OxiplexTS200 by ISS Medical, Inc.

The OxiplexTS200 tissue oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. It is indicated for monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device can be used for monitoring in Medical Clinics, laboratories and outpatient facilities.

The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy. The value of these measurements in disease states has not been demonstrated.

Device Description

The ISS Medical non-invasive tissue oximeter. OxiplexTS200. is intended for use as an adjunct monitor of regional oxy- and deoxy-hemoglobin concentration, and of hemoglobin oxygen saturation of blood in tissues during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The OxiplexTS200 is a device for use in spot-checking as well as continuous monitoring of patients in healthcare facilities. It is not intended for home use or to be used for "out of hospital" transport.

The OxiplexTS200 is an instrument system and includes the following components:

OxiplexTS200 Unit with two sensors and phantom block ●
Power cable ●
Accessories (straps for sensors; strap for phantom block; dark cloth) ●
ISS flash memory
Operation Manual
Analoq Input module with USB cable (optional)
. Analog Output module with USB cable (optional)

The OxiplexTS200 uses near-Infrared Spectroscopy (NIRS), a noninvasive diagnostic tool, to offer features for the assessment and monitoring of oxygenation in tissues such as brain and muscle. Near-infrared light (in the wavelength range 700-900 nm) can penetrate several centimeters into numerous body tissues. NIRS enables continuous real time measurements of changes in the hemoglobin oxygenation state, thus providing information on tissue oxygenation and hemodynamics.

AI/ML Overview

The ISS Medical OxiplexTS200 is a tissue oximeter that non-invasively estimates percent oxygen saturation (StO2) in tissue. Its performance testing compared it to the ViOptix ODISsey Tissue Oximeter model OXY-2.

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Device ViOptix ODISsey)	Reported Device Performance (OxiplexTS200)
Accuracy (StO2)	80-100%: 2.7% 60-80%: 2.3% 40-60%: 5.2% 10-40%: 13.3%	50-100%: 2% 26-49%: 3% 0-25%: 10%
Range (StO2)	0-100%	0-100%

Note about accuracy: The provided tables show the stated accuracy of the predicate device (ViOptix ODISsey) and the OxiplexTS200, which are presented as similar. The study's finding of "essentially identical sensitive, reliable and accurate measurements of StO2" suggests that the OxiplexTS200 meets or performs comparably to the predicate's accuracy levels over a relevant range.

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

Sample Size (Clinical Test Set): 25 human subjects
Data Provenance (Clinical Test Set): Data was collected through comparison measurements acquired in the Biomedical Optics Research Laboratory at the Department of Neonatology at University Hospital Zürich in Zürich, Switzerland. This indicates prospective data collection from human subjects.
Sample Size (Bench Test Set): Not explicitly stated as a number of "samples", but the test involved a phantom containing human blood diluted in an optically scattering medium "at three levels; from physiological levels to increasingly higher concentrations."

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

There is no mention of experts being used to establish a ground truth for the test set. The comparison was made between the OxiplexTS200 and a legally marketed predicate device (ViOptix ODISsey Tissue Oximeter model OXY-2). The predicate device's measurements serve as the reference for comparison. The study was conducted in a research laboratory directed by a Professor in Neonatology, indicating scientific oversight.

4. Adjudication Method for the Test Set

No adjudication method is described. The study compared the StO2 readings of the OxiplexTS200 directly against those of the predicate device.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an oximeter, not an AI-powered diagnostic tool requiring human interpretation.

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

Yes, a standalone performance assessment was conducted for the OxiplexTS200 by comparing its readings to a predicate device. The device's output (StO2 measurements) was directly compared, as it functions as an automated measurement device.

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

The ground truth for the clinical study was established by comparing the OxiplexTS200's StO2 readings against those obtained simultaneously from the legally marketed predicate device, the ViOptix ODISsey Tissue Oximeter model OXY-2. For the bench testing, a phantom with simulated physiological properties and known (controlled) StO2 levels was used, where the predicate device's readings served as the reference.

8. The sample size for the training set

The document does not provide information about a "training set" characteristic of machine learning models. The OxiplexTS200 is a hardware device utilizing Near-Infrared Spectroscopy (NIRS) principles, not a software algorithm that undergoes a training phase with a dataset in the conventional sense.

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

As there is no mention of a "training set" in the context of machine learning, this information is not applicable. The device's operation is based on established NIRS principles and optical parameters, which are inherent to its design and calibration, rather than on a trained dataset.

