(122 days)
No
The device description explicitly states "There is limited firmware capability within the sensor which simply enables the LEDs to turn on when a video feed from the camera is requested by the PC. The device functions with any Off-the-shelf (OTS) software with a camera display capability." This indicates a simple hardware device with no complex processing or AI/ML capabilities. The software mentioned is for basic camera display, not advanced analysis.
No.
The device is used for examination and tissue sampling, which are diagnostic procedures, not therapeutic ones.
Yes
Explanation: The device is intended to be used to examine the rectum and perform tissue sampling, which are activities related to gathering information for a clinical assessment. Although it's stated that the device does not determine a final diagnosis without further confirmatory tests, its purpose is to provide visual information and enable sample collection, which are diagnostic activities.
No
The device description clearly states it is a "re-usable handheld rigid endoscope" with physical components like LEDs, a CMOS sensor, a camera tube, and a cable. While it uses software for image display, it is fundamentally a hardware device with embedded software.
Based on the provided information, the LumenEye® X1 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The LumenEye® X1 is a device used to directly visualize the rectum within the body. It does not process or analyze biological samples like blood, urine, or tissue outside the body.
- The intended use is direct examination and tissue sampling in situ. The device is used to look inside the rectum and, with accessories, take tissue samples. The analysis of these tissue samples would be done separately, likely in a laboratory, which would involve IVD procedures, but the LumenEye® X1 itself is the tool for obtaining the sample and performing the visual examination.
- The device description focuses on imaging and mechanical function. The description details the camera, lighting, power, and physical characteristics of the endoscope. It does not mention any components or processes related to the analysis of biological samples.
In summary, the LumenEye® X1 is a medical device used for direct visualization and sample collection within the body, not for the in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
The LumenEye® X1 device is intended to be used to examine the rectum, and using additional accessories, perform tissue sampling of the rectum, if required.
The LumenEye® X1 can enable suitably trained healthcare professionals in clinical environments, when used in conjunction with other tests, to examine the rectum as part of a clinical assessment in adults.
The LumenEye® X1 is not intended to determine a final clinical diagnosis without further confirmatory tests. Following examination, the healthcare practitioner may make recommendations for further investigations as appropriate.
Product codes
FAN
Device Description
The LumenEye" X1 is a re-usable handheld rigid endoscope that permits insufflation of the rectum and endoluminal high-definition video capture to enable an examination of the rectum (Figure 1). The device has no lumens or channels within the reusable elements of the handle.
The area of interest is illuminated by a distally mounted ring of LEDs which emit white light (5300K). Light reflected from the subject is captured by the HD CMOS sensor. The LEDs and camera sensor are housed in the distal end of a stainless-steel camera tube. The image is transferred via USB protocol to a PC and displayed on a screen. There is limited firmware capability within the sensor which simply enables the LEDs to turn on when a video feed from the camera is requested by the PC. The device functions with any Off-the-shelf (OTS) software with a camera display capability. The full HD CMOS camera provides 1080p, 90° field of view and a frame rate of 60 frames per second. The camera enclosure is IP67 rated.
The device features a 1.8m long PVC cable and is powered via USB 3.0 Type-A connection (maximum input voltage 5V, rated current 500mA).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
White Light Imaging
Anatomical Site
rectum
Indicated Patient Age Range
adults
Intended User / Care Setting
suitably trained healthcare professionals in clinical environments
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data
The LumenEye® X1 has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards. Testing has been conducted as per IEC60601-1, IEC 60601-1-2, IEC 62471, and ISO 10993. Risk analysis was carried out in accordance with ISO 14971:2019. Design verifications tests and acceptance criteria were defined and performed as a result of this risk analysis assessment. Verification bench testing of the LumenEye® X1 was performed including operational and functional testing, to ensure that the subject device meets the design specifications and performs as intended. These following performance data provided in support of the substantial equivalence determination.
Optical Testing
Optical properties including signal to noise ratio, spatial resolution (Modulation Transfer Function, MTF), distortion, liqht distribution, and spectral distribution were measured for the Lumen Eye X1's HD CMOS camera. All results show that there are no differences between the subject and the reference device.
