PeriFlux 6000 equipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.

Device Description

PeriFlux 6000 is a transcutaneous oxygen/carbon dioxide (tcpO2/CO2) monitor, and consists of a main unit, PF 6001, that can be equipped with 1 to 8 PF 6040 function units. An electrode E5250 or E5280 is connected to each function unit and is applied to a patient's skin. Electrode E5250 consists of a Clark sensor and is used for O2 measurement. Electrode E5280 is a combined Clark sensor and Stow-Severinghaus-type sensor, and is used for both O2 and CO2 measurement. Upon measurement, the electrode is heated to make the skin permeable to gas diffusion, which allows O2 and CO2 to diffuse through the skin into the sensor. The instrument is operated from its touch screen interface and allows the users to record, analyze and report top(22 and tcpCO2 values.

AI/ML Overview

The provided document describes the PeriFlux 6000, a transcutaneous oxygen/carbon dioxide monitor, and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to predicate devices and demonstrating compliance with safety and performance standards. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the way typically expected for an AI/ML device.

The information provided is largely about regulatory compliance, intended use, device description, and comparison to predicate devices, rather than a detailed performance study with quantitative acceptance metrics.

Therefore, I cannot directly extract the full requested information about acceptance criteria and a study proving device performance as it's not present in the provided text. I will address the points that can be inferred or are explicitly stated, and note where information is missing.

Summary of Acceptance Criteria and Device Performance for PeriFlux 6000

The provided document describes the regulatory submission for the PeriFlux 6000, focusing on its substantial equivalence to predicate devices and compliance with relevant safety and performance standards. It does not present specific quantitative acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, the "acceptance criteria" are implied to be adherence to recognized international consensus standards for medical electrical equipment and transcutaneous partial pressure monitoring.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1:2005 (General safety)	Device "fully complies" with IEC 60601-1:2005 (which includes IEC 60601-1-4)
Compliance with IEC 60601-1-2:2007 (Electromagnetic compatibility)	Device "fully complies" with IEC 60601-1-2:2007
Compliance with IEC 60601-2-23:2011 (Transcutaneous partial pressure monitoring specific)	Device "fully complies" with IEC 60601-2-23:2011 (which includes IEC 60601-3-1)
Compliance with IEC 60601-1-8:2006 (Alarm systems)	Device "fully complies" with IEC 60601-1-8:2006
Compliance with Class II Special Controls Guidance Document (2002)	Device "has been tested to the requirements" of the guidance document
Measurement Range: tcpO₂: 0 - 800 mmHg (combined electrode)	No specific performance data provided beyond stating the range
Measurement Range: tcpCO₂: 5 - 100 mmHg (combined electrode)	No specific performance data provided beyond stating the range
Measurement Range: tcpO₂: 0 - 1999 mmHg (single tcpO₂ electrode)	No specific performance data provided beyond stating the range
Performance requirements for modern transcutaneous monitor	Device "meets the performance requirements"
Required safety mechanisms for transcutaneous monitor	Device "is equipped with the required safety mechanisms"

Note: The document explicitly states that the new device "meets the performance requirements" and "is equipped with the required safety mechanisms," and "fully complies" with the listed international standards. However, it does not provide detailed measurement accuracy, precision, bias, sensitivity, specificity, or similar quantitative performance metrics that would typically be expected from a device study. The provided text is a summary for regulatory clearance, focusing on equivalence and standard compliance rather than a detailed performance report.

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

This information is not provided in the document. The filing focuses on compliance with standards rather than clinical testing with a specific test set.

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

This information is not provided in the document. Ground truth establishment with experts is generally associated with clinical or image-based diagnostic studies, which is not the type of study described here for a transcutaneous monitor.

4. Adjudication method for the test set:

This information is not provided in the document. Adjudication methods are typically used in studies involving expert review where consensus on ground truth is required.