Summary

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March 1, 2024

ISS Medical, Inc. Beniamino Barbieri President 1602 Newton Drive Champaign, Illinois 61822

Re: K232385

Trade/Device Name: OxiplexTS200 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: August 4, 2023 Received: August 9, 2023

Dear Beniamino Barbieri:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tanisha L. Tanisha L. Hithe -S 2024 03 01 Hithe -S 14:49:37 -05'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232385

Device Name OxiplexTS200

Indications for Use (Describe)

The OxiplexTS200 should not be used as the sole basis for diagnosis or therapy. The value of these measurements in disease states has not been demonstrated.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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ISS Medical 510(k) Premarket Notification OxiplexTS200

Section 5: 510(k) Summary

510(k) Summary and Certification

1. Submitter's Name/Contact Person

Submitted by:	Contact Person:
ISS Medical, Inc.1602 Newton DriveChampaign, IL 61822	Beniamino BarbieriPresidentTel: 217.359.8681 x 11Fax: 217.359.7879Email: beniamino.barbieri@iss.com

Summary Date: July 31, 2017

2. General Information

a. Proprietary Name: OxiplexTS200
b. Common/Usual Name: Tissue Oximeter
Classification Name: Oximeter C.
d. Class: Il
e. Product Code: 74MUD
CFR Reference: 21 CFR 870.2700 f.
g. Identification of Equivalent Devices:

InSpectra StO2Tissue Oxygenation Monitor, Model 650 (K100915) ViOptix ODISsey Tissue Oximeter (K042657)

3. Device Description

The OxiplexTS200 is an instrument system and includes the following components:

OxiplexTS200 Unit with two sensors and phantom block ●
Power cable ●
Accessories (straps for sensors; strap for phantom block; dark cloth) ●
ISS flash memory
Operation Manual

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ISS Medical 510(k) Premarket Notification OxiplexTS200

Analoq Input module with USB cable (optional)
. Analog Output module with USB cable (optional)

4. Indications for Use

5. Comparison with Predicate Devices

ISS Medical's OxiplexTS200 System is compared to the InSpectra StO2Tissue Oxygenation Monitor, Model 650 and the ViOptix ODISsey Tissue Oximeter in Table 1 below.

	OxiplexTS200	InSpectraStO2TissueOxygenationMonitor, Model650 (K100915)	ViOptix ODISseyTissue Oximeter(K042657)	Similar/Same
Indications forUse	The OxiplexTS200tissue oximeter isintended to non-invasively estimatethe percent oxygensaturation (StO2) ina volume of tissue.It is indicated formonitoring patientsduring circulatory orwhen there is asuspicion of	HutchinsonTechnologyIncorporated'sInSpectra™StO2TissueOxygenationMonitor is intendedfor use as anoninvasivemonitoring systemthat measures anapproximated value	The ViOptixODISsey TissueOximeter isintended tononinvasivelyestimate thepercent oxygensaturation (StO2) ina volume of tissue.

Table 5-1: Comparison to Predicate Devices

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ISS Medical 510(k) Premarket Notification OxiplexTS200

