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 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.

AI/ML Overview

The provided text describes a 510(k) submission for the LUMINELLE DTx Hysteroscopy System, which includes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).

The study aims to demonstrate substantial equivalence to a previously cleared predicate device (LUMINELLE DTx Hysteroscopy System, K190827).

Summary of Acceptance Criteria and Device Performance:

The document primarily focuses on verifying the safety and effectiveness of the new accessory by demonstrating that the modified device remains as safe and effective as the predicate. It does not provide specific quantitative acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity for detecting specific conditions) for the new diagnostic sheath, as the intent of this 510(k) is an engineering performance change and limitation of use for the new accessory rather than a new diagnostic claim. Instead, the "acceptance criteria" are implied through the successful completion of various engineering, biocompatibility, and usability tests.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Sterilization adoption for the new sheath in accordance with AAMI TIR28:2016.	Product adoption and Process Equivalence for Ethylene Oxide Sterilization was conducted. Results demonstrated that the LUMINELLE Dx 360° Rotatable Disposable Sheath sterilization may be adopted into the existing validation protocol after microorganism characterization and EO residuals testing.
13-month shelf life for the new sheath, confirmed by accelerated aging.	An accelerated aging shelf life study was performed for packaged LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ASTM F1980-16. Visual inspection and functional design verification confirmed that all samples met specifications after aging.
Packaging maintaining a sterile barrier throughout normal transportation and distribution.	Distribution simulation testing in accordance with ASTM D4169-16 (Distribution Cycle 13: Assurance Level I) was performed. This included seal strength testing (ASTM F88-15) and bubble leak testing (ASTM F2096-11). Packages were confirmed to maintain integrity following simulated distribution.
New sheath performing according to its intended use in in vivo models; user able to operate the system as intended; product conforming to user needs.	Usability and design validation testing was repeated for the LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). This testing was conducted "in in vivo models." Devices met predefined acceptance criteria.
New sheath not inducing sensitization or irritation.	Sensitization and irritation testing was performed for the final finished LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-10:2016. Results demonstrate the device is not irritating or sensitizing.
New sheath not inducing cytotoxicity.	Cytotoxicity testing was performed for the final finished LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-5:2009. Results demonstrate the device is not cytotoxic.

Detailed Information about the Study:

A table of acceptance criteria and the reported device performance: Refer to the table above.
- Note: The document does not specify quantitative diagnostic performance metrics because the submission is for an engineering change and a limitation of use for an accessory, not a new diagnostic claim that would require clinical performance study. The "acceptance criteria" are primarily related to safety, sterility, shelf life, and basic functionality as a medical device to ensure equivalence to the predicate.
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state specific sample sizes for the various tests (e.g., how many sheaths were tested for accelerated aging, how many "in vivo models" were used for usability). It refers to "all samples met specifications" or "packages were confirmed."
- Data Provenance: The information provided is retrospective in nature, as it's a summary of testing already performed for a 510(k) submission. The country of origin for the data is implied to be within the scope of UVision360 Inc.'s operations (Raleigh, NC, USA), but not explicitly stated for the testing sites.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of submission. The "ground truth" for these engineering, biocompatibility, and usability tests is established by adherence to recognized standards (e.g., AAMI TIR28, ASTM F1980-16, ASTM D4169-16, ASTM F88-15, ASTM F2096-11, ISO 10993-10:2016, ISO 10993-5:2009) and predefined acceptance criteria set during the device's development and validation. Experts in relevant engineering, toxicology, and quality assurance fields would have designed and overseen these tests, but their specific number and qualifications are not detailed in this regulatory summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This document describes technical device performance testing (e.g., sterility, shelf life, biocompatibility, mechanical function), not clinical diagnostic performance requiring expert adjudication of patient cases.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML-enabled device and no MRMC study was performed or needed for this type of submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-enabled device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the tests described is the adherence to specified technical and safety standards (e.g., ISO, ASTM standards for biocompatibility, packaging integrity, and accelerated aging) and predefined functional specifications for the device. For the usability and design validation, it implicitly relies on objective performance measures and user feedback in "in vivo models" compared against "predefined acceptance criteria."
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established: Not applicable.

Summary

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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.

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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

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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.

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

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)

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510(k) Summary

UVision360 Inc.

