Hysteroscopy: The LUMINELLE DTx System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include: Abnormal bleeding, Infertility and pregnancy wastage, Evaluation of abnormal hysterosalpingogram, Intrauterine foreign body, Amenorrhea, Pelvic pain. Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy, Polypectomy, Submucous myomectomy, Transection of intrauterine adhesions, Transection of intrauterine septa, Endometrial ablation. Cystoscopy: The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

Device Description

The LUMINELLE DTx System, previously known as the LUMINELLE DTx Hysteroscope System, originally received 510(k) clearance in 2018 as a hysteroscopic system (K181909). In addition, LUMINELLE DTx Hysteroscopy System received 510(k) clearance in 2019 for the addition of a sheath component, LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to the system (K190827) and LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) (K19227). The LUMINELLE DTx System permits viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The LUMINELLE DTx System is intended for use in endoscopic access to the examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the LUMINELLE DTx System allows the user to perform various diagnostic and therapeutic procedures. The LUMINELLE DTx System is comprised of the following components: LUMINELLE DTx Scope; LUMINELLE Communication Cable; LUMINELLE Control Hub: USB cable: HDMI cable, and; power cord. UVision360, Inc. (hereafter UVision360) designed a new accessory, the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) that is compatible with the LUMINELLE DTx System that permits direct viewing of the cervical canal and uterine cavity during biopsy procedures. LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) is a single use accessory and is made of the same materials as the previously cleared sheaths (K190827, K192278). The LUMINELLE DTx Scope is reprocessed after each use, depending on the procedure. High Level Disinfection (HLD) solutions can be used to reprocess the LUMINELLE DTx Scope when used with a cystoscopy procedure. 0.6% Ortho-Phthalaldehyde (OPA), a chemical disinfectant, has been previously cleared for HLD. However, UVision360 has verified and validated an additional chemical, Steris Revital-Ox™ RESERT® High Level Disinfectant, for HLD with the LUMINELLE DTx System. Steris Revital Ox™ RESERT® High Level Disinfectant has been tested in order to determine that it identically cleans the LUMINELLE DTx Scope as 0.6% OPA and does not adversely affect the functionality of the LUMINELLE DTx System. Before a hysteroscope procedure, the LUMINELLE DTx Scope must be sterilized to be reprocessed. In the previous submissions, Ethylene Oxide, qualified by Andersen Scientific, Inc., has been used to sterilize the LUMINELLE DTx Scope. An additional sterilization method, V-PRO® Low Temperature Sterilization, qualified by Steris located in Mentor, OH, has been validated and verified as an additional sterilization method to ensure that it properly sterilizes the LUMINELLE DTx Scope.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the LUMINELLE DTx System. This type of document is a submission for a medical device to demonstrate it is substantially equivalent to a legally marketed predicate device. This typically involves performance and design testing rather than clinical study data regarding AI performance. Based on the provided text, the LUMINELLE DTx System and its new accessory (LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)) are a hysteroscopy and cystoscopy system, which are medical imaging devices for direct viewing of internal body cavities. There is no mention of Artificial Intelligence (AI) or an AI-powered component within the LUMINELLE DTx System.

Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for AI test sets, expert ground truth establishment for AI, MRMC studies, standalone AI performance) are not applicable to this device submission.

However, I can extract the general acceptance criteria and study information related to the device's performance, safety, and effectiveness as a medical device, which are based on "bench testing" (engineering tests) and compliance with relevant standards.

Here's the breakdown of the information that is available in the document:

1. Table of acceptance criteria and the reported device performance (based on the device's technical specifications and safety/performance testing):

