The PeriCam PSI is intended for non-invasive two-dimensional imaging of peripheral tissue blood perfusion. This can be used in a wide range of applications and disciplines including dermatology, wound healing, burns assessment etc.

Device Description

The PeriCam PSI is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using Laser Speckle contrast analysis. The full measurement area surface is illuminated with a laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate high resolution color code images showing the blood perfusion in the tissue.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PeriCam PSI device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or a threshold for "similar response"). Instead, the acceptance criteria are implicitly defined by the concept of "substantial equivalence" to predicate devices. The performance data focuses on demonstrating this equivalence through comparative studies.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to PIM Laser Doppler Perfusion Imager (K920844) in Measurement Response	"Several comparative studies of the new device and the predicate device have been performed to show, the substantial equivalence of the two devices. These include absolute measurements as well relative response to provocations such as heating and occlusion. It can be seen that the response is very similar between the two devices for the intended use of the instruments. It can thus be concluded that the two devices show substantial equivalence." The text emphasizes that while the techniques (LASCA vs. Laser Doppler) are different, their integration times can be selected to give "similar response to flow changes for the relevant measurement objects."
Improved Laser Safety compared to PIM Laser Doppler Perfusion Imager (K920844)	PeriCam PSI is classified as a Class 1 laser product (IEC 60825-1:2007), which is considered safe for long-term intra-beam viewing. The predicate PIM Laser Doppler is Class 2 (IEC 60825-1:1993+A1:1997+A2:2001), for which staring into the beam must be avoided. The new device is therefore "safer" due to a wider, homogenous light distribution despite higher total laser radiation.
Faster Acquisition Rate compared to PIM Laser Doppler Perfusion Imager (K920844)	PeriCam PSI has a frame-rate of up to 100 fps for a complete flowmap. The predicate PIM Laser Doppler takes "minutes" for larger areas due to sequential measurement. This is described as a "huge advantage."
Substantial Equivalence to moorFLPI Full Field Laser Perfusion Imager (K063586) in Measurement Effectiveness	"From the description of the technological character stics it can be concluded that the PeriCam PSI and the moorFLPI Full Field Laser Perfusion Imager are equally effective in measuring tissue perfusion. The two devices measure using the same fundamental property of reduction of the speckle contrast from blurring caused by moving objects. Thus it can be concluded that the PeriCam PSI show substantial equivalence to the moorFLPI Full Field Laser Perfusion Imager in terms of the measurement effectiveness." The text notes both use a wide divergent NIR laser beam and share "approximately the same areas and acquisition rates."
Equivalent Laser Safety compared to moorFLPI Full Field Laser Perfusion Imager (K063586)	Both devices are classified as Class 1 laser products (PeriCam PSI: IEC 60825-1:2007; moorFLPI: IEC 60825-1:2001). "Since both instruments are assigned to laser Class 1 there are no limitations to safe use of the instruments. There is not considered to be any hazard in using the instruments." Therefore, "the hazard of using the two instruments is identical."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document repeatedly mentions "Several comparative studies" and "comparative studies" but does not specify the sample size (number of subjects, measurements, or data points) for these studies.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that the manufacturer is Swedish (Perimed AB, Järfälla, Sweden) and the predicate device is also mentioned as being from Perimed (PIM 3 Laser Doppler Perfusion Imager PIM 3), it's highly probable the studies were conducted by the manufacturer, likely in Sweden or a related research setting. The nature of the studies (comparative performance with provocations) suggests prospective data collection in a controlled environment. However, this is an inference, not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The concept of "ground truth" as it's typically understood in diagnostic AI (e.g., pathology, clinical outcome data) is not directly applicable here. This submission is for a medical device (PeriCam PSI) that measures physiological parameters (blood perfusion), not for a diagnostic algorithm that interprets images for disease.