This 510(k) Summary is in conformance with 21CFR 807.92

Submitter:	UVision360 Inc.158 Wind Chime Ct.Suite 201Raleigh, NC 27615Phone: 888-855-9360
Primary Contact:	Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979
Company Contact:	Allison London BrownCEO
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 accessories21 CFR 876.1500 Endoscope and accessories
Classification Panel:	Obstetrics/GynecologyGastroenterology/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 accessories21 CFR 876.1500 Endoscope and accessories
Classification Panel	Gastroenterology/UrologyObstetrics/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.

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Device Description

. 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

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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.

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Detailed Comparison of the Subject and Predicate Devices

Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTxHysteroscopy System	LUMINELLE DTx Hysteroscopy System (K190827)General
Indications for Use	Hysteroscopy:The LUMINELLE DTxHysteroscopy System is used topermit viewing of the cervicalcanal and uterine cavity for thepurpose of performingdiagnostic and surgicalprocedures.NOTE: Hysteroscopes are usedas tools to access the uterinecavity and are not, in and ofthemselves, a method ofsurgery. When LUMINELLEDTx Hysteroscopy System isspecifically used with theLUMINELLE Dx 360° RotatableDisposable Sheath (Diagnostic),the system is limited toperforming diagnosticprocedures only.	Hysteroscopy:The LUMINELLE DTxHysteroscopy System is used topermit viewing of the cervical canaland uterine cavity for the purposeof performing diagnostic andsurgical procedures.NOTE: Hysteroscopes are usedas tools to access the uterinecavity and are not, in and ofthemselves, a method of surgery.Generally recognized indicationsfor diagnostic hysteroscopy include:Abnormal bleeding Infertility and pregnancy wastage Evaluation of abnormal hysterosalpingogram Intrauterine foreign body Amenorrhea Pelvic Pain	The Indications for Use ofthe LUMINELLE DTxHysteroscopy System areidentical to the Indicationsfor Use of the previouslycleared LUMINELLE DTXHysteroscopy System(K190827), except thatwhen specifically used withthe LUMINELLE Dx 360°Rotatable DisposableSheath (Diagnostic), thesystem is limited toperforming diagnosticprocedures 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 DTxHysteroscopy Systemand examination of the lowerurinary tract, including the bladder.When combined with accessoryinstruments, the System allows theuser to perform various diagnosticand therapeutic procedures.NOTE: When LUMINELLE DTxHysteroscopy System isspecifically used with theLUMINELLE Dx 360° RotatableDisposable Sheath (Diagnostic),the system is limited toperforming diagnosticprocedures only.	LUMINELLE DTx HysteroscopySystem (K190827)
Intended Use	Hysteroscopy Intended Use:The LUMINELLE DTxHysteroscopy System is used topermit direct viewing of thecervical canal and uterine cavityfor the purpose of performingdiagnostic and surgicalprocedures.NOTE: When LUMINELLE DTxHysteroscopy System isspecifically used with the	Hysteroscopy Intended Use:The LUMINELLE DTxHysteroscopy System is used topermit direct viewing of the cervicalcanal and uterine cavity for thepurpose of performing diagnosticand surgical procedures.Cystoscopy Intended Use:The LUMINELLE DTx HysteroscopySystem is intended for use inendoscopic access to the examinationof the lower urinary tract, including the	The Intended Use of theLUMINELLE DTxHysteroscopy System isidentical to the IntendedUse of the previouslycleared LUMINELLE DTxHysteroscopy System(K181909), except thatwhen specifically used withthe LUMINELLE Dx 360°Rotatable DisposableSheath (Diagnostic), the
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTxHysteroscopy 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 DTxHysteroscopy System	LUMINELLE DTx HysteroscopySystem (K190827)
			cleared LUMINELLE DTxHysteroscopy System(K190827).
PatientContactingMaterials(Biocompatibility)	ISO 10993 Compliant	ISO 10993 Compliant	The biocompatibilitycompliance of patientcontacting materials of theLUMINELLE DTxHysteroscopy System isidentical to the complianceof the previously clearedLUMINELLE DTxHysteroscopy System(K190827).
Components	LUMINELLE DTx●HysteroscopeLUMINELLE DTx 360°●Rotatable DisposableSheathLUMINELLE DTx 360°●Rotatable DisposableSheath RigidLUMINELLE●Communication CableLUMINELLE Control Hub●LUMINELLE Dx 360°●Rotatable DisposableSheath (Diagnostic)	LUMINELLE DTx●HysteroscopeLUMINELLE DTx 360°●Rotatable DisposableSheathLUMINELLE DTx 360°Rotatable DisposableSheath RigidLUMINELLE●Communication CableLUMINELLE Control Hub●	The main components ofthe LUMINELLE DTxHysteroscopy System aremainly the same as themain components of thepreviously clearedLUMINELLE DTxHysteroscopy System(K190827). The onlydifference is the addition ofa new accessory. Thisdifference only limits theintended use and does notraise different questions ofsafety and effectiveness.
ltem	Subject Device	Predicate Device	Comparison
	LUMINELLE DTxHysteroscopy System	LUMINELLE DTx HysteroscopySystem (K190827)
			This difference does notalter the intended use.
		Sheath
