Who is the manufacturer of PERIFLUX 6000?

Perimed AB filed the 510(k) submission for PERIFLUX 6000 (K131253).

What is the FDA product code for PERIFLUX 6000?

LKD. It is classified under 21 CFR 868.2480 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for PERIFLUX 6000?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for PERIFLUX 6000?

TCM4 Monitoring System (K043003); TCM400 (K001866).

Who can help prepare an FDA 510(k) submission like PERIFLUX 6000?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PERIFLUX 6000

K131253 · Perimed AB · LKD · Oct 22, 2013 · Anesthesiology

Device Facts

Record ID	K131253
Device Name	PERIFLUX 6000
Applicant	Perimed AB
Product Code	LKD · Anesthesiology
Decision Date	Oct 22, 2013
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 868.2480
Device Class	Class 2
Attributes	Pediatric

Indications for Use

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 Story

PeriFlux 6000 is a transcutaneous oxygen/carbon dioxide (tcpO2/tcpCO2) monitor; consists of main unit (PF 6001) and up to 8 function units (PF 6040). Uses Clark-type sensors (E5250 for O2) and combined Clark/Stow-Severinghaus-type sensors (E5280 for O2/CO2). Electrodes are applied to patient skin and heated to increase permeability for gas diffusion. Operated via touch screen interface; records, analyzes, and reports tcpO2 and tcpCO2 values. Used in hospital, laboratory, and intensive care environments by clinicians. Provides continuous monitoring to assist in clinical assessment of patient oxygenation and ventilation status; includes technical and physiological alarm functionality.

Clinical Evidence

Bench testing only. Device tested against Class II Special Controls Guidance Document for Cutaneous Carbon Dioxide (tcpCO2) and Oxygen (tcpO2) Monitors and international consensus standards (IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-23).

Technological Characteristics

Main unit PF 6001 with up to 8 PF 6040 function units. Sensors: Clark-type (O2) and Stow-Severinghaus-type (CO2). Electrodes: E5250 (O2), E5280 (O2/CO2). Heated electrode interface for gas diffusion. Touch screen UI. Standards: IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-8:2006, IEC 60601-2-23:2011.

Indications for Use

Indicated for continuous non-invasive transcutaneous monitoring of partial pressures of oxygen and/or carbon dioxide in neonates, pediatrics, and adults not under gas anesthesia.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

TCM4 Monitoring System (K043003)
TCM400 (K001866)

Submission Summary (Full Text)

