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.

Device Description

The InSpectra™ is designed to estimate the percent oxygen saturation of hemoglobin in a volume of tissue (StO2). This value is a reflection of localized perfusion of that tissue. The InSpectra™ is composed of the following components: Monitor, Patient Cable, Patient Interface, Printer, Optical Converter, Set-up Accessories, and Inspectra System Software.

AI/ML Overview

The provided text outlines the submission of a Special 510(k) for a modified device, the InSpectra™ Tissue Spectrometer System, Model 325. However, it does not contain the detailed acceptance criteria or the specific study results that prove the device meets these criteria. The document states that "All test results verify that the device meets or exceeds all predetermined specifications," but does not list these specifications or the performance metrics.

Therefore, for the requested information, many fields will be marked as "Not provided in the input text."

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy)	Reported Device Performance
Not provided in the input text	"meets or exceeds all predetermined specifications" (specific numbers are not provided)

2. Sample size used for the test set and the data provenance:

Sample Size: Not provided in the input text.
Data Provenance: Not provided in the input text (e.g., country of origin, retrospective or prospective). The submission is from Hutchinson, MN, USA.

The document indicates "extensive testing" was conducted to verify adherence to requirements, but does not detail the nature or scale of this testing for the test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: Not provided in the input text.
Qualifications of experts: Not provided in the input text.

4. Adjudication method for the test set:

Not provided in the input text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device described is a non-invasive monitoring system for measuring tissue oxygen saturation (StO2), not an AI-assisted diagnostic imaging device that human readers would interpret. Therefore, the concept of human readers improving with AI assistance is not applicable to this device.

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

Yes, implicitly. The InSpectra™ Tissue Spectrometer System, Model 325, measures an "approximated value of percent hemoglobin oxygen saturation in tissue (StO2)." It is a standalone monitoring device. While clinicians interpret the StO2 readings, the device itself provides the measurement without human input into the measurement process. The "Test Conclusions" state that "All test results verify that the device meets or exceeds all predetermined specifications," which implies testing of the device's performance in isolation.

7. The type of ground truth used:

Not explicitly stated, but for a device measuring "percent hemoglobin oxygen saturation in tissue (StO2)," the ground truth would typically be established by:
- Direct, invasive measurements (e.g., blood gas analysis of tissue samples): This is a common method for validating non-invasive oximetry devices.
- Other established gold-standard non-invasive methods: If such a method exists for tissue oxygen saturation.
- Physiological models or controlled experiments: Where tissue oxygenation levels can be precisely manipulated and known.

8. The sample size for the training set:

Not applicable as this seems to be a hardware device with an algorithm for calculating StO2, rather than a machine learning model that requires a distinct training set. The text refers to "predetermined specifications" and "extensive testing" for the modified device itself.

9. How the ground truth for the training set was established:

Not applicable (as per point 8).

Summary of what the document does provide:

Device Name: InSpectra™ Tissue Spectrometer System, Model 325
Intended Use: Noninvasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO2). Indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.
Predicate Device: InSpectra™ Tissue Spectrometer System, Model 325, (K042020)
Rationale for Equivalence: Based on design, technological characteristics, intended use, and extensive testing, the modified device is substantially equivalent to the unmodified predicate device and raises no new issues of safety or effectiveness.
Conclusion: "All test results verify that the device meets or exceeds all predetermined specifications."

Summary

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SMDA Summary -- Special 510(k) Modified Device

Submitted by:	Hutchinson Technology, Inc.BioMeasurement Division40 West Highland Park NEHutchinson, MN 55350Phone: 320.587.1926Fax: 320.587.1555
Contact Person:	Joseph P. OrtnerManager, Product ResearchHutchinson Technology, Inc.Phone: 320.587.1435Fax: 320.587.1555
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 oxygensaturation of hemoglobin in a volume of tissue (StO2). This value is areflection of localized perfusion of that tissue.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).

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:

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)

Blummmma
ision Sign-Off

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).