Hutchinson Technology Incorporated's InSpectra™ Tissue 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.

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: 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;
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.
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.

AI/ML Overview

The provided document is a Special 510(k) Modified Device summary and an FDA clearance letter for the InSpectra™ Tissue Spectrometer System, Model 325. This specific submission is for a modification to an already cleared device, primarily involving new software that allows viewing, storing, and charting of the output measurement.

Therefore, the document does not contain typical acceptance criteria and a detailed study proving the device meets those criteria, as one would expect for a de novo device submission or a substantial re-evaluation. Instead, it focuses on demonstrating that the modification (new software) does not alter the fundamental safety and effectiveness of the previously cleared predicate device.

Here's an attempt to answer your questions based on the limited information provided in the context of this specific submission:

1. A table of acceptance criteria and the reported device performance

Based on the nature of this 510(k) submission (modification of an existing device with new software), explicit quantitative acceptance criteria for clinical performance are not detailed in this document. The primary acceptance criterion for this specific submission seems to be that the new software does not degrade the performance or introduce new risks compared to the predicate device.

Acceptance Criteria (Inferred from modification nature)	Reported Device Performance (as stated)
Software Functionality: New software must accurately view, store, and chart the StO2 output.	"All test results verify that the software meets or exceeds all predetermined specifications."
Data Integrity: The software does not alter the StO2 information already displayed on the predicate device.	"The software does not alter the information already displayed on the predicate device. There is a one-way communication from the monitor to the user PC."
Safety: The modification does not introduce new safety concerns.	(Implicit in 510(k) clearance for a software modification)
Substantial Equivalence: The modified device is as safe and effective as the predicate device.	"HTI believes that the modified device is substantially equivalent to the unmodified predicate device." (Accepted by FDA)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Hutchinson Technology, Inc. has conducted extensive testing of the new Inspectra™ Software to verify adherence to requirements."

Sample Size: Not specified.
Data Provenance: Not specified (country of origin, retrospective/prospective). Given it's a software functionality test, it's likely internal validation on test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable or not specified. For a software update focused on displaying existing data, a panel of clinical experts for ground truth establishment is not typically required in the same way as for a diagnostic algorithm. The "ground truth" here would relate to the correct display and storage of the StO2 values generated by the core spectrometer, which is assumed to be accurate from the predicate device's clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable or not specified. Adjudication methods are typically employed in studies where human interpretation or consensus is needed to establish a ground truth for diagnostic accuracy, which is not the primary focus of this software modification submission.

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

No, an MRMC study was not done. This submission is for a software modification that allows viewing and storing existing data, not for an AI-assisted diagnostic tool.

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

The software itself is a standalone component for data visualization and storage. Its performance as described is independent of human interpretation for its basic function (displaying and storing data). The core device (the spectrometer) is a standalone algorithm (measuring StO2), and its standalone performance would have been established during the predicate device's clearance (K012759). This submission focuses on the software's functionality related to that existing device's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the software modification, the "ground truth" would be the known, expected output values from the InSpectra™ Tissue Spectrometer. The software's performance is validated against whether it accurately receives, displays, and stores these values without alteration. This is a technical (software) validation against the original device's output, not a clinical ground truth like pathology or outcomes.

8. The sample size for the training set

Not applicable. This is a software modification for data display and storage, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of software modification.

Summary

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Appendix C-1

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:	Thomas A. DoldRegulatory Affairs ManagerHutchinson Technology, Inc.Phone: 320.587.1435Fax: 320.587.1555
Summary Date:	November 18, 2002
Proprietary Name:	InSpectra™ Tissue Spectrometer System, Model 325
Common Name:	Tissue Spectrometer
CFR Reference:	21CFR§870.2700
Class:	ll
Product Code:	74 MUD
Equivalent marketed device:	InSpectra™ Tissue Spectrometer System, Model 325, (K012759)

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.

Hutchinson Technology, Inc.

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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;
미 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.
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:

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

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

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Technological Characteristics:

The modified device has the same basic technological characteristics as the predicate device. The modification includes:

New software provided via compact disk that can be downloaded onto a personal computer. The software enables the user to view, store and chart the output measurement of the Inspectra System. The software does not alter the information already displayed on the predicate device. There is a one-way communication from the monitor to the user PC.

Substantial Equivalence Rationale:

HTI believes that the modified device is substantially equivalent to the unmodified predicate device. The unmodified device already provides the capability to display information through its output device (Optolink) to a thermal printer.

The predicate to our unmodified Inspectra device was the Hutchinson Technology, Inc. Biospectrometer NB Model 1111, FDA control # K963903. The Biospectrometer used a laptop personal computer for the primary display of StO2 and other output information including date and time, and allowed the data to be marked, saved and charted.

Test Conclusions:

Hutchinson Technology, Inc. has conducted extensive testing of the new Inspectra™ Software to verify adherence to requirements. All test results verify that the software meets or exceeds all predetermined specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the image.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas A. Dold Regulatory Affairs Manager Hutchison Technology, Incorporated BioMeasurement Division 40 West Highland Park Drive NE Hutchinson, Minnesota 55350

Re: K023938

Trade/Device Name: InSprectra™ Tissue Spectrometer System, Model 325 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: MUD Dated: November 18, 2002 Received: November 26, 2002

Dear Mr. Dold:

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. Thomas A. Dold

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (301) 594- 4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/odrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Indications for Use Statement

Device Name:

InSprectra™ Tissue Spectrometer System, Model 325

Indications For Use:

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

DHWatehausen

Division Sign-Off) Division of Anesthesiology General Hospital. Infection Control, Dental Devices

510(k) Number: KC

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Hutchinson Technology, Inc.

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).