The "ground truth" in this context is the actual blood perfusion measurement from an established, substantially equivalent device. The comparative studies aim to show that the new device's readings match those of the predicate device under various conditions. Therefore, there's no mention of experts establishing a separate "ground truth" to which the device readings are compared. The predicate device itself acts as the reference.

4. Adjudication Method for the Test Set

Not applicable. As described above, the studies involve direct comparison of measurements between devices, not adjudication of interpretations by human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document describes comparative studies of the new device against predicate devices to demonstrate substantial equivalence in measurement output, not a study of human readers using the device.

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

Yes, the studies described are inherently "standalone" in the sense that they evaluate the device's measurement performance (algorithm + hardware) directly against predicate devices. The PeriCam PSI is a measurement device that generates color-coded flow maps; its performance is evaluated based on the similarity of these measurements to existing technology, not on human interpretation of the output.

7. The Type of Ground Truth Used

The "ground truth" is established by the measurements from the predicate device(s) (PIM Laser Doppler Perfusion Imager K920844, and implicitly moorFLPI Full Field Laser Perfusion Imager K063586). The studies directly compared the absolute measurements and relative responses to provocations (heating, occlusion) between the PeriCam PSI and the predicate device.

8. The Sample Size for the Training Set

Not applicable. The PeriCam PSI is a measurement device based on physical principles (Laser Speckle Contrast Analysis), not a machine learning algorithm that requires a "training set" in the conventional sense. Its "training" or calibration would involve ensuring the physical parameters and algorithms are correctly implemented to yield accurate and consistent measurements, not learning from a labeled dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of a machine learning algorithm. The device's underlying physics and algorithms are designed based on established scientific principles for measuring blood perfusion.

Summary

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	K120884
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	PERIMED
Document Type	Traditional 510(k) Notification	Submission Date	2012-03-15	Section-Page	5-1/5
Object/Subject	PeriCam PSI - 510(k) Summary

JUL 3 2012

Section 5-

510(k) Summary

Perimed AB, Datavägen 9A, SE-175 43 Järfälla, Sweden Tel: +46-8-680 119 90 Fax: +46-8-580 100 28 E-mail: mail@perimed_se Website: http://www.perimed-instruments.com

YOUR PARTNER IN MICROCIRCULATION

・

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	Document TypeTraditional 510(k) Notification	Submission Date2012-03-15	Section-Page5-2/5
Object/SubjectPeriCam PSI - 510{k) Summary

Submitter's Name & Address
Perimed AB
Datavägen 9A
SE-175 43 Järfälla, Sweden
Tel: (011) 46 8 580 119 90
Fax: (011) 46 8 580 100 28
	Official Correspondent: Maria Liljevret
	Contact Person for this submission: Maria Liljevret
Date of Summary
	The Summary was prepared 15th of March 2012.

Device Information
Trade name:	PeriCam PSI
Model No:	PeriCam PSI NR, PeriCam PSI HR
Type of product:	Finished product
Panel:	Cardiovascular
	Common Name, Classification Name, Class & Classification Regulation:

Common Name	Sant Ave Andrew And Andrew Sales of American	Classification Name Class Classification Regulation Product Code
	Blood Perfusion Cardios ascular blood H	870.2100	IDPW
Imager	flow meter

Predicate Device Information

Predicate Device No 1
Trade name:	PIM 3 Laser Doppler Perfusion Imager
Model No:	PIM 3
510(k) No:	K920844
Type of product:	Finished product
Panel:	Cardiovascular

Common Name, Classification Name, Class & Classification Regulation.

