Who can help prepare an FDA 510(k) submission like Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

Q: Who is the manufacturer of Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)?

Uvision360, Inc. filed the 510(k) submission for Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) (K192278).

Q: What is the FDA product code for Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)?

HIH. It is classified under 21 CFR 884.1690 as a Class 2 device in the Obstetrics/Gynecology panel.

Q: What is the regulatory pathway for Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)?

510(k) clearance (submission type: Special).

K192278 · Uvision360, Inc. · HIH · Nov 1, 2019 · Obstetrics/Gynecology

Device Facts

Record ID	K192278
Device Name	Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
Applicant	Uvision360, Inc.
Product Code	HIH · Obstetrics/Gynecology
Decision Date	Nov 1, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 884.1690
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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: - 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 blader. When combined with accessory instruments, 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.

Device Story

LUMINELLE DTx Hysteroscopy System; endoscopic visualization tool for cervical canal, uterine cavity, and lower urinary tract. System comprises hysteroscope, control hub, and rotatable disposable sheaths. New accessory: LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic); features single fluid inflow channel and combined scope/fluid channel; lacks operative channel. Used by physicians in clinical settings. Provides direct visualization to assist in diagnostic and therapeutic procedures. New sheath limits system to diagnostic-only use. Benefits include thinner profile for diagnostic procedures. System connects to external distending medium (gravity-fed or pressurized bag).

Clinical Evidence

Bench testing only. Includes sterilization adoption (AAMI TIR28:2016), accelerated aging (ASTM F1980-16), distribution simulation (ASTM D4169-16), seal strength (ASTM F88-15), bubble leak (ASTM F2096-11), usability/design validation in in vivo models, and biocompatibility (ISO 10993-10:2016 sensitization/irritation, ISO 10993-5:2009 cytotoxicity).

Technological Characteristics

Endoscopic system with rigid/flexible sheaths. Rigid sheaths use 304 stainless steel; flexible sheaths use PEEK hypotube. Single-use disposable sheaths provided sterile. Connectivity via communication cable to control hub. No software algorithm described.

Indications for Use

Indicated for diagnostic and surgical hysteroscopy (abnormal bleeding, infertility, pregnancy wastage, abnormal hysterosalpingogram, foreign body, amenorrhea, pelvic pain, biopsy, polypectomy, myomectomy, adhesion/septum transection, ablation) and endoscopic access/examination of the lower urinary tract/bladder. When used with the LUMINELLE Dx 360 Diagnostic Sheath, limited to diagnostic procedures only.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

LUMINELLE DTx Hysteroscopy System (K190827)

