Hysteroscopy: The Luminelle DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery.

Generally recognized indications for diagnostic hysteroscopy include:

Abnormal bleeding
Infertility and pregnancy wastage
· Evaluation of abnormal hysterosalpingogram
· Intrauterine foreign body
· Amenorrhea
· Pelvic pain

Generally recognized indications for operative hysteroscopy include:

· Directed endometrial biopsy
· Polypectomy
Submucous myomectomy
· Transection of intrauterine adhesions
· Transection of intrauterine septa
· Endometrial ablation

Cystoscopy: The Luminelle DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.

Device Description

The Luminelle DTx Hysteroscopy System is comprised of four components:

Luminelle DTx Hysteroscope - a non-sterile, reusable flexible hysteroscope with an integrated light source, light fiber bundle and CMOS sensor.
The Luminelle DTx 360° Rotatable Disposable Sheath - a sterile, two-part sheath installed over the insertion tube of the Hysteroscope and comprised of the Operative Introducer and the 360° RotoSheath. The Operative Introducer contains an operative channel for inserting surgical accessories, two fluid management lines (inflow/outflow), and a channel to protect the scope insertion tube. The 360° RotoSheath allows for rotational positioning of the camera and provides rigidity to the Scope/Introducer assembly.
Luminelle Communication Cable - a cable that provides both the power to the hysteroscope and transmits the image.
Luminelle Control Hub - the main power supply, image converter and visualization connection. The Control Hub has both HDMI and USB connectors for connection to a monitor and/or a PC. USB and HDMI cables are provided in the package.

The Luminelle DTx Hysteroscope, Communication Cable, Control Hub, USB and HDMI cables and power cord are provided together in a single package. The 360° Rotatable Disposable Sheath is provided in a separate sterile package. The 360º Rotatable Disposable Sheath is required for use with the Hysteroscope, therefore it is a component of the system and not an accessory to the system.

The CMOS sensor and fiber optic illumination bundles are contained in the Hysteroscope Insertion Tube. The insertion tube length is 29.8 cm (11.73 in.) and the outside diameter is 1.95 mm (0.077 in.). The Luminelle DTx Hysteroscope is packaged in a white form fit tray with a clear slide-on cover. The tray is made of high-impact polystyrene (HIPS). The clear cover is made of polyethylene terephthalate with glycol (PETG).

The Luminelle 360° RotoSheath has a working length of 24.0 cm (9.45 in.) with an outside diameter of 5.7 mm (0.244 in.). The Luminelle Operative Introducer has an outside diameter of 4.8 mm (0.189 in.) and the inside diameter of the operative channel is 1.85 mm (0.073 in.).

Both the Luminelle 360º RotoSheath and Luminelle Operative Introducer are supplied as a single assembled unit packaged in a bottom tray with retaining lid made of polyethylene terephthalate with glycol (PETG) and sealed with Tyvek. The assembled package is sterilized using ethylene oxide (EO).

The Control Hub supplies power to the Hysteroscope via a reusable Communication Cable. The CMOS sensors have a processor that converts the visual image into data to be transferred. A processor in the Control Hub converts this image data into streaming HDMI language, takes still images when the button is pushed, and also controls the light exposure during changing light conditions.

Visualization on a video monitor is provided via a HDMI cable, and image transfer to a PC is provided via a Type A USB cable. A 12V DC, 3A power adapter is also provided. Technical specifications for these reusable components are provided in the Instructions for Use.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Luminelle DTx Hysteroscopy System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, effect sizes) is not present in this document.

However, based on the provided text, I can infer and extract information related to performance testing that was conducted to support the substantial equivalence claim.

Here's the breakdown of what can be gleaned:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a table of specific quantitative acceptance criteria with corresponding performance metrics for image quality in a way that would be typical for an AI/ML device validating diagnostic accuracy. Instead, it refers to compliance with established standards for medical devices and compares features to predicates.

