(89 days)
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 grams 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 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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the MolecuLight i:X:
The MolecuLight i:X device is an autofluorescence detection device for general surgery and dermatological use. The 510(k) summary details a modification to the device's labeling to clarify the relationship between cyan fluorescence and the increased likelihood of Pseudomonas aeruginosa bacterial loads. The study's purpose is to demonstrate that this additional labeling statement does not raise new questions of safety or efficacy and is supported by existing clinical data.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to the performance metrics of the device in identifying bacterial loads, specifically Pseudomonas aeruginosa and Total Bacterial Load (TBL), as established in the original K191371 clearance. The current submission's goal is to demonstrate that the expanded labeling around cyan fluorescence's association with P. aeruginosa is supported by the data and does not alter the previous safety and effectiveness profile.
The performance is reported in terms of sensitivity, specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and Likelihood Ratio for different fluorescence signatures (Cyan, Red, Red or Cyan) in detecting bacterial loads.
| Performance Metric Category | Specific Metric | Acceptance Criteria (Implied from K191371 and consistency) | Reported Device Performance (95% CI) for Cyan Fluorescence and P. aeruginosa ≥ 10^4 CFU/g |
|---|---|---|---|
| Detection of Pseudomonas aeruginosa (Pa) at Species Specific Levels ≥ 10^4 CFU/g (Table 2 & 3) | Sensitivity | Clinical utility demonstrated by previous clearance | 43.75% (26.26, 62.34) |
| Specificity | Clinical utility demonstrated by previous clearance | 94.97% (91.96, 97.10) | |
| Positive Predictive Value (PPV) | Clinical utility demonstrated by previous clearance | 46.67% (28.34, 65.67) | |
| Negative Predictive Value (NPV) | Clinical utility demonstrated by previous clearance | 94.38% (91.26, 96.63) | |
| Likelihood Ratio | Clinical utility demonstrated by previous clearance | 8.70 (4.69, 16.14) | |
| Detection of Total Bacterial Load (TBL) at Levels ≥ 10^4 CFU/g (Table 4) | PPV for Cyan FL | Clinical utility demonstrated by previous clearance | 0.967 (0.828, 0.999) |
| Likelihood Ratio for Cyan FL | Clinical utility demonstrated by previous clearance | 6.366 | |
| Detection of TBL at Levels ≥ 10^4 CFU/g in Absence of Pseudomonas aeruginosa (Table 5) | PPV for Cyan FL | Clinical utility demonstrated by previous clearance | 0.938 (0.698, 0.998) |
| Likelihood Ratio for Cyan FL | Clinical utility demonstrated by previous clearance | 3.706 |
Note: The document states "The additional labeling statement does not raise different questions of safety or efficacy. Retrospective analysis has demonstrated the safety and effectiveness of MolecuLight i:X with regards to the additional labeling statement." This implies that the acceptance criteria are met if the performance metrics continue to support the device's utility in identifying bacterial loads and the new labeling is consistent with the observed data.
2. Sample Size and Data Provenance
- Sample Size for Test Set: Data from 350 patients were retrospectively analyzed.
- Data Provenance: The document does not explicitly state the country of origin but refers to "retrospective analysis" of existing clinical study data. Given MolecuLight Inc. is based in Toronto, Canada, and the clinical study was "reported in support of K191371", it is likely the data was collected in either Canada or the US, or potentially a multi-site international study. The study was retrospective.
3. Number of Experts and their Qualifications
The document does not specify the number of experts used to establish the ground truth for the test set, nor does it explicitly state their qualifications. The interpretation of "fluorescence image, when used in combination with clinical signs and symptoms" suggests that the ground truth was established by clinicians based on the convergence of factors, potentially including microbiological culture results (as indicated by CFU/g measurements).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given that the analysis is "retrospective analysis" of existing clinical study data, the ground truth was likely established as part of the original study design.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed for this 510(k) submission. This submission is a "Real-World Data" (retrospective analysis) supporting a labeling change for a previously cleared device, not a new device clearance or a comparative effectiveness study with human readers. The document states: "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 grams as compared to examination of clinical signs and symptoms alone." This sentence refers to a finding from the original K191371 clearance, not a new MRMC study in this submission.
6. Standalone (Algorithm Only) Performance
This device, the MolecuLight i:X, is an imaging tool used by clinicians to view and record images of fluorescence. It is not an AI algorithm that generates a diagnosis or interpretation autonomously. Therefore, a standalone (algorithm only) performance study was not applicable or performed in the context of this 510(k). The device provides visual information (fluorescence images) that clinicians interpret in conjunction with clinical signs and symptoms.
7. Type of Ground Truth Used
The ground truth for the test set appears to be microbiological culture results (bacterial loads measured in CFU/g) combined with clinical assessment. The specific phrases "identify wounds containing bacterial loads >10^4 CFU per grams" and "Pseudomonas aeruginosa at Species Specific Levels ≥ 10^4 CFU/q" clearly indicate that quantitative bacterial culture was the definitive ground truth for bacterial presence and load.
