(195 days)
The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.
The PeriFlux System 5000 Modular Laser Doppler Flowmeter System 5000 consists of a PF 5001 Main Unit, which can accommodate up to four Function Units. The first available Function Unit is the PF 5010 LDPM (Laser Doppler Perfusion Monitor) Unit. A PF 5990 Blank Panel takes the place of a Function Unit if less than four Units are required. Probes are attached to collect the information, which is analysed, using the PeriSoft analysis program.
Here's an analysis of the provided text regarding the PeriFlux System 5000 Modular Laser Doppler Flowmeter, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary letter from the FDA. It does not contain detailed information about specific acceptance criteria, study designs, or performance metrics. It primarily establishes substantial equivalence to a predicate device. Therefore, many of the requested details cannot be extracted directly from this document.
1. Table of Acceptance Criteria and Reported Device Performance
As the provided document is a 510(k) summary for substantial equivalence, it does not specify explicit acceptance criteria or report detailed device performance metrics in the way a clinical study report would. The primary "acceptance criterion" met here is the FDA's determination of substantial equivalence to the predicate device, the PeriFlux System 4000. This implies that the performance characteristics are considered comparable.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Substantial Equivalence to Predicate Device (PeriFlux System 4000) | Technological Characteristics: "The technology is the same but the design has been modified to simplify use... and allow customers to more easily choose the number of channels they need." |
| Functionality: "The PeriFlux System 5000 presents only Perfusion and TB (CMBC and Velocity are measured by the instrument to calculate Perfusion)." (Predicate presented CMBC and Velocity directly) | |
| Probe Compatibility: "The probes... are identical in every way with those used for the PeriFlux System 4000 laser Doppler Flowmeter - they are interchangeable between the two systems." | |
| Safety | Implicitly deemed safe through substantial equivalence to a legally marketed device and compliance with general controls. |
| Effectiveness | Implicitly deemed effective for its stated intended use through substantial equivalence to a legally marketed device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document focuses on technological comparison rather than a formal clinical or performance testing study with a defined test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. As there's no mention of a formal clinical test set or ground truth establishment, this detail is absent.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study is present in this 510(k) summary. Given the nature of the device (a Laser Doppler Flowmeter measuring microvascular perfusion, not an imaging diagnostic device that typically involves human interpretation), such a study would be highly unlikely and generally not relevant for this type of device.
6. Standalone (Algorithm Only) Performance Study
This is not applicable and not mentioned. The PeriFlux System 5000 is a measurement device, not an algorithm that operates independently without human interaction or a physical sensor. Its "performance" would relate to the accuracy and precision of its measurements, not to algorithm-only operation in the context of interpretation.
7. Type of Ground Truth Used
Given that this is a 510(k) submission primarily focused on demonstrating substantial equivalence based on technological characteristics and intended use, there is no explicit mention of a 'ground truth' in the context of a performance study. For a measurement device like a flowmeter, "ground truth" would typically refer to a validated reference method for measuring microvascular perfusion against which the device's measurements are compared for accuracy and precision. This document does not detail such a comparison study.
8. Sample Size for the Training Set
This information is not provided. Laser Doppler Flowmeters are typically based on established physical principles for blood flow measurement, not on machine learning algorithms that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as the device does not appear to be an AI/ML-based system requiring a training set with established ground truth.
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Section 2: 510(k) Summary or Statement
2.1. 510(k) Summary
PERIMED
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Laser Doppler Flowmeter (Blood Flow Meter).
PeriFlux System 5000 Modular Laser Doppler Flowmeter,
including: PF 5001 Main Unit, PF 5010 LDPM Unit, PF 5990 Blank Panel", PeriSoft
PeriFlux PF 4001 Laser Doppler Flowmeter: K 922368, plus additional
PeriFlux System 5000 Modular Laser Doppler Flowmeter System 5000
consists of a PF 5001 Main Unit, which can accommodate up to four Function Units. The first available Function Unit is the PF 5010 LDPM (Laser Doppler Perfusion Monitor) Unit. A PF 5990 Blank Panel takes the place of a Function Unit if less than four Units are required. Probes are attached to collect the information, which is analysed, using the PeriSoft
Assigned 510(k) no .:
Kjell Bakken*, President, Perimed Inc and Perimed AB. Applicant/Contact:
Address Perimed Inc 821 West Jericho Turnpike, Suite A Smithtown New York 11787 USA Phone: 1-516-543 0881 Fax: 1-516-543 08 93
Perimed AB Datavägen 9 A, Box 564 S-175 26 Järfälla, Stockholm Sweden Tel: +46-8-580 119 90 Fax: +46-8-580 100 28 e-mail: mail@perimed.se
Date Prepared:
20/10/97
probes: K935495.
analysis program.
Laser Doppler Flowmeter
Analysis Software and 400-series Probes.
Classification Name: Common/Usual Name: Trade/Proprietary Name:
Predicate Device:
Device description:
Intended Use:
The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.
Summary of the technological characteristics of the PeriFlux System 5000 compared with the PeriFlux System 4000:
The PeriFlux System 5000 Modular Laser Doppler Flowmeter is developed directly from the PeriFlux System 4000. The technology is the same but the design has been modified to simplify use of the instrument and allow customers to more easily choose the number of channels they need. Whereas the PeriFlux System 4000 presented the parameters Perfusion, CMBC (Concentration of Moving Blood Cells), Velocity and TB (Total Backscatter) to the user the PeriFlux System 5000 presents only Perfusion and TB (CMBC and Velocity are measured by the instrument to calculate Perfusion). The probes which are used with the PF 5010 LDPM Unit are identical in every way with those used for the PeriFlux System 4000 laser Doppler Flowmeter - they are interchangeable between the two systems.
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MAY 28 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kjell Bakken President Perimed, Inc. 821 West Jericho Turnpike Suite A Smithtown, NY 11787
Re: K974285 PeriFlux System 5000 Modular Laser Doppler Flowmeter Requlatory Class: II (Two) Product Code: DPW Dated: May 2, 1998 May 7, 1998 Received:
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 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 Requlations, 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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements 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 in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html. "
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K974285 |
|---|---|
| Device Name: | Peri Flux System 5000 |
Indications For Use:
The PeriFlux System 5000 is indicated for use in measuring microvascular perfusion, in skin and muscle, in humans. It is also indicated for use in measuring microvascular perfusion in all tissues in animals.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
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Spee
Division of Cardiovascular, Respiratory, and Neurological Devices < 91428 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-9(
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).