(30 days)
Not Found
No
The document describes standard image processing for converting sensor data to video output and controlling light exposure, but there is no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.
Yes
The device is described as being used for "performing diagnostic and surgical procedures," and its indications for use include various operative hysteroscopy procedures like polypectomy and endometrial ablation, which are therapeutic interventions. Additionally, for cystoscopy, it states that "the System allows the user to perform various diagnostic and therapeutic procedures".
Yes
The device is indicated for "direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures" and "endoscopic access to and examination of the lower urinary tract, including the bladder... to perform various diagnostic and therapeutic procedures." The document also lists "Generally recognized indications for diagnostic hysteroscopy," which include conditions the device helps to evaluate, such as "Abnormal bleeding" and "Infertility and pregnancy wastage."
No
The device description clearly outlines multiple hardware components including a hysteroscope with integrated sensor and light source, a disposable sheath, a communication cable, and a control hub. While software is mentioned for image processing and control, it is an integral part of a larger hardware system.
Based on the provided information, the Luminelle DTx Hysteroscopy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used for "direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures" and "endoscopic access to and examination of the lower urinary tract, including the bladder." These are procedures performed in vivo (within the living body) for visualization and intervention.
- Device Description: The device components are designed for endoscopic visualization and surgical access (scope, sheath with operative channel, fluid management). There is no mention of components or processes that analyze biological samples in vitro (outside the living body).
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Luminelle DTx System does not perform this function. It provides visual information directly from within the body.
The device is an endoscopic system used for visualization and surgical procedures within the body. While it is used for diagnostic purposes (e.g., evaluating abnormal bleeding, infertility), the diagnosis is made based on the visual information obtained in vivo, not through the analysis of a biological sample in vitro.
N/A
Intended Use / Indications for Use
Hysteroscopy: The Luminelle DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include: Abnormal bleeding, Infertility and pregnancy wastage, · Evaluation of abnormal hysterosalpingogram, · Intrauterine foreign body, · Amenorrhea, · Pelvic pain. Generally recognized indications for operative hysteroscopy include: · Directed endometrial biopsy, · Polypectomy, Submucous myomectomy, · Transection of intrauterine adhesions, · Transection of intrauterine septa, · Endometrial ablation. Cystoscopy: The Luminelle DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
FAJ, HIH
Device Description
The Luminelle DTx Hysteroscopy System is comprised of four components: 1) Luminelle DTx Hysteroscope - a non-sterile, reusable flexible hysteroscope with an integrated light source, light fiber bundle and CMOS sensor. 2) The Luminelle DTx 360° Rotatable Disposable Sheath - a sterile, two-part sheath installed over the insertion tube of the Hysteroscope and comprised of the Operative Introducer and the 360° RotoSheath. The Operative Introducer contains an operative channel for inserting surgical accessories, two fluid management lines (inflow/outflow), and a channel to protect the scope insertion tube. The 360° RotoSheath allows for rotational positioning of the camera and provides rigidity to the Scope/Introducer assembly. 3) Luminelle Communication Cable - a cable that provides both the power to the hysteroscope and transmits the image. 