8. Sample Size for the Training Set
The document does not describe a training set in the context of an AI/algorithm. The "study" described is a retrospective analysis of previously collected clinical data to support a labeling claim for a medical device. If there was any machine learning involved (which is not directly implied for this device's function as an imaging tool), that would have been part of the original K191371 submission and is not detailed here.
9. How the Ground Truth for the Training Set was Established
As no training set (in the context of an AI/ML algorithm) is described, this question is not applicable based on the provided document. The device's function described (capturing and displaying fluorescence) implies it is a viewing tool, not an AI-powered diagnostic algorithm requiring a training phase for its output beyond the initial development of its optical and imaging capabilities.
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June 22, 2021
MolecuLight Inc. Jordan John Director, Quality Assurance & Regulatory Affairs Suite 700, 425 University Avenue Toronto, Ontario M5G 1T6 Canada
Re: K210882
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: QJF, FXN Dated: March 24, 2021 Received: March 25, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
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
(i) View and digitally record images of a wound.
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 (iii) 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 grams 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)
□ Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
□ Over-The-Counter Use (21 CFR 801
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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: Jordan John
Date Prepared: June 22, 2021
Name of Device
MolecuLight i:X
Device Classification and Product Code
Autofluorescence detection device, 21 CFR 878.4550, Class II, QJF Tape, Camera, Surqical, 21 CFR 878.4160, Class I, FXN
Predicate Devices
MolecuLight i:X (K191371)
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 (iii) 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.
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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.
Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device
The intended use and technological characteristics of the subject MolecuLight i:X are identical to the previously cleared MolecuLight i:X. The only difference between the subject and predicate device is an additional statement in the device's labeling clarifying the relationship between the presence of a cyan fluorescence signature and the increased likelihood that wound contains Pseudomonas aeruqinosa. This statement does not change the indications for use of the device, and does not raise any new questions of safety or efficacy. The statement is supported by additional analysis of the clinical study reported in support of K191371.
| SUBJECT DEVICEMolecuLight i:X | Predicate DeviceMolecuLight i:X (K191371) | |
|---|---|---|
| Device Name | MolecuLight i:X | 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 devicefor general surgery anddermatological use | Autofluorescence detection devicefor general surgery anddermatological use |
| Intended Use | Intended for general surgery anddermatological use as an adjuncttool that uses autofluorescence todetect tissues or structures. Thisdevice is not intended to provide adiagnosis. | Intended for general surgery anddermatological use as an adjuncttool that uses autofluorescence todetect tissues or structures. Thisdevice is not intended to provide adiagnosis. |
| Indications forUse | The MolecuLight i:X is a handheldimaging tool that allows cliniciansdiagnosing and treating skinwounds, at the point of care, to(i) View and digitally recordimages of a wound,(ii) Measure and digitallyrecord the size of a wound, and | The MolecuLight i:X is a handheldimaging tool that allows cliniciansdiagnosing and treating skinwounds, at the point of care, to(i) View and digitally recordimages of a wound,(ii) Measure and digitallyrecord the size of a wound, and |
| Table 1: Comparison of Technological Characteristics for Fluorescence Imaging | ||
|---|---|---|
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| (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. | (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. | |
|---|---|---|
| Labelled relationship between Cyan fluorescence and Pseudomonas aeruginosa | Yes | No |
| Target Organ | Wounds | Wounds |
| Patient Population | Adult patients | Adult patients |
| Operating Modes | Standard and fluorescence imaging, video and image capture | Standard and fluorescence imaging, video and image capture |
| Excitation Light | 405 nm light emitted from light emitting diodes (LED)s | 405 nm light emitted from light emitting diodes (LED)s |
| Laser Power Density | N/A | N/A |
| Infrared LED | N/A | N/A |
| White LED | N/A | N/A |
| Emission Wavelength | 500-545 nm and 600-665 nm | 500-545 nm and 600-665 nm |
| Contrast agent | Not required - autofluorescent target | Not required - autofluorescent target |
| Working Distance | 8-12 cm | 8-12 cm |
| Resolution (focal plane) | 5 megapixels | 5 megapixels |
| Magnification | N/A | N/A |
| Camera Bit Depth | 8 bits | 8 bits |
| Image Size (Pixels) | 1136 x 640 pixels | 1136 x 640 pixels |
| Image Format | JPEG | JPEG |
| Video Format | MOV | MOV |
| Software Operating System (OS) | Apple iOS 9.3.5 | Apple iOS 9.3.5 |
| Compatibility Measurement Functionality | Wound length, width, and area measurements | Wound length, width, and area measurements |
| Power Supply | Battery and Wall | Battery and Wall |
| Display | Handheld device; no remote display | Handheld device; no remote display |
| Patient Contacting Materials | Non-patient contacting device (held 8-12 cm from skin) | Non-patient contacting device (held 8-12 cm 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 with which the Device Complies | IEC 60601-1-2IEC 60601-1IEC 60601-2-57IEC 62471 | IEC 60601-1-2IEC 60601-1IEC 60601-2-57IEC 62471 |
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In summary, the modified MolecuLight i:X with the additional labeling statement is substantially equivalent to the legally marketed MolecuLight i:X. The intended use of the i:X device is the same as the predicate, and there are no differences in technological characteristics. The additional labeling statement does not raise different questions of safety or efficacy. Retrospective analysis has demonstrated the safety and effectiveness of MolecuLight i:X with regards to the additional labeling statement. Thus, the MolecuLight i:X is substantially equivalent to the previously cleared MolecuLight i:X.
