(185 days)
When installed in the Periflux System 5000, the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is intended to monitor the levels of oxygen and/or carbon dioxide from tissue transcutaneously. The unit provides continuous, non-invasive monitoring of cutaneous oxygen and carbon dioxide.
The Periflux System 5000 with the pO₂/pCO₂ module is intended to be used in hospitals and facility offices. It is intended to monitor transcutaneous pCO₂ in adults and pO₂ in infants not under gas anesthesia. The system is not intended for use by patients without the supervision of a physician.
The Transcutaneous PO₂ and PCO₂ Monitor (PF5040) is a modular unit which can be installed in the Periflux System 5000 transcutaneous monitoring system. Patient monitoring is accomplished by the application of an electrode to specific sites on the patient after calibration of the unit.
The Periflux System 5000 is a multi-channel, multi-function system capable of hosting several function units including: the Modular Laser Doppler system for blood perfusion and the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) for monitoring oxygen and/or carbon dioxide levels. The Periflux system 5000 can accommodate up to four different function units enabling different types of simultaneous measurements.
The provided document is a 510(k) Summary of Safety and Effectiveness Data for the Perimed Transcutaneous PO₂ and PCO₂ Monitor (PF5040). It details the device's general information, a brief description, its intended use, and a comparison to a predicate device. Importantly, it mentions testing was performed to demonstrate the safety and performance characteristics and that the device met test requirements and performed in accordance with applicable standards. However, it does not explicitly detail the acceptance criteria or the specifics of the study that proves the device meets those criteria.
Therefore, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text. The document refers generally to "test requirements" and "applicable standards." | "The testing demonstrated that the Transcutaneous PO₂ and PCO₂ Monitor (PF5040) met test requirements and performed in accordance with applicable standards." (Specific performance metrics are not provided.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not specified in the provided text. The document refers to "testing" but does not describe the methodology for establishing ground truth or the involvement of experts in that process.
4. Adjudication Method for the Test Set:
- Not specified in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size Improvements:
- Not mentioned or implied in the provided text. The document focuses on demonstrating the device's performance against "test requirements" and "applicable standards," not comparative effectiveness with human readers or AI assistance.
6. If a Standalone Performance Study was done:
- The text states, "Testing was performed to demonstrate the safety and performance characteristics of the Transcutaneous PO₂ and PCO₂ Monitor (PF5040)." This implies a standalone performance evaluation of the device itself. However, it does not explicitly use the term "standalone study" in the context of an algorithm's performance only without human in the loop. Given the nature of a medical monitoring device, the "device" performance is inherently standalone in its measurement function.
7. Type of Ground Truth Used:
- Not specified in the provided text. The nature of transcutaneous monitoring suggests comparison with a reference standard for blood gas measurements, but this is not explicitly stated.
8. Sample Size for the Training Set:
- Not applicable/mentioned. This device is a monitor, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable/mentioned, as it is not an AI/machine learning algorithm.
Summary of what is present:
The document states that the device was tested to demonstrate its safety and performance and that it met test requirements and applicable standards. It establishes substantial equivalence to a predicate device, the Novametrix TCO₂M Transcutaneous O₂/CO₂ Monitor, based on similar indications for use, measurement principles, and output ranges. However, specific quantitative acceptance criteria or detailed study results are not included in this summary. The FDA's letter indicates clearance for marketing based on this summary.
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| Transcutaneous PO₂ and PCO₂ Monitor (PF5040) | |
|---|---|
| Perimed, Inc. | Appendix VII, 510(k) Summary of Safety and Effectiveness Data |
| 510(k) Premarket Notification | Page 1 of 2 |
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I. General Information
| A. | Submitted By: | Perimed, Inc.821 West Jericho Turnpike, Suite ASmithtown, NY 11787 |
|---|---|---|
| Contact Person: | Kjell Bakken | |
| B. | Device Trade Name: | Perimed Transcutaneous PO₂ and PCO₂ Monitor (PF5040) |
| Common Name: | Transcutaneous Oxygen/Carbon Dioxide Monitor | |
| Classification Name: | 868.2500, Monitor, Oxygen, Cutaneous, for Infant notunder Gas Anesthesia868.2500, Monitor, Oxygen, Cutaneous, for Use Other thanfor Infant not under Gas Anesthesia868.2480, Monitor Carbon Dioxide, Cutaneous | |
| C. | Predicate Device: | Novametrix TCO₂M Transcutaneous O₂/CO₂ Monitor |
Device Description: D.
