View and digitally record images of a wound, (i)
Measure and digitally record the size of a wound, and (ii)
View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. (iii)

The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound.

The MolecuLight i:X does not diagnose or treat skin wounds.

Device Description

The MolecuLight i:X Imaging Device is a handheld medical imaging device comprised of a high-resolution color LCD display and touch-sensitive screen with integrated optical and microelectronic components. Moleculight i:X uses its patented technology to enable real-time standard digital imaging and fluorescence imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the MolecuLight i:X device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The core clinical claim for the MolecuLight i:X related to bacterial identification is: "The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per gram as compared to examination of clinical signs and symptoms alone."

While the document doesn't explicitly state quantitative acceptance criteria in the "we will achieve X performance" format, the demonstrated performance serves as the evidence for meeting their stated claim. The crucial part of the performance is the improvement in identifying wounds with relevant bacterial loads.

Acceptance Criteria (Implied by Clinical Claim and Study Results)

Metric (vs. CSS alone)	Acceptance Threshold (Implied)	Reported Device Performance (CSS + iX vs. CSS)
Sensitivity Increase	Increase in likelihood of identifying wounds with >10^4 CFU/g bacteria	CSS+iX: 60.98% CSS: 15.33% (~4x increase)
Specificity Change	Maintain acceptable specificity / avoid significant decrease in correctly ruling out bacteria	CSS+iX: 84.13% CSS: 93.65% (~9.5% decrease)
False Positive Rate	< 10% increase in incorrectly identified ^1	< 10% increase

^1 The document states: "The use of the MolecuLight i:X in combination with clinical signs and symptoms resulted in a <10% increase as compared to CSS alone in the rate in wounds that were incorrectly identified as having bacterial load >10^4 CFU/g, whose resulting bacterial load determined by conventional microbiological analysis was <10^4 CFU/q." This is a specific claim about the false positive rate.

2. Sample Size and Data Provenance

Sample Size for Test Set: n = 350 wound sites (referred to as "All patients")
- Microbiology Positive (>10^4 CFU/g): n = 287
- Microbiology Negative (<10^4 CFU/g): n = 63
Data Provenance: The document does not specify the country of origin. It indicates it was a "clinical study," implying prospective data collection for this purpose.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "clinicians" evaluating clinical signs and symptoms (CSS) and then interpreting MolecuLight i:X fluorescence images. However, it does not specify the number or qualifications of these clinicians related to establishing the clinical ground truth for the test set.
The primary ground truth for bacterial load (>10^4 CFU/g) was "quantitative microbiological analysis," which is a lab-based, objective method, not dependent on expert consensus.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the clinical evaluation of CSS or the interpretation of MolecuLight i:X images. It compares these clinical assessments directly against the quantitative microbiological analysis. This suggests that individual clinicians' interpretations were the data points, rather than a consensus interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A formal MRMC study is not explicitly mentioned as having been performed. The study evaluates the likelihood that clinicians can identify wounds, comparing performance with and without the device. While it involves multiple clinicians, it's presented as a direct comparison of the combined CSS+iX approach versus CSS alone, rather than a statistical comparison of reader performance improvement.
Effect Size:
- The sensitivity for identifying high bacterial loads increased from 15.33% (CSS alone) to 60.98% (CSS + iX). This is a substantial increase, making the device significantly more likely to flag relevant wounds.
- The specificity decreased from 93.65% (CSS alone) to 84.13% (CSS + iX). This indicates a trade-off where more wounds were incorrectly identified as having high bacterial loads with the device, but the report explicitly states this increase in false positives was "<10%".

6. Standalone Performance (Algorithm Only)

Not applicable/Not done. The MolecuLight i:X is described as a "handheld imaging tool" used by "clinicians." Its function is to provide an image that clinicians interpret. It is not an AI/algorithm that provides a standalone diagnosis or classification. The "performance" reported is the combination of the device's output and human interpretation ("clinician's interpretation of the MolecuLight i:X fluorescence image and CSS").