Reprocessing Validation
Simulated use testing, pre-cleaning, cleaning, rinsing and sterilization studies of the Lumen Eye X1 were conducted and confirmed the effectiveness of reprocessing procedures in accordance with FDA's 2015 Final Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling ("FDA's 2015 Reprocessing Guidance") and ISO 17664:2017. Acceptance criteria were established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency. Acceptance criteria were met after each phase of reprocessing. Note that sterilization is performed using the V-PRO maX 2 method and replaces high level disinfection as the Lumen Eye X1 endoscope cannot be fully immersed in liquid.
Biocompatibility
Biocompatibility of direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization and intracutaneous reactivity of the surface device with limited (less than 24 hours) contact with mucosal membrane in accordance with ISO 10993-1, 5, and 10: Biological Evaluation of Medical Devices.
Software
Software verification and validation testing were 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 level of concern is "Moderate".
Cybersecurity risks have been assessed and mitigated according to the FDA Guidance for Industry and Staff "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
EMC and Electrical Safety
The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the Lumen Eye X1 were confirmed by the following standards:
-IEC 60601-1 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AMD1 (2012)
-IEC 60601-1-2:2014 (4th Edition) -
IE C 60601-2-18:2009
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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November 30, 2023
SurgEase Innovations Limited Roger Parker Head of Hardware Engineering Pendle Innovation Centre, Brook Street Nelson Lancashire, BB9 9PU United Kingdom
Re: K232262
Trade/Device Name: LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FAN Dated: October 10, 2023 Received: October 16, 2023
Dear Roger Parker:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
LumenEye® X1 endoscope (LX1-SCP-203);
LumenEye® X1 consumables (LX1-CSB-201);
LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
Indications for Use (Describe)
The LumenEye® X1 device is intended to be used to examine the rectum, and using additional accessories, perform tissue sampling of the rectum, if required.
The LumenEye® X1 can enable suitably trained healthcare professionals in clinical environments, when used in conjunction with other tests, to examine the rectum as part of a clinical assessment in adults.
The LumenEye® X1 is not intended to determine a final clinical diagnosis without further confirmatory tests. Following examination, the healthcare practitioner may make recommendations for further investigations as appropriate.
Type of Use (Select one or both, as applicable)
X 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. All data included in this document is accurate and complete to the best of SurgEase Innovations' knowledge.
1. Device Details
| Applicant: | SurgEase Innovations Ltd.
Pendle Innovation Centre
Brook Street, Nelson
Lancashire, UK
BB9 9PU |
| ------------ | ------------------------------------------------------------------------------------------------------------ |
|---|
- Roger Parker Contact: Head of Hardware Email: roger.parker@surgease.co.uk Mobile: +44 (0) 7793054510
- Date Prepared: 2023-Jul-31
- Common Name: Rectoscope (Rigid)
- Trade names: LumenEye® X1 Endoscope LumenEye® X1 Consumable Pack LumenEye® X1 Consumable Carton (25 Sets)
- Model Number: LumenEye® X1 Endoscope: LX1-SCP-203 LumenEye® X1 Consumable Pack: LX1-CSB-201 LumenEye® X1 Consumable Carton (25 Sets): LX1-CSP-201
| Regulation Number: | 21 CFR Part 876.1500 |
|---|---|
| Regulation Name: | Endoscopes and Accessories |
| Regulatory Class: | Class II |
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LumenEye® X1 FDA 510(k) – Administrative Documentation – 510(k) Summary
AD001 Ver. 1
| Product Code: | FAN - Sigmoidoscope, electric, rigid. |
|---|---|
| Medical Speciality: | Gastroenterology/Urology |
| Predicate Device: | SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 |
| Manufacturer: | Welch Allyn, Inc., United States |
| 510(K) Number: | K770291 |
| Reference device: | PENTAX Medical VIVIDEO ENT Videoscope Solution, VNL9-CF |
| Manufacturer: | Pentax Medical |
| 510(K) Number: | K171011 |
2. Device Description
The LumenEye" X1 is a re-usable handheld rigid endoscope that permits insufflation of the rectum and endoluminal high-definition video capture to enable an examination of the rectum (Figure 1). The device has no lumens or channels within the reusable elements of the handle.
