(173 days)
No
The document describes a standard transcutaneous gas monitor using established sensor technology and does not mention any AI or ML components or capabilities.
No.
The device is a monitoring device that measures partial pressures of oxygen and carbon dioxide, rather than providing or delivering any therapy.
Yes
Explanation: The device is intended for continuous non-invasive transcutaneous monitoring of partial pressures of oxygen and/or carbon dioxide for diagnostic purposes. It measures physiological parameters (tcpO2/CO2 values) to provide information that can be used to identify current or potential health problems.
No
The device description explicitly states it consists of a "main unit, PF 6001," "PF 6040 function units," and "electrodes E5250 or E5280," which are physical hardware components.
Based on the provided information, the PeriFlux 6000 equipped with PF 6040 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential transfusions, or to monitor therapeutic measures.
- PeriFlux 6000 Function: The PeriFlux 6000 measures the partial pressures of oxygen and carbon dioxide transcutaneously, meaning through the skin. It does not analyze specimens taken from the body.
- Direct Measurement: The device directly measures gases diffusing through the skin into a sensor applied to the patient's surface. This is a non-invasive, in vivo measurement, not an in vitro analysis of a specimen.
Therefore, the PeriFlux 6000 falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
LKD, KLK, 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 tcpO2 and tcpCO2 values.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates, pediatrics, and adults
Intended User / Care Setting
In hospital environment, laboratory environment and in hospital intensive care unit environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (tcpCO2) and Oxygen (tcpO2) 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 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 |
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
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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.
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.
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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
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)
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