7. Type of Ground Truth Used

The primary ground truth for validation of the bacterial load identification claim was quantitative microbiological analysis (i.e., bacterial culture results defining >10^4 CFU per gram). This is an objective and laboratory-confirmed ground truth, considered a strong reference standard for bacterial burden.

8. Sample Size for the Training Set

The document does not specify a separate training set or its size. This is typical for a medical device that provides direct imaging for human interpretation, rather than a machine learning algorithm that is "trained" on data. The clinical study described here functions as the pivotal performance validation.

9. How Ground Truth for the Training Set was Established

As no separate training set or AI/ML training is indicated, this point is not applicable. The ground truth for the clinical study was established by quantitative microbiological analysis of wound samples.

Summary

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December 4, 2019

MolecuLight Inc. % Joel Ironstone President Ironstone Product Development Suite 222, 276 Carlaw Avenue Toronto, M4M 3L1 Canada

Re: K191371

Trade/Device Name: MolecuLight i:X Regulation Number: 21 CFR 878.4550 Regulation Name: Autofluorescence detection device for general surgery and dermatological use Regulatory Class: Class II Product Code: OJF, FXN Dated: October 28, 2019 Received: October 29, 2019

Dear Joel Ironstone:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use
Food and Druq Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191371

Device Name

MolecuLight i:X

Indications for Use (Describe)

The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to

View and digitally record images of a wound, (i)
Measure and digitally record the size of a wound, and (ii)
View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. (iii)

The MolecuLight i:X does not diagnose or treat skin wounds.

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801

Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K191371 510(k) SUMMARY

MolecuLight i:X

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

MolecuLight Inc. Suite 700, 425 University Avenue Toronto, ON, Canada M5G 1T6 Phone: 647-362-4684 Contact Person: Tyler Chackowicz

Date Prepared: December 3, 2019

Name of Device

MolecuLight i:X

Device Classification and Product Code

Autofluorescence detection device, 21 CFR 878.4550, Class II, QJF Tape, Camera, Surgical, 21 CFR 878.4160, Class I, FXN

Predicate Devices

Fluobeam 800 Clinic Imaging Device (DEN170092, Predicate Device) WoundVision Scout (Class I, Predicate Device) MolecuLight i:X (DEN180008, Reference Device)

Indications for Use

The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to

View and digitally record images of a wound, (i)

Measure and digitally record the size of a wound, and (ii)

(iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.

The MolecuLight i:X does not diagnose or treat skin wounds.

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Device Description

Clinical Testing

Clinical testing was performed to evaluate the potential increase in the identification of wounds containing >104 CFU per gram of bacteria when the MolecuLight i:X is added to a clinician's evaluation of a subject's clinical signs and symptoms (CSS). In the study, the clinician's interpretation of the MolecuLight i:X fluorescence image and CSS were compared to quantitative microbiological analysis.

The baseline demographics of the study population is provided in the Table 1 below.

Characteristic	Measure	All patients(n = 350)	MicrobiologyPositive (n=287)	MicrobiologyNegative (n=63)
Age (years)	Mean(SD)	60.19 (12.44)	59.95 (12.11)	61.27 (13.87)
	Median(Minimum, Maximum)	59.76(27.83, 96.03)	59.72(27.83, 94.76)	60.27(28.47, 96.03)
Sex (Female)		125 (35.71)	87 (30.31)	38 (60.32)
Systemic Antibiotic Use (Yes)		90 (25.71)	56 (19.51)	34 (53.97)
Fitzpatrick Score
Light (I or II)	Count (%)	224 (64)	179 (62.37)	45 (71.43)
Medium (III or IV)		83 (23.71)	74 (25.78)	9 (14.29)
Dark (V or VI)		43 (12.29)	34 (11.85)	9 (14.29)

Table 1 Baseline demographics of study population

The clinical testing demonstrated that the fluorescence image, when used in combination with clinical signs and symptoms (CSS), increased the likelihood that clinicians could identify wounds containing bacterial loads >104 CFU per gram as compared to examination of CSS alone. The use of the MolecuLight i:X in combination with clinical signs and symptoms resulted in a <10% increase as compared to CSS alone in the rate in wounds that were incorrectly identified as having bacterial load >104 CFU/g, whose resulting bacterial load determined by conventional microbiological analysis was <104 CFU/q.