Image /page/5/Figure/7 description: The image shows a LumenEye device, which is a medical instrument used for eye examinations. The device has a white and blue color scheme, with a cylindrical probe extending from the front. The handle is ergonomically designed for a comfortable grip, and a cable is attached to the rear, suggesting it is powered by an external source.
Figure 1 | Image of device assembled with sheath and obturator attached.
The area of interest is illuminated by a distally mounted ring of LEDs which emit white light (5300K). Light reflected from the subject is captured by the HD CMOS sensor. The LEDs and camera sensor are housed in the distal end of a stainless-steel camera tube. The image is transferred via USB protocol to a PC and displayed on a screen. There is limited firmware capability within the sensor which simply enables the LEDs to turn on when a video feed from the camera is requested by the PC. The device functions with any Off-the-shelf (OTS) software with a camera display capability. The full HD CMOS camera provides 1080p, 90° field of view and a frame rate of 60 frames per second. The camera enclosure is IP67 rated.
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The device features a 1.8m long PVC cable and is powered via USB 3.0 Type-A connection (maximum input voltage 5V, rated current 500mA).
3. Indications for Use
The LumenEye® X1 device is intended to be used to examine the rectum, and using additional accessories, perform tissue sampling of the rectum, if required.
The LumenEye® X1 can enable suitably trained healthcare professionals in clinical environments, when used in conjunction with other tests, to examine the rectum as part of a clinical assessment in adults.
The LumenEye® X1 is not intended to determine a final clinical diagnosis without further confirmatory tests. Following examination, the healthcare practitioner may make recommendations for further investigations as appropriate.
4. Summary of Technological Characteristics
The LumenEye® X1 is substantially equivalent to the predicate device. The subject and predicate share the same intended use and the indicated patient population and anatomical site for the subject device are also identical. However, there are some differences in technological characteristics, as summarised in Table 1.
The major difference between the subject device and predicate device is that the LumenEye® X1 is a device with a HD camera allowing HD digital visualisation of the rectum, whereas the predicate provides a method for direct viewing of the rectum via a proximally placed viewing window. Owing to the differences between the subject and predicate device (i.e. analogue versus digital visualisation), a reference device with a similar technological profile was selected (PENTAX Medical VIVIDEO ENT Videoscope Solution, Model VNL9-CP). The technical (optical) specifications of the chosen reference device closely match those of the subject device.
While there are some differences in the dimensional specifications in the subject device, these differences have been evaluated through performance testing and raise no issue of
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AD001 Ver. 1
safety and effectiveness of the subject device as these differences have no effect on the performance, function or general intended use of the device.
| | Subject
Device | Predicate
Device | Reference
Device |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Indications For
Use | Used to examine
the rectum, and
using additional
accessories,
perform tissue
sampling of the
rectum, if required. | Used to examine the
rectum and lower bowel,
and using additional
accessories, perform
various diagnostic and/or
therapeutic procedures. | N/A |
| Reusable | Yes | Yes | N/A |
| Reprocessing | Manual cleaning
Sterilisation (V-PRO
maX 2)¹ | Manual cleaning
Intermediate Level
Disinfection | N/A |
| Power Source | 5V (USB-A
connection to
PC/Laptop) | 3.5V (Battery) | N/A |
| Material | Endoscope Handle:
PC+ABS
Sheath and
Obturator:
Polypropylene
Endoscope Camera
Stalk: SS 316L | Sigmoidoscope Handle:
Stainless Steel
Obturator: Plastic | N/A |
| | Subject
Device | Predicate
Device | Reference
Device |
| Insufflation | Insufflation Bulb
(integrated)
Single use filter | Insufflation Bulb
(separate)
Single use filter | N/A |
| Diameter
(Sheath) | 19mm | 19mm | N/A |
| Length
(Sheath) | 20cm | 25cm | N/A |
| Integrated LED | Yes (tip) | No (Halogen light) | Yes (tip) |
| Imaging
Technology | White Light Imaging | N/A | White Light
Imaging |
| Depth of Field | 40mm | N/A | 5-50mm |
| Field of View | 90° | N/A | 90° |
| MTF50 | 0.12 (@40mm)
[cycle/mm] | N/A | 3.58 (@30mm)
[cycle/mm] |
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Image /page/8/Picture/1 description: The image shows the logo for SurgEase Innovations. The logo consists of a stylized eye symbol on the left, followed by the text "SurgEase" in a larger, bolder font. Below "SurgEase" is the word "INNOVATIONS" in a smaller, thinner font. The logo is in a dark blue color and is set against a white background.
