(160 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 >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.
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 (FL) imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.
The MolecuLight i:X is a handheld imaging tool that helps clinicians identify wounds containing elevated bacterial loads. The provided text outlines the acceptance criteria and the study that supports the device's claims.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device had to meet for clearance. Instead, it presents performance metrics from a clinical study, which implicitly serve as evidence for addressing the added labeling claims. The key performance metrics are related to the device's ability to guide wound sampling for detecting bacterial burden.
Derived Acceptance Criteria (based on the device's claims and study outcomes) and Reported Device Performance:
| Acceptance Criteria (Implicit from device claims) | Reported Device Performance |
|---|---|
| Clinical Efficacy: Increased likelihood for clinicians to identify wounds with bacterial loads >10^4 CFU/g when using fluorescence imaging vs. clinical signs alone. | Sensitivity to Detect Elevated Bacterial Load ($\ge 10^4$ CFU/g): - SoC-guided sample: 87.2% (95% CI: 77.7%, 93.7%) - FL-guided sample: 98.7% (95% CI: 93.06%, 99.97%) P-value: P = 0.012 (FL-guided sampling was significantly more sensitive) Ability to detect a higher number of bacterial species: - Mean number of species by FL-guided Biopsy: 3.026 (SD 1.667) - Mean number of species by SoC-guided Biopsy: 2.231 (SD 1.528) - Difference: 0.795 (SD 1.804) P-value: P < 0.001 (FL-guided sampling detected significantly more species) Ability to detect a higher number of pathogens of interest (CDC-defined): - Mean number of pathogens of interest by FL-guided Biopsy: 1.731 (SD 1.124) - Mean number of pathogens of interest by SoC-guided Biopsy: 1.423 (SD 1.134) - Difference: 0.308 (SD 0.916) P-value: P = 0.002 (FL-guided sampling detected significantly more pathogens of interest) |
| Non-Clinical Performance: Ability to detect red fluorescence from specific bacterial species in vitro. | All listed bacterial species (not explicitly detailed in the provided text beyond "each species listed") produced red fluorescence that was detectable through fluorescence imaging with the MolecuLight i:X using a custom algorithm. Negative controls were consistently negative. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: Data from a post hoc retrospective analysis of 78 patients were analyzed. The analysis specifically looked at "all wounds that had two samples obtained in the study."
- Data Provenance: The document does not explicitly state the country of origin. The study was a retrospective analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical test set. The ground truth for bacterial load was established through "wound sampling" implying microbiological culture results (CFU/g).
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the clinical test set. Given that the ground truth appears to be based on microbiological culture results from wound samples, an adjudication process by experts, as might be seen for image interpretation consensus, would not be directly applicable for this type of ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, where human readers interpret images with and without AI assistance, was not explicitly described in the provided text. The clinical performance testing focused on comparing the effectiveness of FL-guided wound sampling versus Standard of Care (SoC) guided sampling to detect bacterial burden, rather than a direct comparison of human reader performance with and without AI assistance in image interpretation. The device's role is presented as a tool to guide sampling, not as an AI for image interpretation by clinicians.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The provided information focuses on the device's clinical utility in guiding sampling with a clinician in the loop. While the device itself processes images to show fluorescence, its performance is evaluated in the context of improving a clinical procedure (wound sampling), not as a standalone diagnostic algorithm for automated interpretation. The non-clinical testing mentions a "custom algorithm" to detect red fluorescence, which implies standalone analytical capability, but this is distinct from clinical diagnostic performance.
7. The Type of Ground Truth Used
- Clinical Performance Testing: The ground truth for bacterial load was established by microbiological culture results from wound samples, quantified as Colony Forming Units (CFU) per gram (CFU/g). Specifically, "bacterial loads >10^4 CFU per gram" were the key threshold. Pathogen identification was also a part of the ground truth.
- Non-Clinical Testing: The ground truth for demonstrating red fluorescence production for specific bacterial species was based on sub-culturing on Porphyrin Test Agar (PTA) and direct observation of fluorescence using the MolecuLight i:X.
