(71 days)
No
The summary describes a modification to a previously cleared hysteroscopy/cystoscopy system, primarily involving a new disposable sheath with design changes for diagnostic use. There is no mention of AI, ML, image processing, or any computational analysis of the endoscopic images. The performance studies focus on sterilization, shelf life, packaging, usability, and biocompatibility of the new sheath.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "performing diagnostic and surgical procedures" in hysteroscopy and for "diagnostic and therapeutic procedures" in cystoscopy.
Yes
The intended use explicitly states that the LUMINELLE DTx Hysteroscopy System is for viewing the cervical canal and uterine cavity for diagnostic and surgical procedures, and specifically mentions that when used with a particular sheath, it is limited to diagnostic procedures only. It also lists several generally recognized indications for diagnostic hysteroscopy. Additionally, it states its use for examination of the lower urinary tract and bladder for diagnostic and therapeutic procedures, and again, specifically mentions diagnostic procedures when used with a particular sheath.
No
The device description explicitly details physical components and modifications to a disposable sheath, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used for "viewing of the cervical canal and uterine cavity" and "endoscopic access to and examination of the lower urinary tract, including the bladder" for the purpose of performing diagnostic and surgical procedures. This involves direct visualization and physical procedures within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Device Description: The device is described as a hysteroscopy and cystoscopy system with sheaths, which are instruments used for direct visualization and access within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or performing tests on bodily fluids or tissues outside the body.
The device is an endoscopic system used for direct examination and intervention within the body, which falls under the category of medical devices used for diagnosis and treatment in vivo.
N/A
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 surgery. When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
Generally recognized indications for diagnostic hysteroscopy include:
- · Abnormal bleeding
- · Infertility and pregnancy wastage
- · Evaluation of abnormal hysterosalpingogram
- · Intrauterine foreign body
- · Amenorrhea
- Pelvic Pain
Generally recognized indications for use for operative hysteroscopy include:
- · Directed endometrial biopsy
- · Polypectomy
- · Submucous myomectomy
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa
- Endometrial ablation
Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the blader. When combined with accessory instruments, the user to perform various diagnostic and therapeutic procedures.
NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
Product codes (comma separated list FDA assigned to the subject device)
HIH, FAJ
Device Description
The LUMINELLE DTx Hysteroscopy System originally received 510(k) clearance in 2018 as a hysteroscopic and cystoscopic 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).
Based on user feedback for a thinner option for the disposable sheath for only diagnostic use, UVision360, Inc. (hereafter UVision) proposes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), as part of an engineering performance change.
The LUMINELLE DTx Hysteroscopy System indications for use is identical to the previously cleared indications for use for the system. However, when the system is used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the indications for use are limited to diagnostic use only.
No changes are proposed for the previously cleared components of the LUMINELLE DTx Hysteroscopy System. The new LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) accessory is a modification of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid component of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) with the following main changes:
- . The new accessory has one fluid line rather than the two fluid lines of the previously cleared component.
- . The new accessory has a combined channel for the scope and the fluid line rather than the separate channels of the previously cleared component.
- The new accessory has no operative channel available unlike the previously cleared . component, due to the fact that it is for diagnostic use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and uterine cavity, lower urinary tract, including the bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- A sterilization adoption was performed for the LUMINELLE Dx 360° Rotatable . Disposable Sheath in accordance with AAMI TIR28:2016. Product adoption and Process Equivalence for Ethylene Oxide Sterilization to confirm that the previously performed sterilization validation is also applicable to the LUMINELLE Dx 360° Rotatable Disposable Sheath. To substantiate the conclusion that the processes are equivalent, microorganism characterization, and EO residuals testing was performed. Results demonstrated that the LUMINELLE Dx 360° Rotatable Disposable Sheath sterilization may be adopted into the existing validation protocol.
- . An accelerated aging shelf life study was performed for packaged LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) to confirm the 13 month shelf life of the sheaths. After accelerating aging in accordance with ASTM F1980-16, visual inspection was performed to inspect for product damage caused by the aging process, and functional design verification was performed to verify that the documented inputs met the documented outputs. All samples met specifications after aging.
- Distribution simulation testing in accordance with ASTM D4169-16, Distribution Cycle 13: . Assurance Level I was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). This testing consisted of seal strength testing in accordance with ASTM F88-15 and bubble leak testing in accordance with ASTM F2096-11 to confirm that the packaging maintained a sterile barrier throughout the normal transportation and distribution of the device. Packages were confirmed to maintain integrity following simulated distribution.
- Usability and design validation testing was repeated for the LUMINELLE DTx ● Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) to confirm that the sheath performs according to its intended use in in vivo models, the user is able to operate the system as intended, and the product conforms to user needs. Devices met predefined acceptance criteria.
- Sensitization and irritation testing was performed for the final finished LUMINELLE Dx ● 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-10:2016 to confirm that the Sheath does not induce sensitization or irritation. Results demonstrate the device is not irritating or sensitizing.
