INPECTRA STO2 SPOT CHECK

K103613 · Hutchinson Technology, Inc. · MUD · Mar 2, 2011 · Cardiovascular

Device Facts

• Record ID: K103613
• Device Name: INPECTRA STO2 SPOT CHECK
• Applicant: Hutchinson Technology, Inc.
• Product Code: MUD · Cardiovascular
• Decision Date: Mar 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

Hutchinson Technology Incorporated's InSpectra™ StO2 Spot Check is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in thenar skeletal muscle tissue (StO2). The InSpectraTM StO2 Spot Check is indicated for use in monitoring patients during circulatory or perfusion examinations or when there is a suspicion of compromised circulation of thenar skeletal muscle.

Device Story

InSpectra StO2 Spot Check System (Model 300) provides non-invasive monitoring of hemoglobin oxygen saturation (StO2) in thenar skeletal muscle. System components include a monitor with LCD screen, light source/detection circuitry, microcontrollers, and internal software; a fiber-optic cable; and a reusable thenar clip. The clip attaches to the thenar eminence, shielding the measurement site from ambient light. The monitor transmits light through the cable to the tissue and receives reflected light via a photosensitive detector. Internal software processes these optical signals to estimate StO2. Results are displayed on the monitor for clinician review during circulatory or perfusion examinations. The device aids in assessing tissue oxygenation status to inform clinical decision-making regarding patient circulation. It is powered by a rechargeable lithium-ion battery and includes a charging station.

Clinical Evidence

Bench testing only. The manufacturer verified that the device meets or exceeds all predetermined performance specifications.

Technological Characteristics

Near-infrared spectroscopy (NIRS) based tissue oximeter. Components: monitor (LCD, light source/detector, microcontrollers), fiber-optic cable, reusable thenar clip. Power: rechargeable lithium-ion battery. Connectivity: standalone system with charging station. Software: internal firmware for signal processing and StO2 estimation.

Indications for Use

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

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™ StO2 Tissue Oxygenation Monitor System (Model 650 and accessories) (K100915)

Submission Summary (Full Text)

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K 103613

MAR - 2 2011

Image /page/0/Picture/2 description: The image shows the logo for Hutchinson Technology. The logo consists of a stylized triangle with a wavy line running through it on the left. To the right of the triangle is the word "Hutchinson" in a serif font, with the word "TECHNOLOGY" in a smaller sans-serif font below it. Underneath the word "TECHNOLOGY" is the phrase "Advancing Better Therapies".

Hutchinson Technology Incorporated BioMeasurement Division 40 W Highland Park Dr Hutchinson, MN 55350-9784 USA -800 419 1007 320 587 1555 Fax [e-mail]

## 510(k) Summary

#### 1. Submitter's Name / Contact Person

#### Submitted by:

Hutchinson Technology Inc. BioMeasurement Division 40 West Highland Park Drive NE Hutchinson, MN 55350

Contact Person: Colin M. McGraw Operations Manager Tel: [phone] Fax: [phone]

Summary Preparation Date: March 2, 2011

## 2. General Information

Trade/Device Name:

Common/Usual Name: Classification Name: Class: Product Code: Classification Panel: CFR Reference:

InSpectra™ StO2 Spot Check System (Model 300 and accessories) Oximeter, Tissue Saturation (StO2) Oximeter, Tissue Saturation II MUD 74 (Cardiovascular) 21CFR8870.2700

#### Identification of Substantially Equivalent Device 3.

K100915: Hutchinson Technology Inc., BioMeasurement Division - InSpectra™ StO2 Tissue Oxygenation Monitor System (Model 650 and accessories)

## 4. Device Description

The InSpectra™ StO2 Spot Check System and its predicate device are designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The InSpectra"M StO2 Spot Check System is composed of the following components:

The InSpectra™ StO2 Spot Check Monitor (model 300) contains an LCD screen, light source/detection circuitry, microcontrollers, internal software, one set of optical fibers to transmit light to the Cable, a second set of optical fibers that receive light from the Cable and return it to a photosensitive detector and internal software.

The InSpectra™ StO2 Cable (model 3003) is a replaceable component of the InSpectra™ StO2 Spot Check System that transmits light between the Spot Check and the clip.

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The InSpectra™ StO2 Thenar Clip (model 1315) has a shield to protect the measurement from ambient light interference and a clip to facilitate the attachment to the patient's thenar for integre the first in a clip to laciniale the attaching
thenar eminones (the flock thenar eminence (the fleshy mass on the palmar surface the hand at the base of the thumb) and connects to the InSpectra™ StO2 Cable, model 3003.

- The Charging Station contains circuitry to simultaneously charge the InSpectra™ StO2 Spot Check Monitor and a spare battery. LED indicators display the status of the charging batteries.
The Spot Check System also includes a replaceable/rechargeable lithium ion battery and a wall/IV pole mounting system

#### 5. Intended Use

Hutchinson Technology Incorporated's InSpectra™ StO2 Spot Check is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in thenar skeletal muscle tissue (StO2),

The InSpectraTM StO2 Spot Check is indicated for use in monitoring patients during circulatory or perfusion examinations or when there is a suspicion of compromised circulation of thenar skeletal muscle.

## 6.

Technological Characteristics
The InSpectra"™ StO2 Spot Check System 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, operating principle, performance specifications and intended use. When compared to the predicated device, the subject device utilizes a multiple-use thenar clip rather than single-use advise patient interface. Differences did not affect safety and/or effectiveness.

#### 7. Substantial Equivalence Rationale

The subject device and the predicate device have substantially equivalent indications, . Substantially equivalent to the predicate device cleared under 5 I (K) number: K100915.

#### 8. Test Conclusions

Hutchinson Technology Inc. has conducted extensive testing of the InSpectra™ StO2 Spot Check System to verify adherence to requirements. All test results verify that the device meets or exceeds all predetermined specifications.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Hutchinson Technology, Inc. % BioMeasurement Division Mr. Colin M. McGraw Operations Manager 40 West Highland Park Drive, NE Hutchinson, Minnesota 55350

MAR - 2 2011

Re: K103613

Trade/Device Name: InSpectra™ StO2 Spot Check System (Model 300 and accessories) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: February 16, 2011 Received: February 17, 2011

Dear Mr. McGraw:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Colin M. McGraw

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggv/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Dr. Thomas D.C.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

#### 510(k) Number (if known): K103613

Device Name: InSpectraTM StO2 Spot Check System (Model 300 and accessories)

#### Indications For Use:

Hutchinson Technology Incorporated's InSpectra™ StO2 Spot Check is intended for use as a non-invasive monitoring system that measures an approximated mltoned percent hemoglobin oxygen saturation in thenar skeletal muscle tissue (StO2).

The InSpectra™ StO2 Spot Check is indicated for use in monitoring patients during circulatory or perfusion examinations or when there is a suspicion of compromised circulation of thenar skeletal muscle.

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Qyden for MKM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103613