Measure	Total (%)n= 350
	Sensitivity	Specificity
CSS+iX	60.98	84.13
CSS	15.33	93.65

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No device attributable adverse events were recorded in the study. These study results demonstrated that the MolecuLight i:X increased the likelihood that clinicians can identify wounds containing wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone . The fluorescence output of the device is not ground truth regarding wound bacterial load >104 CFU/g and must be used in combination with CSS and other confirmatory methods such as bacterial culture, to make a determination of bacterial load.

Non-Clinical Testing

Nonclinical testing included the following on the subject device:

1. Standards Compliance Testing
1. Software Verification and Validation
1. System Verification and Validation
1. Cleaning and Disinfection Validation
1. Accuracy and Inter/Intra Reader Variability Testing of Wound Measurement Function
1. Bioburden Testing for the DarkDrape Accessory
Biocompatibility according to ISO 10993-1 including Cytotoxicity, Sensitization, 7) Acute Systemic Toxicity for the DarkDrape and Wound Stickers.
Packaging and Transport validation 8)

Compliance with Special Controls of 21 CFR 878.4550

The device complies with the all applicable special controls as per 21 CFR 878.4550 as follows:

1. A clinical study has been conducted that evaluates the device's performance under anticipated use conditions.
1. Patient Contact Materials have been demonstrated to be biocompatible.
1. Performance testing demonstrated the electromagnetic compatibility and electrical, mechanical and thermal safety of the device.
1. Software verification and validation has been completed.
1. LED light safety testing has been demonstrated according to IEC 60601-2-57:2011.
1. Labeling is provided that includes instructions for use as well as the performance of the device when used as intended.

Note: There are no components labeled as sterile included with this product.

Standards Compliance

MolecuLight i:X has been tested to comply with the following FDA recognized standards:

Safety Testing per IEC 60601-1:2005+A1:2012& US National Differences per ANSI/AAMI ES . 60601-1:2005/A1:2012
EMC Testing per IEC 60601-1-2:2014 4th Edition ●

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LED Testing per IEC 60601-2-57:2011 and IEC 62471:2006 ●
Biocompatibility according to ISO 10993-1 ●

Software Verification and Validation Testing

Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device

The intended use for both the subject device, MolecuLight i:X, and predicate device, Fluobeam 800 Clinic Imaging Device (DEN170092), are the same. Both the subject and predicate devices illuminate target tissues or structures and detect a resulting autofluorescence image using a charge-coupled device (CCD) camera. Additionally, the subject device's wound measurement feature is similar in indication and technical characteristics to the second predicate device, WoundVision Scout. Table 2 below compares the characteristics of the subject device (MolecuLight i:X), the predicate device (Fluobeam 800 Clinic Imaging Device, DEN170092), and the reference device (MoleouLight i.X, DEN180008). Table 3 below compares the wound measurement characteristics of the subject device (MolecuLight i:X) and the predicate device (WoundVision Scout).

The subject device and the predicate devices have different technological characteristics. The submitted information, including both Non-Clinical testing establish that the MolecuLight i:X device is at least as safe and effective as the predicate devices. Both devices operate on the principle of tissue autofluorescence, which is the property of fluorescent molecules (fluorophores) absorbing a wavelength of light and then emitting a longer wavelength of light. However, while the predicate device uses a laser for illumination, the subject device uses non-coherent light-emitting diodes (LEDs) as an excitation light source. These differences do not raise different questions of safety or effectiveness.