- . Cytotoxicity testing was performed for the final finished LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-5:2009 to confirm that the Sheath does not induce cytotoxicity. Results demonstrate the device is not cytotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2019
UVision360 Inc. Rita King CEO MethodSense, Inc. 1 Copley Pkwy. Ste. 410 Morrisville, NC 27560
Re: K192278
Trade/Device Name: LUMINELLE DTx Hysteroscopy System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: II Product Code: HIH, FAJ Dated: September 26, 2019 Received: October 2, 2019
Dear Rita King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sharon Andrews Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K192278
Device Name
LUMINELLE DTx Hysteroscopy System
Indications for Use (Describe)
Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
Generally recognized indications for diagnostic hysteroscopy include:
- · Abnormal bleeding
- · Infertility and pregnancy wastage
- · Evaluation of abnormal hysterosalpingogram
- · Intrauterine foreign body
- · Amenorrhea
- Pelvic Pain
Generally recognized indications for use for operative hysteroscopy include:
- · Directed endometrial biopsv
- · Polypectomy
- · Submucous myomectomy
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa
- Endometrial ablation
Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the blader. When combined with accessory instruments, the user to perform various diagnostic and therapeutic procedures.
NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
Type of Use (Select one or both, as applicable)
✔ | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
UVision360 Inc.
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | UVision360 Inc.
158 Wind Chime Ct.
Suite 201
Raleigh, NC 27615
Phone: 888-855-9360 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Allison London Brown
CEO |
| Date Prepared: | October 9, 2019 |
| Device Name and Classification | |
| Trade Name: | LUMINELLE DTx Hysteroscopy System |
|---|---|
| Common Name: | Hysteroscope and accessories, Endoscope and accessories |
| Classification: | Class II |
| Regulation Number: | 21 CFR 884.1690 Hysteroscope and accessories |
| 21 CFR 876.1500 Endoscope and accessories | |
| Classification Panel: | Obstetrics/Gynecology |
| Gastroenterology/Urology | |
| Product Code: | HIH Hysteroscope (And Accessories) |
| FAJ Cystoscope And Accessories; Flexible/Rigid |
Predicate Device:
| Predicate Device | ||
|---|---|---|
| Trade Name | LUMINELLE DTx Hysteroscopy System | |
| Common Name | Hysteroscope (and accessories); Cystoscope | |
| (and accessories) | ||
| 510(k) Submitter / Holder | UVision360 Inc. | |
| 510(k) Number | K190827 | |
| Regulation Number | 21 CFR 884.1690 Hysteroscope and accessories | |
| 21 CFR 876.1500 Endoscope and accessories | ||
| Classification Panel | Gastroenterology/Urology | |
| Obstetrics/Gynecology | ||
| Product Code | HIH Hysteroscope (And Accessories) | |
| FAJ Cystoscope And Accessories; Flexible/Rigid |
The predicate device has not been subject to a design-related recall.
4
Device Description
The LUMINELLE DTx Hysteroscopy System originally received 510(k) clearance in 2018 as a hvsteroscopic and cvstoscopic svstem (K181909). In addition, LUMINELLE DTx Hysteroscopy System received 510(k) clearance in 2019 for the addition of a sheath component, LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to the system (K190827).
Based on user feedback for a thinner option for the disposable sheath for only diagnostic use, UVision360, Inc. (hereafter UVision) proposes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), as part of an engineering performance change.
The LUMINELLE DTx Hysteroscopy System indications for use is identical to the previously cleared indications for use for the system. However, when the system is used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the indications for use are limited to diagnostic use only.
No changes are proposed for the previously cleared components of the LUMINELLE DTx Hysteroscopy System. The new LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) accessory is a modification of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid component of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) with the following main changes:
- . The new accessory has one fluid line rather than the two fluid lines of the previously cleared component.
- . The new accessory has a combined channel for the scope and the fluid line rather than the separate channels of the previously cleared component.
- The new accessory has no operative channel available unlike the previously cleared . component, due to the fact that it is for diagnostic use only.
Indications for Use
Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal bleeding ●
- Infertility and pregnancy wastage
- . Evaluation of abnormal hysterosalpingogram
- . Intrauterine foreign body
- . Amenorrhea
- Pelvic Pain
5
Generally recognized indications for use for operative hysteroscopy include:
- . Directed endometrial biopsy
- Polypectomy
- Submucous myomectomy
- . Transection of intrauterine adhesions
- . Transection of intrauterine septa
- . Endometrial ablation
Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.
NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.
Substantial Equivalence
The table below provides a detailed comparison of the LUMINELLE DTx Hysteroscopy System to the predicate device.
6
Detailed Comparison of the Subject and Predicate Devices
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| LUMINELLE DTx | |||
| Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) | ||
| General | |||
| Indications for Use | Hysteroscopy: | ||
| The LUMINELLE DTx | |||
| Hysteroscopy System is used to | |||
| permit viewing of the cervical | |||
| canal and uterine cavity for the | |||
| purpose of performing | |||
| diagnostic and surgical | |||
| procedures. |
NOTE: Hysteroscopes are used
as tools to access the uterine
cavity and are not, in and of
themselves, a method of
surgery. When LUMINELLE
DTx Hysteroscopy System is
specifically used with the
LUMINELLE Dx 360° Rotatable
Disposable Sheath (Diagnostic),
the system is limited to
performing diagnostic
procedures only. | Hysteroscopy:
The LUMINELLE DTx
Hysteroscopy System is used to
permit viewing of the cervical canal
and uterine cavity for the purpose
of performing diagnostic and
surgical procedures.