Acceptance Criteria (Implied/Standard Complied)	Reported Device Performance (as stated in the document)
Optical Resolution (per ISO 8600)	Performed, but specific resolution metrics (e.g., lp/mm) and comparison to predicate are not explicitly stated in the summary. The "Image Resolution" comparison mentions "CMOS chip is 400 x 400 pixels. USAF 1951 bar code Group-Element: 1-5" for the proposed device, and "CCD chip specifications not stated in product literature" for the predicate. Conclusion states "Different chip technologies are used, but differences do not raise different questions on safety or effectiveness."
Biocompatibility (per ISO 10993; cytotoxicity, sensitization, irritation)	Compliant. "Biocompatibility testing per ISO 10993" for the proposed device and "Biocompatibility testing per ISO 10993" for the predicates resulted in the conclusion "All three devices have patient contacting materials which have been tested per ISO 10993 for biocompatibility."
Electrical Safety (per IEC 60601-1; IEC 60601-2-18)	Compliant. "Compliant with requirements of IEC 60601-1; IEC 60601-2-18" for both proposed and primary predicate. Conclusion: "Both the proposed and primary predicate are compliant with the requirements of IEC 60601-1 and IEC 60601-2-18 for electrical safety."
Thermal Safety (per IEC 60601-1; IEC 60601-2-18)	Compliant. "Compliant with requirements of IEC 60601-1; IEC 60601-2-18." Conclusion: "Both the proposed and primary predicate are compliant with the requirements of IEC 60601-1 and IEC 60601-2-18 for thermal safety."
Electromagnetic Compatibility (EMC) (per IEC 60601-1-2)	Performed (stated simply as "electromagnetic compatibility per IEC 60601-1-2"). No specific results.
Endoscope Specific Safety and Performance (per IEC 60601-2-18)	Performed, no specific results given beyond general compliance.
Usability	Performed. No specific results or metrics given.
Reprocessing Validation (per FDA reprocessing guidance)	Performed. Conclusion: "Both the proposed device and primary predicate are reprocessed the same way between each use, depending on whether it was used as a hysteroscope or cystoscope."
Sterilization Validation (per ISO 11135)	Performed. The 360° Rotatable Disposable Sheath is sterilized using ethylene oxide (EO).
Shelf Life and Packaging Validation	Performed. No specific results given.
Software Validation (per FDA software guidance for moderate level of concern)	Performed. No specific results given. The Control Hub has a processor that converts image data into streaming HDMI language, takes still images, and controls light exposure.
Degree of Protection Against Electrical Shock	Type BF. Conclusion: "Both the proposed and primary predicate have the same degree of protection against electrical shock."
Degree of Protection Against Invasion of Liquids	IPX7 for proposed device. "Fully immersible (per reprocessing instructions)" for predicate. Conclusion: "Both the proposed and primary predicate can be immersed in liquids for reprocessing (the primary predicate does not have an IP rating)."
Objective Lens Characteristics (Focal Length, Field of View, Direction of View)	Proposed: Focal Length: 5 – 50 mm, Field of View: 120° in air, Direction of View: Forward (0°). Predicate: Focal length: 3 – 50 mm, Field of view: 110° in air, Direction of View: Forward (0°). Conclusion: "Both the proposed and primary predicate have similar objective lens characteristics. The differences do not raise different questions on safety or effectiveness of the device."
Mode of Operation	Continuous. Conclusion: "Both the proposed and primary predicate are used in a continuous mode of operation."

2. Sample sizes used for the test set and the data provenance:

Sample Size for Test Set: Not applicable in the context of an AI/ML test set with patient data. The performance testing described is primarily engineering and bench testing, as well as validation of reprocessing and sterilization.
Data Provenance: Not applicable for AI/ML validation. The testing described is hardware and system functionality testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable as this is not an AI/ML device requiring clinical diagnostic ground truth. The "ground truth" for the tests performed would be adherence to engineering specifications and regulatory standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable as this is not an AI/ML device nor a clinical study involving human readers and image interpretation.

5. 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:

No MRMC study was performed as this is not an AI-assisted diagnostic device. It is an endoscope for direct visualization.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

Not applicable, as this device does not contain an AI algorithm. It is an imaging system (hysteroscope/cystoscope).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance validation is adherence to established international and FDA standards for medical devices (e.g., ISO, IEC). For example, electrical safety is validated against IEC 60601-1; biocompatibility against ISO 10993; optical resolution against ISO 8600.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 16, 2018

UVision360 Inc. % Dave Yungvirt Official Correspondent Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

Re: K181909

Trade/Device Name: Luminelle DTx Hysteroscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FAJ, HIH Dated: July 14, 2018 Received: July 17, 2018

Dear Dave Yungvirt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Glenn B. Bell -S

for

Benjamin R. Fisher. Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181909

Device Name

Luminelle DTx Hysteroscopy System

Indications for Use (Describe)

Hysteroscopy: The Luminelle DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery.