4) Luminelle Control Hub - the main power supply, image converter and visualization connection. The Control Hub has both HDMI and USB connectors for connection to a monitor and/or a PC. USB and HDMI cables are provided in the package. The Luminelle DTx Hysteroscope, Communication Cable, Control Hub, USB and HDMI cables and power cord are provided together in a single package. The 360° Rotatable Disposable Sheath is provided in a separate sterile package. The 360º Rotatable Disposable Sheath is required for use with the Hysteroscope, therefore it is a component of the system and not an accessory to the system. The CMOS sensor and fiber optic illumination bundles are contained in the Hysteroscope Insertion Tube. The insertion tube length is 29.8 cm (11.73 in.) and the outside diameter is 1.95 mm (0.077 in.). The Luminelle DTx Hysteroscope is packaged in a white form fit tray with a clear slide-on cover. The tray is made of high-impact polystyrene (HIPS). The clear cover is made of polyethylene terephthalate with glycol (PETG). The Luminelle 360° RotoSheath has a working length of 24.0 cm (9.45 in.) with an outside diameter of 5.7 mm (0.244 in.). The Luminelle Operative Introducer has an outside diameter of 4.8 mm (0.189 in.) and the inside diameter of the operative channel is 1.85 mm (0.073 in.). Both the Luminelle 360º RotoSheath and Luminelle Operative Introducer are supplied as a single assembled unit packaged in a bottom tray with retaining lid made of polyethylene terephthalate with glycol (PETG) and sealed with Tyvek. The assembled package is sterilized using ethylene oxide (EO). The Control Hub supplies power to the Hysteroscope via a reusable Communication Cable. The CMOS sensors have a processor that converts the visual image into data to be transferred. A processor in the Control Hub converts this image data into streaming HDMI language, takes still images when the button is pushed, and also controls the light exposure during changing light conditions. Visualization on a video monitor is provided via a HDMI cable, and image transfer to a PC is provided via a Type A USB cable. A 12V DC, 3A power adapter is also provided. Technical specifications for these reusable components are provided in the Instructions for Use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and uterine cavity; lower urinary tract, including the bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing was performed to verify that the performance of the Luminelle DTx Hysteroscopy System is substantially equivalent to currently marketed Cogentix scope (K072180). Testing included: optical resolution per ISO 8600, biocompatibility per ISO 10993 including cytotoxicity, sensitization, and irritation, electrical and thermal safety per IEC 60601-1, electromagnetic compatibility per IEC 60601-1-2, endoscope specific safety and performance per IEC 60601-2-18, usability, reprocessing validation per FDA reprocessing guidance, sterilization validation per ISO 11135, shelf life and packaging validation, software validation per FDA software guidance for moderate level of concern. Overall Conclusions: The Luminelle DTx Hysteroscopy System has been shown to be substantially equivalent to the predicates
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2018
UVision360 Inc. % Dave Yungvirt Official Correspondent Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K181909
Trade/Device Name: Luminelle DTx Hysteroscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FAJ, HIH Dated: July 14, 2018 Received: July 17, 2018
Dear Dave Yungvirt:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell -S
for
Benjamin R. Fisher. Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181909
Device Name
Luminelle DTx Hysteroscopy System
Indications for Use (Describe)
Hysteroscopy: The Luminelle DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery.
Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal bleeding
- Infertility and pregnancy wastage
- · Evaluation of abnormal hysterosalpingogram
- · Intrauterine foreign body
- · Amenorrhea
- · Pelvic pain
Generally recognized indications for operative hysteroscopy include:
- · Directed endometrial biopsy
- · Polypectomy
- Submucous myomectomy
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa
- · Endometrial ablation
Cystoscopy: The Luminelle DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.
