(127 days)
No
The document describes a hysteroscopy/cystoscopy system and its accessories, focusing on mechanical design, reprocessing, and sterilization. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Image Processing" section only mentions a "Digital Video Processor," which is standard for endoscopic systems and does not imply AI/ML.
Yes.
The device is indicated for performing "therapeutic procedures" in the lower urinary tract and for "operative hysteroscopy" which includes therapeutic interventions like polypectomy and endometrial ablation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the LUMINELLE DTx System "permits viewing... for the purpose of performing diagnostic and surgical procedures" and, when used with specific sheaths, "the system is limited to performing diagnostic procedures only." Furthermore, it lists "Generally recognized indications for diagnostic hysteroscopy" and states it's intended for "examination of the lower urinary tract... When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures." These statements confirm its diagnostic capabilities.
No
The device description explicitly lists multiple hardware components including a scope, communication cable, control hub, USB cable, HDMI cable, and power cord. The performance studies also detail testing related to hardware aspects like durability, electrical safety, and reprocessing of physical components.
Based on the provided text, the LUMINELLE DTx 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 viewing and performing diagnostic and surgical procedures within the cervical canal, uterine cavity, and lower urinary tract. This involves direct visualization and physical intervention within the body.
- Device Description: The description details a system comprised of a scope, cables, control hub, and disposable sheaths. These are all components used for endoscopic procedures, which are performed in vivo (within a living organism).
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside the body to obtain information about a patient's health. The LUMINELLE DTx System does not perform this function. While it can be used for biopsy (collecting tissue), the analysis of that tissue would be performed separately, likely by an IVD device or laboratory test.
- Performance Studies: The performance studies described focus on aspects like useful life, durability, usability in simulated models, reprocessing, biocompatibility, electrical safety, and shelf-life of the device itself and its components. These are typical performance studies for medical devices used in vivo, not for IVD devices.
In summary, the LUMINELLE DTx System is an endoscopic system used for visualization and procedures within the body, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hysteroscopy:
The LUMINELLE DTx System is used to permit 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. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
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 use for operative hysteroscopy include:
- · Directed endometrial biopsy
- · Polypectomy
- Submucous myomectomy
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa
- · Endometrial ablation
Cystoscopy:
The LUMINELLE DTx 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.
NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
Product codes (comma separated list FDA assigned to the subject device)
HIH, FAJ, HFF, FCK
Device Description
The LUMINELLE DTx System is comprised of the following components:
- LUMINELLE DTx Scope;
- . LUMINELLE Communication Cable;
- LUMINELLE Control Hub: ●
- USB cable: .
- HDMI cable, and;
- power cord.
UVision360, Inc. (hereafter UVision360) designed a new accessory, the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) that is compatible with the LUMINELLE DTx System that permits direct viewing of the cervical canal and uterine cavity during biopsy procedures. LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) is a single use accessory and is made of the same materials as the previously cleared sheaths (K190827, K192278).
The LUMINELLE DTx Scope is reprocessed after each use, depending on the procedure. High Level Disinfection (HLD) solutions can be used to reprocess the LUMINELLE DTx Scope when used with a cystoscopy procedure. 0.6% Ortho-Phthalaldehyde (OPA), a chemical disinfectant, has been previously cleared for HLD. However, UVision360 has verified and validated an additional chemical, Steris Revital-Ox™ RESERT® High Level Disinfectant, for HLD with the LUMINELLE DTx System. Steris Revital
Ox™ RESERT® High Level Disinfectant has been tested in order to determine that it identically cleans the LUMINELLE DTx Scope as 0.6% OPA and does not adversely affect the functionality of the LUMINELLE DTx System.
Before a hysteroscope procedure, the LUMINELLE DTx Scope must be sterilized to be reprocessed. In the previous submissions, Ethylene Oxide, qualified by Andersen Scientific, Inc., has been used to sterilize the LUMINELLE DTx Scope. An additional sterilization method, V-PRO® Low Temperature Sterilization, qualified by Steris located in Mentor, OH, has been validated and verified as an additional sterilization method to ensure that it properly sterilizes the LUMINELLE DTx Scope.
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
Hospitals and Physician offices
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 - Bench:
- Design verification and validation of the LUMINELLE DTx System included useful life testing following multiple cycles of high-level cleaning and disinfectional performance testing after accelerated aging in accordance with ASTM F1980-16, durability of the reusable handle markings following multiple cycles of high-level cleaning and disinfection, and shipping and handling simulation for the reusable components of the system.