Acceptance Criteria/Characteristic	Reported Device Performance (LUMINELLE DTx System)	Comparison to Predicate (LUMINELLE DTx Hysteroscopy System K192278)
Indications for Use	Hysteroscopy: Viewing cervical canal and uterine cavity for diagnostic/surgical procedures. Cystoscopy: Endoscopic access/examination of lower urinary tract (bladder) for diagnostic/therapeutic procedures. Bx Sheath for endometrial/lower urinary tract biopsy by aspiration.	Identical, with the addition of biopsy aspiration capability for the new Bx Sheath. This difference does not raise new questions of safety and effectiveness.
Intended Use	Same as Indications for Use.	Identical.
Product Code	HIH (Hysteroscope and Accessories), FAJ (Cystoscope and Accessories), HFF (Aspirator, Endometrial), FCK (Instrument, Biopsy, Suction)	Primary codes identical. The addition of HFF and FCK product codes is due to the new Bx Sheath's biopsy aspiration capability.
Biocompatibility	ISO 10993 Compliant. Results confirmed materials are not cytotoxic, sensitizing, or irritating.	Identical compliance.
Components	LUMINELLE DTx Scope, Communication Cable, Control Hub, USB/HDMI cables, power cord. New accessory: LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy).	Main components identical. The new Bx Sheath was validated/verified to not affect safety/effectiveness.
Rigid/Flexible Sheath	Both flexible (with PEEK hypotube) and rigid (with 304 stainless steel inner tube) sheaths available.	Identical.
Sheath Channels	DTx & DTx Rigid Sheaths: 4 channels (scope, 2 fluid, 1 operative). Dx & Bx Sheaths: 2 channels (scope, 1 fluid) merging into single channel.	Bx Sheath channels identical to Dx Sheath channels of predicate.
Syringes during Biopsy	10 mL Luer Lock syringe attached to the sheath (for biopsy procedures).	Not applicable for predicate specifically, but difference (Bx adapter) validated to not affect safety/effectiveness.
Images	Device can take and transmit images.	Identical.
Scope Working Length	240 mm	Identical.
Image Processing & Display	Digital Video Processor; Standard HD Monitor/TV.	Identical.
Objective Lens	Focal Length: 5-50 mm; Field of View: 120° in air; Direction of View: Forward (0°).	Identical.
Image Resolution	CMOS chip is 400 x 400 pixels; USAF 1951 bar code Group-Element: 1-5.	Identical.
Power Requirements	120V AC	Identical.
Power Supply	LUMINELLE Control Hub (converts 120V AC to 12V DC, image converter, visualization connection).	Identical.
Cables	LUMINELLE Communication Cable (powers scope, transmits image), HDMI, USB.	Identical.
Mode of Operation	Continuous	Identical.
Electrical Safety	Compliant with IEC 60601-1, IEC 60601-2-18.	Identical compliance.
Thermal Safety	Compliant with IEC 60601-1, IEC 60601-2-18.	Identical compliance.
Electromagnetic Compatibility	Compliant with IEC 60601-1-2 4th edition.	Identical compliance.
Degree of Protection Against Electrical Shock	Type BF	Identical.
Degree of Protection Against Invasion of Liquids	IPX7	Identical.
Site of Use	Hospitals and Physician offices.	Identical.
Reprocessing (Sheaths)	Single-use, disposable, provided sterile. No reprocessing required.	Identical.
Sterilization Cycles (Scope)	Andersen Scientific Standard Ethylene Oxide (EO) Flexible Bag Process. New: Steris V-PRO® Low Temperature Sterilization.	EO cycle identical. V-PRO added and validated to ensure no effect on safety/effectiveness.
High Level Disinfectants (Scope for Cystoscopy)	0.6% ortho-Phthalaldehyde (OPA). New: Steris Revital-Ox™ RESERT® High Level Disinfectant.	OPA identical. Steris Revital-Ox™ added and validated to ensure no effect on safety/effectiveness.

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

Test Sets (Bench Testing): The document describes various bench tests:
- Performance - Bench: "useful life testing following multiple cycles of high-level cleaning and disinfection," "performance testing after accelerated aging," "durability of the reusable handle markings."
- Design Validation: "usability testing in accordance with IEC 62366-1 and ANSVAAMI HE75 in simulated uterine and bladder models." "in vivo models" (for LUMINELLE Bx sheath).
- Shelf-Life: "an established 100% Ethylene Oxide (EO) sterilization process in accordance with ISO 1135:2014, with a Sterility Assurance Level (SAL) of 10-6." "leak testing in accordance with ASTM F2096-11 and seal strength testing in accordance with ASTM F88-15 following accelerated aging in accordance with ASTM F1980-16." "simulated distribution testing in accordance with ASTM D4169-16, Distribution Cycle 13."
- Reprocessing: Validation per "FDA guidance document 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'"
- Biocompatibility: In accordance with "ISO 10993-1," "ISO 10993-10:2016," "ISO 10993-5:2009."
- Electrical Safety/EMC: Compliant with "IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-1-2."
Data Provenance: The studies are described as "Design verification and validation" and "Bench testing." These are laboratory-based engineering and performance tests, not clinical studies with patient data. The provenance is internal company testing to meet regulatory standards. No country of origin for patient data (as there isn't any) or retrospective/prospective status (as it's not a human study) is relevant here.
Sample Size: Specific numerical sample sizes for these bench tests are not provided in the summary. The document states "multiple cycles," "accelerated aging," and refers to compliance with various ASTM and ISO standards, which would imply defined sample sizes within those methodologies, but the specific numbers are not disclosed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the "usability testing," it states "Instructions for Use were also evaluated by the physicians during the design validation testing." and "The reprocessing instructions were validated for use by Sterile Processing Department technicians."
For the "in vivo models" with the LUMINELLE Bx sheath, it aimed to "confirm that [...] the user is able to operate the system as intended, and the sheath conforms to user needs."
The document implies that qualified professionals (physicians, Sterile Processing Department technicians) provided input on usability and operational aspects, serving as "experts" for this kind of "ground truth" (i.e., whether the device is usable and meets user needs). However, no specific number of experts or detailed qualifications (e.g., 10 years of experience) are provided.