	SUBJECT DEVICE'Modified' MolecuLight i:X	PREDICATE DEVICEFluobeam 800 Clinic ImagingDevice (DEN170092)	REFERENCE DEVICEGrantedMolecuLight i:X(DEN180008)
Device Name	MolecuLight i:X	Fluobeam 800 Clinic ImagingDevice	MolecuLight i:X
Manufacturer	MolecuLight Inc.	Fluoptics	MolecuLight Inc.
510(k)Number	-	DEN170092	DEN180008
RegulatoryClass	Class II	Class II	Class I
RegulationNumber	QJF	QDG	QCR
ProductClassification	21 CFR 878.4550	21 CFR 878.4550	21 CFR 878.4165
ClassificationName	Autofluorescencedetectiondevice for general surgery anddermatological use	Autofluorescencedetectiondevice for general surgery anddermatological use	Wound Autofluorescence ImagingDevice

		Table 2: Comparison of Technological Characteristics for Fluorescence Imaging
Intended Use	Intended for general surgery anddermatological use as an adjuncttool that uses autofluorescenceto detect tissues or structures.This device is not intended toprovide a diagnosis.	Intended for general surgery anddermatological use as an adjuncttool that uses autofluorescenceto detect tissues or structures.This device is not intended toprovide a diagnosis.	A wound autofluorescenceimaging device is a tool to viewautofluorescence images fromskin wounds that are exposed toan excitation light. The device isnot intended to providequantitative or diagnosticinformation.
Indicationsfor Use	The MolecuLight i:X is ahandheld imaging tool thatallows clinicians diagnosing andtreating skin wounds, at thepoint of care, to(i) View and digitallyrecord images of a wound,(ii) Measure and digitallyrecord the size of a wound, and(iii) View and digitallyrecord images of fluorescenceemitted from a wound whenexposed to an excitation light.The fluorescence image, whenused in combination with clinicalsigns and symptoms, has beenshown to increase the likelihoodthat clinicians can identifywounds containing bacterialloads >104 CFU per gram ascompared to examination ofclinical signs and symptomsalone. The MolecuLight i:Xdevice should not be used torule-out the presence of bacteriain a wound.The MolecuLight i:X does notdiagnose or treat skin wounds.	The Fluoptics Fluobeam®Imaging system is intended toprovide real-time near infrared(NIR) fluorescence imaging oftissue during surgicalprocedures. The FluopticsFluobeam® Imaging system isindicated for use in capturing andviewing fluorescent images forthe visual assessment of bloodflow in adults as an adjunctivemethod for the evaluation oftissue perfusion, perfusedorgans, and related tissue-transfer circulation in tissue andfree flaps used in plastic, micro-and reconstructive and organtransplant surgeries.The Fluoptics Fluobeam®Imaging system can also beused to assist in the imaging ofparathyroidglands and can be used as anadjunctive method to assist in thelocation of parathyroid glandsdue to the auto-fluorescence ofthis tissue.Use of the Fluobeam® device isintended to assist, not replace,experienced visual assessment,and biopsy with conventionalhistopathological confirmationper standard of care. The systemis not to be used to confirm theabsence of parathyroid tissue orglands and is only to be used toassist in locating visuallyidentified gland/tissues.	The MolecuLight i:X is a handheldimaging tool that allows cliniciansdiagnosing and treating skinwounds, at the point of care, to(i) view and digitallyrecord images of awound, and(ii) view and digitallyrecord images offluorescenceemitted from awound whenexposed to anexcitation light.The MolecuLight i:X is forprescription use only.
Target Organ	Wounds	Tissue during surgicalprocedures	Wounds
PatientPopulation	Adult patients	Adult patients	Adult patients
OperatingModes	Standard and fluorescenceimaging, video and imagecapture	Fluorescence imaging	Standard and fluorescentimaging, video and image capture
ExcitationLight	405 nm light emitted from lightemitting diodes (LED)s	750 nm emitted from a laserdiode	405 nm light emitted from lightemitting diodes (LED)s
Laser PowerDensity	N/A	$5 \pm 1$ mW/cm²	N/A
Infrared LED	N/A	Unknown	N/A
White LED	N/A	Broadband LEDs with normalillumination	N/A