- Design validation testing of the LUMINELLE DTx System included usability testing in accordance with IEC 62366-1 and ANSI/AAMI HE75 in simulated uterine and bladder models. Instructions for Use were also evaluated by the physicians during the design validation testing. The reprocessing instructions were validated for use by Sterile Processing Department technicians.
- Design validation testing was performed for the LUMINELLE DTx System with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) to confirm that the sheath performs according to its intended use in in vivo models, the user is able to operate the system as intended, and the sheath conforms to user needs.
- Bench testing was performed on the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) to confirm that the sheath performs as expected.
Software Validation:
- Software verification and validation testing of the LUMINELLE DTx System was performed for its software component.
Reprocessing:
- Validation of the cleaning and high-level disinfection procedures was performed in accordance with the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
- Validation of the Steris V-PRO® Low Temperature Sterilization cycle and was performed for reprocessing of the LUMINELLE DTx Scope in accordance with the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling -Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
- Validation of the Steris Revital-Ox™ RESERT® High Level Disinfectant for High Level Disinfection was performed for reprocessing of the LUMINELLE DTx Scope per the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
Biocompatibility:
- The biocompatibility of the patient contacting materials of the sterile, single-use 360° Rotatable Disposable Sheath and insertion tube of the reusable LUMINELLE DTx Scope was established in accordance with ISO 10993-1. The results of biocompatibility testing confirmed that the materials of the 360º Rotatable Disposable Sheath and insertion tube are not cytotoxic, sensitizing, or irritating when in contact with human skin. Sensitization testing, was also performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-10:2016 to confirm that the sheath does not induce sensitization or irritation. Cytotoxicity testing was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-5:2009 to confirm that the sheath does not induce cytotoxicity.
Electromagnetic Compatibility / Electrical Safety:
- The LUMINELLE DTx System was tested and found to be compliant with the following standards for electrical safety and EMC: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-1-2.
- The LUMINELLE DTx System was tested and found to be compliant with the following standards for medical endoscopes: ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 8600-5.
Shelf-Life:
- To verify the shelf life of the disposable sheaths, the LUMINELLE DTx 360° Rotatable Disposable Sheath was sterilized using an established 100% Ethylene Oxide (EO) sterilization process in accordance with ISO 1135:2014, with a Sterility Assurance Level (SAL) of 106. An initial shelf life of one (1) year for the sterile packaging was verified by leak testing in accordance with ASTM F2096-11 and seal strength testing in accordance with ASTM F88-15 following accelerated aging in accordance with ASTM F1980-16. Following EO sterilization and environmental conditioning in accordance with ISTA 2A (2011), simulated distribution testing was conducted in accordance with ASTM D4169-16, Distribution Cycle 13 (intercity air/local motor freight), Assurance Level 1, Schedules: A, C, F, E, J, and A. Subsequent leak testing and seal strength testing demonstrated that the packaging maintained a sterile barrier throughout the normal transportation and distribution of the device.
- Additional testing occurred in K192278 as an accelerated-aging shelf-life study was performed for packaged LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) to confirm the thirteenmonth (13) shelf life of the sheaths. After accelerating aging in accordance with ASTM F1980-16, visual inspection was performed to inspect for product damage caused by the aging process, and functional design verification was performed to verify that the documented inputs met the documented outputs.
- Accelerated aging was performed on the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) for a thirteen (13) month period in accordance with ASTM F1980-16. After aging was complete, visual inspection was performed to inspect for product damage caused by the aging process, and functional design verification was performed to verify that the documented inputs met the documented outputs of the device.
Distribution / Transit:
- Distribution simulation testing in accordance with ASTM D4169-16, Distribution Cycle 13; Assurance Level I was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). This testing consisted of seal strength testing in accordance with ASTM F88-15 and bubble leak testing in accordance with ASTM F2096-11 to confirm that the packaging maintained a sterile barrier throughout the normal transportation and distribution of the device.
Sterilization:
- A sterilization adoption evaluation was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath in accordance with AAMI TIR28:2016. Product adoption and process equivalence for Ethylene Oxide (EO) Sterilization to confirm that the previously performed sterilization validation is also applicable to the LUMINELLE Dx 360° Rotatable Disposable The evaluation confirmed that the differences between the LUMINELLE Dx 360° Sheath. Rotatable Disposable Sheath and the validated product are insignificant. Bioburden, microorganism characterization, and EO residuals testing was performed to substantiate the rationale leading to the conclusion that the changes are minor.
