Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related terms, and the device description focuses on optical and microelectronic components for imaging and measurement. The performance studies evaluate the clinician's interpretation of the fluorescence image, not an automated AI/ML analysis.

Therapeutic

No.
The "Intended Use / Indications for Use" section explicitly states: "The MolecuLight i:X does not diagnose or treat skin wounds." This device is described as an imaging tool to help clinicians view, record, and measure wounds, and to identify wounds with higher bacterial loads, but not for direct diagnosis or treatment.

Diagnostic

No

The "Intended Use / Indications for Use" section explicitly states, "The MolecuLight i:X does not diagnose or treat skin wounds."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of "integrated optical and microelectronic components" and is a "handheld medical imaging device," indicating it includes hardware beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the MolecuLight i:X is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
MolecuLight i:X Function: The MolecuLight i:X is a handheld imaging tool that directly images the wound on the patient's body (in vivo). It uses light and fluorescence to visualize the wound and potential bacterial presence. It does not analyze a sample taken from the body.
Intended Use: The intended use clearly states it's a "handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to... View and digitally record images... Measure and digitally record the size... View and digitally record images of fluorescence..." This describes an imaging process performed directly on the patient.
No Specimen Analysis: There is no mention of collecting or analyzing a biological specimen from the patient. The device works by interacting with the wound itself.

While the device provides information that can aid in diagnosis and treatment decisions, the method of obtaining that information (direct imaging of the wound on the body) places it outside the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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)
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 >10^4 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.

Product codes (comma separated list FDA assigned to the subject device)

OJF, FXN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Standard digital imaging, fluorescence imaging

Anatomical Site

Wounds

Indicated Patient Age Range

Adult patients

Intended User / Care Setting

Clinicians diagnosing and treating skin wounds, at the point of care.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

A clinical study was performed to evaluate the potential increase in the identification of wounds containing >10^4 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.

Sample size: 350 patients (287 Microbiology Positive, 63 Microbiology Negative)

Annotation protocol: Clinician's interpretation of the MolecuLight i:X fluorescence image and CSS compared to quantitative microbiological analysis.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study type: Clinical testing
Sample size: 350
Key results: 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 >10^4 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 10^4 CFU/g, whose resulting bacterial load determined by conventional microbiological analysis was 10^4 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

DEN170092, WoundVision Scout

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

DEN180008

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

1

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 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.

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 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.

4

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.

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) | Microbiology
Positive (n=287) | Microbiology
Negative (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 104 CFU/g, whose resulting bacterial load determined by conventional microbiological analysis was 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 DEVICE
Fluobeam 800 Clinic Imaging
Device (DEN170092) | REFERENCE DEVICE
Granted
MolecuLight i:X
(DEN180008) |
|---------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Device Name | MolecuLight i:X | Fluobeam 800 Clinic Imaging
Device | MolecuLight i:X |
| Manufacturer | MolecuLight Inc. | Fluoptics | MolecuLight Inc. |
| 510(k)
Number | - | DEN170092 | DEN180008 |
| Regulatory
Class | Class II | Class II | Class I |
| Regulation
Number | QJF | QDG | QCR |
| Product
Classification | 21 CFR 878.4550 | 21 CFR 878.4550 | 21 CFR 878.4165 |
| Classification
Name | Autofluorescence
detection
device for general surgery and
dermatological use | Autofluorescence
detection
device for general surgery and
dermatological use | Wound Autofluorescence Imaging
Device |

		Table 2: Comparison of Technological Characteristics for Fluorescence Imaging
Intended Use	Intended for general surgery and
dermatological use as an adjunct
tool that uses autofluorescence
to detect tissues or structures.
This device is not intended to
provide a diagnosis.	Intended for general surgery and
dermatological use as an adjunct
tool that uses autofluorescence
to detect tissues or structures.
This device is not intended to
provide a diagnosis.	A wound autofluorescence
imaging device is a tool to view
autofluorescence images from
skin wounds that are exposed to
an excitation light. The device is
not intended to provide
quantitative or diagnostic
information.
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
(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 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. | The Fluoptics Fluobeam®
Imaging system is intended to
provide real-time near infrared
(NIR) fluorescence imaging of
tissue during surgical
procedures. The Fluoptics
Fluobeam® Imaging system is
indicated for use in capturing and
viewing fluorescent images for
the visual assessment of blood
flow in adults as an adjunctive
method for the evaluation of
tissue perfusion, perfused
organs, and related tissue-
transfer circulation in tissue and
free flaps used in plastic, micro-
and reconstructive and organ
transplant surgeries.

The Fluoptics Fluobeam®
Imaging system can also be
used to assist in the imaging of
parathyroid
glands and can be used as an
adjunctive method to assist in the
location of parathyroid glands
due to the auto-fluorescence of
this tissue.

7

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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

9

| Classification
Name | Autofluorescence detection device for general
surgery and dermatological use | | TAPE, CAMERA, SURGICAL | |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use
/ 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
(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 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. | | The Scout is a combination digital camera and long-
wave infrared camera. The digital camera is
indicated for the use of capturing visual images to
measure the diameter, surface area, and perimeter
of a part of the body or two body surfaces. The long-
wave infrared camera is indicated for the use of
capturing thermal images to measure the thermal
intensity data of a part of the body or two body
surfaces. Both components of the Scout are non-
contact with respect to the patient and provide an
adjunctive tool to help a trained and qualified health
care professional measure and record external
wound and body surface data.

Intended for qualified healthcare professionals who
are trained in its use, the Scout is a non-invasive and
non-radiating device.

The Scout is to be used on a patient population that
includes non-pregnant female or male patients 18
years of age or older. The Scout is intended to be
used in hospital, acute and sub-acute care settings,
long term care, surgery, health care practitioner
facilities, outpatient, home healthcare, or in any
environment where health care is provided by a
qualified health care professional.

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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).