Non-Clinical Testing
No non-clinical performance testing was performed for this 510(k) submission.
Clinical Performance Testing
Data from 350 patients were retrospectively analyzed to evaluate the effectiveness of MolecuLight i:X to identify wounds with Pseudomonas aeruginosa at bacterial loads ≥ 104 CFU/g based on sensitivity, specificity, PPV, NPV, and likelihood ratio.
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Table 2: Cyan Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/q
| FluorescenceSignature | Sensitivity(95% CI)ªn=32 | Specificity(95% CI)ªn=318 | PPVb(95% CI)ªn=30 | NPVb(95% CI)ªn=320 | LikelihoodRatio(95% CI)N=30 |
|---|---|---|---|---|---|
| Cyan | 43.75%(26.26,62.34) | 94.97%(91.96,97.10) | 46.67%(28.34,65.67) | 94.38%(91.26,96.63) | 8.70(4.69, 16.14) |
o aTwo-sided 95% Clopper Pearson Confidence Intervals.
o bThe PPV and NPV are computed for the study prevalence of 9.14%.
-
o Likelihood ratio is the probability of a wound with Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/q being positive for cyan fluorescence divided by the probability of a wound that does not have Pseudomonas aeruginosa at Specific Levels ≥ 104 CFU/q being positive for cyan fluorescence.
Detailed retrospective analysis included assessment for the presence of any i:X fluorescence signature (red and/or cyan), presence of cyan fluorescence, presence of red fluorescence, and total bacterial load (TBL; CFU/g; sum of all species). Results for three separate analyses of the diagnostic parameters are presented below: -
Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ i. 104 CFU/g
-
Fluorescence in the Detection of Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g ii.
-
iii. Fluorescence in the Detection Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g in Absence of Pseudomonas aeruginosa
| Test | Post.Test.Risk (PPV) | Likelihood | ||||
|---|---|---|---|---|---|---|
| Output | Pa.High | Pa.Low | Post.Test.Risk | LowerConfidenceLimit | UpperConfidenceLimit | Ratio |
| Cyan FL | 14 | 16 | 0.467 | 0.283 | 0.657 | 8.695 |
| Red FL | 14 | 145 | 0.088 | 0.049 | 0.143 | 0.959 |
| Red orCyan FL | 25 | 150 | 0.143 | 0.095 | 0.204 | 1.656 |
| Total | 32 | 318 | 0.091 | 0.063 | 0.127 | 1.000 |
Table 3: Cyan, Red, and Cyan or Red Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/g
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Table 4: Cyan, Red, and Cyan or Red Fluorescence in the Detection of Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g
| Post.Test.Risk (PPV) | ||||||
|---|---|---|---|---|---|---|
| TestOutput | TBL.High | TBL.Low | Post.Test.Risk | LowerConfidenceLimit | UpperConfidenceLimit | LikelihoodRatio |
| Cyan FL | 29 | 1 | 0.967 | 0.828 | 0.999 | 6.366 |
| Red FL | 152 | 7 | 0.956 | 0.911 | 0.982 | 4.767 |
| Red orCyan FL | 168 | 7 | 0.960 | 0.919 | 0.984 | 5.268 |
| Total | 287 | 63 | 0.820 | 0.776 | 0.859 | 1.000 |
Table 5: Cyan, Red, and Cyan or Red Fluorescence in the Detection of Wounds with Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g negative for Pseudomonas aeruginosa
| TestOutput | TBL(AbsentPA).High | TBL(AbsentPA).Low | Post.Test.Risk (PPV) | LikelihoodRatio | ||
|---|---|---|---|---|---|---|
| Post.Test.Risk | LowerConfidenceLimit | UpperConfidenceLimit | ||||
| CyanFL | 15 | 1 | 0.938 | 0.698 | 0.998 | 3.706 |
| Red FL | 138 | 7 | 0.952 | 0.903 | 0.980 | 4.871 |
| Red orCyanFL | 143 | 7 | 0.953 | 0.906 | 0.981 | 5.047 |
| Total | 255 | 63 | 0.802 | 0.754 | 0.844 | 1.000 |
Conclusion
The modified MolecuLight i:X is substantially equivalent to the cleared MolecuLight i:X.
§ 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.