- A sterilization adoption evaluation was performed for the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) in accordance with AAMI TIR28:2016. Product adoption and process equivalence for Ethylene Oxide (EO) Sterilization to confirm that the previously performed sterilization validation is also applicable to the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy). The evaluation confirmed that the differences between the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) and the validated product are insignificant. To substantiate the rationale leading to the conclusion that the changes are minor, bioburden, microorganism characterization, and EO residuals testing was performed.
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.
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.
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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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 30, 2021
UVision360, Inc. % Rita King CEO and Senior Consultant MethodSense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville, NC 27560
Re: K210512
Trade/Device Name: LUMINELLE DTx System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH, FAJ, HFF, FCK Dated: June 1, 2021 Received: June 2, 2021
Dear Rita King:
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 statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210512
Device Name LUMINELLE DTx System
Indications for Use (Describe)
Hysteroscopy:
The LUMNELLE DTx System is used to permit 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. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
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 use for operative hysteroscopy include:
- · Directed endometrial biopsy
- · Polypectomy
- Submucous myomectomy
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa
- · Endometrial ablation
Cystoscopy:
The LUMINELLE DTx 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.
NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic 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)
3
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4
510(k) Summary
| Submitter: | UVision360 Inc.
158 Wind Chime Ct.
Suite 201
Raleigh, NC 27615
Phone: 888-855-9360 |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Allison London Brown
CEO |
| Date Prepared: | June 1, 2021 |
| Device Name and Classification | |
| Trade Name:
Common Name:
Classification:
Regulation Number: | LUMINELLE DTx System
Hysteroscope and accessories, Endoscope and accessories
Class II
21 CFR 884.1690 Hysteroscope and accessories
21 CFR 876.1500 Endoscope and accessories
21 CFR 884.1060 Endometrial Aspirator
21 CFR 876.1075 Gastroenterology-urology biopsy instrument |
| Classification Panel: | Obstetrics/Gynecology
Gastroenterology/Urology |
| Product Code: | HIH Hysteroscope (And Accessories)
FAJ Cystoscope And Accessories; Flexible/Rigid
HFF Aspirator, Endometrial
FCK Instrument, Biopsy, Suction |
5
| Predicate Device | |
|---|---|
| Trade Name | LUMINELLE DTx System |
| Common Name | Hysteroscope (and accessories); Cystoscope |
| (and accessories) | |
| 510(k) Submitter / Holder | UVision360 Inc. |
| 510(k) Number | K192278 |
| Regulation Number | 21 CFR 884.1690 Hysteroscope and accessories |
| 21 CFR 876.1500 Endoscope and accessories | |
| Classification Panel | Gastroenterology/Urology |
| Obstetrics/Gynecology | |
| Product Code | HIH Hysteroscope (And Accessories) |
| FAJ Cystoscope And Accessories; Flexible/Rigid |
Predicate Device:
The predicate device has not been subject to a design-related recall.
Device Description
The LUMINELLE DTx System, previously known as the LUMINELLE DTx Hysteroscope System, originally received 510(k) clearance in 2018 as a hysteroscopic system (K181909). In addition, LUMINELLE DTx Hysteroscopy System received 510(k) clearance in 2019 for the addition of a sheath component, LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to the system (K190827) and LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) (K19227).
The LUMINELLE DTx System permits viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The LUMINELLE DTx System is intended for use in endoscopic access to the examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the LUMINELLE DTx System allows the user to perform various diagnostic and therapeutic procedures.
The LUMINELLE DTx System is comprised of the following components:
- LUMINELLE DTx Scope;
- . LUMINELLE Communication Cable;
- LUMINELLE Control Hub: ●
- USB cable: .
- HDMI cable, and;
- power cord.
UVision360, Inc. (hereafter UVision360) designed a new accessory, the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) that is compatible with the LUMINELLE DTx System that permits direct viewing of the cervical canal and uterine cavity during biopsy procedures. LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) is a single use accessory and is made of the same materials as the previously cleared sheaths (K190827, K192278).
The LUMINELLE DTx Scope is reprocessed after each use, depending on the procedure. High Level Disinfection (HLD) solutions can be used to reprocess the LUMINELLE DTx Scope when used with a cystoscopy procedure. 0.6% Ortho-Phthalaldehyde (OPA), a chemical disinfectant, has been previously cleared for HLD. However, UVision360 has verified and validated an additional chemical, Steris Revital-Ox™ RESERT® High Level Disinfectant, for HLD with the LUMINELLE DTx System. Steris Revital
6
Ox™ RESERT® High Level Disinfectant has been tested in order to determine that it identically cleans the LUMINELLE DTx Scope as 0.6% OPA and does not adversely affect the functionality of the LUMINELLE DTx System.