EmissionWavelength	500-545 nm and 600-665 nm	>800 nm	500-545 nm and 600-665 nm
Contrast	Not required – autofluorescent	Autofluorescent target or	Not required – autofluorescent
agent	target	Indocyanine green (ICG)	target

Working	8-12 cm	20-30 cm	8-12 cm
Distance
Resolution	5 megapixels	300 µm to 50 µm depending onmagnification	5 megapixels
(focal plane)
Magnification	N/A	X10 zoom	N/A
Maximum	30 images/sec	25 images/sec	30 images/sec
Frame Rate
CameraBit	8 bits	8 bits	8 bits
Depth
ImageSize	1136 x 640 pixels	696 x 576 pixels	1136 x 640 pixels
(Pixels)
Image Format	JPEG	PNG	JPEG
Video Format	MOV	MP4	MOV
Software	Apple iOS 9.3.5	Windows 7 or Windows 10	Apple iOS 9.3.5
Operating
System (OS)
Compatibility
Measurement	Wound length, width, and areameasurements	None	None
Functionality
Power	Battery and Wall	Wall	Battery and Wall
Supply
Display	Handheld device; no remotedisplay	Handheld device with remotedisplay	Handheld device; no remotedisplay

Patient	Non-patient contacting device(held 8-12 cm from skin)	Non-patient contacting device	Non-patient contacting device(held 8-12 cm from skin)
Contacting
Materials
Sterility	Used non-sterile	Used with off-the-shelf sterilesleeve when placed in the sterilefield during surgical procedures	Used non-sterile


Electrical	Compliance to IEC 60601-1	Compliance to IEC 60601-1	Compliance to IEC 60601-1
Safety
Mechanical	Compliance to IEC 60601-1	Compliance to IEC 60601-1	Compliance to IEC 60601-1
Safety
Chemical	No chemical delivered or used aspart of the system	No chemical delivered or used aspart of the system	No chemical delivered or used aspart of the system
Safety
Standards	IEC 60601-1-2	As per K132475:	IEC 60601-1-2
withwhich	IEC 60601-1	IEC 60601-1-2	IEC 60601-1
theDevice	IEC 60601-2-57	IEC 60601-1	IEC 60601-2-57
Complies	IEC 62471	IEC 60825-1	IEC 62471

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Table 3: Comparison of Technological Characteristics for Wound Measurement

	SUBJECT DEVICE	PREDICATE DEVICE - Wound Measurement
	'Modified' MolecuLight i:X	WoundVision Scout
Device Name	MolecuLight i:X	WoundVision Scout
Manufacturer	MolecuLight Inc.	Wound Vision LLC
510(k)	-	-
Number
Regulatory	Class II	Class I
Class
Regulation	QDG	FXN
Number
Product	21 CFR 878.4550	21 CFR 878.4160
Classification