8. The Sample Size for the Training Set
The document primarily discusses a retrospective analysis for clinical validation and in-vitro testing. It does not mention a separate training set size for any specific AI/algorithm development, as the device's core functionality appears to be based on known autofluorescence properties of bacteria rather than a deep learning model trained on large datasets for complex pattern recognition. The study mentioned ([K191371](https://510k.innolitics.com/search/K191371)) was used to support subsequent claims, implying this may have provided data for initial claims.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set for a machine learning algorithm is detailed, the method for establishing ground truth for such a set is not provided. The non-clinical testing described involves culturing specific bacterial species to verify their autofluorescent properties, which would serve as a 'ground truth' for the physical principle the device leverages.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2022
MolecuLight, Inc. Jordan John Director. Quality Assurance & Regulatory Affairs Suite 700, 425 University Avenue Toronto, Ontario M5G 1T6 Canada
Re: K213840
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
Dear Jordan John:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 18, 2022. Specifically, FDA is updating this SE Letter as an administrative correction for an inappropriate product code that does not categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Office of Surgical and Infection Control Devices at 301-796-7674 Jianting Wang, or Jianting.wang(@fda.hhs.gov.
Sincerely,
Digitally signed by Jianting Wang
Jianting Wang -S
Date: 2022.07.20 11:11:28 -04'00'
Jianting Wang 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
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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 18, 2022
MolecuLight, Inc. Jordan John Director. Quality Assurance & Regulatory Affairs Suite 700, 425 University Avenue Toronto, Ontario M5G 1T6 Canada
Re: K213840
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: QDG, QJF Dated: April 13, 2022 Received: April 20, 2022
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 mav, 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.
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
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Page 2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) 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 U. Pandya -S
Purva Pandya, D.Eng. 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) K213840
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,
(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 >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.
| 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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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: May 13, 2022
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
MolecuLight i:X (K210882)
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)
(ii) Measure and digitally record the size of a wound, and
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 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 (FL) 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 I. identical to the previously cleared MolecuLight i.X. The only difference between the subject and predicate device are additional statements in the device's labeling clarifying: i) that the fluorescence in a region of a wound corresponds to the presence of elevated bacterial loads (>104 CFU/g); ii) that fluorescence in a region of a wound corresponds to the presence of more bacterial species and bacterial species of interest; iii) that species that produce red fluorescence is detectable by the MolecuLight i.X in vitro; iv) that Gram(+), Gram(-), aerobic and anaerobic species produce fluorescence detected by the MolecuLight i:X.
These statements do 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 DEVICE | Predicate Device | |
|---|---|---|
| MolecuLight i:X | MolecuLight i:X (K210882) | |
| Device Name | MolecuLight i:X | MolecuLight i:X |
| Manufacturer | MolecuLight Inc. | MolecuLight Inc. |
| 510(k) Number | - | K191371 |
| Regulatory Class | Class II | Class II |
| Regulation Number | QJF | QJF |
| Product Classification | 21 CFR 878.4550 | 21 CFR 878.4550 |
| Classification Name | 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 toolthat uses autofluorescence to detecttissues or structures. This device is notintended to provide 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 for Use | The MolecuLight i:X is a handheldimaging tool that allows cliniciansdiagnosing and treating skin wounds,at the point of care, to(i) View and digitally recordimages of a wound. | The MolecuLight i:X is a handheldimaging tool that allows cliniciansdiagnosing and treating skin wounds,at the point of care, to(i) View and digitally recordimages of a wound. |
| Table 1: Comparison of Technological Characteristics for Fluorescence Imaging | ||||||
|---|---|---|---|---|---|---|
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| SUBJECT DEVICEMolecuLight i:X | Predicate DeviceMolecuLight i:X (K210882) | |
|---|---|---|
| (ii) Measure and digitally recordthe size of a wound, and(iii) View and digitally recordimages of fluorescence emitted from awound when exposed to an excitationlight. | (ii) Measure and digitally recordthe size of a wound, and(iii) View and digitally recordimages of fluorescence emitted from awound when exposed to an excitationlight. | |
| The fluorescence image, when used incombination with clinical signs andsymptoms, has been shown to increasethe likelihood that clinicians canidentify wounds containing bacterialloads >104 CFU per gram as comparedto examination of clinical signs andsymptoms alone. The MolecuLighti:X device should not be used to rule-out the presence of bacteria in awound.The MolecuLight i:X does notdiagnose or treat skin wounds. | The fluorescence image, when used incombination with clinical signs andsymptoms, has been shown to increasethe likelihood that clinicians canidentify wounds containing bacterialloads >104 CFU per gram as comparedto examination of clinical signs andsymptoms alone. The MolecuLighti:X device should not be used to rule-out the presence of bacteria in awound.The MolecuLight i:X does notdiagnose or treat skin wounds. | |
| Labelled relationshipbetween Cyanfluorescence andPseudomonasaeruginosa | Yes | Yes |
| Labelled relationshipbetween region of awound and presence ofelevated bacterialloads (>104 CFU/g) | Yes | No |
| Labelled relationshipbetween fluorescencein a region of a woundand the presence ofmore bacterial speciesand bacterial species ofinterest | Yes | No |
| Labelled relationshipbetween species thatproduce redfluorescence and redfluorescence signature | Yes | No |
| Labelled relationshipbetween fluorescenceimaging andidentifying woundswith elevated bacterialload including Gram | Yes | No |
| SUBJECT DEVICEMolecuLight i:X | Predicate DeviceMolecuLight i:X (K210882) | |
| (+) Gram (-), aerobicand anaerobic species. | ||
| 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 |
| Maximum Frame Rate | 30 images/sec | 30 images/sec |
| 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)Compatibility | Apple iOS 9.3.5 | Apple iOS 9.3.5 |
| 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 |
| Shelf-Life | 2 Years | 2 Years |
| Lifetime | 5 Years | 5 Years |
| 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 statements 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 statements do 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 statements. Thus, the MolecuLight i:X is substantially equivalent to the previously cleared MolecuLight i:X.