Before a hysteroscope procedure, the LUMINELLE DTx Scope must be sterilized to be reprocessed. In the previous submissions, Ethylene Oxide, qualified by Andersen Scientific, Inc., has been used to sterilize the LUMINELLE DTx Scope. An additional sterilization method, V-PRO® Low Temperature Sterilization, qualified by Steris located in Mentor, OH, has been validated and verified as an additional sterilization method to ensure that it properly sterilizes the LUMINELLE DTx Scope.
Indications for Use
Hysteroscopy:
The LUMINELLE DTx System is used to permit 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. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 3600 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
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 use for operative hysteroscopy include:
- Directed endometrial biopsy .
- . Polypectomy
- Submucous myomectomy
- Transection of intrauterine adhesions ●
- Transection of intrauterine septa
- . Endometrial ablation
Cystoscopy:
The LUMINELLE DTx 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.
NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
7
NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.
Substantial Equivalence
The table below provides a detailed comparison of the LUMINELLE DTx System to the predicate device.
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Detailed Comparison of the Subject and Predicate Devices
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System | ||
| (K192278) | |||
| Indications for | |||
| Use | Hysteroscopy: | ||
| The LUMINELLE DTx System is used to permit | |||
| 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. When LUMINELLE DTx
System is specifically used with the LUMINELLE
Dx 360° Rotatable Disposable Sheath (Diagnostic),
the system is limited to performing diagnostic
procedures only. When the LUMINELLE DTx
System is used with the LUMINELLE Bx 360°
Rotatable Disposable Sheath (Biopsy), the system is
limited to performing diagnostic procedures only.
The Bx Sheath can be used for endometrial or lower
urinary tract (including bladder) biopsy by
aspiration with a syringe during diagnostic
procedures.
Generally recognized indications for diagnostic
hysteroscopy include:
• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal
hysterosalpingogram | Hysteroscopy:
The LUMINELLE DTx Hysteroscopy System is
used to permit 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. When
LUMINELLE DTx Hysteroscopy System is
specifically used with the LUMINELLE Dx 360°
Rotatable Disposable Sheath (Diagnostic), the
system is limited to performing diagnostic
procedures only
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 use for
operative hysteroscopy include: | The Indications for Use of the
LUMINELLE DTx System is
the same as the Indications for
Use of the primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| | Intrauterine foreign body Amenorrhea Pelvic pain Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Transection of intrauterine septa Endometrial ablation Cystoscopy:
The LUMINELLE DTx 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.
NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | 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.
NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| | NOTE: When the LUMINELLE DTx System is
used with the LUMINELLE Bx 360° Rotatable
Disposable Sheath (Biopsy), the system is limited to
performing diagnostic procedures only. The Bx
Sheath can be used for endometrial or lower urinary
tract (including bladder) biopsy by aspiration with a
syringe during diagnostic procedures. | | |
| Intended Use | Hysteroscopy Intended Use:
The LUMINELLE DTx System is used to permit
direct viewing of the cervical canal and uterine
cavity for the purpose of performing diagnostic and
surgical procedures.
