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 user to perform various diagnostic and therapeutic procedures.

Device Description

The LUMINELLE DTx Hysteroscopy System previously received 510(k) clearance (K181909) in 2018 as a hysteroscopic and cystoscopic system. To provide the user with a more rigid option for the RotoSheath and Introducer, UVision360, Inc. (hereafter UVision) proposes the addition of a new component to the system, the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid in addition to the currently available flexible Rotatable Disposable Sheath option cleared during the previous submission (K181909). No changes are proposed for the previously cleared components or the principles of operation of the LUMINELLE DTx Hysteroscopy System. The proposed change includes only the addition of a new component which is a modification to the previously cleared flexible LUMINELLE DTx 360° Rotatable Disposable Sheath.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the LUMINELLE DTx Hysteroscopy System. This submission is for the addition of a new component, a rigid sheath, to an already cleared system. Therefore, the focus of the documentation is on demonstrating the substantial equivalence of the modified device, particularly the new rigid sheath, to the previous cleared flexible sheath version.

Based on the provided text, a formal study demonstrating the device meets a specific set of acceptance criteria in the conventional sense (e.g., accuracy, sensitivity, specificity for an AI/diagnostic device) is not explicitly detailed. Instead, the document describes design validation testing and other engineering tests to ensure the new component performs as intended and does not raise new questions of safety or effectiveness compared to the predicate device.

Here's a breakdown of the information requested, based on the provided text:

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that:

Acceptance Criteria Category	Reported Device Performance
Design Validation	"The LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid met all predefined acceptance criteria" for confirming the sheath performs 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.
Sterility and Shelf-life	Previous sterilization, simulated distribution, and packaging shelf-life test documentation from the predicate device (K181909) were leveraged. The 1-year shelf-life was demonstrated through pull testing on the stainless steel hypotube bond, maintaining specifications after accelerated aging.
Biocompatibility	Biocompatibility data from the predicate device (K181909) was leveraged because there are no differences in patient-contacting materials, manufacturing, or processing between the new rigid sheath and the predicate flexible sheath.
Electrical Safety	Dielectric strength testing was conducted for the rigid sheath to confirm it can withstand voltages in accordance with IEC 60601-1:2005/(R)2012 and A1:2012. Results were "acceptable per IEC 60601-2-2 [...] which is specified by IEC 60601-2-18."
Substantial Equivalence	"Performance testing shows that the LUMINELLE DTx Hysteroscopy System is as safe and effective as the previously cleared LUMINELLE DTx Hysteroscopy System (K181909)." The intended use and indications for use are identical to the predicate. The only technological difference (rigid vs. flexible sheath) "does not raise different questions of safety and effectiveness." The rigid sheath is also noted to be similar to a component of a reference device (K150158).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample size for the "in vivo models" used in design validation testing.
Data Provenance: Not specified. The study is described as "design validation testing" using "in vivo models," which typically refers to animal or cadaveric models for medical devices, but specific details are absent. No information on country of origin or retrospective/prospective nature is provided.

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)

This is not applicable to the type of testing described. The design validation testing focuses on confirming the sheath's functional performance and user operability, rather than diagnostic accuracy against a ground truth established by experts.

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

Not applicable. The testing described is functional and safety testing of a medical device component, not a diagnostic performance study requiring expert adjudication of results.

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

Not applicable. This document describes a hysteroscopy system, which is an imaging device for direct viewing and performing procedures. It does not appear to incorporate AI or machine learning for diagnostic interpretation that would warrant an MRMC study.

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

Not applicable. This is not an AI algorithm.

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

The concept of "ground truth" in the diagnostic sense (expert consensus, pathology, outcomes) is not applicable here. The "ground truth" for the design validation testing would be the predefined functional and user performance specifications of the device component.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable.

Summary

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June 6, 2019

UVision360, Inc. % Rita King CEO MethodSense, Inc. 1 Copley Pkwy, Suite 410 Morrisville, NC 27560

Re: K190827

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: May 6, 2019 Received: May 10, 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.

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/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,

Sharon M. Andrews Assistant Division 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) K190827

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

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 user to perform various diagnostic and therapeutic procedures.

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. K190827

Submitter:	UVision360 Inc.158 Wind Chime Ct.Suite 201Raleigh, NC 27615Phone: 888-855-9360Fax:
Primary Contact:	Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979
Company Contact:	Allison London BrownCEO

Date Prepared: June 4, 2019

Device Name and Classification

Trade Name:	LUMINELLE DTx Hysteroscopy System
Common Name:	Hysteroscope with sheath
Classification:	Class II
Regulation Number:	21 CFR 884.1690 Hysteroscope and accessories
	21 CFR 876.1500 Endoscope and accessories
Classification Panel:	Obstetrics/Gynecology, Gastroenterology/Urology
Product Code:	HIH Hysteroscope (And Accessories)
	FAJ Cystoscope And Accessories; Flexible/Rigid

Predicate Device:

	Predicate Device	Reference Device
Trade Name	LUMINELLE DTxHysteroscopy System	SchoellyCystoscopies/Hysteroscopeand Accessories
Common Name	Hysteroscope (andaccessories); Cystoscope(and accessories)	Hysteroscope andaccessories
510(k) Submitter / Holder	UVision360 Inc.	Schoelly Fiberoptic GmbH
510(k) Number	K181909	K150158
Regulation Number	21 CFR 876.150021 CFR 884.1690	21 CFR 876.150021 CFR 884.1690
Classification Panel	Gastroenterology/UrologyObstetrics/Gynecology	Obstetrics/Gynecology
Product Code	FAJ, HIH	FAJ, HIH

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

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Device Description

No changes are proposed for the previously cleared components or the principles of operation of the LUMINELLE DTx Hysteroscopy System. The proposed change includes only the addition of a new component which is a modification to the previously cleared flexible LUMINELLE DTx 360° Rotatable Disposable Sheath.