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 (or at least not reported) as this device is a standalone physiological monitor, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

The PeriFlux 6000 is a standalone device for continuous non-invasive transcutaneous monitoring. The document states it is "a modern transcutaneous oxygen/carbon dioxide monitor that meets the performance requirements." While it doesn't detail a specific "standalone study" with quantitative results beyond compliance with standards, its function is as a standalone measurement device. The performance claims are inherently for the algorithm/device itself.

7. The type of ground truth used:

For the technical and performance standards, the "ground truth" would be the defined specifications and test methods within the cited international consensus standards (e.g., IEC 60601-1, IEC 60601-2-23). The device's performance is measured against these established engineering and safety benchmarks.
For the physiological measurements (tcpO2/tcpCO2), traditional ground truth in such devices often involves comparison to arterial blood gas measurements, but the document does not specify if such a comparison was part of the "performance requirements" that were met.

8. The sample size for the training set:

This information is not applicable as the PeriFlux 6000 is a hardware monitor based on established physiological measurement principles (Clark sensor, Stow-Severinghaus-type sensor), not an AI/ML device that requires a "training set" in the conventional sense.

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

This information is not applicable for the same reason as point 8.

Summary

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Image: PERIMED logo	Document TypeResponse to Additional Information Requestfor K131253	Original Submission Date	Section-Page
		2013-04-26	6-2/6

PeriFlux 6000 - 510(k) Summary

Submitter's Name & Address

Perimed AB Datavägen 9A SE-175 43 Järfälla, Sweden Tel: (011) 46 8 580 119 90 い、 Fax: (011) 46 8 580 100 28 Official Correspondent: Maria Liljevret Contact Person for this submission: Maria Liljevret

OCT 2 2 2013

Date of Summary

The Summary was prepared 26th of April 2013 and revised 23th of October 2013.

Device Information

Trade name:	PeriFlux 6000
Type of product:	Finished product
Panel:	Anesthesiology

Common Name, Classification Name, Class & Classification Regulation:

Common Name	Classification Name	Class	Classification Regulation	Product Code
TranscutaneouspO2/pCO2monitoringsystem	Cutaneous carbondioxide (PcCO2)monitorCutaneous oxygen(PcO2) monitor	II	868.2480	LKD,LPP, KLK,

Predicate Device Information

Predicate Device No 1

Trade name:	TCM4 Monitoring System
510(k) No:	K043003
Type of product:	Finished product
Panel:	Anesthesiology

Common Name, Classification Name, Class & Classification Regulation:

Common Name	Classification Name	Class	Classification Regulation	Product Code
TranscutaneouspO2/pCO2/SpO2/pulse monitoringsystem	Cutaneous carbondioxide ( $PcCO_2$ ) monitor,Cutaneous oxygen( $PcO_2$ ) monitor	II	868.2480	LKD,LPP, KLK

://www.perimedianstrume

YOUR PARTNER IN MICROCIRCULATION 88

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PERIMED	Document TypeResponse to Additional Information Requestfor K131253
Original Submission Date	2013-04-26
Section-Page	6-3/6
Object Subject

| PeriFlux 6000 - 510(k) Summary

Predicate Device No 2

Trade name:	TCM400
510(k) No:	K001866
Type of product:	Finished product
Panel:	Anesthesiology

Common Name, Classification Name, Class & Classification Regulation:

Common Name	Classification Name	Clas	Classification Regulation	Product Code
TranscutaneouspO2 monitoringsystem	Cutaneous oxygen(PcO2) monitor	II	868.2500	LPP