NOTE: When LUMINELLE DTx System is
specifically used with the LUMINELLE Dx 360°
Rotatable Disposable Sheath (Diagnostic), the
system is limited to performing diagnostic
procedures only. | Hysteroscopy Intended Use:
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: When LUMINELLE DTx Hysteroscopy
System is specifically used with the
LUMINELLE Dx 360° Rotatable Disposable
Sheath (Diagnostic), the system is limited to
performing diagnostic procedures only. | The Intended Use of the
LUMINELLE DTx System is
the same as the Intended Use of
the Primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| | Cystoscopy Intended Use:
The LUMINELLE DTx System is intended for use
in endoscopic access to the 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. | Cystoscopy Intended Use:
The LUMINELLE DTx Hysteroscopy System is
intended for use in endoscopic access to the
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. | |
| | NOTE: When LUMINELLE DTx System is
specifically used with the LUMINELLE Dx 360°
Rotatable Disposable Sheath (Diagnostic), the | NOTE: When LUMINELLE DTx Hysteroscopy
System is specifically used with the
LUMINELLE Dx 360° Rotatable Disposable | |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| | system is limited to performing diagnostic
procedures only. | Sheath (Diagnostic), the system is limited to
performing diagnostic procedures only. | |
| | NOTE: When the LUMINELLE DTx System is
used with the LUMINELLE Bx 360° Rotatable
Disposable Sheath (Biopsy), the system is limited to
performing diagnostic procedures only. The Bx
Sheath can be used for endometrial or lower urinary
tract (including bladder) biopsy by aspiration with a
syringe during diagnostic procedures. | | |
| Product Code | HIH (Hysteroscope and Accessories)
FAJ (Cystoscope and Accessories) | HIH (Hysteroscope and Accessories)
FAJ (Cystoscope and Accessories) | The Product Codes of the
LUMINELLE DTx System are
identical to the product codes of
the primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Patient
Contacting
Materials
(Biocompatibility
) | ISO 10993 Compliant | ISO 10993 Compliant | The biocompatibility compliance
of patient contacting materials of
the LUMINELLE DTx System
is identical to the compliance of
the primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Components | ● LUMINELLE DTx Hysteroscope
● LUMINELLE DTx 360° Rotatable
Disposable Sheath | ● LUMINELLE DTx Hysteroscope
● LUMINELLE DTx 360° Rotatable
Disposable Sheath | The main components of the
LUMINELLE DTx System are
identical to the main components
of the primary predicate |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| | LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid LUMINELLE Communication Cable LUMINELLE Control Hub LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) LUMINELLE Bx 360° Rotatable Disposable Sheath (Sheath) | LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid LUMINELLE Communication Cable LUMINELLE Control Hub LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) | LUMINELLE DTx
Hysteroscopy System
(K192278). The only difference
is the addition of a new
accessory, LUMINELLE Bx
360° Rotatable Disposable
Sheath (Biopsy). This difference
does not affect the safety and
effectiveness of the device as
validation and verification has
been performed on the new
sheath. |
| Rigid/Flexible
Sheath | Flexible and rigid sheaths available:
Flexible sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath) contains a PEEK
(polyetheretherketone) hypotube for flexibility. Rigid sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid,
LUMINELLE Dx 360° Rotatable Disposable
Sheath (Diagnostic) and LUMINELLE Bx 360°
Rotatable Disposable Biopsy Sheath) contains a
304 stainless steel inner tube for rigidity. | Flexible and rigid sheaths available:
Flexible sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath) contains a
PEEK (polyetheretherketone) hypotube for
flexibility. Rigid sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid and
LUMINELLE Dx 360° Rotatable Disposable
Sheath (Diagnostic)) contains a 304 stainless
steel inner tube for rigidity | The LUMINELLE DTx System
is substantially equivalent to the
primary predicate, LUMINELLE
DTx Hysteroscopy System
(K192278), as they both contain
rigid and flexible sheaths. |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| Sheath Channels | LUMINELLE DTx 360° Rotatable Disposable
Sheath and LUMINELLE DTx 360° Rotatable
Disposable Sheath Rigid - 4 Channels; one for the
scope, two for fluid management, and one for
operative instruments.
LUMINELLE Dx 360° Rotatable Disposable
Sheath (Diagnostic) and LUMINELLE Bx 360°
Rotatable Disposable Sheath (Biopsy) - 2
Channels that merge into a single channel; one for
the scope and one for fluid management that merge
through a funnel to become a single channel. | LUMINELLE DTx 360° Rotatable Disposable
Sheath and LUMINELLE DTx 360° Rotatable
Disposable Sheath Rigid - 4 Channels; one for the
scope, two for fluid management, and one for
operative instruments.
LUMINELLE Dx 360° Rotatable Disposable
Sheath (Diagnostic) - 2 Channels that merge
into a single channel; one for the scope and one
for fluid management that merge through a
funnel to become a single channel. | The sheath channels of the
LUMINELLE DTx System of
the LUMINELLE Bx 360°
Rotatable Disposable Sheath
(Biopsy) are identical to the
LUMINELLE Dx 360°
Rotatable Disposable Sheath
(Diagnostic) of the primary
predicate device, LUMINELLE
DTx Hysteroscopy System
(K192278). |
| Syringes during
Biopsy Procedure | For biopsy procedures, a 10 mL Luer Lock syringe
is attached to the sheath | Not applicable | The LUMINELLE DTx System
is substantially equivalent to the
primary predicate, LUMINELLE
DTx Hysteroscopy System
(K192278). The only difference
is the addition of the Bx adapter
that enables a syringe to be
connected via a luer lock. This
difference does not affect the
safety and effectiveness of the
device as validation and
verification has been performed
on the new sheath. |
| Images | Devices can take and transmit images | Device can take and transmit images | The LUMINELLE DTx System
is identical to the primary
predicate device, LUMINELLE
DTx Hysteroscope System |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| | | | (K192278), as the device can |
| Scope Working
Length | 240 mm | 240 mm | take and transmit images.