	OxiplexTS200	InSpectraStO2TissueOxygenationMonitor, Model650 (K100915)	ViOptix ODISseyTissue Oximeter(K042657)	Similar/Same
Indications forUse	compromisedcirculation. Thedevice can be usedfor monitoring inMedical Clinics,laboratories andoutpatient facilities.The OxiplexTS200should not be usedas the sole basisfor diagnosis ortherapy. The valueof thesemeasurements indisease states hasnot beendemonstrated.	of percenthemoglobin oxygensaturation in tissue(StO2).The InSpectra™StO2TissueOxygenationMonitor is indicatedfor use inmonitoring patientsduring circulatory orperfusionexaminations ofskeletal muscle orwhen there is asuspicion ofcompromisedcirculation.	This is performed inmedicalenvironmentsincluding physicianoffices, hospitals,ambulatory care,and EmergencyMedical Services.The ODISseyTissue Oximeter isindicated for use inmonitoring patientsduring circulatory orperfusionexaminations ofskeletal muscle orwhen there is asuspicion ofcompromisedcirculation.	Similar
	OxiplexTS200	InSpectraStO2TissueOxygenationMonitor, Model650 (K100915)	ViOptix ODISseyTissue Oximeter(K042657)	Similar/Same
Principle ofOperation	Light is used toprobe the region ofthe tissue under thesensor. Light issent through theissue at fourdifferent locations; afraction of it returnsto the surface and itis collected at setdistances from thepoints of insertion.Optical parametersof the tissue aredetermined andhence theconcentration ofoxy- and deoxy-hemoglobin. Thetissue oxygensaturation isderived.	Diffuse reflectancespectroscopy. Lightis used to probe across section of themicrovasculature oftissue (mixed bed ofarterioles,capillaries, andvenuoles). The lightreturning fromtissue, after havingpassed throughtissues, forhemoglobin in itsoxygenated anddeoxygenatedforms in theoptically sampledregion. The tissueoxygen saturation(%StO2), a valuereflectingpercentage ofoxygenatedhemoglobin in thesampledmicrovasculature oftissue is calculated.	Diffuse reflectancespectroscopy. Lightis used to probe across section of themicrovasculature oftissue (mixed bed ofarterioles,capillaries andvenuoles). Thelight returning fromtissue, after havingpassed throughtissues, forhemoglobin in itsoxygenated anddeoxygenatedforms in theoptically sampledregion. The tissueoxygen saturation(%StO2), a valuereflectingpercentage ofoxygenatedhemoglobin in thesampledmicrovasculature oftissue, is calculated.	Similar
Range (StO2)	0-100%	0-99%	0-100%	Similar
Accuracy[parameterStO2]	50-100%: 2%26-49%: 3%0-25%: 10%	70-99%; 1.63 StO2units0-70%; 2.94 StO2units	80-100%: 2.7%60-80%: 2.3%40-60%: 5.2%10-40%: 13.3%	Similar
Alarm LimitRange	Visual alarms whenvalue is belowcustom setthreshold.	Visual alarms forerror conditions	Audio and visualalarms whenrange limit isexceeded	Same forViOptix;differentforInSpectra
MeasuresNear-infraredWavelength	Yes	Yes	Yes	Same
	OxiplexTS200	InSpectraStO2TissueOxygenationMonitor, Model650 (K100915)	ViOptix ODISseyTissue Oximeter(K042657)	Similar/Same
Sensor	Re-useable	Single use;disposable	Single use;disposable	Different
SampleAcquisition	Fiber optic bundleplaced in contactwith skin.	Fiber optic probeplaced on intactskin	Fiber optic probeplaced on intactskin	Same
Features (e.g.,alarms, displayand indicators,modes)	Several errors andalarms are reportedby the softwareduring the operationof the instrument:a. OverloadWarning (whenthe signal fromthe environmentsaturates thedetectors);b. Signal StrengthWarning(regarding theplacement of thesensors on thepatient;c. Visual Alarm forset thresholds of[THC] andoxygensaturation;d. Overvoltagewarning.e. Warningsresulting fromError conditiontests (AC slope,regressioncoefficient,phase standarddeviation, out ofrange opticalparameters).	Audiovisual•high/low StO2error condition,• Defective LEDor cable sensor• Communicationerror• Overtemperature• Cable notconnectedCustomizable StO2alarm limits andnotification of errorconditions	System will performself-test whenpower is turned on.Visual and audiblealarms include: lowStO2, high StO2,StO2 drop rate andlow battery. Visualalarms include:inadequate patientcontact, sensorlaser ON, and ACpower ON. Alarmvolume 50 to 80dbA at 30cm (1foot). Single-channel (default) ordual channel(applies to consoleswith dual channeloption when 2sensors areattached.) 3-cellLithium Ion Batterywith 30 minuteminimum.	Similar
Time to firstreading	Continuous readingwith up to 8 hourstrended display.Max display updaterate 0.5 seconds	Continuous readingwith up to 8 hourstrended display.Display update rate2 seconds.	~20 seconds	Same forInSpectra;differentforViOptix
	OxiplexTS200	InSpectraStO2TissueOxygenationMonitor, Model650 (K100915)	ViOptix ODISseyTissue Oximeter(K042657)	Similar/Same
Number ofdifferentwavelengths oflight emitted	Two (2); 690nm and830nm	Four (4); 680, 720,760, and 800nm	Two (2); 690nm and830nm	Same forViOptix;differentforInSpectra
Battery	Not available,(the instrumentdoes not operatewith a battery)	Lithium battery;capacity 2 hours(new/full charge);Life 300 fullcharge/dischargecycles	Lithium battery	Different
Product LaserRating	Class I	Class I	Class 3R	Same forInSpectra;differentfromViOptix

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ISS Medical 510(k) Premarket Notification OxiplexTS200

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ISS Medical 510(k) Premarket Notification OxiplexTS200

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ISS Medical 510(k) Premarket Notification OxiplexTS200

Similarities between the OxiplexTS200 and the predicates include:

1. The intended use for all three devices is similar.
1. The principles of operation are similar.
1. The range and accuracy are similar.
1. All three devices measure near-infrared wavelength.
1. The sample acquisition is the same for all three devices.
1. The safety specifications are the same.
1. The features of the three devices are similar.

Differences between the OxiplexTS200 and the predicates include:

1. The OxiplexTS200 and ViOptix have both audio and visual alarms; the InSpectra has only visual alarms.
1. The InSpectra and ViOptix have disposable sensors; the OxiplexTS200 has reusable sensors.
1. The OxiplexTS200 and InSpectra have continuous readings with up to 8 hours trending displayed; the ViOptix has 20 second time to read.
1. The OxiplexTS200 and ViOptix have two (2) different wavelengths of light emitted; InSpectra has four (4).
1. The InSpectra and ViOptix have battery option: OxiplexTS200 does not have a battery option.
1. OxiplexTS200 is considered to be a Class I laser product (as the InSpectra), while the ViOptix is classified as a Class 3R laser product.