Device Description

Intended Use of the Device

New device		Predicate Device No 1	Predicate Device No 2	Similar/Different*
Property	PeriFlux 6000	TCM4	TCM400
510(k) number	New submission	K043003	K001866	-
510(k) holder	Perimed AB	Radiometer	Radiometer	-
Intended use(Indicationsfor use, targetpopulation)	PeriFlux 6000 equippedwith PF 6040 is intendedfor continuous non-invasive transcutaneousmonitoring of the partialpressures of oxygen	The TCM4 MonitoringSystem is intended forcontinuoustranscutaneousmonitoring of oxygenand carbon dioxide	The TCM400 system isa device that uses up tosix non-invasiveelectrodes placed on thepatient's skin and that isintended to record	Similar
Object/SubjectPeriFlux 6000 - 510(k) Summary
	New device	Predicate Device No 1	Predicate Device No 2	Similar/Different*
Property	PeriFlux 6000	TCM4	TCM400
	and/or carbon dioxide. Itis intended for use onneonates, pediatrics, andadults not under gasanesthesia.	partial pressures. It isindicated for use onneonates, pediatrics,and adults not under gasanesthesia.	transcutaneous oxygenpartial pressures inadults not under gasanesthesia.
Environmentof use	In hospitalenvironment, laboratoryenvironment and inhospital intensive careunit environment.	In hospital/clinicalenvironment.	Unspecified	Similar
Measurementprinciple	Clark-type O₂ sensorStow-Severinghaus-type CO₂ sensor	Clark-type O₂ sensorStow-Severinghaus-type CO₂ sensor	Clark-type O₂ sensor	Similar
Maximumnumber ofelectrodes	8 electrodes	1 electrode	6 electrodes	Different
Acceptedelectrodemodels	Electrode E5250 is usedfor O₂ measurement.Electrode E5280 is usedfor combined O₂ andCO₂ measurement. Bothelectrodes aremanufactured andpackaged byRadiometer underRadiometer label.	Electrode E5280 orE5480 is used forcombined O₂ and CO₂measurement. ElectrodeE5260 is used for CO₂measurement. Allelectrodes aremanufactured andpackaged byRadiometer underRadiometer label.	Electrode E5250 is usedfor O₂ measurement.Electrode E5250 ismanufactured andpackaged byRadiometer underRadiometer label.	Similar
MeasurementRange	Combined electrode:tcpO₂: 0 - 800 mmHgtcpCO₂: 5 - 100 mmHgSingle tcpO₂ electrode:tcpO₂: 0 - 1999 mmHg	Combined electrode:tcpO₂: 0 - 800 mmHgtcpCO₂: 5 - 100 mmHgSingle tcpCO₂electrode:tcpCO₂: 5 - 100 mmHg	--Single tcpO₂ electrode:tcpO₂: 0 - 1999 mmHg-	Similar
SafetyStandards	IEC 60601-1:2005IEC 60601-1-2:2007IEC 60601-1-8:2006IEC 60601-2-23:2011	IEC 60601-1IEC 60601-1-2IEC 60601-1-4IEC 60601-1-8IEC 60601-2-23	IEC 60601-1IEC 60601-1-2IEC 60601-2-23	SimilarSimilarDifferentSimilarSimilar
PerformanceStandards/GuidanceDocument	IEC 60601-1-8:2006IEC 60601-2-23:2011	IEC 60601-1-8IEC 60601-2-23IEC 60601-3-1Special Controls	IEC 60601-2-23IEC 60601-3-1Special Controls	SimilarSimilarDifferentSimilar

Table of Device Similarities and Differences to Predicate Devices

ite: http://www.perimed-instrum

YOUR PARTNER IN MICROCIRCULATION 18

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** PERIMED

Document Type Original Submission Date Response to Additional Information Request 2013-04-26 for K131253

Perimed AB, Datavagen 9A, SE-175 43 Järfälla, Sweden

Tel: +48-8-680 119 90 Fax: +46-8-680 100 28 E-mail: mail@perimed.se Website: http://www.perimed-instruments.com

YOUR PARTNER IN MICROCIRCULATION &

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Image: PERIMED logo
Object/SubjectPeriFlux 6000 – 510(k) Summary
Property	New devicePeriFlux 6000	Predicate Device No 1TCM4	Predicate Device No 2TCM400	Similar/Different*
	Cutaneous CarbonDioxide (tcpCO2) andOxygen (tcpO2)Monitors; Guidance forIndustry and FDA, 2002	Cutaneous CarbonDioxide (tcpCO2) andOxygen (tcpO2)Monitors; Guidance forIndustry and FDA, 2002	Cutaneous CarbonDioxide (tcpCO2) andOxygen (tcpO2)Monitors; Guidance forIndustry and FDA, 2002

Similar is stated for a property when the table clearly shows a significant similarity between the new device and either both the predicate devices or one of the two predicate devices. Different is stated when a justification is needed for claiming equivalency.