AD001 Ver. 1
Table 1 | Comparison table of technological characteristics between subject, predicate and reference devices.
Note 1: Recommended by the FDA
5. Non-Clinical Performance Data
The LumenEye® X1 has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards. Testing has been conducted as per IEC60601-1, IEC 60601-1-2, IEC 62471, and ISO 10993. Risk analysis was carried out in accordance with ISO 14971:2019. Design verifications tests and acceptance criteria were defined and performed as a result of this risk analysis assessment. Verification bench testing of the LumenEye® X1 was performed including operational and functional testing, to ensure that the subject device meets the design specifications and performs as intended. These following performance data provided in support of the substantial equivalence determination.
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Image /page/9/Picture/1 description: The image shows the logo for SurgEase Innovations. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a blue circle with a stylized eye in the center. The company name is also in blue, with the word "SurgEase" in a larger font than the word "Innovations" which is located below and to the right of "SurgEase".
AD001 Ver. 1
Optical Testing
Optical properties including signal to noise ratio, spatial resolution (Modulation Transfer Function, MTF), distortion, liqht distribution, and spectral distribution were measured for the Lumen Eye X1's HD CMOS camera. All results show that there are no differences between the subject and the reference device.
Reprocessing Validation
Simulated use testing, pre-cleaning, cleaning, rinsing and sterilization studies of the Lumen Eye X1 were conducted and confirmed the effectiveness of reprocessing procedures in accordance with FDA's 2015 Final Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling ("FDA's 2015 Reprocessing Guidance") and ISO 17664:2017. Acceptance criteria were established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency. Acceptance criteria were met after each phase of reprocessing. Note that sterilization is performed using the V-PRO maX 2 method and replaces high level disinfection as the Lumen Eye X1 endoscope cannot be fully immersed in liquid.
Sterilization and Shelf Life
Shelf-life is not applicable to the subject device and consumables as they are not provided sterile as they are indicated for use in an anatomical region inherently contaminated (high burden of microbes), and therefore the risk of harm is negligible. Furthermore, the predicate device is not provided sterile. Additionally, shelf-life is not applicable to the subject device and consumables because the materials do not degrade significantly over time (i.e. performance is unaffected).
Biocompatibility
Biocompatibility of direct and indirect contact materials was confirmed by assessing the cytotoxicity, sensitization and intracutaneous reactivity of the surface device with limited
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(less than 24 hours) contact with mucosal membrane in accordance with ISO 10993-1, 5, and 10: Biological Evaluation of Medical Devices.
Software
Software verification and validation testing were 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 level of concern is "Moderate".
Cybersecurity risks have been assessed and mitigated according to the FDA Guidance for Industry and Staff "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
EMC and Electrical Safety
The acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) for the Lumen Eye X1 were confirmed by the following standards:
- -IEC 60601-1 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AMD1 (2012)
- IEC 60601-1-2:2014 (4th Edition) -
- -IEC 60601-2-18:2009
6. Substantial Equivalence Discussion
After analysing the intended use, indications for use, technological characteristics (including fundamental operating principle, energy source, scientific technology, functional characteristics, design features, performance characteristics, and constituent materials), labelling, and sterilization method, we conclude that the subject device is as safe and effective as the predicate device. The differences in indications and intended use between the subject and predicate devices, do not raise new concerns of safety and effectiveness and are therefore, substantially equivalent. The technological differences in terms of design features, performance characteristics and constituent materials are not substantive.
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LumenEye® X1 FDA 510(k) – Administrative Documentation – 510(k) Summary AD001 Ver. 1
7. Conclusion
It can be concluded that the LumenEye X1® is substantially equivalent to the predicate Welch Allyn disposable sigmoidoscope with respect to the intended use, principles of operation and technical characteristics.