compromised circulation.

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 (K042020)

Submission Summary (Full Text)

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# SMDA Summary -- Special 510(k) Modified Device

| Submitted by: | Hutchinson Technology, Inc.<br>BioMeasurement Division<br>40 West Highland Park NE<br>Hutchinson, MN 55350<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph P. Ortner<br>Manager, Product Research<br>Hutchinson Technology, Inc.<br>Phone: [phone]<br>Fax: [phone] |
| Summary Date: | December 23, 2005 |
| Proprietary Name: | InSpectra™ Tissue Spectrometer System, Model 325 |
| Common Name: | Tissue Spectrometer |
| CFR Reference: | 21CFR§870.2700 |
| Class: | II |
| Product Code: | 74 MUD |
| Equivalent marketed device: | InSpectra™ Tissue Spectrometer System, Model 325, (K042020) |
| Device Description: | The InSpectra™ is designed to estimate the percent oxygen<br>saturation of hemoglobin in a volume of tissue (StO2). This value is a<br>reflection of localized perfusion of that tissue.<br>The InSpectra™ is composed of the following components. |

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- . Monitor: The "InSpectra Tissue Spectrometer" houses the user interface, and associated electronics. It serves as the analytical and display instrument.
- . Patient Cable: The "Optical Integrator" transmits light to and from the Tissue Spectrometer and the patient;
- 비 Patient Interface: The "OptoShield™" interface is a disposable pad that mechanically attaches to the distal end of the Optical Integrator. Its bottom has an adhesive backing for attachment to the patients skin for continuous monitoring. Until ready for use, the adhesive is covered with a liner to allow intermittent measurements.
- Printer: A "Thermal Printer" may be used to print out the StO2 results for time trending and recording purposes.
- 사 Optical Converter: An "Optolink™" RS232 Optical Converter -Model 300 is a device that converts the optical output of the Spectrometer to an electrical signal.
- . Set-up Accessories: A "System Check™" module with both "High" and "Low" "Single Point References" are provided to verify proper system operation.
- . Inspectra System Software: Software provided on a compact disk for use on a personal computer that displays data from the tissue spectrometer on a computer during a live session or from an encrypted data file.

### Intended Use:

Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is intended for use as a noninvasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).

The InSpectra™ Tissue Spectrometer is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

# Technological Characteristics:

The modified device has the same basic technological characteristics as the predicate device based on near-infrared technology. The modified device is equivalent in terms of design, functionality, principles of operation, performance specifications and intended use. When compared to the unmodified device, the modified device raises no new technological issues.

Hutchinson Technology, Inc.

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# Substantial Equivalence Rationale:

Based on design, technological characteristics, intended use, and extensive testing, HTI believes that the modified device is substantially equivalent to the unmodified predicate device currently marketed under 510(k) #042020.

The modified device raises no new issues of safety or effectiveness.

## Test Conclusions:

Hutchinson Technology, Inc. has conducted extensive testing of the modified device to verify adherence to requirements. All test results verify that the device meets or exceeds all predetermined specifications.

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem. The seal is presented in black and white.

FEB 8 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hutchinson Technology, Inc. BioMeasurement Division c/o Mr. Joseph P. Ortner Manager, Product Research 40 West Highland Park NE Hutchinson, MN 55350

Re: K053618

Trade Name: InSpectra™ Tissue Spectrometer System, Model 325 Regulation Number: 21 CFR 870.2700 Regulation Name: Tissue Saturation Oximeter Regulatory Class: Class II (two) Product Code: MUD Dated: December 23, 2005 Received: December 28, 2005

#### Dear Mr. Ortner:

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 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.

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

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# Page 2 – Mr. Joseph P. Ortner

or any Federal statutes and regulations administered by other Federal agencies. You must of any Federal statutes and regulations adminitions on the limited to: registration and listing (21 compry with an the Act 3 requirements) memailing practice requirements as sen CFR Part 807), labeling (21 CFR Part 807), good imagation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section (Section ) our device as described in your Section 510(K) I his letter will anow you to begin manceang your article equivalence of your device to a legally premaired notincation: "The PDF mising of easification 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 If you desire specific acrite for your accell 2011 276-0120. Also, please note the regulation entitled, Contact the Office of Complanes at (21 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = Milsoraning of telefono to premation on your responsibilities under the Act from the Division of Small other general Information on your responsibilities and its toll-free number (800) 638-204) or Manufacturers, Internet and Octisenher : http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmar 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): K053618

### Device Name: InSpectra™ Tissue Spectrometer System, Model 325

### Indications for Use:

Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).

The InSpectra™ Tissue Spectrometer is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

Prescription Use X AND/OR (Part 2) CFR 801 Subpart D)

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 Device Evaluation (ODE)

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