Generally recognized indications for diagnostic hysteroscopy include:

Abnormal bleeding
Infertility and pregnancy wastage
· Evaluation of abnormal hysterosalpingogram
· Intrauterine foreign body
· Amenorrhea
· Pelvic pain

Generally recognized indications for operative hysteroscopy include:

· Directed endometrial biopsy
· Polypectomy
Submucous myomectomy
· Transection of intrauterine adhesions
· Transection of intrauterine septa
· Endometrial ablation

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Date SummaryPrepared:	August 15, 2018
510(k) Owner:	UVision360 Inc.
Contact Person:	Allison London Brown
	CEO, UVision360 Inc.
	4441-106 Six Forks Road, #179
	Raleigh, NC 27609
Device Name:	Trade Name:	Luminelle DTx Hysteroscopy System
	Common Name:	Hysteroscope (and accessories); Cystoscope(and accessories)
	Regulation:	876:1500 Endoscope and accessories
	Class:	II
	Product Code:	FAJ, HIH
Predicate Device(s):	PrimaryPredicate	K072180 Cogentix Flexible Video Cystoscopewith Digital Video Processor and DisposableEndoSheath Systems
	SecondaryPredicate	K071127 Vision-Sciences Flexible Cystoscopewith EndoSheath System (with additionalHysteroscope Indications for use)
		The predicate devices have not been subject to adesign related recall.
Device Description:	The Luminelle DTx Hysteroscopy System is comprised of fourcomponents:
	1) Luminelle DTx Hysteroscope - a non-sterile, reusable flexiblehysteroscope with an integrated light source, light fiber bundle andCMOS sensor.
	2) The Luminelle DTx 360° Rotatable Disposable Sheath - a sterile,two-part sheath installed over the insertion tube of the Hysteroscopeand comprised of the Operative Introducer and the 360° RotoSheath.The Operative Introducer contains an operative channel for insertingsurgical accessories, two fluid management lines (inflow/outflow),and a channel to protect the scope insertion tube. The 360°RotoSheath allows for rotational positioning of the camera andprovides rigidity to the Scope/Introducer assembly.
	3) Luminelle Communication Cable - a cable that provides both thepower to the hysteroscope and transmits the image.
	4) Luminelle Control Hub - the main power supply, image converterand visualization connection. The Control Hub has both HDMI and

510(k) Summary

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USB connectors for connection to a monitor and/or a PC. USB and HDMI cables are provided in the package.

Indications for Use Statement: Hysteroscopy: The Luminelle DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery.

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Generally recognized indications for diagnostic hysteroscopy include:

. Abnormal bleeding
. Infertility and pregnancy wastage
Evaluation of abnormal hysterosalpingogram
Intrauterine foreign body ●
. Amenorrhea
Pelvic pain

Generally recognized indications for operative hysteroscopy include:

Directed endometrial biopsy
Polypectomy
Submucous myomectomy
Transection of intrauterine adhesions ●
. Transection of intrauterine septa
Endometrial ablation ●