The Transcutaneous PO2 and PCO2 Monitor (PF5040) is a modular unit which can be installed in the Periflux System 5000 transcutaneous monitoring system. Patient monitoring is accomplished by the application of an electrode to specific sites on the patient after calibration of the unit.
The Periflux System 5000 is a multi-channel, multi-function system capable of hosting several function units including: the Modular Laser Doppler system for blood perfusion and the Transcutaneous PO2 and PCO2 Monitor (PF5040) for monitoring oxygen and/or carbon dioxide levels. The Periflux system 5000 can accommodate up to four different function units enabling different types of simultaneous measurements.
- E. Indications for Use:
When installed in the Periflux System 5000, the Transcutaneous PO2 and PCO2
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Monitor (PF5040) is intended to monitor the levels of oxygen and/or carbon Monitor (PF5040) is intended to monitor the reveals of - - 90
dioxide from tissue transcutaneously. The unit provides continuous, non-invasive
s and issue transcutaneously. monitoring of cutaneous oxygen and carbon dioxide.
-
Technological Comparison: F.
The Novametrix TCO₂M Transcutaneous Monitor has the same indications for The Novametrix TCO2M Transcutaneous PO2 and PCO2 Monitor (PF5040) in that both
use as the Perimed Transcutaneous PO2 and PCO2 extenseutaneous oxygen and carbon use as the Perimed Transculancous 1 O2 and 1 O2 museus oxygen and carbon measure and display continuous, noninvasive attached to the patient. They utilize
dioxide levels using O2/CO2 electrode sensors attached to the connected to dioxide levels using Oz/CO2 elections arable output ranges. Both can be connected to similar types of display and comparabit output rialiges. External Governmerature when monitoring PCO2. -
Testing II.
Testing was performed to demonstrate the safety and performance characteristics of the Testing was performed to demonsulate the sales and perseting demonstrated that the Transcutaneous PO2 and PCO2 Monitor (11 5010). The seems
device met test requirements and performed in accordance with applicable standards.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1999
Mr. Kjell Bakken Perimed, Inc. 4873 Princeton Drive North Royalton, OH 44133
K990960 Re : Perimed Transcutaneous p02/pCO2 Monitor Regulatory Class: II (two) 73 LKD and 73 KLK Product Code: Dated: June 23, 1999 Received: June 25, 1999
Dear Mr. Bakken:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Kjell Bakken
This letter will allow you to begin marketing your device as described This letter will allow you to begin marketing your association of substantial
in your 510(k) premarket notification. The FDA finding of sebstantial in your 510(k) premarket notification. The assn beeing to be equivalence of your device to a legarly markets prom
results in a classification for your device and thus, permits your commits your device to proceed to the market.
If you desire specific advice for your device on our labeling
If you desire and additionally 809.10 for in vi If you desire specific advice for your dellow 809.10 for in vitro
regulation (21 CFR Part 801 and additionally 809.10 for in vitance at regulation (21 CFR Part 801 and address of Compliance at
diagnostic devices), please contact the office of Compliance a diagnostic devices), please contact the office of com-tion and (301) 594–4648. Additionally, for quescions on Efic promoted on
advertising of your device, please contact the Office of Compliance at
s and 1991 and and annone photo pote t advertising of your device, prease the regulation entitled, (301) 594-4639. Also, please note the regulaces. Services (21 CFR 807.97).
"Misbranding by reference to premarket notification" (21 CFR 807.97). "Misbranding by reference to premarket noter the Act may
Other general information on your responsibilities under the Act may Other general information of Small Manufacturers Assistance at its be obtained from the Division of Sila1 Manufacturer (18)
toll-free number (800) 638–2041 or (301) 443–6597, or at its internet (1 toll-free number (600) 050 2011 05 mm == == == == == == = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Sincerely yours,
Sincerely, yours,
Thomas J. Callahan
allahan, Ph.D. Thomas J. C Director Division of Cardiovascular, Vision of Carant Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K9909600
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040) Device Name:
Perimed, Inc. Sponsor Name:
Indications for Use:
When installed in the Periflux System 5000, the Transcutaneous pO2/pCO2 Monitor (PF5040) is When installed in the refinal System 3000, the From tissue transculatedusly. The pO2 monitor is intended only for use with infants not under gas anesthesia. The unit provides pon inomics in intended only for the of cutaneous oxygen and carbon dioxide.
The Periflux System 5000 with the pO2/pCO2 module is intended to be used in hopitals and I he rectility offices. It is intended to monitor transcutancous pCO2 in adults and intended without gas anesthesia and pO2 in infants not under gas anesthesia. The system is not intended for use by patients without the supervision of a physician.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over the Counter Use
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K990960
§ 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.