Common Name	Classification Name	Class	Classification Regulation	Product Code
Blood PerfusionImager	Cardiovascular bloodflowmeter	II	870.2100	DPW

Predicate Device No 2

Trade name:	moorFLPI Full-Field Laser Perfusion Imager
Model No:	moorFLPI Full-Field Laser Perfusion Imager
510(k) No:	K063586
Type of product:	Finished product
Panel:	Cardiovascular

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

Tel: +46-8-580 119 90 Fax: +46-8-680 100 28 E-mail: mail@perimed.se Website: http://www.perimed-instruments.com

258 YOUR PARTNER IN MICROCIRCULATION

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	*** PERIMED
Document Type	Traditional 510(k) Notification
Submission Date	2012-03-15
Section-Page	5-3/5
Object/Subject

PeriCam PSI - 510(k) Summary

		Common Name, Classification Name, Class & Classification Regulation:------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Common Name	Classification Name	Class	Classification Regulation	Product Code
Full-Field LaserPerfusionImager	Probe, Blood-flow,Extravascular	II	870.21:20	DPT

Device Description (for detailed description see Section 11)

Intended Use of the Device

Summary of technological characteristics of Device and Predicate Device

The new device, PeriCam PSI, illuminates tissue with infra-red laser light. An extended area of the tissue is illuminated using a wide diverging laser beam with homogenous light distribution. The reemitted laser light is imaged using a camera. An interference pattern called speckle pattern is generated in the camera image. The camera image is integrated over a finite exposure time. From the timeintegrated images the contrast is calculated as the standard deviation of the intensity-values divided by the mean. For a static measurement object the speckle pattern is constant in time and the contrast over the integrated images will be high. For a dynamic measurement object the speckle pattern will move over time and the contrast will be reduced due to blurring as the speckle pattern is redistributed between the camera-pixels over the integration-time.

Since the measurement laser is invisible a visible laser is also used in the system to indicate the measurement area by generating a visible line surrounding the illuminated area.

The camera images are acquired at video rates in real-time by a PC-software. This PC-software generates colour-coded flow maps of the tissue perfusion from the contrast images.

Comparison to the predicate device K920844, PIM Laser Doppler Perfusion Imager

Laser safety

The predicate device, PIM Laser Doppler Perfusion Imager, employs a collimated narrow laser beam. For each measurement point only a small area is illuminated and measured. By scanning the laser beam using a moving mirror

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PERIMED

Object/Subject

Traditional 510(k) Notification

Document Type

PeriCam PSI - 510(k) Summary

the entire area is measured sequentially. Since the new device, PeriCam PSI measures the entire area simultaneously a higher total laser radiation is required but since the light is spread out over a larger area the new device is more safe to use. The PeriCam PSI is classified as a Class 1 laser product according to IEC 60825-1:2007, even though it contains two lasers and one is powerful, whereas PIM Laser Doppler Perfusion Imager is classified as a Class 2 faser product according to IEC 60825-1:1993+A1:1997+A2:2001. A Class 1 laser product like PeriCam PSI is considered safe to use also including long-term intra-beam viewing. This is thus safer than the predicate device PIM Laser Doppler Perfusion Imager, which is a Class 2 laser product for which starring into the beam must be avoided.

Acquisition rate

Since the PeriCam PSI is an imaging device the frame-rate of a complete flowmap is up to 100 fps. The predicate device, PIM Laser Doppler Perfusion Imager, is measuring all measurement points sequentially and typical acquisition rate of a complete flow map is minutes for larger areas. The increased frame rate for the new device is a huge advantage enabling several applications that were previously hindered by the slow acquisition rate. Also the fact that the whole image is recorded simultaneously reduces the uncertainty of physiological variations during the recording of one image.

Different measurement techniques

The PeriCam PSI measures blood flow using the LASCA technique whereas the PIM Laser Doppler Perfusion Imager measures blood flow using the laser Doppler technique. The LASCA technique measures the contrast of the timeintegrated intensity variations, whereas the laser Doppler technique calculates the frequency content of the time variations of the intensity signal in a single point. These two techniques are different ways of analysing the same fluctuations in the speckle pattern. The integration time of the LASCA technique can be selected so that the response for the LASCA signal and the laser Doppler signal give similar response to flow changes for the relevant measurement objects used in the intended use.