The scope working length of the
LUMINELLE DTx System is
identical to the scope working
length of the primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Image Processing
and Display | Image Processing: Digital Video Processor
Display: Standard HD Monitor/TV. | Image Processing: Digital Video Processor
Display: Standard HD Monitor/TV. | The image processing and
display of the LUMINELLE
DTx System is identical to the
image processing and display of
the primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Objective Lens
• Focal Length
• Field of View
• Direction of
View | Focal Length: 5 – 50 mm
Field of View: 120° in air
Direction of View: Forward (0°) | Focal Length: 5 – 50 mm
Field of View: 120° in air
Direction of View: Forward (0°) | The objective lens of the
LUMINELLE DTx System is
identical to the objective lens of
the primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Image Resolution | CMOS chip is 400 x 400 pixels.
USAF 1951 bar code Group-Element: 1-5 | CMOS chip is 400 x 400 pixels.
USAF 1951 bar code Group-Element: 1-5 | The image resolution of the
LUMINELLE DTx System is
identical to the image resolution
of the primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| Power
Requirements | 120V AC | 120V AC | The power requirements of the
LUMINELLE DTx System are
identical to the power
requirements of the primary
predicate, LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Power Supply | LUMINELLE Control Hub includes the power
supply which converts 120V AC to 12V DC. The
Control Hub also serves as the image converter and
visualization connection. | LUMINELLE Control Hub includes the power
supply which converts 120V AC to 12V DC.
The Control Hub also serves as the image
converter and visualization connection. | The power supply of the
LUMINELLE DTx System is
identical to the power supply of
the primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Cables | LUMINELLE Communication Cable which powers
the Scope from the Control Hub and transmits the
image, HDMI and USB cables for connection of the
Control Hub to a monitor or computer | LUMINELLE Communication Cable which
powers the Scope from the Control Hub and
transmits the image, HDMI and USB cables for
connection of the Control Hub to a monitor or
computer | The cables of the LUMINELLE
DTx System are identical to the
primary predicate, LUMINELLE
DTx Hysteroscopy System
(K192278). |
| Mode of
Operation | Continuous | Continuous | The mode of operation of the
LUMINELLE DTx System is
identical to the mode of
operation primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Electrical Safety | Compliant with requirements of
IEC 60601-1:
IEC 60601-2-18 | Compliant with requirements of
IEC 60601-1:
IEC 60601-2-18 | The electrical safety compliance
of the LUMINELLE DTx
System is identical to the
electrical safety compliance of
the primary predicate. |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| Thermal Safety | Compliant with requirements of
IEC 60601-1;
IEC 60601-2-18 | Compliant with requirements of
IEC 60601-1;
IEC 60601-2-18 | LUMINELLE DTx
Hysteroscopy System
(K192278).