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

Not applicable. This is a medical device submission based on bench and performance testing, not a study evaluating human reader performance or image interpretation requiring adjudication of discrepancies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No. This device is not an AI-powered diagnostic tool, and the submission does not involve comparative effectiveness studies of human readers with versus without AI assistance.

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

No. There is no algorithm or AI component mentioned in the LUMINELLE DTx System.

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

The "ground truth" for this device's validation is primarily based on engineering specifications, compliance with international standards (ISO, IEC, ASTM), and user/usability feedback. For biocompatibility, it's lab test results showing lack of cytotoxicity, sensitization, or irritation. For performance, it's successful operation within defined parameters, durability under testing conditions, and maintaining sterile barriers. For usability, it's feedback from physicians and technicians. There is no mention of pathology or outcomes data as "ground truth" in this 510(k) summary for the device itself.

8. The sample size for the training set:

Not applicable. There is no AI component, so no training set.

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

Not applicable. There is no AI component, so no training set ground truth.

Summary

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

June 30, 2021

UVision360, Inc. % Rita King CEO and Senior Consultant MethodSense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville, NC 27560

Re: K210512

Trade/Device Name: LUMINELLE DTx System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH, FAJ, HFF, FCK Dated: June 1, 2021 Received: June 2, 2021

Dear Rita King:

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

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

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

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210512

Device Name LUMINELLE DTx System

Indications for Use (Describe)

Hysteroscopy:

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

NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

Generally recognized indications for diagnostic hysteroscopy include:

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

Generally recognized indications for use for operative hysteroscopy include:

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

Cystoscopy:

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

NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

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:	June 1, 2021
Device Name and Classification
Trade Name:Common Name:Classification:Regulation Number:	LUMINELLE DTx SystemHysteroscope and accessories, Endoscope and accessoriesClass II21 CFR 884.1690 Hysteroscope and accessories21 CFR 876.1500 Endoscope and accessories21 CFR 884.1060 Endometrial Aspirator21 CFR 876.1075 Gastroenterology-urology biopsy instrument
Classification Panel:	Obstetrics/GynecologyGastroenterology/Urology
Product Code:	HIH Hysteroscope (And Accessories)FAJ Cystoscope And Accessories; Flexible/RigidHFF Aspirator, EndometrialFCK Instrument, Biopsy, Suction

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	Predicate Device
Trade Name	LUMINELLE DTx System
Common Name	Hysteroscope (and accessories); Cystoscope(and accessories)
510(k) Submitter / Holder	UVision360 Inc.
510(k) Number	K192278
Regulation Number	21 CFR 884.1690 Hysteroscope and accessories21 CFR 876.1500 Endoscope and accessories
Classification Panel	Gastroenterology/UrologyObstetrics/Gynecology
Product Code	HIH Hysteroscope (And Accessories)FAJ Cystoscope And Accessories; Flexible/Rigid

Predicate Device:

The predicate device has not been subject to a design-related recall.

Device Description

The LUMINELLE DTx System permits viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The LUMINELLE DTx System is intended for use in endoscopic access to the examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the LUMINELLE DTx System allows the user to perform various diagnostic and therapeutic procedures.

The LUMINELLE DTx System is comprised of the following components:

LUMINELLE DTx Scope;
. LUMINELLE Communication Cable;
LUMINELLE Control Hub: ●
USB cable: .
HDMI cable, and;
power cord.

UVision360, Inc. (hereafter UVision360) designed a new accessory, the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) that is compatible with the LUMINELLE DTx System that permits direct viewing of the cervical canal and uterine cavity during biopsy procedures. LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) is a single use accessory and is made of the same materials as the previously cleared sheaths (K190827, K192278).