Summary of Technological Characteristics of Device and Predicate Device

The new device has the same overall design and size as the predicate devices. The intended use of the new device is a combination of both predicate devices. The new device uses the same measuring technology as the predicate devices, a Clark sensor (tcpO2) and a Stow-Severinghaus-type sensor (tcpCO2). Electrodes of the same brand and model as for the predicate devices are used with the new device, E5250 (tcpO2) and E5280 (tcpO2/tcpCO2) manufactured and packaged by Radiometer under Radiometer label. As a consequence, both the pressure measurements and temperature ranges of the electrodes are identical for the new device as the predicate devices. The new device can employ a combination of up to eight electrodes, contrary to the predicate devices (one electrode for TCM4 and six electrodes for TCM400). Both the new device and the predicate devices contain alarm functionality that includes both technical and physiological alarms.

Summary of Safety and Performance Tests

To ensure that the new device, PeriFlux 6000 equipped with PF 6040, is safe and effective for its intended use, it has been tested to the requirements of the Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (1cpCO2) and Oxygen (tcp()2) Monitors: Guidance for Industry and FDA (December 13, 2002), as well as the following international consensus standards:

. IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
IEC 60601-2-23:2011

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PeriFlux 6000 - 510(k) Summary

Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

. IEC 60601-1-8:2006
General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

A detailed analysis of the fulfilled safety and performance standards between the new device and the predicate devices show that the new device fulfills the same safety and performance requirements as the predicate devices, with the following iustification: Standard IEC 60601-1-4 has been included in the updated version of standard IEC 60601-1:2005, and standard IEC 60601-3-1 has been included in the updated version of standard IEC 60601-2-23:2011, both of which the new device has been tested against and fully complies with.

Conclusions

Ohiect/Subject

The results of the safety and performance testing show that the PeriFlux 6000, equipped with PF 6040, is a modern transcutaneous oxygen/carbon dioxide monitor that meets the performance requirements and is equipped with the required safety mechanisms. Further, the analysis fully justifies substantial equivalence to both predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

October 22, 2013

Perimed AB Maria Liljevret Quality Assurance and Regulatory Affairs Manager Datavagen 9A SE-175 43 Jarfalla. Sweden

Re: K131253

Trade/Device Name: PeriFlux System 6000 Regulation Number: 21 CFR 868.2480 Regulation Name: Cutaneous Carbon Dioxide (P.CO2) Monitor Regulatory Class: Class II Product Code: LKD, KLK, LPP Dated: September 20, 2013 Received: September 23. 2013

Dear Ms. Liljevret:

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 - Ms. Liljevret

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

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Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Document Type Submission Date Section-Page Abbreviated 510(k) Notification 2013-04-26 5-2/2 ct/Subject

PeriFlux 6000 - Indications for Use

Indications for Use

510(k) Number (if known): _K131253

Device Name:

PeriFlux 6000

Indications for Use:

PeriFlux 6000 cquipped with PF 6040 is intended for continuous non-invasive transcutaneous monitoring of the partial pressures of oxygen and/or carbon dioxide. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia.

Prescription Use Yes (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No (21 CFR 801 Subpart C)

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

COMPANY CONFIDENTIAL

Regulation Number and Section

§ 868.2480 Cutaneous carbon dioxide (PcCO2) monitor.

(a)
Identification. A cutaneous carbon dioxide (PcCO2) monitor is a noninvasive heated sensor and a pH-sensitive glass electrode placed on a patient's skin, which is intended to monitor relative changes in a hemodynamically stable patient's cutaneous carbon dioxide tension as an adjunct to arterial carbon dioxide tension measurement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document.