Performance Data ? -

Several comparative studies of the new device and the predicate device have been performed to show, the substantial equivalence of the two devices. These include absolute measurements as well relative response to provocations such as heating and occlusion. It can be seen that the response is very similar between the two devices for the intended use of the instruments. It can thus be concluded that the two devices show substantial equivalence.

Perimed AB, Datavägen 9A, SE-175 43 Järfälla, Sweden:
Tel: +46-8-580 119 90 Fax: +46-8-580 100 28 E-mail: mall@perimed.se
Website: http://www.perimed-instruments.com

YOUR PARTNER IN MICROCIRCULATION

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** PERIMED	Document TypeTraditional 510(k) Notification	Submission Date2012-03-15	Section-Page-------
Object/Subject
PeriCam PSI - 510(k) Summarv

Conclusion

From the description of the technological characteristics and the performance data, it can be concluded that the PeriCam PSI show substantial equivalence to PIM Laser Doppler Perfusion Imager in terms of the measurement response. The new device is safer than the predicate device since it is defined to laser Class 1 according IEC 60825-1:2007. The new device allows fast acquisition rates for larger measurement areas.

Comparison to the predicate device K063586, moorFLPI Full Field Laser Perfusion Imager

Laser safetv -

Both instruments employ a wide divergent near infra-red (785 nm) laser beam to illuminate an extended area simultaneously. The new device PeriCam PSI system is assigned to Class 1 according to IEC 60825-1:2007 which is the same class as the moorFLPI Full Field Laser Perfusion Imager which is assigned to Class 1 according to IEC 60825-1:2001. Since both instruments are assigned to laser Class 1 there are no limitations to safe use of the instruments. There is not considered to be any hazard in using the instruments.

Measurement efficiency

The two instruments can measure over approximately the same areas and acquisition rates and are thus considered to be equally efficient in measuring tissue perfusion.

Measurement technique

Both instruments measure tissue perfusion from the contrast reduction of a timeintegrated speckle image. Thus the fundamental measurement is based on the same principal for the two instruments, even though the detailed signal processing may differ slightly.

Performance Data

We are not in possession of any moorFLPI Full Field Laser Perfusion Imager so we have not been able to perform any comparative studies.

Conclusion

From the description of the technological character stics it can be concluded that the PeriCam PSI and the moorFLPI Full Field Laser Perfusion Imager are equally effective in measuring tissue perfusion. The two devices measure using the same fundamental property of reduction of the speckle contrast from blurring caused by moving objects. Thus it can be concluded that the PeriCam PSI show substantial equivalence to the moorFLPI Full Field Laser Perfusion Imager in terms of the measurement effectiveness. The hazard of using the two instruments is identical.

rimed AB. Datavagen 9A. SE-175 43 Järfälla, S Tel: +46-8-580 119 90 Fax: +46-8-580 100 28 E-mail: mall@rerimed.se Website: http://www.perimed-instruments.com

YOUR PARTNER IN MICROCIRCULATION

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background. The overall design is simple and recognizable, representing the department's role in public health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Perimed AB % Ms. Maria Liljevret Datavagen 9 A Jarfalla, Sweden 17543

3 2012 JUL

Re: K120884 Trade/Device Name: PeriCam PSI Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: Class II Product Code: DPT Dated: June 11, 2012 Received: June 26, 2012

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.

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

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Page 2 – Ms. Maria Liljevret

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours.

Mark H. Millerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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	PERIMED	Document Type	Traditional 510(k) Notification	Submission Date	2012-06-11	Section-Page	4-2/2
Object/Subject	PeriCam PSI- Indications for Use

Indications for Use

510(k) Number (if known): צ

Device Name:

PeriCam PSI

Indications for Use:

The PeriCam PSI is intended for non-invasive two-dimensional imaging of peripheral tissue blood perfusion.

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)

Concurrence of CDRH, Office of Device Eve

Sign-Off) Division Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120884

Regulation Number and Section

§ 870.2120 Extravascular blood flow probe.

(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).