Rigid/FlexibleSheath	Flexible and rigid sheathsavailable:Flexible sheath (LUMINELLE●DTx 360° RotatableDisposable Sheath) containsa PEEK(polyetheretherketone)hypotube for flexibility.Rigid sheath (LUMINELLE●DTx 360° RotatableDisposable Sheath Rigid andLUMINELLE Dx 360°Rotatable Disposable Sheath(Diagnostic)) contains a 304stainless steel inner tube forrigidity.	Flexible and rigid sheathsavailable:Flexible sheath (LUMINELLE●DTx 360° Rotatable DisposableSheath) contains a PEEK(polyetheretherketone)hypotube for flexibility.Rigid sheath (LUMINELLE DTx●360° Rotatable DisposableSheath Rigid) contains a 304stainless steel inner tube forrigidity.	The rigidity of theLUMINELLE DTxHysteroscopy System isidentical to the rigidity ofthe LUMINELLE DTx 360°Rotatable DiagnosticSheath Rigid of thepreviously clearedLUMINELLE DTxHysteroscopy System(K190827).
Sheath	Rotatable sheath with a curved	Rotatable sheath with a curved tip	The sheath manipulation of
manipulation	tip		the LUMINELLE DTxHysteroscopy System isidentical to the sheathmanipulation of thepreviously clearedLUMINELLE DTxHysteroscopy System(K190827).
Item	Subject Device	Predicate Device	Comparison
SheathChannels	LUMINELLE DTxHysteroscopy SystemLUMINELLE DTx 360°Rotatable Disposable Sheathand LUMINELLE DTx 360°Rotatable Disposable SheathRigid - 4 Channels; one for thescope, two for fluidmanagement, and one foroperative instruments.LUMINELLE Dx 360° RotatableDisposable Sheath(Diagnostic) - 2 Channels thatmerge into a single channel; onefor the scope and one for fluidmanagement that mergethrough a funnel to become asingle channel.	LUMINELLE DTx HysteroscopySystem (K190827)4 Channels; one for the scope, twofor fluid management, and one foroperative instruments.	The sheath channels of theLUMINELLE DTxHysteroscopy System aredifferent from the sheathchannels of the previouslycleared LUMINELLE DTxHysteroscopy System(K190827). This differenceonly limits the intended useand does not raise differentquestions of safety andeffectiveness. Thisdifference does not alterthe intended use.
InstrumentChannelDiameter	LUMINELLE DTx 360°Rotatable Disposable Sheathand LUMINELLE DTx 360°Rotatable Disposable SheathRigid - 5 Fr (1.7 mm)LUMINELLE Dx 360° RotatableDisposable Sheath(Diagnostic) - Not applicable.There is no instrument channel.	5 Fr. (1.7 mm)	There is no instrumentchannel in the LUMINELLEDTx Hysteroscopy Systemcompared to the 5 Fr.instrument channeldiameter of the previouslycleared LUMINELLE DTxHysteroscopy System(K190827). This differenceonly limits the intended useand does not raise different
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTxHysteroscopy System	LUMINELLE DTx HysteroscopySystem (K190827)
			questions of safety andeffectiveness. Thisdifference does not alterthe intended use.
Sheath FluidManagement	LUMINELLE DTx 360°Rotatable Disposable Sheathand LUMINELLE DTx 360°Rotatable Disposable SheathRigid - 2 fluid channels (inflowand outflow), with manualmanipulation of fluid flow byattaching gravity-fed orpressurized bag of distendingmediumLUMINELLE Dx 360° RotatableDisposable Sheath(Diagnostic) - 1 fluid channel(inflow), with manualmanipulation of fluid flow byattaching gravity-fed orpressurized bag of distendingmedium	2 fluid channels (inflow andoutflow), with manual manipulationof fluid flow by attaching gravity-fed or pressurized bag ofdistending medium	The sheath fluidmanagement of theLUMINELLE DTxHysteroscopy System isdifferent from that of thepreviously clearedLUMINELLE DTxHysteroscopy System(K190827). This differenceonly limits the intended useand does not raise differentquestions of safety andeffectiveness. Thisdifference does not alterthe intended use.
SheathReprocessing	No reprocessing required - theLUMINELLE DTx 360°Rotatable Disposable Sheath,LUMINELLE DTx 360°Rotatable Disposable Sheath	No reprocessing required - theLUMINELLE DTx 360° RotatableDisposable Sheath andLUMINELLE DTx 360° RotatableDisposable Sheath Rigid are	The sheath reprocessing ofthe LUMINELLE DTxHysteroscopy System isidentical to the sheathreprocessing of the
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTxHysteroscopy System	LUMINELLE DTx HysteroscopySystem (K190827)
	Rigid, and LUMINELLE Dx 360°Rotatable Disposable Sheath(Diagnostic) are single-usedisposable and are providedsterile.	single-use disposable and areprovided sterile.	previously clearedLUMINELLE DTxHysteroscopy System(K190827).
Scope andSheathConnection	LUMINELLE DTx 360°Rotatable Disposable Sheathand LUMINELLE DTx 360°Rotatable Disposable SheathRigid - The Insertion Tube ofthe Scope inserts through thescope channel of the OperativeIntroducer Manifold and slidesthrough the Operative IntroducerTube. The Operative Introducertube fully inserts into the 360°RotoSheath until thecomponents snap together.LUMINELLE Dx 360° RotatableDisposable Sheath(Diagnostic) - The InsertionTube of the Scope insertsthrough the scope channel ofthe Introducer Manifold. TheIntroducer Manifold snapstogether with the 360°RotoSheath.	The Insertion Tube of the Scopeinserts through the scope channelof the Operative IntroducerManifold and slides through theOperative Introducer Tube. TheOperative Introducer tube fullyinserts into the 360° RotoSheathuntil the components snaptogether.	The scope and sheathconnection for theLUMINELLE DTxHysteroscopy System isdifferent from that of thepreviously clearedLUMINELLE DTxHysteroscopy System(K190827). This differenceonly limits the intended useand does not raise differentquestions of safety andeffectiveness. Thisdifference does alter theintended use.