The LUMINELLE DTx Scope is reprocessed after each use, depending on the procedure. High Level Disinfection (HLD) solutions can be used to reprocess the LUMINELLE DTx Scope when used with a cystoscopy procedure. 0.6% Ortho-Phthalaldehyde (OPA), a chemical disinfectant, has been previously cleared for HLD. However, UVision360 has verified and validated an additional chemical, Steris Revital-Ox™ RESERT® High Level Disinfectant, for HLD with the LUMINELLE DTx System. Steris Revital

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Ox™ RESERT® High Level Disinfectant has been tested in order to determine that it identically cleans the LUMINELLE DTx Scope as 0.6% OPA and does not adversely affect the functionality of the LUMINELLE DTx System.

Before a hysteroscope procedure, the LUMINELLE DTx Scope must be sterilized to be reprocessed. In the previous submissions, Ethylene Oxide, qualified by Andersen Scientific, Inc., has been used to sterilize the LUMINELLE DTx Scope. An additional sterilization method, V-PRO® Low Temperature Sterilization, qualified by Steris located in Mentor, OH, has been validated and verified as an additional sterilization method to ensure that it properly sterilizes the LUMINELLE DTx Scope.

Indications for Use

Hysteroscopy:

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

NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not. in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 3600 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

Generally recognized indications for diagnostic hysteroscopy include:

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

Generally recognized indications for use for operative hysteroscopy include:

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

Cystoscopy:

NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

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Substantial Equivalence

The table below provides a detailed comparison of the LUMINELLE DTx System to the predicate device.

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Detailed Comparison of the Subject and Predicate Devices

Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
Indications forUse	Hysteroscopy:The LUMINELLE DTx System is used to permitviewing of the cervical canal and uterine cavity forthe purpose of performing diagnostic and surgicalprocedures.NOTE: Hysteroscopes are used as tools to accessthe uterine cavity and are not, in and of themselves,a method of surgery. When LUMINELLE DTxSystem is specifically used with the LUMINELLEDx 360° Rotatable Disposable Sheath (Diagnostic),the system is limited to performing diagnosticprocedures only. When the LUMINELLE DTxSystem is used with the LUMINELLE Bx 360°Rotatable Disposable Sheath (Biopsy), the system islimited to performing diagnostic procedures only.The Bx Sheath can be used for endometrial or lowerurinary tract (including bladder) biopsy byaspiration with a syringe during diagnosticprocedures.Generally recognized indications for diagnostichysteroscopy include:• Abnormal bleeding• Infertility and pregnancy wastage• Evaluation of abnormalhysterosalpingogram	Hysteroscopy:The LUMINELLE DTx Hysteroscopy System isused to permit viewing of the cervical canal anduterine cavity for the purpose of performingdiagnostic and surgical procedures.NOTE: Hysteroscopes are used as tools toaccess the uterine cavity and are not, in and ofthemselves, a method of surgery. WhenLUMINELLE DTx Hysteroscopy System isspecifically used with the LUMINELLE Dx 360°Rotatable Disposable Sheath (Diagnostic), thesystem is limited to performing diagnosticprocedures onlyGenerally recognized indications for diagnostichysteroscopy include:• Abnormal bleeding• Infertility and pregnancy wastage• Evaluation of abnormalhysterosalpingogram• Intrauterine foreign body• Amenorrhea• Pelvic PainGenerally recognized indications for use foroperative hysteroscopy include:	The Indications for Use of theLUMINELLE DTx System isthe same as the Indications forUse of the primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
	Intrauterine foreign body Amenorrhea Pelvic pain Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Transection of intrauterine septa Endometrial ablation Cystoscopy:The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.	Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Transection of intrauterine septa Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
	NOTE: When the LUMINELLE DTx System isused with the LUMINELLE Bx 360° RotatableDisposable Sheath (Biopsy), the system is limited toperforming diagnostic procedures only. The BxSheath can be used for endometrial or lower urinarytract (including bladder) biopsy by aspiration with asyringe during diagnostic procedures.
Intended Use	Hysteroscopy Intended Use:The LUMINELLE DTx System is used to permitdirect viewing of the cervical canal and uterinecavity for the purpose of performing diagnostic andsurgical procedures.NOTE: When LUMINELLE DTx System isspecifically used with the LUMINELLE Dx 360°Rotatable Disposable Sheath (Diagnostic), thesystem is limited to performing diagnosticprocedures only.	Hysteroscopy Intended Use:The LUMINELLE DTx Hysteroscopy System isused to permit direct viewing of the cervicalcanal and uterine cavity for the purpose ofperforming diagnostic and surgical procedures.NOTE: When LUMINELLE DTx HysteroscopySystem is specifically used with theLUMINELLE Dx 360° Rotatable DisposableSheath (Diagnostic), the system is limited toperforming diagnostic procedures only.	The Intended Use of theLUMINELLE DTx System isthe same as the Intended Use ofthe Primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
	Cystoscopy Intended Use:The LUMINELLE DTx System is intended for usein endoscopic access to the examination of the lowerurinary tract, including the bladder. When combinedwith accessory instruments, the System allows theuser to perform various diagnostic and therapeuticprocedures.	Cystoscopy Intended Use:The LUMINELLE DTx Hysteroscopy System isintended for use in endoscopic access to theexamination of the lower urinary tract, includingthe bladder. When combined with accessoryinstruments, the System allows the user toperform various diagnostic and therapeuticprocedures.
	NOTE: When LUMINELLE DTx System isspecifically used with the LUMINELLE Dx 360°Rotatable Disposable Sheath (Diagnostic), the	NOTE: When LUMINELLE DTx HysteroscopySystem is specifically used with theLUMINELLE Dx 360° Rotatable Disposable
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
	system is limited to performing diagnosticprocedures only.	Sheath (Diagnostic), the system is limited toperforming diagnostic procedures only.
	NOTE: When the LUMINELLE DTx System isused with the LUMINELLE Bx 360° RotatableDisposable Sheath (Biopsy), the system is limited toperforming diagnostic procedures only. The BxSheath can be used for endometrial or lower urinarytract (including bladder) biopsy by aspiration with asyringe during diagnostic procedures.
Product Code	HIH (Hysteroscope and Accessories)FAJ (Cystoscope and Accessories)	HIH (Hysteroscope and Accessories)FAJ (Cystoscope and Accessories)	The Product Codes of theLUMINELLE DTx System areidentical to the product codes ofthe primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
PatientContactingMaterials(Biocompatibility)	ISO 10993 Compliant	ISO 10993 Compliant	The biocompatibility complianceof patient contacting materials ofthe LUMINELLE DTx Systemis identical to the compliance ofthe primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
Components	● LUMINELLE DTx Hysteroscope● LUMINELLE DTx 360° RotatableDisposable Sheath	● LUMINELLE DTx Hysteroscope● LUMINELLE DTx 360° RotatableDisposable Sheath	The main components of theLUMINELLE DTx System areidentical to the main componentsof the primary predicate
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
	LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid LUMINELLE Communication Cable LUMINELLE Control Hub LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) LUMINELLE Bx 360° Rotatable Disposable Sheath (Sheath)	LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid LUMINELLE Communication Cable LUMINELLE Control Hub LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic)	LUMINELLE DTxHysteroscopy System(K192278). The only differenceis the addition of a newaccessory, LUMINELLE Bx360° Rotatable DisposableSheath (Biopsy). This differencedoes not affect the safety andeffectiveness of the device asvalidation and verification hasbeen performed on the newsheath.
Rigid/FlexibleSheath	Flexible and rigid sheaths available:Flexible sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath) contains a PEEK(polyetheretherketone) hypotube for flexibility. Rigid sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid,LUMINELLE Dx 360° Rotatable DisposableSheath (Diagnostic) and LUMINELLE Bx 360°Rotatable Disposable Biopsy Sheath) contains a304 stainless steel inner tube for rigidity.	Flexible and rigid sheaths available:Flexible sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath) contains aPEEK (polyetheretherketone) hypotube forflexibility. Rigid sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid andLUMINELLE Dx 360° Rotatable DisposableSheath (Diagnostic)) contains a 304 stainlesssteel inner tube for rigidity	The LUMINELLE DTx Systemis substantially equivalent to theprimary predicate, LUMINELLEDTx Hysteroscopy System(K192278), as they both containrigid and flexible sheaths.
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