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)
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3
| Date Summary
| Prepared: | August 15, 2018 | |
|---|---|---|
| 510(k) Owner: | UVision360 Inc. | |
| Contact Person: | Allison London Brown | |
| CEO, UVision360 Inc. | ||
| 4441-106 Six Forks Road, #179 | ||
| Raleigh, NC 27609 | ||
| Device Name: | Trade Name: | Luminelle DTx Hysteroscopy System |
| Common Name: | Hysteroscope (and accessories); Cystoscope | |
| (and accessories) | ||
| Regulation: | 876:1500 Endoscope and accessories | |
| Class: | II | |
| Product Code: | FAJ, HIH | |
| Predicate Device(s): | Primary | |
| Predicate | K072180 Cogentix Flexible Video Cystoscope | |
| with Digital Video Processor and Disposable | ||
| EndoSheath Systems | ||
| Secondary | ||
| Predicate | K071127 Vision-Sciences Flexible Cystoscope | |
| with EndoSheath System (with additional | ||
| Hysteroscope Indications for use) | ||
| The predicate devices have not been subject to a | ||
| design related recall. | ||
| Device Description: | The Luminelle DTx Hysteroscopy System is comprised of four | |
| components: | ||
| 1) Luminelle DTx Hysteroscope - a non-sterile, reusable flexible | ||
| hysteroscope with an integrated light source, light fiber bundle and | ||
| CMOS sensor. | ||
| 2) The Luminelle DTx 360° Rotatable Disposable Sheath - a sterile, | ||
| two-part sheath installed over the insertion tube of the Hysteroscope | ||
| and comprised of the Operative Introducer and the 360° RotoSheath. | ||
| The Operative Introducer contains an operative channel for inserting | ||
| surgical accessories, two fluid management lines (inflow/outflow), | ||
| and a channel to protect the scope insertion tube. The 360° | ||
| RotoSheath allows for rotational positioning of the camera and | ||
| provides rigidity to the Scope/Introducer assembly. | ||
| 3) Luminelle Communication Cable - a cable that provides both the | ||
| power to the hysteroscope and transmits the image. | ||
| 4) Luminelle Control Hub - the main power supply, image converter | ||
| and visualization connection. The Control Hub has both HDMI and |
510(k) Summary
4
USB connectors for connection to a monitor and/or a PC. USB and HDMI cables are provided in the package.
The Luminelle DTx Hysteroscope, Communication Cable, Control Hub, USB and HDMI cables and power cord are provided together in a single package. The 360° Rotatable Disposable Sheath is provided in a separate sterile package. The 360º Rotatable Disposable Sheath is required for use with the Hysteroscope, therefore it is a component of the system and not an accessory to the system.
The CMOS sensor and fiber optic illumination bundles are contained in the Hysteroscope Insertion Tube. The insertion tube length is 29.8 cm (11.73 in.) and the outside diameter is 1.95 mm (0.077 in.). The Luminelle DTx Hysteroscope is packaged in a white form fit tray with a clear slide-on cover. The tray is made of high-impact polystyrene (HIPS). The clear cover is made of polyethylene terephthalate with glycol (PETG).
The Luminelle 360° RotoSheath has a working length of 24.0 cm (9.45 in.) with an outside diameter of 5.7 mm (0.244 in.). The Luminelle Operative Introducer has an outside diameter of 4.8 mm (0.189 in.) and the inside diameter of the operative channel is 1.85 mm (0.073 in.).
Both the Luminelle 360º RotoSheath and Luminelle Operative Introducer are supplied as a single assembled unit packaged in a bottom tray with retaining lid made of polyethylene terephthalate with glycol (PETG) and sealed with Tyvek. The assembled package is sterilized using ethylene oxide (EO).
The Control Hub supplies power to the Hysteroscope via a reusable Communication Cable. The CMOS sensors have a processor that converts the visual image into data to be transferred. A processor in the Control Hub converts this image data into streaming HDMI language, takes still images when the button is pushed, and also controls the light exposure during changing light conditions.
Visualization on a video monitor is provided via a HDMI cable, and image transfer to a PC is provided via a Type A USB cable. A 12V DC, 3A power adapter is also provided. Technical specifications for these reusable components are provided in the Instructions for Use.
Indications for Use Statement: Hysteroscopy: The Luminelle DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery.
5
Generally recognized indications for diagnostic hysteroscopy include:
- . Abnormal bleeding
- . Infertility and pregnancy wastage
- Evaluation of abnormal hysterosalpingogram
- Intrauterine foreign body ●
- . Amenorrhea
- Pelvic pain
Generally recognized indications for operative hysteroscopy include:
- Directed endometrial biopsy
- Polypectomy
- Submucous myomectomy
- Transection of intrauterine adhesions ●
- . Transection of intrauterine septa
- Endometrial ablation ●
Cystoscopy: The Luminelle DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.