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Testing

UVision performed the following testing of the LUMINELLE DTx Hysteroscopy System as used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) accessory, to ensure its continued performance, safety, and effectiveness:

A sterilization adoption was performed for the LUMINELLE Dx 360° Rotatable . Disposable Sheath in accordance with AAMI TIR28:2016. Product adoption and Process Equivalence for Ethylene Oxide Sterilization to confirm that the previously performed sterilization validation is also applicable to the LUMINELLE Dx 360° Rotatable Disposable Sheath. To substantiate the conclusion that the processes are equivalent, microorganism characterization, and EO residuals testing was performed. Results demonstrated that the LUMINELLE Dx 360° Rotatable Disposable Sheath sterilization may be adopted into the existing validation protocol.
. An accelerated aging shelf life study was performed for packaged LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) to confirm the 13 month 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. All samples met specifications after aging.
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. Packages were confirmed to maintain integrity following simulated distribution.
Usability and design validation testing was repeated for the LUMINELLE DTx ● Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) 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 product conforms to user needs. Devices met predefined acceptance criteria.
Sensitization and irritation testing was performed for the final finished 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. Results demonstrate the device is not irritating or sensitizing.
. Cytotoxicity testing was performed for the final finished LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-5:2009 to confirm that the Sheath does not induce cytotoxicity. Results demonstrate the device is not cytotoxic.

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Substantial Equivalence Discussion and Conclusion

The intended use for LUMINELLE DTx Hysteroscopy System is identical to the intended use of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) with only a limitation in the intended use when used with the new accessory. LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). This limitation is a subset of the predicate indications, and so does not represent a new intended use. The technological characteristics of the subject LUMINELLE DTx Hysteroscopy System are different as compared to the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) in that the subject device includes the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). However, the addition of this accessory does not raise different questions of safety and effectiveness. Performance testing demonstrates that the subject device, LUMINELLE DTx Hysteroscopy System, is as safe and effective as the previously cleared LUMINELLE DTx Hysteroscopy System (K190827). Therefore, the subject device, LUMINELLE DTx Hysteroscopy System, is substantially equivalent to the predicate LUMINELLE DTx Hysteroscopy System (K190827).

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.