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Device Comparisons
Feature	Proposed Luminelle DTxHysteroscopy System	Primary PredicateCogentix (K072180)	Secondary PredicateVision-Sciences(K071127)
Product Codes	HIHFAJ	FAJ (primary)	HIH (Primary)FAJ
	Conclusion: Both predicate devices combined have the same productcodes as the subject device.
Indications forUse(hysteroscopy)	Used to permit directviewing of the cervicalcanal and uterine cavityfor the purpose ofperforming diagnostic andsurgical procedures.	n/a	Used to permit directviewing of thecervical canal andthe uterine cavity forthe purpose ofperformingdiagnostic andtherapeutic/surgicalprocedures.
	Conclusion: The proposed device and the secondary predicate device havethe same indications for use for hysteroscopy.
Feature	Proposed Luminelle DTxHysteroscopy System	Primary PredicateCogentix (K072180)	Secondary PredicateVision-Sciences(K071127)
Indications forUse(Cystoscopy)	The Luminelle DTxHysteroscopy System isintended for use inendoscopic access to andexamination of the lowerurinary tract including thebladder. When combinedwith accessoryinstruments, the Systemallows the user to performvarious diagnostic andtherapeutic procedures.	The Cogentix MedicalCST-5000/ 5000iFlexible VideoCystoscope/Hysteroscope with Slide-On® EndoSheath®Technology is intendedto be used forendoscopic access to andexamination of the lowerurinary tract, includingthe bladder. Whencombined with accessoryinstruments, theendoscopic systemallows the user toperform variousdiagnostic andtherapeutic procedures.	The CST-2000A andSlide-OnEndoSheath Systemprovides forendoscopic accessand examination ofthe lower urinarytract, including thebladder, and usingadditionalaccessories, toperform variousdiagnostic andtherapeuticprocedures.
Conclusion: All three devices have the same indications for useregarding cystoscopy.
SystemOverview	Handheld AC poweredhysteroscope/cystoscope,consisting of a reusablehandle and insertion tube,and a sterile disposablesheath	Handheld AC poweredhysteroscope/cystoscope, consisting ofreusable handle andinsertion tube, and asterile disposable sheath.	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
Conclusion: Both the proposed and primary predicate are comprisedof the same general system.
CannulaDiameter	5.7 mm outer diameter	5.6 mm outer diameter	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
Conclusion: Slight differences in the outer diameter do not raisedifferent questions of safety and effectiveness.
Scope WorkingLength	240 mm	370 mm	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
Conclusion: Both the proposed and primary predicate have scope lengthstypical for devices of this type and the differences do not raise different
Device Comparisons
Feature	Proposed Luminelle DTxHysteroscopy System	Primary PredicateCogentix (K072180)	Secondary PredicateVision-Sciences(K071127)
ImageProcessing andDisplay	Image Processing: DigitalVideo ProcessorDisplay: Standard HDMonitor/TV.	Image Processing:Digital Video ProcessorDisplay: LCD Display	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
	Conclusion: The differences in types of do not raise different questions ofsafety and effectiveness.
ImageTransmission	Image transmitted from avideo camera to theDigital Video Processorthen to the display.	Image transmitted from avideo camera to theDigital Video Processorthen to the display.	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
Conclusion: Both the proposed and primary predicate transmit theimage the same way.
Image Capture	Still image capture duringa procedure by depressinga camera button on thehandle.	Image and Video captureand retrieval capabilitieson Digital VideoProcessor	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
	Conclusion: Predicate device requires purchase of a separate Digital VideoProcessor that has more recording capabilities than the proposed device.These differences do not raise different questions of safety and effectivenessfor the intended uses.
InstrumentChannelDiameter	5 Fr. (1.7 mm)	6.3 Fr (2.1 mm)	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate
Conclusion: While the subject device accommodates slightly smallerinstruments than the predicate, this does not raise different questions ofsafety and effectiveness, as operative instruments are readily available inboth sizes.
IlluminationLight Source	Integrated solid state LEDlight source with fiberoptic transmission.	Integrated solid stateLED light source withfiber optic transmission.	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate
Conclusion: Both the proposed and primary predicate have the sameillumination light source.
Device Comparisons
Feature	Proposed Luminelle DTxHysteroscopy System	Primary PredicateCogentix (K072180)	Secondary PredicateVision-Sciences(K071127)
Objective Lens- Focal Length- Field of Vie- Direction ofView	Focal Length: 5 – 50 mmField of View: 120° in airDirection of View:Forward (0°)	Focal length: 3 – 50 mmField of view: 110° in airDirection of View:Forward (0°)	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate