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.

The LUMINELLE DTx Hysteroscopy System is also 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.

Indications for Use

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.

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.

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Substantial Equivalence

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

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Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTxHysteroscopy System	LUMINELLE DTxHysteroscopy System(K181909)
Intended Use
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 surgeryGenerally recognized indications for diagnostic hysteroscopy include:• Abnormal bleeding• Infertility and pregnancy wastage• Evaluation of abnormal hysterosalpingogram	Hysteroscopy:The LUMINELLE DTx Hysteroscopy System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgeryGenerally recognized indications for diagnostic hysteroscopy include:• Abnormal bleeding• Infertility and pregnancy wastage• Evaluation of abnormal hysterosalpingogram• Intrauterine foreign body• Amenorrhea• Pelvic Pain	The Indications for Use of the LUMINELLE DTx Hysteroscopy System are identical to the Indications for Use of the previously cleared LUMINELLE DTx Hysteroscopy System (K181909).
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTxHysteroscopy System	LUMINELLE DTxHysteroscopy System(K181909)
	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 Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access and examination of the lower	Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various
Item	Subject Device	Predicate Device	Comparison
	LUMINELLE DTxHysteroscopy System	LUMINELLE DTxHysteroscopy System(K181909)
	urinary tract, includingthe bladder. Whencombined withaccessory instruments,the System allows theuser to perform variousdiagnostic andtherapeutic procedures.	diagnostic and therapeuticprocedures.
Technological Characteristics
Rigid/FlexibleSheath	Flexible and rigidsheaths available:• Flexible sheath(LUMINELLE DTx360° RotatableDisposable Sheath)contains a PEEK(polyetheretherketone)hypotube forflexibility.• Rigid sheath(LUMINELLE DTx360° RotatableDisposable SheathRigid) contains a304 stainless steelinner tube forrigidity.	Flexible sheath only(LUMINELLE DTx 360°Rotatable DisposableSheath), contains a PEEK(polyetheretherketone)hypotube for flexibility.	The flexibility of the LUMINELLE DTx 360° RotatableDisposable Sheath of the LUMINELLE DTxHysteroscopy System is identical to the flexibility of thesheath of the previously cleared LUMINELLE DTxHysteroscopy System (K181909).The rigidity of the LUMINELLE DTx 360° RotatableDisposable Sheath Rigid of the LUMINELLE DTxHysteroscopy System is higher than that of the predicateRotatable Disposable Sheath. However, this differencedoes not raise different questions of safety andeffectiveness. The reference device, SchoellyCystoscopes/ Hysteroscopes and Accessories(K150158) includes a rigid sheath similar to theproposed device.All other technological characteristics are the samebetween the subject and predicate device.

Detailed Comparison of the Subject and Predicate Device

UVision360 LUMINELLE DTx Hysteroscopy System Special 510(k)

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K190827 Page 5 of 8

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K190827 Page 6 of 8

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Testing

Sterility and shelf-life

LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid is packaged in the same packaging as the predicate Rotatable Disposable Sheath, with the same sealing parameters. As the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid has the same dimensions as the predicate LUMINELLE DTx 360° Rotatable Disposable Sheath and the packaging materials and sealing parameters are identical, previous sterilization, simulated distribution and packaging shelf-life test documentation from the predicate was leveraged to support the sterilization and seal integrity of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid.

The shelf-life of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid of 1 year was demonstrated through pull testing on the stainless steel hypotube bond. The device was demonstrated to maintain specifications after accelerated aging.

Design validation

Design validation testing and usability testing was conducted on the LUMINELLE DTx Hysteroscopy System with the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to confirm that the sheath performs 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. Testing was identical to that conducted on the predicate LUMINELLE DTx 360° Rotatable Disposable Sheath. The LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid met all predefined acceptance criteria.

Biocompatibility

There is no difference in patient-contacting materials, manufacturing or processing between the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid and the predicate Rotatable Disposable Sheath. Therefore, biocompatibility data from the predicate was leveraged to support the biocompatibility of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid.

Electrical Safety

Due to the additional stainless steel utilized in the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid, dielectric strength testing was conducted for the LUMINELLE DTx Rigid 360° Rotatable Disposable Sheath Rigid to confirm that the rigid sheath can withstand dielectric strength voltages in accordance with IEC 60601-1:2005/(R)2012 and A1:2012. Results of the testing were acceptable per IEC 60601-2-2 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories, which is specified by IEC 60601-2-18 Particular requirements for the basic safety and essential performance of endoscopic equipment.

Substantial Equivalence Discussion

The intended use for LUMINELLE DTx Hysteroscopy System is the same as that of the previously cleared LUMINELLE DTx Hysteroscopy System (K181909). The technological characteristics of the LUMINELLE DTx Hysteroscopy System are different from the LUMINELLE DTx Hysteroscopy System (K181909) in that the LUMINELLE DTx Hysteroscopy System includes the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid, a modified version of

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the LUMINELLE DTx 360° Rotatable Disposable Sheath (K181909). However, this difference does not raise different questions of safety and effectiveness. Performance testing shows that the LUMINELLE DTx Hysteroscopy System is as safe and effective as the previously cleared LUMINELLE DTx Hysteroscopy System (K181909).

Conclusion

The LUMINELLE DTx Hysteroscopy System is substantially equivalent to the legally marketed predicate device K181909.

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.