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ISS Medical 510(k) Premarket Notification OxiplexTS200

6. Performance Test - Bench

The differences in the technological character between the OxiplexTS200 and the predicates do not raise new types of question regarding safety and effectiveness. In response to the reviewer's request that ISS Medical conducts a direct comparison of the OxiplexTS200 with a predicate instrument, it was arranged to compare it to the ODISey Tissue Oximeter model OXY-2 by Vioptix Inc. The comparison measurements were acquired in the Biomedical Optics Research Laboratory directed by Professor Martin Wolf at the Department of Neonatology at University Hospital Zürich in Zürich, Switzerland.

The staff and equipment there enabled us to conduct a series of simultaneous SO2 measurements using the Vioptix predicate device and the OxiplexTS200 on a phantom containing human blood diluted in an optically scattering medium to simulate a physiologically appropriate level of tissue hemoglobin concentration [tHb] and a physiologically realistic optical scattering and absorption properties. Measurements were made at three levels; from physiological levels to increasingly higher concentrations. The primary comparison of interest is the relation of the OxiplexTS200 percent oxygen saturation [SO2%] estimates with the Vioptix SO2% estimates. These are presented in section 19 performance bench testing where it can be seen that for physiologically realistic tissue hemoglobin concentrations [tHb] both instruments report nearly identical values over the range of 20% to 98% SO2. The presence of the pigmented "skin" filter had no discernable effect on either instrument.

7. Performance Testing- Clinical

We conducted testing using the OxiplexTS200 and the Vioptix devices to compare StO2 readings from a total of 25 human subjects.

Measurements were acquired over the brachioradialis, the largest muscle in the forearm, and over the thenar of the thumb, a complex region of small muscles and connective tissue. In addition to baseline measures of StO2, we varied StO2 by occluding blood flow to the arm both completely (venous and arterial occlusion) and partially (venous occlusion only), using a blood pressure cuff on the upper arm.

We found that the rate of change of StO2 after both types of occlusions was very similar for both instruments, and baseline measurements on the thenar were not statistically different, while the two instruments gave different estimates of StO2 after two minutes of occlusion at both locations, and on the arm at baseline.

These results are consistent with the results of our previous in vitro comparison of these two instruments which demonstrated that at physiologically realistic levels of [tHb] the OxiplexTS200™ and ViOptix ODISsey instruments provided essentially identical sensitive, reliable and accurate measurements of StO2.

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ISS Medical 510(k) Premarket Notification OxiplexTS200

ISS Medical Inc. has also conducted human factors testing to verify and demonstrate the safety and effectiveness of the OxiplexTS200 for its intended users, use and environment.

Most of the tests mimic the actual daily use of the system. The primary goal of these studies was to evaluate if the device operators are able to accomplish routine tasks with the provided instructions and to assess the clarity of the Instructions For Use (IFU).

Based on the results of the usability studies, the majority of users would be able to make successful and accurate measurements on first use of the device. We conclude that the device could be used effectively without any changes to the user interface.

8. Performance Testing

Bench testing and biocompatibility testing was conducted to demonstrate that the OxiplexTS200 functions as intended. The OxiplexTS200 is designed to conform to the applicable requirements of electrical safety, laser safety and electromagnetic compatibility requirements as summarized below:

. Evaluation of Risk Management in accordance with IEC 60601-1 3rd Ed. and ISO 14971.
. Evaluation to 60601-1 (3.1 Edition) IEC, EN, ANSI/AAMI, and CSA. Includes European, US, and Canadian National differences.
. Evaluation of Programmable Electrical Medical Systems (PEMS) compliance, using IEC 62304:2006 - (Software)
. Laser classification testing according to IEC 60825-1 2nd Ed. for two laser diodes (830nm and 690nm)
Evaluation of Usability compliance, using IEC 60601-1-6 :2010 . Collateral standard.
Full EMC evaluation for mains powered device using EN/IEC 60601-. 1-2:2007.
Testing for biocompatibility (ISO 10993-5:2009) ●

All testing met specified requirements. Test reports were provided in the submission as Appendices 4, 6 and 7.

9. Conclusions

The OxiplexTS200 device that is the subject of this 510k pre-market notification, is the same or similar in design, intended use, principles of operation, and technological

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ISS Medical 510(k) Premarket Notification OxiplexTS200

characteristics, compared to the predicate devices. Differences of the subject device's output parameters compared to those of the predicate devices' output parameters do not raise new types of questions regarding safety and effectiveness, and performance testing provided in this 510k supports that the device can be used safely and effectively for the proposed indications for use. The OxiplexTS200 device that is the subject of this 510K is considered to be substantially equivalent to the predicate devices.

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).