The thermal safety compliance
of the LUMINELLE DTx
System is identical to the
thermal safety compliance of the
primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Electromagnetic
Compatibility | Compliant with requirements of:
IEC 60601-1-2 4th edition | Compliant with requirements of:
IEC 60601-1-2 4th edition | The electromagnetic
compatibility compliance of the
LUMINELLE DTx System is
identical to that of the primary
predicate, LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Degree of
Protection
Against
Electrical Shock | Type BF | Type BF | The degree of protection against
electrical shock of the
LUMINELLE DTx
Hysteroscopy System is identical
to the degree of protection
against electrical shock of the
primary predicate,
LUMINELLE DTx
Hysteroscopy System
(K192278). |
| Degree of
Protection | IPX7 | IPX7 | The degree of protection against
invasion of liquids of the
LUMINELLE DTx System is |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| Against Invasion
of Liquids | | | identical to the degree of
protection against invasion of
liquids of the primary predicate,
LUMINELLE DTx
Hysteroscopy System (K192278) |
| Site of Use | Hospitals and Physician offices | Hospitals and Physician offices | The LUMINELLE DTx System
is identical to the primary
predicate, LUMINELLE DTx
Hysteroscopy (K192278) as they
are both used in hospitals and
physician offices. |
| Reprocessing | No reprocessing required on the sheaths - the
LUMINELLE DTx 360° Rotatable Disposable
Sheath, LUMINELLE DTx 360° Rotatable
Disposable Sheath Rigid, LUMINELLE Dx 360°
Rotatable Disposable Sheath (Diagnostic), and
LUMINELLE Bx 360° Rotatable Disposable
Biopsy Sheath and are single-use disposable and are
provided sterile. | No reprocessing required on the sheaths - the
LUMINELLE DTx 360° Rotatable Disposable
Sheath, LUMINELLE DTx 360° Rotatable
Disposable Sheath Rigid, and LUMINELLE Dx
360° Rotatable Disposable Sheath (Diagnostic)
are single-use disposable and are provided
sterile. | The reprocessing of the sheaths
of the LUMINELLE DTx
System is identical to the sheath
reprocessing of the primary
predicate, LUMINELLE DTx
Hysteroscopy System
(K192278), as they are both
intended for single-use. |
| Sterilization
Cycles | Andersen Scientific Standard Ethylene Oxide (EO)
Flexible Bag Process
Steris V-PRO Low Temperature Sterilization | Andersen Scientific Standard Ethylene Oxide
(EO) Flexible Bag Process | The sterilization of the
LUMINELLE DTx system is
substantial equivalent to the
primary predicate, LUMINELLE
DTx Hysteroscope System
(K192278), as they both use an
Ethylene Oxide Cycle. However,
the LUMINELLE DTx System
uses an additional cycle, Steris
V-PRO Low Temperature
Sterilization, for sterilization. |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System
(K192278) | |
| | | | This difference was validated
and tested to ensure that this
sterilization cycle does not affect
the safety and effectiveness of
the device. |
| High Level
Disinfectants
(intended for
cystoscopy
procedures only
for High Level
Disinfection) | 0.6% ortho-Phthalaldehyde (OPA)
Steris Revital-Ox™ RESERT High Level
Disinfectant | 0.6% ortho-Phthalaldehyde (OPA) | The High Level Disinfectants of
the LUMINELLE DTx system is
substantial equivalent to the
primary predicate, LUMINELLE
DTx Hysteroscope System
(K192278), as they both use an
0.6% ortho-Phthalaldehyde
(OPA). However, the
LUMINELLE DTx System uses
an additional disinfectant, Steris
Revital-Ox™ RESERT High
Level Disinfectant, for high level
disinfection. This difference was
validated and tested to ensure
that this sterilization cycle does
not affect the safety and
effectiveness of the device. |
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10
11
12
13
14
15
16
17
18
19
Testing
LUMINELLE DTx System was verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed. completed the following testing:
Performance - Bench
- . Design verification and validation of the LUMINELLE DTx System included useful life testing following multiple cvcles of high-level cleaning and disinfectional performance testing after accelerated aging in accordance with ASTM F1980-16, durability of the reusable handle markings following multiple cycles of high-level cleaning and disinfection, and shipping and handling simulation for the reusable components of the system.
- Design validation testing of the LUMINELLE DTx System included usability testing in accordance with IEC 62366-1 and ANSVAAMI HE75 in simulated uterine and bladder models. Instructions for Use were also evaluated by the physicians during the design validation testing. The reprocessing instructions were validated for use by Sterile Processing Department technicians.
- . Design validation testing was performed for the LUMINELLE DTx System with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) to confirm that the sheath performs according to its intended use in in vivo models, the user is able to operate the system as intended, and the sheath conforms to user needs.
- . Bench testing was performed on the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) to confirm that the sheath performs as expected
Software Validation
- Software verification and validation testing of the LUMINELLE DTx System was performed for ● its software component.
Reprocessing
- Validation of the cleaning and high-level disinfection procedures was performed in accordance with the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
- . Validation of the Steris V-PRO® Low Temperature Sterilization cycle and was performed for reprocessing of the LUMINELLE DTx Scope in accordance with the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling -Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
- Validation of the Steris Revital-Ox™ RESERT® High Level Disinfectant for High Level ● Disinfection was performed for reprocessing of the LUMINELLE DTx Scope per the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
20
Biocompatibility
- The biocompatibility of the patient contacting materials of the sterile, single-use 360° Rotatable Disposable Sheath and insertion tube of the reusable LUMINELLE DTx Scope was established in accordance with ISO 10993-1. The results of biocompatibility testing confirmed that the materials of the 360º Rotatable Disposable Sheath and insertion tube are not cytotoxic, sensitizing, or irritating when in contact with human skin. Sensitization testing, was also performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-10:2016 to confirm that the sheath does not induce sensitization or irritation. Cytotoxicity testing was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-5:2009 to confirm that the sheath does not induce cytotoxicity.