Related Devices

K190827 — Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid · Uvision360, Inc. · Jun 6, 2019
K181909 — Luminelle DTx Hysteroscopy System · Uvision360, Inc. · Aug 16, 2018
K210512 — LUMINELLE DTx System · Uvision360, Inc. · Jun 30, 2021
K081070 — INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM · Interlace Medical, Inc. · Jul 23, 2008
K141515 — AED HYSTEROSCOPE AND ACCESSORIES · National Advanced Endoscopy Devices, Inc. · Jan 7, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 1, 2019 UVision360 Inc. Rita King CEO MethodSense, Inc. 1 Copley Pkwy. Ste. 410 Morrisville, NC 27560 Re: K192278 > Trade/Device Name: LUMINELLE DTx Hysteroscopy System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: II Product Code: HIH, FAJ Dated: September 26, 2019 Received: October 2, 2019 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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 medical devices and radiation-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. Sharon Andrews 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) #### K192278 Device Name LUMINELLE DTx Hysteroscopy System #### Indications for Use (Describe) 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: - · Directed endometrial biopsv - · 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 blader. When combined with accessory instruments, 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. Type of Use (Select one or both, as applicable) ✔ | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # UVision360 Inc. This 510(k) Summary is in conformance with 21CFR 807.92 | 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: | October 9, 2019 | | Device Name and Classification | | | Trade Name: | LUMINELLE DTx Hysteroscopy System | |-----------------------|-------------------------------------------------------------------------------------------| | Common Name: | Hysteroscope and accessories, Endoscope and accessories | | Classification: | Class II | | Regulation Number: | 21 CFR 884.1690 Hysteroscope and accessories 21 CFR 876.1500 Endoscope and accessories | | Classification Panel: | Obstetrics/Gynecology Gastroenterology/Urology | | Product Code: | HIH Hysteroscope (And Accessories) FAJ Cystoscope And Accessories; Flexible/Rigid | ### Predicate Device: | | Predicate Device | | |---------------------------|-------------------------------------------------------------------------------------------|--| | Trade Name | LUMINELLE DTx Hysteroscopy System | | | Common Name | Hysteroscope (and accessories); Cystoscope (and accessories) | | | 510(k) Submitter / Holder | UVision360 Inc. | | | 510(k) Number | K190827 | | | 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 | | The predicate device has not been subject to a design-related recall. {4}------------------------------------------------ ### Device Description The LUMINELLE DTx Hysteroscopy System originally received 510(k) clearance in 2018 as a hvsteroscopic and cvstoscopic svstem (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). Based on user feedback for a thinner option for the disposable sheath for only diagnostic use, UVision360, Inc. (hereafter UVision) proposes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), as part of an engineering performance change. The LUMINELLE DTx Hysteroscopy System indications for use is identical to the previously cleared indications for use for the system. However, when the system is used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the indications for use are limited to diagnostic use only. No changes are proposed for the previously cleared components of the LUMINELLE DTx Hysteroscopy System. The new LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) accessory is a modification of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid component of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) with the following main changes: - . The new accessory has one fluid line rather than the two fluid lines of the previously cleared component. - . The new accessory has a combined channel for the scope and the fluid line rather than the separate channels of the previously cleared component. - The new accessory has no operative channel available unlike the previously cleared . component, due to the fact that it is for diagnostic use only. ### Indications for Use 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 {5}------------------------------------------------ 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 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. ### Substantial Equivalence The table below provides a detailed comparison of the LUMINELLE DTx Hysteroscopy System to the predicate device. {6}------------------------------------------------ ## Detailed Comparison of the Subject and Predicate Devices | Item | Subject Device | Predicate Device | Comparison | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | LUMINELLE DTx Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) General | | | Indications for Use | 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. | 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. Generally recognized indications for diagnostic hysteroscopy include: Abnormal bleeding Infertility and pregnancy wastage Evaluation of abnormal hysterosalpingogram Intrauterine foreign body Amenorrhea Pelvic Pain | The Indications for Use of the LUMINELLE DTx Hysteroscopy System are identical to the Indications for Use of the previously cleared LUMINELLE DTX Hysteroscopy System (K190827), except that when 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 Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) | | | | 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 Hysteroscopy System is intended for use in endoscopic access to | 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 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. | | | Item | Subject Device | Predicate Device | Comparison | | | LUMINELLE DTx Hysteroscopy System 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. | LUMINELLE DTx Hysteroscopy System (K190827) | | | Intended Use | 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 | 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. 