Sheath Channels	LUMINELLE DTx 360° Rotatable DisposableSheath and LUMINELLE DTx 360° RotatableDisposable Sheath Rigid - 4 Channels; one for thescope, two for fluid management, and one foroperative instruments.LUMINELLE Dx 360° Rotatable DisposableSheath (Diagnostic) and LUMINELLE Bx 360°Rotatable Disposable Sheath (Biopsy) - 2Channels that merge into a single channel; one forthe scope and one for fluid management that mergethrough a funnel to become a single channel.	LUMINELLE DTx 360° Rotatable DisposableSheath and LUMINELLE DTx 360° RotatableDisposable Sheath Rigid - 4 Channels; one for thescope, two for fluid management, and one foroperative instruments.LUMINELLE Dx 360° Rotatable DisposableSheath (Diagnostic) - 2 Channels that mergeinto a single channel; one for the scope and onefor fluid management that merge through afunnel to become a single channel.	The sheath channels of theLUMINELLE DTx System ofthe LUMINELLE Bx 360°Rotatable Disposable Sheath(Biopsy) are identical to theLUMINELLE Dx 360°Rotatable Disposable Sheath(Diagnostic) of the primarypredicate device, LUMINELLEDTx Hysteroscopy System(K192278).
Syringes duringBiopsy Procedure	For biopsy procedures, a 10 mL Luer Lock syringeis attached to the sheath	Not applicable	The LUMINELLE DTx Systemis substantially equivalent to theprimary predicate, LUMINELLEDTx Hysteroscopy System(K192278). The only differenceis the addition of the Bx adapterthat enables a syringe to beconnected via a luer lock. Thisdifference does not affect thesafety and effectiveness of thedevice as validation andverification has been performedon the new sheath.
Images	Devices can take and transmit images	Device can take and transmit images	The LUMINELLE DTx Systemis identical to the primarypredicate device, LUMINELLEDTx Hysteroscope System
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
			(K192278), as the device can
Scope WorkingLength	240 mm	240 mm	take and transmit images.The scope working length of theLUMINELLE DTx System isidentical to the scope workinglength of the primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
Image Processingand Display	Image Processing: Digital Video ProcessorDisplay: Standard HD Monitor/TV.	Image Processing: Digital Video ProcessorDisplay: Standard HD Monitor/TV.	The image processing anddisplay of the LUMINELLEDTx System is identical to theimage processing and display ofthe primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
Objective Lens• Focal Length• Field of View• Direction ofView	Focal Length: 5 – 50 mmField of View: 120° in airDirection of View: Forward (0°)	Focal Length: 5 – 50 mmField of View: 120° in airDirection of View: Forward (0°)	The objective lens of theLUMINELLE DTx System isidentical to the objective lens ofthe primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
Image Resolution	CMOS chip is 400 x 400 pixels.USAF 1951 bar code Group-Element: 1-5	CMOS chip is 400 x 400 pixels.USAF 1951 bar code Group-Element: 1-5	The image resolution of theLUMINELLE DTx System isidentical to the image resolutionof the primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
PowerRequirements	120V AC	120V AC	The power requirements of theLUMINELLE DTx System areidentical to the powerrequirements of the primarypredicate, LUMINELLE DTxHysteroscopy System(K192278).
Power Supply	LUMINELLE Control Hub includes the powersupply which converts 120V AC to 12V DC. TheControl Hub also serves as the image converter andvisualization connection.	LUMINELLE Control Hub includes the powersupply which converts 120V AC to 12V DC.The Control Hub also serves as the imageconverter and visualization connection.	The power supply of theLUMINELLE DTx System isidentical to the power supply ofthe primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
Cables	LUMINELLE Communication Cable which powersthe Scope from the Control Hub and transmits theimage, HDMI and USB cables for connection of theControl Hub to a monitor or computer	LUMINELLE Communication Cable whichpowers the Scope from the Control Hub andtransmits the image, HDMI and USB cables forconnection of the Control Hub to a monitor orcomputer	The cables of the LUMINELLEDTx System are identical to theprimary predicate, LUMINELLEDTx Hysteroscopy System(K192278).
Mode ofOperation	Continuous	Continuous	The mode of operation of theLUMINELLE DTx System isidentical to the mode ofoperation primary predicate,LUMINELLE DTxHysteroscopy System(K192278).
Electrical Safety	Compliant with requirements ofIEC 60601-1:IEC 60601-2-18	Compliant with requirements ofIEC 60601-1:IEC 60601-2-18	The electrical safety complianceof the LUMINELLE DTxSystem is identical to theelectrical safety compliance ofthe primary predicate.
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
Thermal Safety	Compliant with requirements ofIEC 60601-1;IEC 60601-2-18	Compliant with requirements ofIEC 60601-1;IEC 60601-2-18	LUMINELLE DTxHysteroscopy System(K192278).The thermal safety complianceof the LUMINELLE DTxSystem is identical to thethermal safety compliance of theprimary predicate,LUMINELLE DTxHysteroscopy System(K192278).
ElectromagneticCompatibility	Compliant with requirements of:IEC 60601-1-2 4th edition	Compliant with requirements of:IEC 60601-1-2 4th edition	The electromagneticcompatibility compliance of theLUMINELLE DTx System isidentical to that of the primarypredicate, LUMINELLE DTxHysteroscopy System(K192278).
Degree ofProtectionAgainstElectrical Shock	Type BF	Type BF	The degree of protection againstelectrical shock of theLUMINELLE DTxHysteroscopy System is identicalto the degree of protectionagainst electrical shock of theprimary predicate,LUMINELLE DTxHysteroscopy System(K192278).
Degree ofProtection	IPX7	IPX7	The degree of protection againstinvasion of liquids of theLUMINELLE DTx System is
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
Against Invasionof Liquids			identical to the degree ofprotection against invasion ofliquids of the primary predicate,LUMINELLE DTxHysteroscopy System (K192278)
Site of Use	Hospitals and Physician offices	Hospitals and Physician offices	The LUMINELLE DTx Systemis identical to the primarypredicate, LUMINELLE DTxHysteroscopy (K192278) as theyare both used in hospitals andphysician offices.
Reprocessing	No reprocessing required on the sheaths - theLUMINELLE DTx 360° Rotatable DisposableSheath, LUMINELLE DTx 360° RotatableDisposable Sheath Rigid, LUMINELLE Dx 360°Rotatable Disposable Sheath (Diagnostic), andLUMINELLE Bx 360° Rotatable DisposableBiopsy Sheath and are single-use disposable and areprovided sterile.	No reprocessing required on the sheaths - theLUMINELLE DTx 360° Rotatable DisposableSheath, LUMINELLE DTx 360° RotatableDisposable Sheath Rigid, and LUMINELLE Dx360° Rotatable Disposable Sheath (Diagnostic)are single-use disposable and are providedsterile.	The reprocessing of the sheathsof the LUMINELLE DTxSystem is identical to the sheathreprocessing of the primarypredicate, LUMINELLE DTxHysteroscopy System(K192278), as they are bothintended for single-use.
SterilizationCycles	Andersen Scientific Standard Ethylene Oxide (EO)Flexible Bag ProcessSteris V-PRO Low Temperature Sterilization	Andersen Scientific Standard Ethylene Oxide(EO) Flexible Bag Process	The sterilization of theLUMINELLE DTx system issubstantial equivalent to theprimary predicate, LUMINELLEDTx Hysteroscope System(K192278), as they both use anEthylene Oxide Cycle. However,the LUMINELLE DTx Systemuses an additional cycle, SterisV-PRO Low TemperatureSterilization, for sterilization.
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTx System	LUMINELLE DTx Hysteroscopy System(K192278)
			This difference was validatedand tested to ensure that thissterilization cycle does not affectthe safety and effectiveness ofthe device.
High LevelDisinfectants(intended forcystoscopyprocedures onlyfor High LevelDisinfection)	0.6% ortho-Phthalaldehyde (OPA)Steris Revital-Ox™ RESERT High LevelDisinfectant	0.6% ortho-Phthalaldehyde (OPA)	The High Level Disinfectants ofthe LUMINELLE DTx system issubstantial equivalent to theprimary predicate, LUMINELLEDTx Hysteroscope System(K192278), as they both use an0.6% ortho-Phthalaldehyde(OPA). However, theLUMINELLE DTx System usesan additional disinfectant, SterisRevital-Ox™ RESERT HighLevel Disinfectant, for high leveldisinfection. This difference wasvalidated and tested to ensurethat this sterilization cycle doesnot affect the safety andeffectiveness of the device.