6
| Device Comparisons | |||
|---|---|---|---|
| Feature | Proposed Luminelle DTx | ||
| Hysteroscopy System | Primary Predicate | ||
| Cogentix (K072180) | Secondary Predicate | ||
| Vision-Sciences | |||
| (K071127) | |||
| Product Codes | HIH | ||
| FAJ | FAJ (primary) | HIH (Primary) | |
| FAJ | |||
| Conclusion: Both predicate devices combined have the same product | |||
| codes as the subject device. | |||
| Indications for | |||
| Use | |||
| (hysteroscopy) | Used to permit direct | ||
| viewing of the cervical | |||
| canal and uterine cavity | |||
| for the purpose of | |||
| performing diagnostic and | |||
| surgical procedures. | n/a | Used to permit direct | |
| viewing of the | |||
| cervical canal and | |||
| the uterine cavity for | |||
| the purpose of | |||
| performing | |||
| diagnostic and | |||
| therapeutic/surgical | |||
| procedures. | |||
| Conclusion: The proposed device and the secondary predicate device have | |||
| the same indications for use for hysteroscopy. | |||
| Feature | Proposed Luminelle DTx | ||
| Hysteroscopy System | Primary Predicate | ||
| Cogentix (K072180) | Secondary Predicate | ||
| Vision-Sciences | |||
| (K071127) | |||
| Indications for | |||
| Use | |||
| (Cystoscopy) | The Luminelle DTx | ||
| Hysteroscopy System is | |||
| intended for use in | |||
| endoscopic access to and | |||
| examination of the lower | |||
| urinary tract including the | |||
| bladder. When combined | |||
| with accessory | |||
| instruments, the System | |||
| allows the user to perform | |||
| various diagnostic and | |||
| therapeutic procedures. | The Cogentix Medical | ||
| CST-5000/ 5000i | |||
| Flexible Video | |||
| Cystoscope/ | |||
| Hysteroscope with Slide- | |||
| On® EndoSheath® | |||
| Technology is intended | |||
| to be used for | |||
| endoscopic access to and | |||
| examination of the lower | |||
| urinary tract, including | |||
| the bladder. When | |||
| combined with accessory | |||
| instruments, the | |||
| endoscopic system | |||
| allows the user to | |||
| perform various | |||
| diagnostic and | |||
| therapeutic procedures. | The CST-2000A and | ||
| Slide-On | |||
| EndoSheath System | |||
| provides for | |||
| endoscopic access | |||
| and examination of | |||
| the lower urinary | |||
| tract, including the | |||
| bladder, and using | |||
| additional | |||
| accessories, to | |||
| perform various | |||
| diagnostic and | |||
| therapeutic | |||
| procedures. | |||
| Conclusion: All three devices have the same indications for use | |||
| regarding cystoscopy. | |||
| System | |||
| Overview | Handheld AC powered | ||
| hysteroscope/cystoscope, | |||
| consisting of a reusable | |||
| handle and insertion tube, | |||
| and a sterile disposable | |||
| sheath | Handheld AC powered | ||
| hysteroscope/ | |||
| cystoscope, consisting of | |||
| reusable handle and | |||
| insertion tube, and a | |||
| sterile disposable sheath. | N/A: All technical | ||
| information for the | |||
| SE comparison will | |||
| be taken from the | |||
| primary predicate. | |||
| Conclusion: Both the proposed and primary predicate are comprised | |||
| of the same general system. | |||
| Cannula | |||
| Diameter | 5.7 mm outer diameter | 5.6 mm outer diameter | N/A: All technical |
| information for the | |||
| SE comparison will | |||
| be taken from the | |||
| primary predicate. | |||
| Conclusion: Slight differences in the outer diameter do not raise | |||
| different questions of safety and effectiveness. | |||
| Scope Working | |||
| Length | 240 mm | 370 mm | N/A: All technical |
| information for the | |||
| SE comparison will | |||
| be taken from the | |||
