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 a modified version of the previously cleared Hutchinson Technology 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, 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: An "OptoCheck™" module as well as both "High" and "Low" "Single Point References" are provided to verify proper system operation.

AI/ML Overview

The provided 510(k) summary for the InSpectra™ Tissue Spectrometer System, Model 325, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

However, based on the limited information available in the document, here's an attempt to extract and infer what is presented regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or specific thresholds for StO2 measurement. Instead, it relies on demonstrating equivalent clinical performance to its predicate device.

Acceptance Criteria (Inferred from "Substantial Equivalence")	Reported Device Performance (Inferred from "equivalent clinical performance")
Functional Equivalence: Ability to estimate percent oxygen saturation of hemoglobin in a volume of tissue (StO2) non-invasively and continuously.	The InSpectra™ (new device) shares the intended use of, and measures the same approximated value of percent oxygen saturation of hemoglobin in a volume of tissue as, the Biospectrometer - NB Oximeter, Model 1111 (predicate device).
Clinical Performance Equivalence: Provide comparable StO2 measurements to the predicate device in a clinical setting.	"A human study comparing device performance between the InSpectra™ and the predicate system demonstrated equivalent clinical performance." (No specific quantitative metrics for "equivalent" are provided).
Hardware and Software Functionality: Proper operation of new electronic components and software platforms.	"Hutchinson Technology, Inc. has conducted extensive testing of the new electronic components to verify adherence to requirements. The new electronic [components that] 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." (No specific quantitative results are provided).
Safety: Device operates without introducing new or increased risks.	(Implicit in 510(k) clearance process by demonstrating substantial equivalence to a legally marketed predicate device).

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

Sample Size: Not explicitly stated. The document only mentions "A human study."
Data Provenance: Not explicitly stated regarding country of origin. The study was a "human study" and implied to be prospective due to comparing a new device against an existing one, but retrospecive analysis of data from the predicate device might have informed design, though not explicitly stated for the "human study".

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

This information is not provided in the document. The study compared the new device's performance against a predicate device, not against an independently established "ground truth" using expert consensus. The predicate device's readings served as the comparator.

4. Adjudication Method for the Test Set

This information is not provided. The study focused on comparing the new device against the predicate.

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

Not applicable. This device is a tissue spectrometer, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. The study mentioned is a comparison of two medical devices measuring StO2.

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

Yes, in essence, the "human study comparing device performance between the InSpectra™ and the predicate system" can be considered a standalone performance study. The InSpectra™ system itself, with its enclosed software and hardware, generates the StO2 measurement. The study aimed to show that this standalone measurement from the InSpectra™ was equivalent to the standalone measurement from the predicate device.

7. The Type of Ground Truth Used

The "ground truth" in this context was the measurements provided by the predicate device (Biospectrometer - NB Oximeter, Model 1111). The study aimed to demonstrate that the InSpectra™ measurements were equivalent to those of the predicate. This is a common approach for 510(k) submissions demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable/Not provided. The document describes a medical device, not a machine learning algorithm that requires a separate "training set" for its core functionality. While the device contains "software" and an "algorithm," the context here is a traditional medical device demonstrating equivalence, not an AI/ML device being developed and trained.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. As stated above, this device is not presented as an AI/ML device with a training set. The "algorithm" mentioned is fundamental to how it calculates StO2, not a learned model from a training set.

Summary

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K01275.9

Premarket Notification [510(K)] Summary

Submitter:	JAN 1 7 2002Hutchinson Technology, Inc.BioMeasurement Division40 West Highland Park NEHutchinson, MN 55350Phone: 320.587.1926Fax: 320.587.1555
Contact:	Joseph OrtnerEngineering ManagerHutchinson Technology, Inc.Phone: 320.587.1435Fax: 320.587.1555
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 HutchinsonTechnology, Inc. (K963903)
Description:	This premarket notification (510(K) Notification) is submitted to obtainmarketing clearance for the Hutchinson Technology, Inc.BioMeasurement Division "InSpectra™ Tissue Spectrometer System,Model 325" (hereinafter referred to as InSpectra ™).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 amodified 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 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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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged vertically along the left side of the logo, and the word "USA" is arranged vertically along the right side of the logo. The logo is black and white.

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 (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 Oivision 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/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 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)

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).