Hutchinson Technology Incorporated's InSpectra™ StO2 Tissue Oxygenation Monitor 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™ StO2 Tissue Oxygenation Monitor 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 Description

The InSpectra" StO2 Tissue Oxygenation Monitor ("Model 650"), is a lightweight and transportable system that is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). The Model 650 is composed of the following components:

InSpectra™ StO2 Tissue Oxygenation Monitor. The InSpectra™ StO2 Monitor contains an LCD screen, a microcontroller, cooling fan, back-up battery, and internal software. The monitor has an internal lithium ion battery and two external data ports. It is equipped with an adjustable C-clamp for attachment to an IV pole.

InSpectra™ StO2 Cable, which can be removed from the monitor and replaced, contains light detection circuitry, a microcontroller, one set of optical fibers to transmit light to the tissue, and a second set of optical fibers that receive light from the tissue and return it to a photosensitive detector and internal software.

The InSpectraTM StO2 Sensor. The single-use InSpectra™ StO2 Sensor, when connected to the InSpectra™ StO2 Cable, conducts the optical signal to the patient and back to the monitor. The sensor has a shield to protect the measurement from ambient light interference, a reinforced cable to protect the optical fibers, and an adhesive surface to facilitate attachment of the sensor to the patient for continuous monitoring.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for the InSpectra™ StO₂ Tissue Oxygenation Monitor, Model 650, nor does it describe a specific study proving the device meets particular numerical criteria.

Instead, the document is a 510(k) premarket notification for a labeling clarification for an existing device (Model 650). The key takeaway from the provided text is that no new testing was required or conducted because the change was only a labeling clarification, and the manufacturer concluded no new technological issues were raised.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document.

Here's what can be inferred or explicitly stated based on the provided text, along with what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not detailed. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance meets the level established by those devices. However, no specific numerical acceptance criteria (e.g., accuracy, precision ranges, sensitivity, specificity) are provided for this submission.
Reported Device Performance: Not reported for this submission. The submission is for a labeling clarification, not new performance data.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable/not provided. No new performance testing was conducted for this 510(k) submission.
Data Provenance: Not applicable/not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable/not provided. No new performance testing was conducted to establish ground truth.
Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No, an MRMC study was not done as part of this submission. The document explicitly states "no new testing was required."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Study: Not applicable to this submission. The device is a monitor that measures physiological parameters. Performance evaluation would typically be against a gold standard measurement, not human interpretation of an algorithm's output in the same way as an imaging AI. However, no new performance studies of any kind were conducted for this submission.

7. The Type of Ground Truth Used:

Ground Truth Type: Not applicable/not provided for this submission. Any original ground truth for the predicate device would have been established, but it's not detailed here.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable/not provided. This device is a measurement monitor, not an AI model requiring a training set in the typical sense.

9. How the Ground Truth for the Training Set was Established:

Ground Truth for Training Set: Not applicable/not provided.

Summary of Device Rationale for Substantial Equivalence (from the text):

The manufacturer (HTI) claims substantial equivalence for the "Model 650 with labeling clarifications" to predicate devices (K061619 and K053618) based on:

Design
Technological characteristics
Intended use
Equivalence in terms of design, functionality, principles of operation, performance specifications
The conclusion that the labeling clarifications raise "no new technological issues."
A risk analysis was conducted, which supported the conclusion that no new testing was required.

Summary

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K100915

510(k) Summary and Certification

1. Submitter's Name / Contact Person

Submitted by:	Contact Person	APR 30 2010
Hutchinson Technology, Inc.	Colin M McGraw
BioMeasurement Division	Operations Manager
40 West Highland Park NE	Tel: (320) 587-1272
Hutchinson, MN 55350	Fax: (320) 587-1671

Summary Date: March 30, 2010

2. General Information
Proprietary Name	InSpectra™ StO₂ Tissue Oxygenation Monitor, Model 650
Common / Usual Name	Tissue Oximeter
Classification Name	Oximeter
Class	II
Product Code	74MUD
CFR Reference	21CFR§870.2700
Identification of Equivalent Devices	Hutchinson Technology, Inc. - InSpectra™ StO₂ TissueOxygenation Monitor, Model 650 (K061619)
	Hutchinson Technology, Inc. - InSpectra™ Tissue SpectrometerSystem, Model 325 (K053618)

3. Device Description

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4. Intended Use

Hutchinson Technology Incorporated's InSpectra"" StO2Tissue Oxygenation Monitor is intended for use as a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2).

The InSpectraTM StO2Tissue Oxygenation Monitor is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

5. Technological Characteristics

The InSpectraThe StO2Tissue Oxygenation Monitor has the same basic technological characteristics as the predicate device(s) based on near-infrared technology. The modified device is equivalent in terms of design, functionality, principles of operation, performance specifications and intended use. The labeling clarifications raise no new technological issues.

6. Substantial Equivalence Rationale

Based on design, technological characteristics, and intended use, HTI believes that the Model 650 with labeling clarifications is substantially equivalent to the predicate devices currently marketed under 510(k) K061619 and K053618.

7. Test Conclusions

HTI conducted a risk analysis to support the labeling clarification and concluded that no new testing was required. Based on information supplied in the 510(k), we conclude that the subject device with labeling clarifications is safe, effective, and substantially equivalent to the predicate device(s).

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR 30 2010

Hutchinson Technology, Inc. c/o Mr. Colin McGraw Biomeasurement Division 40 West Highland Park Dr., NE Hutchinson, MN 55350

Re: K100915

· Device Name: InSpectra™ StO2 Tissue Oxygenation Monitor, Model 650 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (Two) Product Code: MUD Dated: March 30, 2010 Received: April 1, 2010

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, listing 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 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.fda.gov/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" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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Special 510(k): InSpectra StO2 Tissue Oxygenation Monitor – Model 650 Hutchinson Technology, Inc

INDICATIONS FOR USE STATEMENT

K100915

510(k) Number (if known): __

Device Name:

InSpectraTM StO2 Tissue Oxygenation Monitor, Model 650

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

Wanda

vascular Devi

510(k) Number K000715

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
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.(b)
Classification. Class II (performance standards).