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ClassificationName	Autofluorescence detection device for generalsurgery and dermatological use		TAPE, CAMERA, SURGICAL
Intended Use/ Indicationsfor Use	The MolecuLight i:X is a handheld imaging toolthat allows clinicians diagnosing and treating skinwounds, at the point of care, to(i) View and digitally record images of awound,(ii) Measure and digitally record the size ofa wound, and(iii) View and digitally record images offluorescence emitted from a wound whenexposed to an excitation light.The fluorescence image, when used incombination with clinical signs and symptoms,has been shown to increase the likelihood thatclinicians can identify wounds containingbacterial loads >104 CFU per gram as comparedto examination of clinical signs and symptomsalone. The MolecuLight i:X device should not beused to rule-out the presence of bacteria in awound.The MolecuLight i:X does not diagnose or treatskin wounds.		The Scout is a combination digital camera and long-wave infrared camera. The digital camera isindicated for the use of capturing visual images tomeasure the diameter, surface area, and perimeterof a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use ofcapturing thermal images to measure the thermalintensity data of a part of the body or two bodysurfaces. Both components of the Scout are non-contact with respect to the patient and provide anadjunctive tool to help a trained and qualified healthcare professional measure and record externalwound and body surface data.Intended for qualified healthcare professionals whoare trained in its use, the Scout is a non-invasive andnon-radiating device.The Scout is to be used on a patient population thatincludes non-pregnant female or male patients 18years of age or older. The Scout is intended to beused in hospital, acute and sub-acute care settings,long term care, surgery, health care practitionerfacilities, outpatient, home healthcare, or in anyenvironment where health care is provided by aqualified health care professional.
Target Organ	Wounds		The Scout does not provide a diagnosis or therapy.Body parts, including wounds
PatientPopulation	Adult patients		Non-pregnant female or male patients 18 years ofage or older
PatientContacting	Non-patient contacting		Non-patient contacting
OperatingModes	Standard and fluorescence imaging and video		Standard and thermal imaging
Imaging Aids	Non-sterile WoundStickers; DarkDrape		Unknown
MeasurementFunctionality	Measures wound length, width, and area usingstandard imaging		Measures the diameter, surface area, and perimeterof a part of the body or the distance between twobody surfaces using a standard image and measuresthe thermal intensity variation data of a part of thebody or two body surfaces using a thermal image
MeasurementResults Part1(WoundModels)	Intra-rater	Length: 1.59 CV%Width: 1.92 CV%Area: 2.6 CV%	Intra-rater	Perimeter: 1.94 CV%Trace Area: 2.54 CV%LxW Area: 3.87 CV%
	Inter-rater	Length: 1.23 CV%Width: 1.28 CV%Area: 2.07 CV%	Inter-rater	Perimeter: 1.97 CV%Trace Area: 2.80 CV%LxW Area: 4.20 CV%
	Accuracy*	Length: 3.8%Width: 3.4%Area: 4.3%	Accuracy*	Perimeter: 2%Trace Area: 4%
MeasurementResults Part2 (ClinicalImages)	Intra-rater	Length: 2.77 CV%Width: 3.11 CV%Area: 5.02 CV%	Intra-rater	Perimeter: 2.35 CV%Trace Area: 3.73 CV%LxW Area: 6.26 CV%
	Inter-rater	Length: 3.31 CV%Width: 5.42 CV%Area: 10.76 CV%	Inter-rater	Perimeter: 3.71 CV%Trace Area: 9.29 CV%LxW Area: 9.82 CV %

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In summary, MolecuLight i:X is substantially equivalent to the legally marketed predicate devices, Fluobeam 800 Clinic Imaging Device (DEN170092) and WoundVision Scout (for wound measurement). The intended use of the i:X device is the same as the Fluobeam, and the differences in technological characteristics do not raise different questions of safety or efficacy. In addition, the technical characteristics of the Modified MolecuLight i:X are identical to the reference device. Clinical testing and bench testing to FDA-recognized standards have demonstrated the safety and effectiveness of MolecuLight i:X with regards to differences in technological characteristics. Thus, the MolecuLight i:X is substantially equivalent to the Fluobeam and WoundVision Scout (for wound measurement).

Conclusion

MolecuLight i:X is substantially equivalent to Fluobeam and WoundVision Scout (for wound measurement).

Regulation Number and Section

§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.

(a)
Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.
(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.
(8) Labeling must include the following:
(i) Instructions for use;
(ii) The detection performance characteristics of the device when used as intended; and
(iii) A shelf life for any sterile components.