{0}------------------------------------------------ | Image: PERIMED logo | Document Type Response to Additional Information Request for 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 | |----------------------------------------------------|--------------------------------------------------------------------------------------|-------|---------------------------|-------------------| | Transcutaneous pO2/pCO2 monitoring system | Cutaneous carbon dioxide (PcCO2) monitor Cutaneous 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 | |----------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------|---------------------------|------------------| | Transcutaneous pO2/pCO2/SpO2/ pulse monitoring system | Cutaneous carbon dioxide ( $PcCO_2$ ) monitor, Cutaneous oxygen ( $PcO_2$ ) monitor | II | 868.2480 | LKD, LPP, KLK | ://www.perimedianstrume YOUR PARTNER IN MICROCIRCULATION 88 {1}------------------------------------------------ | PERIMED | Document Type Response to Additional Information Request for 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 | |--------------------------------------------|------------------------------------|------|---------------------------|--------------| | Transcutaneous pO2 monitoring system | Cutaneous oxygen (PcO2) monitor | II | 868.2500 | LPP | # 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. # Intended Use of the Device 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. | 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 (Indications for use, target population) | PeriFlux 6000 equipped with PF 6040 is intended for continuous non- invasive transcutaneous monitoring of the partial pressures of oxygen | The TCM4 Monitoring System is intended for continuous transcutaneous monitoring of oxygen and carbon dioxide | The TCM400 system is a device that uses up to six non-invasive electrodes placed on the patient's skin and that is intended to record | Similar | | Object/Subject PeriFlux 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. It is intended for use on neonates, pediatrics, and adults not under gas anesthesia. | partial pressures. It is indicated for use on neonates, pediatrics, and adults not under gas anesthesia. | transcutaneous oxygen partial pressures in adults not under gas anesthesia. | | | Environment of use | In hospital environment, laboratory environment and in hospital intensive care unit environment. | In hospital/clinical environment. | Unspecified | Similar | | Measurement principle | Clark-type O₂ sensor Stow-Severinghaus- type CO₂ sensor | Clark-type O₂ sensor Stow-Severinghaus- type CO₂ sensor | Clark-type O₂ sensor | Similar | | Maximum number of electrodes | 8 electrodes | 1 electrode | 6 electrodes | Different | | Accepted electrode models | Electrode E5250 is used for O₂ measurement. Electrode E5280 is used for combined O₂ and CO₂ measurement. Both electrodes are manufactured and packaged by Radiometer under Radiometer label. | Electrode E5280 or E5480 is used for combined O₂ and CO₂ measurement. Electrode E5260 is used for CO₂ measurement. All electrodes are manufactured and packaged by Radiometer under Radiometer label. | Electrode E5250 is used for O₂ measurement. Electrode E5250 is manufactured and packaged by Radiometer under Radiometer label. | Similar | | Measurement Range | Combined electrode: tcpO₂: 0 - 800 mmHg tcpCO₂: 5 - 100 mmHg Single tcpO₂ electrode: tcpO₂: 0 - 1999 mmHg | Combined electrode: tcpO₂: 0 - 800 mmHg tcpCO₂: 5 - 100 mmHg Single tcpCO₂ electrode: tcpCO₂: 5 - 100 mmHg | - - Single tcpO₂ electrode: tcpO₂: 0 - 1999 mmHg - | Similar | | Safety Standards | IEC 60601-1:2005 IEC 60601-1-2:2007 IEC 60601-1-8:2006 IEC 60601-2-23:2011 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-1-8 IEC 60601-2-23 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-23 | Similar Similar Different Similar Similar | | Performance Standards/ Guidance Document | IEC 60601-1-8:2006 IEC 60601-2-23:2011 | IEC 60601-1-8 IEC 60601-2-23 IEC 60601-3-1 Special Controls | IEC 60601-2-23 IEC 60601-3-1 Special Controls | Similar Similar Different Similar | Table of Device Similarities and Differences to Predicate Devices ite: http://www.perimed-instrum YOUR PARTNER IN MICROCIRCULATION 18 {2}------------------------------------------------ ** 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 & {3}------------------------------------------------ | Image: PERIMED logo | | | | | Document Type Response to Additional Information Request for K131253 | Original Submission Date 2013-04-26 | Section-Page 6-5/6 | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------|----------------------------------------------------------------------------|----------------------------------------|-----------------------| | Object/Subject PeriFlux 6000 – 510(k) Summary | | | | | | | | | Property | New device PeriFlux 6000 | Predicate Device No 1 TCM4 | Predicate Device No 2 TCM400 | Similar/ Different* | | | | | | Cutaneous Carbon Dioxide (tcpCO2) and Oxygen (tcpO2) Monitors; Guidance for Industry and FDA, 2002 | Cutaneous Carbon Dioxide (tcpCO2) and Oxygen (tcpO2) Monitors; Guidance for Industry and FDA, 2002 | Cutaneous Carbon Dioxide (tcpCO2) and Oxygen (tcpO2) Monitors; Guidance for Industry 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 Image /page/3/Picture/11 description: The image shows the letters 'ION' in bold, black font. To the right of the letters is a cluster of seven black circles arranged in a hexagonal pattern. The circles are closely packed together, forming a compact shape. {4}------------------------------------------------ #### 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. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. #### 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. {6}------------------------------------------------ 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. Image /page/6/Picture/7 description: The image shows a signature followed by the text "Sincerely yours,". Below the signature is the name "Tejashri Purohit-Sheth, M.D.", followed by "Clinical Deputy Director" and "DAGRID". The word "FOR" is at the bottom right of the image. 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 {7}------------------------------------------------ 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

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