| primary predicate. | |||
| Conclusion: Both the proposed and primary predicate have scope lengths | |||
| typical for devices of this type and the differences do not raise different | |||
| Device Comparisons | |||
| Feature | Proposed Luminelle DTx | ||
| Hysteroscopy System | Primary Predicate | ||
| Cogentix (K072180) | Secondary Predicate | ||
| Vision-Sciences | |||
| (K071127) | |||
| Image | |||
| Processing and | |||
| Display | Image Processing: Digital | ||
| Video Processor | |||
| Display: Standard HD | |||
| Monitor/TV. | Image Processing: | ||
| Digital Video Processor | |||
| Display: LCD Display | N/A: All technical | ||
| information for the | |||
| SE comparison will | |||
| be taken from the | |||
| primary predicate. | |||
| Conclusion: The differences in types of do not raise different questions of | |||
| safety and effectiveness. | |||
| Image | |||
| Transmission | Image transmitted from a | ||
| video camera to the | |||
| Digital Video Processor | |||
| then to the display. | Image transmitted from a | ||
| video camera to the | |||
| Digital Video Processor | |||
| then to the display. | N/A: All technical | ||
| information for the | |||
| SE comparison will | |||
| be taken from the | |||
| primary predicate. | |||
| Conclusion: Both the proposed and primary predicate transmit the | |||
| image the same way. | |||
| Image Capture | Still image capture during | ||
| a procedure by depressing | |||
| a camera button on the | |||
| handle. | Image and Video capture | ||
| and retrieval capabilities | |||
| on Digital Video | |||
| Processor | N/A: All technical | ||
| information for the | |||
| SE comparison will | |||
| be taken from the | |||
| primary predicate. | |||
| Conclusion: Predicate device requires purchase of a separate Digital Video | |||
| Processor that has more recording capabilities than the proposed device. | |||
| These differences do not raise different questions of safety and effectiveness | |||
| for the intended uses. | |||
| Instrument | |||
| Channel | |||
| Diameter | 5 Fr. (1.7 mm) | 6.3 Fr (2.1 mm) | N/A: All technical |
| information for the | |||
| SE comparison will | |||
| be taken from the | |||
| primary predicate | |||
| Conclusion: While the subject device accommodates slightly smaller | |||
| instruments than the predicate, this does not raise different questions of | |||
| safety and effectiveness, as operative instruments are readily available in | |||
| both sizes. | |||
| Illumination | |||
| Light Source | Integrated solid state LED | ||
| light source with fiber | |||
| optic transmission. | Integrated solid state | ||
| LED light source with | |||
| fiber optic transmission. | N/A: All technical | ||
| information for the | |||
| SE comparison will | |||
| be taken from the | |||
| primary predicate | |||
| Conclusion: Both the proposed and primary predicate have the same | |||
| illumination light source. | |||
| Device Comparisons | |||
| Feature | Proposed Luminelle DTx | ||
| Hysteroscopy System | Primary Predicate | ||
| Cogentix (K072180) | Secondary Predicate | ||
| Vision-Sciences | |||
| (K071127) | |||
| Objective Lens |
- Focal Length
- Field of Vie
- Direction of
View | Focal Length: 5 – 50 mm
Field of View: 120° in air
Direction of View:
Forward (0°) | Focal length: 3 – 50 mm
Field of view: 110° in air
Direction of View:
Forward (0°) | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate |
| Conclusion: Both the proposed and primary predicate have similar objective
lens characteristics. The differences do not raise different questions on safety
or effectiveness of the device. | | | |
| Image
Resolution | CMOS chip is 400 x 400
pixels.