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 | The Intended Use of the LUMINELLE DTx Hysteroscopy System is identical to the Intended Use of the previously cleared LUMINELLE DTx Hysteroscopy System (K181909), except that when specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the | | Item | Subject Device | Predicate Device | Comparison | | | LUMINELLE DTx Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) | | | | LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. | system is limited to performing diagnostic procedures only. | | | 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 Hysteroscopy System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | | | | 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 Hysteroscopy System are identical to the product codes of the previously | | ltem | Subject Device | Predicate Device | Comparison | | | LUMINELLE DTx Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) | | | | | | cleared LUMINELLE DTx Hysteroscopy System (K190827). | | Patient Contacting Materials (Biocompatibilit y) | ISO 10993 Compliant | ISO 10993 Compliant | The biocompatibility compliance of patient contacting materials of the LUMINELLE DTx Hysteroscopy System is identical to the compliance of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827). | | Components | LUMINELLE DTx ● Hysteroscope LUMINELLE DTx 360° ● Rotatable Disposable Sheath LUMINELLE DTx 360° ● Rotatable Disposable Sheath Rigid LUMINELLE ● Communication Cable LUMINELLE Control Hub ● LUMINELLE Dx 360° ● Rotatable Disposable Sheath (Diagnostic) | LUMINELLE DTx ● Hysteroscope LUMINELLE DTx 360° ● Rotatable Disposable Sheath LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid LUMINELLE ● Communication Cable LUMINELLE Control Hub ● | The main components of the LUMINELLE DTx Hysteroscopy System are mainly the same as the main components of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827). The only difference is the addition of a new accessory. This difference only limits the intended use and does not raise different questions of safety and effectiveness. | | ltem | Subject Device | Predicate Device | Comparison | | | LUMINELLE DTx Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) | | | | | | This difference does not alter the intended use. | | | | 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 and LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic)) 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) contains a 304 stainless steel inner tube for rigidity. | The rigidity of the LUMINELLE DTx Hysteroscopy System is identical to the rigidity of the LUMINELLE DTx 360° Rotatable Diagnostic Sheath Rigid of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827). | | Sheath | Rotatable sheath with a curved | Rotatable sheath with a curved tip | The sheath manipulation of | | manipulation | tip | | the LUMINELLE DTx Hysteroscopy System is identical to the sheath manipulation of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827). | | Item | Subject Device | Predicate Device | Comparison | | Sheath Channels | LUMINELLE DTx Hysteroscopy System 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. | LUMINELLE DTx Hysteroscopy System (K190827) 4 Channels; one for the scope, two for fluid management, and one for operative instruments. | The sheath channels of the LUMINELLE DTx Hysteroscopy System are different from the sheath channels of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827). This difference only limits the intended use and does not raise different questions of safety and effectiveness. This difference does not alter the intended use. | | Instrument Channel Diameter | LUMINELLE DTx 360° Rotatable Disposable Sheath and LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid - 5 Fr (1.7 mm) LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) - Not applicable. There is no instrument channel. | 5 Fr. (1.7 mm) | There is no instrument channel in the LUMINELLE DTx Hysteroscopy System compared to the 5 Fr. instrument channel diameter of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827). This difference only limits the intended use and does not raise different | | Item | Subject Device | Predicate Device | Comparison | | | LUMINELLE DTx Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) | | | | | | questions of safety and effectiveness. This difference does not alter the intended use. | | Sheath Fluid Management | LUMINELLE DTx 360° Rotatable Disposable Sheath and LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid - 2 fluid channels (inflow and outflow), with manual manipulation of fluid flow by attaching gravity-fed or pressurized bag of distending medium LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) - 1 fluid channel (inflow), with manual manipulation of fluid flow by attaching gravity-fed or pressurized bag of distending medium | 2 fluid channels (inflow and outflow), with manual manipulation of fluid flow by attaching gravity- fed or pressurized bag of distending medium | The sheath fluid management of the LUMINELLE DTx Hysteroscopy System is different from that of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827). This difference only limits the intended use and does not raise different questions of safety and effectiveness. This difference does not alter the intended use. | | Sheath Reprocessing | No reprocessing required - the LUMINELLE DTx 360° Rotatable Disposable Sheath, LUMINELLE DTx 360° Rotatable Disposable Sheath | No reprocessing required - the LUMINELLE DTx 360° Rotatable Disposable Sheath and LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid are | The sheath reprocessing of the LUMINELLE DTx Hysteroscopy System is identical to the sheath reprocessing of the | | Item | Subject Device | Predicate Device | Comparison | | | LUMINELLE DTx Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) | | | | Rigid, and LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) are single-use disposable and are provided sterile. | single-use disposable and are provided sterile. | previously cleared LUMINELLE DTx Hysteroscopy System (K190827). | | Scope and Sheath Connection | LUMINELLE DTx 360° Rotatable Disposable Sheath and LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid - The Insertion Tube of the Scope inserts through the scope channel of the Operative…