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Testing

LUMINELLE DTx System was verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed. completed the following testing:

Performance - Bench

. Design verification and validation of the LUMINELLE DTx System included useful life testing following multiple cvcles of high-level cleaning and disinfectional performance testing after accelerated aging in accordance with ASTM F1980-16, durability of the reusable handle markings following multiple cycles of high-level cleaning and disinfection, and shipping and handling simulation for the reusable components of the system.
Design validation testing of the LUMINELLE DTx System included usability testing in accordance with IEC 62366-1 and ANSVAAMI HE75 in simulated uterine and bladder models. Instructions for Use were also evaluated by the physicians during the design validation testing. The reprocessing instructions were validated for use by Sterile Processing Department technicians.
. Design validation testing was performed for the LUMINELLE DTx System with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) to confirm that the sheath performs according to its intended use in in vivo models, the user is able to operate the system as intended, and the sheath conforms to user needs.
. Bench testing was performed on the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) to confirm that the sheath performs as expected

Software Validation

Software verification and validation testing of the LUMINELLE DTx System was performed for ● its software component.

Reprocessing

Validation of the cleaning and high-level disinfection procedures was performed in accordance with the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
. Validation of the Steris V-PRO® Low Temperature Sterilization cycle and was performed for reprocessing of the LUMINELLE DTx Scope in accordance with the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling -Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".
Validation of the Steris Revital-Ox™ RESERT® High Level Disinfectant for High Level ● Disinfection was performed for reprocessing of the LUMINELLE DTx Scope per the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff, Document issued on: March 17, 2015".