Conclusion: Both the proposed and primary predicate have similar objectivelens characteristics. The differences do not raise different questions on safetyor effectiveness of the device.
ImageResolution	CMOS chip is 400 x 400pixels.USAF 1951 bar codeGroup-Element: 1-5	CCD chip specificationsnot stated in productliterature.	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate
Conclusion: Different chip technologies are used, but differences do notraise different questions on safety or effectiveness.
Mode ofOperation	Continuous	Continuous	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate
Conclusion: Both the proposed and primary predicate are used in acontinuous mode of operation.
ElectricalSafety	Compliant withrequirements ofIEC 60601-1;IEC 60601-2-18	Compliant withrequirements ofIEC 60601-1;IEC 60601-2-18	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate
Conclusion: Both the proposed and primary predicate are compliantwith the requirements of IEC 60601-1 and IEC 60601-2-18 forelectrical safety.
Thermal Safety	Compliant withrequirements ofIEC 60601-1;IEC 60601-2-18	Compliant withrequirements ofIEC 60601-1;IEC 60601-2-18	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate
Conclusion: Both the proposed and primary predicate are compliantwith the requirements of IEC 60601-1 and IEC 60601-2-18 for thermalsafety.
Device Comparisons
Feature	Proposed Luminelle DTxHysteroscopy System	Primary PredicateCogentix (K072180)	Secondary PredicateVision-Sciences(K071127)
Degree ofProtectionAgainstElectricalShock	Type BF	Type BF	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate
Conclusion: Both the proposed and primary predicate have the samedegree of protection against electrical shock.
Degree ofProtectionAgainstInvasion ofLiquids	IPX7	Fully immersible (perreprocessinginstructions)	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate
Conclusion: Both the proposed and primary predicate can be immersed inliquids for reprocessing (the primary predicate does not have an IP rating).
PatientContactingMaterials	Biocompatibility testing perISO 10993	Biocompatibility testingper ISO 10993	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
Conclusion: All three devices have patient contacting materials which havebeen tested per ISO 10993 for biocompatibility.
ScopeReprocessing	Reprocessed betweeneach use. When used as ahysteroscope, the scope issterilized between uses.When used as acystoscope, the scope isdisinfected with a high-level disinfectant solution.	Reprocessed betweeneach use. When used asa hysteroscope, thescope is sterilizedbetween uses. Whenused as a cystoscope, thescope is disinfected witha high-level disinfectantsolution.	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
Conclusion: Both the proposed device and primary predicate are reprocessedthe same way between each use, depending on whether it was used as ahysteroscope or cystoscope.
Device Comparisons
Feature	Proposed Luminelle DTxHysteroscopy System	Primary PredicateCogentix (K072180)	Secondary PredicateVision-Sciences(K071127)
DisposableSheath	Rotatable with a curvedtip	Non-rotatable with anarticulating tip	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
Conclusion: Both the proposed device and primary predicate have sheathswhich allow for adequate direction of the camera field of view to perform theintended use. The rotation capabilities of the proposed device allow the userto maintain a comfortable, upright grip on the scope handle while allowingfor independent rotational positioning of the camera field of view. Thedifference does not raise any different questions on safety and effectiveness.
DisposableSheath	Disposable sheath with 4channels; one for thecamera, two for fluiddelivery (inflow andoutflow), and one foroperative instruments.	Disposable sheath with 2channels; one for thecamera and one for fluiddelivery or an operativeinstrument	N/A: All technicalinformation for theSE comparison willbe taken from theprimary predicate.
Conclusion: The protective sheath of the proposed device allows the user toadminister fluids at the same time the operative channel is in use, providingmore flexibility and control to the user. This difference does not raisedifferent questions on safety and effectiveness.

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Performance testing was performed to verify that the performance of Performance Data: the Luminelle DTx Hysteroscopy System is substantially equivalent to currently marketed Cogentix scope (K072180). Testing included:

. optical resolution per ISO 8600
biocompatibility per ISO 10993 including cytotoxicity, sensitization, and irritation
electrical and thermal safety per IEC 60601-1
electromagnetic compatibility per IEC 60601-1-2 ●
endoscope specific safety and performance per IEC 60601-2-18 ●
usability
reprocessing validation per FDA reprocessing guidance
sterilization validation per ISO 11135
shelf life and packaging validation
software validation per FDA software guidance for moderate level ● of concern

Overall Conclusions: The Luminelle DTx Hysteroscopy System has been shown to be substantially equivalent to the predicates

Regulation Number and Section

§ 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.