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

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 MolecuLightDX device should not be used to rule-out the presence of bacteria in a wound.

The MolecuLightDX does not diagnose or treat skin wounds.

Device Description

The MolecuLightDX Imaging Device is a handheld medical imaging device comprised of a high-resolution color AMOLED display and touch-sensitive screen with integrated optical and microelectronic components. MolecuLightDX 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

This document is a 510(k) summary for the MolecuLightDX device. It describes non-clinical testing performed on the device but does not contain information about clinical studies or acceptance criteria for identifying bacterial loads >10^4 CFU per gram. The summary focuses on established equivalence to a predicate device (MolecuLight i:X K191371) based on similar technological characteristics and compliance with electrical safety and software validation standards, rather than direct performance metrics against clinical acceptance criteria for bacterial load detection.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning the identification of bacterial loads, cannot be fully provided from the given text.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily discusses compliance with safety and technical standards rather than specific clinical performance acceptance criteria for bacterial load detection. The key performance claim related to its indication for use 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 this is an indication of efficacy, the document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, or AUC thresholds) for this "increased likelihood" or present a study showing the MolecuLightDX device itself met such criteria. Instead, it refers to its predecessor's demonstrated capability.

2. Sample size used for the test set and the data provenance:

Not provided in this document for the MolecuLightDX's bacterial load identification capability. The non-clinical testing mentioned includes:

Standards Compliance Testing
Software Verification and Validation
System Verification and Validation
Accuracy and Inter/Intra Reader Variability Testing of Wound Measurement Function
Packaging and Transport validation

These tests do not involve clinical test sets for bacterial load identification. The effectiveness claim for bacterial load identification references earlier work/evidence from the predicate device, implicitly assuming the newer device maintains this capability due to similar technology.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided in this document.

4. Adjudication method for the test set:

Not provided in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not provided in this document. The device is a "handheld imaging tool" and not an AI-driven diagnostic algorithm in the typical sense that would necessitate an MRMC comparative effectiveness study for "AI vs without AI assistance". Its primary function is to enable visualization of fluorescence which clinicians then interpret.

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

Not applicable. The device is explicitly described as a "handheld imaging tool that allows clinicians... to view and digitally record images... The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds..." This indicates a human-in-the-loop system.

7. The type of ground truth used:

Not explicitly stated for the MolecuLightDX in this document regarding bacterial load. However, the indication for use refers to "bacterial loads >10^4 CFU per gram," which implies quantitative microbiology (CFU per gram) as the ground truth method in the referenced studies from which the claim of "increased likelihood" originated (likely from the predicate device's clearance).

8. The sample size for the training set:

Not applicable, as this document does not describe a machine learning algorithm requiring a training set for the bacterial load identification claim. The device is an imaging tool.

9. How the ground truth for the training set was established:

Not applicable.

Summary based on available information:

The provided document (a 510(k) summary) focuses on demonstrating substantial equivalence to a predicate device (MolecuLight i:X K191371) through non-clinical testing, regulatory compliance, and comparison of technological characteristics. It does not detail a specific clinical study for MolecuLightDX to establish performance against acceptance criteria for identifying bacterial loads. Instead, it leverages the known efficacy claim from its predicate device for its indication of use, implying that the MolecuLightDX, being technologically similar, shares this established capability. The "increased likelihood" claim for identifying bacterial loads >10^4 CFU per gram is presented as a previously established benefit from the predicate device's performance.

Summary

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July 21, 2021

MolecuLight Inc. Jordan John Director, Quality Assurance & Regulatory Affairs Suite 700, 425 University Avenue Toronto, Ontario M5G 1T6 Canada

Re: K211901

Trade/Device Name: MolecuLightDX Regulation Number: 21 CFR 878.4550 Regulation Name: Autofluorescence Detection Device For General Surgery And Dermatological Use Regulatory Class: Class II Product Code: QJF, FXN Dated: June 21, 2021 Received: June 21, 2021

Dear Jordan John:

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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 mediation-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 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

510(k) Number (if known) K211901

Device Name

MolecuLightDX

Indications for Use (Describe)

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

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

The MolecuLightDX does not diagnose or treat skin wounds.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C)

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K211901

510(k) SUMMARY

MolecuLightDX

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

MolecuLight Inc. Suite 700, 425 University Avenue Toronto, ON, Canada M5G 1T6 Phone: 416-542-5522 Contact Person: Jordan John

Date Prepared: July 19, 2021

Name of Device

MolecuLightDX

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

MolecuLight i:X K191371

Indications for Use

The MolecuLightDX 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 MolecuLightDX does not diagnose or treat skin wounds.

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Device Description

Non-Clinical Testing

Nonclinical testing included the following on the subject device:

Standards Compliance Testing 1)
1. Software Verification and Validation
1. System Verification and Validation
1. Accuracy and Inter/Intra Reader Variability Testing of Wound Measurement Function
ર) Packaging and Transport validation

Compliance with Special Controls of 21 CFR 878.4550

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

Patient Contact Materials have been assessed to be biocompatible. 1.
1. Performance testing demonstrated the electromagnetic compatibility and electrical, mechanical and thermal safety of the device.
Software verification and validation has been completed. 3.
ব LED light safety testing has been demonstrated according to IEC 60601-2-57:2011.
Labeling is provided that includes instructions for use as well as the performance of the device when 5. used as intended.