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Biocompatibility

The biocompatibility of the patient contacting materials of the sterile, single-use 360° Rotatable Disposable Sheath and insertion tube of the reusable LUMINELLE DTx Scope was established in accordance with ISO 10993-1. The results of biocompatibility testing confirmed that the materials of the 360º Rotatable Disposable Sheath and insertion tube are not cytotoxic, sensitizing, or irritating when in contact with human skin. Sensitization testing, was also performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-10:2016 to confirm that the sheath does not induce sensitization or irritation. Cytotoxicity testing was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-5:2009 to confirm that the sheath does not induce cytotoxicity.

Electromagnetic Compatibility / Electrical Safety:

The LUMINELLE DTx System was tested and found to be compliant with the following standards . for electrical safety and EMC: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-1-2.
The LUMINELLE DTx System was tested and found to be compliant with the following standards for medical endoscopes: ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 8600-5.

Shelf-Life

To verify the shelf life of the disposable sheaths, the LUMINELLE DTx 360° Rotatable Disposable Sheath was sterilized using an established 100% Ethylene Oxide (EO) sterilization process in accordance with ISO 1135:2014, with a Sterility Assurance Level (SAL) of 106. An initial shelf life of one (1) year for the sterile packaging was verified by leak testing in accordance with ASTM F2096-11 and seal strength testing in accordance with ASTM F88-15 following accelerated aging in accordance with ASTM F1980-16. Following EO sterilization and environmental conditioning in accordance with ISTA 2A (2011), simulated distribution testing was conducted in accordance with ASTM D4169-16, Distribution Cycle 13 (intercity air/local motor freight), Assurance Level 1, Schedules: A, C, F, E, J, and A. Subsequent leak testing and seal strength testing demonstrated that the packaging maintained a sterile barrier throughout the normal transportation and distribution of the device.

Additional testing occurred in K192278 as an accelerated-aging shelf-life study was performed for ● packaged LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) to confirm the thirteenmonth (13) shelf life of the sheaths. After accelerating aging in accordance with ASTM F1980-16, visual inspection was performed to inspect for product damage caused by the aging process, and functional design verification was performed to verify that the documented inputs met the documented outputs.
Accelerated aging was performed on the LUMINELLE Bx 360° Rotatable Disposable Sheath ● (Biopsy) for a thirteen (13) month period in accordance with ASTM F1980-16. After aging was complete, visual inspection was performed to inspect for product damage caused by the aging process, and functional design verification was performed to verify that the documented inputs met the documented outputs of the device.

Distribution / Transit

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Distribution simulation testing in accordance with ASTM D4169-16, Distribution Cycle 13; ● Assurance Level I was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). This testing consisted of seal strength testing in accordance with ASTM F88-15 and bubble leak testing in accordance with ASTM F2096-11 to confirm that the packaging maintained a sterile barrier throughout the normal transportation and distribution of the device.

Sterilization

. A sterilization adoption evaluation was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath in accordance with AAMI TIR28:2016. Product adoption and process equivalence for Ethylene Oxide (EO) Sterilization to confirm that the previously performed sterilization validation is also applicable to the LUMINELLE Dx 360° Rotatable Disposable The evaluation confirmed that the differences between the LUMINELLE Dx 360° Sheath. Rotatable Disposable Sheath and the validated product are insignificant. Bioburden, microorganism characterization, and EO residuals testing was performed to substantiate the rationale leading to the conclusion that the changes are minor.
A sterilization adoption evaluation was performed for the LUMINELLE Bx 360° Rotatable ● Disposable Sheath (Biopsy) in accordance with AAMI TIR28:2016. Product adoption and process equivalence for Ethylene Oxide (EO) Sterilization to confirm that the previously performed sterilization validation is also applicable to the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy). The evaluation confirmed that the differences between the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) and the validated product are insignificant. To substantiate the rationale leading to the conclusion that the changes are minor, bioburden, microorganism characterization, and EO residuals testing was performed

Substantial Equivalence Discussion

The intended use for LUMINELLE DTx System is the same as that of the previously cleared LUMINELLE DTx Hysteroscope System (K192278). The technological characteristics of the LUMINELLE DTx System are different from the LUMINELLE DTx Hysteroscope System (K192278) in that the LUMINELLE DTx System includes the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy). However, this difference does not raise different questions of safety and effectiveness. Performance testing shows that the LUMINELLE DTx System is as safe and effective as the previously cleared LUMINELLE DTx Hysteroscopy System (K192278).

Conclusion

The LUMINELLE DTx System is substantially equivalent to the legally marketed predicate device K192278.

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.