USAF 1951 bar code
Group-Element: 1-5 | CCD chip specifications
not stated in product
literature. | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate |
| Conclusion: Different chip technologies are used, but differences do not
raise different questions on safety or effectiveness. | | | |
| Mode of
Operation | Continuous | Continuous | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate |
| Conclusion: Both the proposed and primary predicate are used in a
continuous mode of operation. | | | |
| Electrical
Safety | Compliant with
requirements of
IEC 60601-1;
IEC 60601-2-18 | Compliant with
requirements of
IEC 60601-1;
IEC 60601-2-18 | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate |
| Conclusion: Both the proposed and primary predicate are compliant
with the requirements of IEC 60601-1 and IEC 60601-2-18 for
electrical safety. | | | |
| Thermal Safety | Compliant with
requirements of
IEC 60601-1;
IEC 60601-2-18 | Compliant with
requirements of
IEC 60601-1;
IEC 60601-2-18 | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate |
| Conclusion: Both the proposed and primary predicate are compliant
with the requirements of IEC 60601-1 and IEC 60601-2-18 for thermal
safety. | | | |
| Device Comparisons | | | |
| Feature | Proposed Luminelle DTx
Hysteroscopy System | Primary Predicate
Cogentix (K072180) | Secondary Predicate
Vision-Sciences
(K071127) |
| Degree of
Protection
Against
Electrical
Shock | Type BF | Type BF | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate |
| Conclusion: Both the proposed and primary predicate have the same
degree of protection against electrical shock. | | | |
| Degree of
Protection
Against
Invasion of
Liquids | IPX7 | Fully immersible (per
reprocessing
instructions) | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate |
| Conclusion: Both the proposed and primary predicate can be immersed in
liquids for reprocessing (the primary predicate does not have an IP rating). | | | |
| Patient
Contacting
Materials | Biocompatibility testing per
ISO 10993 | Biocompatibility testing
per ISO 10993 | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Conclusion: All three devices have patient contacting materials which have
been tested per ISO 10993 for biocompatibility. | | | |
| Scope
Reprocessing | Reprocessed between
each use. When used as a
hysteroscope, the scope is
sterilized between uses.
When used as a
cystoscope, the scope is
disinfected with a high-
level disinfectant solution. | Reprocessed between
each use. When used as
a hysteroscope, the
scope is sterilized
between uses. When
used as a cystoscope, the
scope is disinfected with
a high-level disinfectant
solution. | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Conclusion: Both the proposed device and primary predicate are reprocessed
the same way between each use, depending on whether it was used as a
hysteroscope or cystoscope. | | | |
| Device Comparisons | | | |
| Feature | Proposed Luminelle DTx
Hysteroscopy System | Primary Predicate
Cogentix (K072180) | Secondary Predicate
Vision-Sciences
(K071127) |
| Disposable
Sheath | Rotatable with a curved
tip | Non-rotatable with an
articulating tip | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Conclusion: Both the proposed device and primary predicate have sheaths
which allow for adequate direction of the camera field of view to perform the
intended use. The rotation capabilities of the proposed device allow the user
to maintain a comfortable, upright grip on the scope handle while allowing
for independent rotational positioning of the camera field of view. The
difference does not raise any different questions on safety and effectiveness. | | | |
| Disposable
Sheath | Disposable sheath with 4
channels; one for the
camera, two for fluid
delivery (inflow and
outflow), and one for
operative instruments. | Disposable sheath with 2
channels; one for the
camera and one for fluid
delivery or an operative
instrument | N/A: All technical
information for the
SE comparison will
be taken from the
primary predicate. |
| Conclusion: The protective sheath of the proposed device allows the user to
administer fluids at the same time the operative channel is in use, providing
more flexibility and control to the user. This difference does not raise
different questions on safety and effectiveness. | | | |
7
8
9
10
11
Performance testing was performed to verify that the performance of Performance Data: the Luminelle DTx Hysteroscopy System is substantially equivalent to currently marketed Cogentix scope (K072180). Testing included:
- . optical resolution per ISO 8600
- biocompatibility per ISO 10993 including cytotoxicity, sensitization, and irritation
- electrical and thermal safety per IEC 60601-1
- electromagnetic compatibility per IEC 60601-1-2 ●
- endoscope specific safety and performance per IEC 60601-2-18 ●
- usability
- reprocessing validation per FDA reprocessing guidance
- sterilization validation per ISO 11135
- shelf life and packaging validation
- software validation per FDA software guidance for moderate level ● of concern
Overall Conclusions: The Luminelle DTx Hysteroscopy System has been shown to be substantially equivalent to the predicates