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

Standards Compliance

MolecuLightDX 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 ●
LED Testing per IEC 60601-2-57:2011 and IEC 62471:2006 ●

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

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	MolecuLightDXSUBJECT DEVICE	MolecuLight i:XPREDICATE DEVICE
Device Name	MolecuLightDX	MolecuLight i:X
Manufacturer	MolecuLight Inc.	MolecuLight Inc.
510(k) Number	-	K191371
Regulatory Class	Class II	Class II
RegulationNumber	QJF	QJF
ProductClassification	21 CFR 878.4550	21 CFR 878.4550
ClassificationName	Autofluorescence detection device forgeneral surgery and dermatological use	Autofluorescence detection device forgeneral surgery and dermatological use
Intended Use	Intended for general surgery anddermatological use as an adjunct tool thatuses autofluorescence to detect tissues orstructures. This device is not intended toprovide a diagnosis.	Intended for general surgery anddermatological use as an adjunct toolthat uses autofluorescence to detecttissues or structures. This device is notintended to provide a diagnosis.
Indications forUse	The MolecuLightDX is a handheld imagingtool that allows clinicians diagnosing andtreating skin wounds, at the point of care, to	The MolecuLight i:X is a handheldimaging tool that allows cliniciansdiagnosing and treating skin wounds, atthe point of care, to
	i) View and digitally record images of awound,ii) Measure and digitally record the size ofa wound, andiii) View and digitally record images offluorescence emitted from a wound whenexposed to an excitation light.	i) View and digitally record images ofa wound,ii) Measure and digitally record thesize of a wound, andiii) View and digitally record imagesof fluorescence emitted from a woundwhen exposed to an excitation light.
	The fluorescence image, when used incombination with clinical signs andsymptoms, has been shown to increase thelikelihood that clinicians can identifywounds containing bacterial loads >104CFU per gram as compared to examinationof clinical signs and symptoms alone. TheMolecuLightDX device should not be usedto rule-out the presence of bacteria in awound.The MolecuLightDX does not diagnose ortreat skin wounds.	The fluorescence image, when used incombination with clinical signs andsymptoms, has been shown to increasethe likelihood that clinicians can identifywounds containing bacterial loads >104CFU per gram as compared toexamination of clinical signs andsymptoms alone. The MolecuLight i:Xdevice should not be used to rule-out thepresence of bacteria in a wound.
		The MolecuLight i:X does not diagnoseor treat skin wounds.
Target Organ	Wounds	Wounds
	MolecuLightDXSUBJECT DEVICE	MolecuLight i:XPREDICATE DEVICE
PatientPopulation	Adult Patients	Adult Patients
Operating Modes	Standard and fluorescence imaging, videoand image capture	Standard and fluorescence imaging, video and image capture
Excitation Light	405nm light emitted from light emittingdiodes (LEDs)	405nm light emitted from light emittingdiodes (LEDs)
Laser PowerDensity	N/A	N/A
Infrared LED	N/A	N/A
White LED	N/A	N/A
EmissionWavelength	500-545nm and 600-665nm	500-545nm and 600-665nm
Contrast Agent	Not required - autofluorescent target	Not required - autofluorescent target
Infrared LaserDistance FinderWavelength	940nm	850nm
Infrared LaserDistance FinderPeak Power Output	17mW	14mW
WorkingDistance	8 – 12 cm (Fluorescence and StandardImaging)8 – 20 cm (Measurement Mode)	8-12cm (All imaging modes)
Torch	Yes	No
Optical head	3 Camera System	1 Camera
Resolution (focalplane)	8 megapixels	5 megapixels
Magnification	N/A	N/A
Maximum FrameRate	30 images/sec	30 images/sec
Camera BitDepth	8 bits	8 bits
Image Size(Pixels)	3264 x 2448 pixels	1135 x 640 pixels
Image Format	JPEG	JPEG
Video Format	MOV	MOV
SoftwareOperating System(OS)	Android 9.1	Apple iOS 9.3.5
Compatibility
MeasurementFunctionality	Stickerless Wound Measurement: Woundlength, width, and area measurements	Wound length, width, and areameasurements
Shelf-Life	2 Years	2 Years
Power Supply	Battery and wall	Battery and wall
Display	5.5" AMOLED	4" LCD
	MolecuLightDXSUBJECT DEVICE	MolecuLight i:XPREDICATE DEVICE
PatientContactingMaterials	Non-patient contacting device (held 8-20cm from skin)	Non-patient contacting device (held 8-12cm from skin)
Sterility	Used non-sterile	Used non-sterile
Electrical Safety	Compliance to IEC 60601-1	Compliance to IEC 60601-1
Mechanical safety	Compliance to IEC 60601-1	Compliance to IEC 60601-1
Chemical Safety	No chemical delivered or used as part of the system	No chemical delivered or used as part of the system
Standards withwhich the Devicecomplies	IEC 60601-1IEC 60601-1-2IEC 60601-2-57IEC 62471	IEC 60601-1IEC 60601-1-2IEC 60601-2-57IEC 62471

Table 1: Comparison of Technological Characteristics for Fluorescence Imaging

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Conclusion

The performance tsting conducted on the MolecuLightDX demonstrates that the device can be used safely and effectively for the indications for use stated above. The MolecuLightDX's technological characteristics are similar to the technological characteristics of the predicate device (K191371) and does not raise new types of questions regarding safety and technology. The proposed MolecuLightDX is considered to be substantially equivalent to the MolecuLight i:X predicate device (K191371).

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.