INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325

K012759 · Hutchinson Technology, Inc. · MUD · Jan 17, 2002 · Cardiovascular

Device Facts

• Record ID: K012759
• Device Name: INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325
• Applicant: Hutchinson Technology, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Indications for Use

Hutchinson Technology Incorporated's InSpectra™ Tissue Spectrometer System, Model 325, is a noninvasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes. The value of these measurements in disease states has not been demonstrated.

Device Story

InSpectra™ Tissue Spectrometer System (Model 325) is a non-invasive monitor for tissue hemoglobin oxygen saturation (StO2). System inputs: optical signals from tissue via fiber-optic patient cable and disposable OptoShield™ interface pad. Operation: light source directs light into tissue; optical detectors measure reflected light; internal software algorithm calculates StO2 based on light absorption. Output: continuous StO2 values displayed on monitor; optional hardcopy via thermal printer. Used in clinical settings by healthcare providers to assess localized tissue perfusion. Benefits: provides real-time monitoring of skeletal muscle perfusion; aids in identifying compromised circulation. System includes monitor, patient cable, disposable interface, and calibration modules (OptoCheck™).

Clinical Evidence

Clinical performance validated via a human study comparing the InSpectra™ system to the predicate Biospectrometer NB Oximeter. Results demonstrated equivalent clinical performance. Additional bench testing included in vitro and in vivo validation of functional specifications, and unit/integration/system-level software verification.

Technological Characteristics

Non-invasive tissue spectrometer. Components: monitor, fiber-optic patient cable, disposable adhesive OptoShield™ interface, thermal printer, RS232 optical converter. Sensing: optical absorption spectroscopy using specific wavelengths. Connectivity: RS232 output. Calibration: OptoCheck™ module with high/low single-point references. Software: updated microprocessor-based algorithm for StO2 estimation.

Indications for Use

Indicated for patients undergoing circulatory or perfusion examinations of skeletal muscle or those with suspected compromised circulation. Used for continuous, noninvasive monitoring of hemoglobin oxygen saturation (StO2) in the upper extremity, shoulder, or lower extremity using 12-25 mm probes.

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

• Biospectrometer - NB Oximeter, Model 1111 (K963903)

Submission Summary (Full Text)

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K01275.9

# Premarket Notification [510(K)] Summary

| Submitter: | JAN 1 7 2002<br>Hutchinson Technology, Inc.<br>BioMeasurement Division<br>40 West Highland Park NE<br>Hutchinson, MN 55350<br>Phone: [phone]<br>Fax: [phone] |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Joseph Ortner<br>Engineering Manager<br>Hutchinson Technology, Inc.<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | January 14, 2002 |
| Proprietary Name: | InSpectra™ Tissue Spectrometer System, Model 325 |
| Common Name: | Tissue Spectrometer |
| CFR Reference: | 21CFR§870.2700 |
| Class: | II |
| Product Code: | 74 MUD |
| Predicate Device: | Biospectrometer - NB Oximeter, Model 1111 by Hutchinson<br>Technology, Inc. (K963903) |
| Description: | This premarket notification (510(K) Notification) is submitted to obtain<br>marketing clearance for the Hutchinson Technology, Inc.<br>BioMeasurement Division "InSpectra™ Tissue Spectrometer System,<br>Model 325" (hereinafter referred to as InSpectra ™).<br><br>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. The InSpectra™ is a<br>modified version of the previously cleared Hutchinson Technology |

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Inc. (HTI) Biospectrometer NB Oximeter, Model 1111, and represents upgrades in hardware and software, while relying on the same principles of operation.

The InSpectra™ is composed of the following components.

- Monitor: The "InSpectra Tissue Spectrometer" houses the user interface, 트 Monico.sociated 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;
- 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 에 time trending and recording purposes.
- Optical Converter: An "Optolink™" RS232 Optical Converter Model 300 is a I device that converts the optical output of the Spectrometer to an electrical signal.
- Set-up Accessories: An "OptoCheck™" module as well as both "High" and L "Low" "Single Point References" are provided to verify proper system operation.

### Intended Use:

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

The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes.

The value of these measurements in disease states has not been demonstrated.

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# Technological Characteristics:

The fundamental changes from the predicate device include:

- New hardware and software platforms for the Tissue Spectrometer (i.e., monitor) ■
- Revised patient cables 8
- Revised patient cables
Increased measurement range for the patient cables (i.e., depths of measurement) .
- Modified calibration modules .
- Inclusion of a printer to provide results in a hardcopy format ■
- Inclusion of a provide rooms for-use statement (note: the fundamental intended use is . retained)

### Substantial Equivalence Rationale:

The HTI Biospectrometer NB Oximeter Model 1111 serves as the The FTT Dioopeotromorposes of this submission. The InSpectra ™ predicate dovios for parpent NB Oximeter share the intended use of and the Diobbot. Smittented value of percent oxygen saturation of hemoglobin in a volume of tissue. In addition, they share the same nemogrobin in a viat incorporate a light source, fiber optic cables (which direct the light to and from the target tissue), optical detectors, (which of specific wavelengths, and a software algorithm that provides the estimate of hemoglobin oxygen saturation.

Changes to the device necessitating this submission include Onanges to the the electronics layout, an integrated component upgraad revised software required by the changes in microprocessor, and microprocessor. The basic operating principles and component algorithm remain the same. There have also been improvements to the patient cable and interface, making them easier to manufacture and improving their performance.

#### Test Reports:

Hutchinson Technology, Inc. has conducted extensive testing of the new electronic components to verify adherence to requirements. The new elcetronic comprise the system have been tested individually to verify operation per design intent. Software has been evaluated at the unit, integration, and system-level to document proper performance. The InSpectra™ has been subjected to both in vitro as well as in vivo testing to validate satisfaction of functional specifications.

A human study comparing device performance between the InSpectra™ and the predicate system demonstrated equivalent clinical performance.

#### Conclusion:

Hutchinson Technology, Inc. concludes that the InSpectra™ is substantially equivalent to the Biospectrometer - NB Model 1111.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Mr. Joseph Ortner Hutchinson Technology Incorporated 40 West Highland Park Drive NE Hutchinson, MN 55350-9784

Re: K012759

InSprectra™ Tissue Spectrometer System, Model 325 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 MUD Dated: December 7, 2001 Received: December 10, 2001

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.

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Page 2 - Mr. Joseph Ortner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toaso be action and i bermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I catalog and 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 CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by stellio (QS) engines (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) This letter will anow you is ought finding of substantial equivalence of your device to a legally promated notifications of 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far 646. Additionally, for questions on the promotion and advertising of Compliance at (301) 59 - 1 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision 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/dsma/dsmamain.html

Sincerely yours,

Nodell Tule

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

Enclosure

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## Indications for Use Statement

Device Name: K012759

InSprectra™ Tissue Spectrometer System, Model 325

### Indications For Use:

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

The InSpectra™ Tissue Spectrometer with 12 to 25 mm probes is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromisec circulation.

The InSpectra™ Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes.

The value of these measurements in disease states has not been demonstrated.

Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
S10(k) Number K012751

| Prescription Use | X | OR Over-The-Counter Use |
|----------------------|---|-------------------------|
| (Per 21 CFR 801.109) | | |