Non-Clinical Testing
Each species listed produced red fluorescence that was detectable through fluorescence imaging with the MolecuLight i:X. To demonstrate this, all species were sub-cultured from frozen isolated on commercially available Porphyrin Test Agar (PTA). Porphyrins fluoresce red under violet light illumination. Aerobic bacterial species were cultured and imaged at 24 and 40 hours, while slower growing anaerobic bacterial species were cultured and imaged at 40 and 120 hours. Negative controls were included and imaged at all time points. The fluorescence images taken with the MolecuLight i:X of each bacterial species were analyzed to determine the presence of red fluorescence using a custom algorithm.
Clinical Performance Testing
Data from post hoc retrospective analysis of 78 patients were analyzed to evaluate the effectiveness of MolecuLight i:X to guide wound sampling to detect bacterial burden, including pathogens of interest, as defined by the CDC, compared to the Standard of Care (SoC) method of sampling, which is collected from the center of the wound.
Data from all wounds that had two samples obtained in the study were analyzed (N = 78). Samples targeted to the brightest location of fluorescence (FL-guided) were more likely to contain elevated bacterial load (≥ 10ª CFU/g) compared to SoC-guided sampling at the center of the wound (See Table 2).
Table 2: Sensitivity of Soc-Guided Biopsy and FL-Guided Biopsy to Detect Any Species at Levels ≥ 104 CFU/G in Patients with Two Biopsies Obtained
| SoC-guided sample | FL-guided sample | P-value | |
|---|---|---|---|
| Sensitivity | 87.2%(95% CI: 77.7%, 93.7%) | 98.7%(95% CI: 93.06%, 99.97%) | P = 0.012 |
Fluorescence-guided biopsies detected a higher number of species compared to SoC-guided biopsies as described in Table 3.
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| Number of Speciesby FL-guided Biopsy(N=78) | Number of Speciesby SoC-guidedBiopsy(N=78) | DifferenceinNumberofPathogens(FLBiopsy # -SoCBiopsy #) | P-value(paired t-test) | 95%ConfidenceInterval | |
|---|---|---|---|---|---|
| Mean (SD) | 3.026 (1.667) | 2.231 (1.528) | 0.795(1.804) | P<0.001 | 0.388,1.202 |
| Med (Min,Max) | 3.0 (0.0, 8.0) | 2.0 (0.0, 6.0) |
Table 3: Count of Bacterial Species Detected by SoC and FL-guided Biopsies
FL-guided biopsies detected a higher number of pathogens of interest, defined by the CDC as increasing risk to develop antibiotic resistance, compared to SoC-guided biopsies as described in Table 4.
| Table 4: Count of pathogens of interest detected by SoC and FL-guided biopsies | |||
|---|---|---|---|
| -- | -- | -- | -------------------------------------------------------------------------------- |
| Number ofPathogens ofInterestby FL-guidedBiopsy(N=78) | Number of Pathogensof Interestby SoC-guidedBiopsy(N=78) | DifferenceinNumberofPathogensof Interest(FLBiopsy # -SoCBiopsy #) | P-value(pairedt-test) | 95%ConfidenceInterval | |
|---|---|---|---|---|---|
| Mean (SD) | 1.731(1.124) | 1.423(1.134) | 0.308(0.916) | P=0.002 | 0.101,0.514 |
| Med (Min,Max) | 2.0 (0.0, 5.0) | 1.0 (1.0, 5.0) |
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.