Electromagnetic Compatibility / Electrical Safety:
- The LUMINELLE DTx System was tested and found to be compliant with the following standards . for electrical safety and EMC: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-1-2.
- The LUMINELLE DTx System was tested and found to be compliant with the following standards for medical endoscopes: ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 8600-5.
Shelf-Life
To verify the shelf life of the disposable sheaths, the LUMINELLE DTx 360° Rotatable Disposable Sheath was sterilized using an established 100% Ethylene Oxide (EO) sterilization process in accordance with ISO 1135:2014, with a Sterility Assurance Level (SAL) of 106. An initial shelf life of one (1) year for the sterile packaging was verified by leak testing in accordance with ASTM F2096-11 and seal strength testing in accordance with ASTM F88-15 following accelerated aging in accordance with ASTM F1980-16. Following EO sterilization and environmental conditioning in accordance with ISTA 2A (2011), simulated distribution testing was conducted in accordance with ASTM D4169-16, Distribution Cycle 13 (intercity air/local motor freight), Assurance Level 1, Schedules: A, C, F, E, J, and A. Subsequent leak testing and seal strength testing demonstrated that the packaging maintained a sterile barrier throughout the normal transportation and distribution of the device.
- Additional testing occurred in K192278 as an accelerated-aging shelf-life study was performed for ● packaged LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) to confirm the thirteenmonth (13) shelf life of the sheaths. After accelerating aging in accordance with ASTM F1980-16, visual inspection was performed to inspect for product damage caused by the aging process, and functional design verification was performed to verify that the documented inputs met the documented outputs.
- Accelerated aging was performed on the LUMINELLE Bx 360° Rotatable Disposable Sheath ● (Biopsy) for a thirteen (13) month period in accordance with ASTM F1980-16. After aging was complete, visual inspection was performed to inspect for product damage caused by the aging process, and functional design verification was performed to verify that the documented inputs met the documented outputs of the device.
Distribution / Transit
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- Distribution simulation testing in accordance with ASTM D4169-16, Distribution Cycle 13; ● Assurance Level I was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). This testing consisted of seal strength testing in accordance with ASTM F88-15 and bubble leak testing in accordance with ASTM F2096-11 to confirm that the packaging maintained a sterile barrier throughout the normal transportation and distribution of the device.
Sterilization
- . A sterilization adoption evaluation was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath in accordance with AAMI TIR28:2016. Product adoption and process equivalence for Ethylene Oxide (EO) Sterilization to confirm that the previously performed sterilization validation is also applicable to the LUMINELLE Dx 360° Rotatable Disposable The evaluation confirmed that the differences between the LUMINELLE Dx 360° Sheath. Rotatable Disposable Sheath and the validated product are insignificant. Bioburden, microorganism characterization, and EO residuals testing was performed to substantiate the rationale leading to the conclusion that the changes are minor.
- A sterilization adoption evaluation was performed for the LUMINELLE Bx 360° Rotatable ● Disposable Sheath (Biopsy) in accordance with AAMI TIR28:2016. Product adoption and process equivalence for Ethylene Oxide (EO) Sterilization to confirm that the previously performed sterilization validation is also applicable to the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy). The evaluation confirmed that the differences between the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) and the validated product are insignificant. To substantiate the rationale leading to the conclusion that the changes are minor, bioburden, microorganism characterization, and EO residuals testing was performed
Substantial Equivalence Discussion
The intended use for LUMINELLE DTx System is the same as that of the previously cleared LUMINELLE DTx Hysteroscope System (K192278). The technological characteristics of the LUMINELLE DTx System are different from the LUMINELLE DTx Hysteroscope System (K192278) in that the LUMINELLE DTx System includes the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy). However, this difference does not raise different questions of safety and effectiveness. Performance testing shows that the LUMINELLE DTx System is as safe and effective as the previously cleared LUMINELLE DTx Hysteroscopy System (K192278).
Conclusion
The LUMINELLE DTx System is substantially equivalent to the legally marketed predicate device K192278.