NOTE: Hysteroscopes are used
as tools to access the uterine
cavity and are not, in and of
themselves, a method of surgery.
Generally recognized indications
for diagnostic hysteroscopy include:
Abnormal bleeding Infertility and pregnancy wastage Evaluation of abnormal hysterosalpingogram Intrauterine foreign body Amenorrhea Pelvic Pain | The Indications for Use of
the LUMINELLE DTx
Hysteroscopy System are
identical to the Indications
for Use of the previously
cleared LUMINELLE DTX
Hysteroscopy System
(K190827), except that
when specifically used with
the LUMINELLE Dx 360°
Rotatable Disposable
Sheath (Diagnostic), the
system is limited to
performing diagnostic
procedures only. |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) | |
| | Generally recognized indications for diagnostic hysteroscopy include:
Abnormal bleeding Infertility and pregnancy wastage Evaluation of abnormal hysterosalpingogram Intrauterine foreign body Amenorrhea Pelvic Pain Generally recognized indications for use for operative hysteroscopy include:
Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Transection of intrauterine septa Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to | Generally recognized indications for use for operative hysteroscopy include:
Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Transection of intrauterine septa Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. | |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx
Hysteroscopy System
and examination of the lower
urinary tract, including the bladder.
When combined with accessory
instruments, the System allows the
user to perform various diagnostic
and therapeutic procedures.
NOTE: When LUMINELLE DTx
Hysteroscopy System is
specifically used with the
LUMINELLE Dx 360° Rotatable
Disposable Sheath (Diagnostic),
the system is limited to
performing diagnostic
procedures only. | LUMINELLE DTx Hysteroscopy
System (K190827) | |
| Intended Use | Hysteroscopy Intended Use:
The LUMINELLE DTx
Hysteroscopy System is used to
permit direct viewing of the
cervical canal and uterine cavity
for the purpose of performing
diagnostic and surgical
procedures.
NOTE: When LUMINELLE DTx
Hysteroscopy System is
specifically used with the | Hysteroscopy Intended Use:
The LUMINELLE DTx
Hysteroscopy System is used to
permit direct viewing of the cervical
canal and uterine cavity for the
purpose of performing diagnostic
and surgical procedures.
Cystoscopy Intended Use:
The LUMINELLE DTx Hysteroscopy
System is intended for use in
endoscopic access to the examination
of the lower urinary tract, including the | The Intended Use of the
LUMINELLE DTx
Hysteroscopy System is
identical to the Intended
Use of the previously
cleared LUMINELLE DTx
Hysteroscopy System
(K181909), except that
when specifically used with
the LUMINELLE Dx 360°
Rotatable Disposable
Sheath (Diagnostic), the |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx
Hysteroscopy System | LUMINELLE DTx Hysteroscopy System (K190827) | |
| | LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. | system is limited to performing diagnostic procedures only. |
| | Cystoscopy Intended Use:
The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to the examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. | | |
| | NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | | |
| Product Code | HIH (Hysteroscope and Accessories)
FAJ (Cystoscope and Accessories) | HIH (Hysteroscope and Accessories)
FAJ (Cystoscope and Accessories) | The Product Codes of the LUMINELLE DTx Hysteroscopy System are identical to the product codes of the previously |
| ltem | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx
Hysteroscopy System | LUMINELLE DTx Hysteroscopy
System (K190827) | |
| | | | cleared LUMINELLE DTx
Hysteroscopy System
(K190827). |
| Patient
Contacting
Materials
(Biocompatibilit
y) | ISO 10993 Compliant | ISO 10993 Compliant | The biocompatibility
compliance of patient
contacting materials of the
LUMINELLE DTx
Hysteroscopy System is
identical to the compliance
of the previously cleared
LUMINELLE DTx
Hysteroscopy System
(K190827). |
| Components | LUMINELLE DTx
●
Hysteroscope
LUMINELLE DTx 360°
●
Rotatable Disposable
Sheath
LUMINELLE DTx 360°
●
Rotatable Disposable
Sheath Rigid
LUMINELLE
●
Communication Cable
LUMINELLE Control Hub
●
LUMINELLE Dx 360°
●
Rotatable Disposable
Sheath (Diagnostic) | LUMINELLE DTx
●
Hysteroscope
LUMINELLE DTx 360°
●
Rotatable Disposable
Sheath
LUMINELLE DTx 360°
Rotatable Disposable
Sheath Rigid
LUMINELLE
●
Communication Cable
LUMINELLE Control Hub
● | The main components of
the LUMINELLE DTx
Hysteroscopy System are
mainly the same as the
main components of the
previously cleared
LUMINELLE DTx
Hysteroscopy System
(K190827). The only
difference is the addition of
a new accessory. This
difference only limits the
intended use and does not
raise different questions of
safety and effectiveness. |
| ltem | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx
Hysteroscopy System | LUMINELLE DTx Hysteroscopy
System (K190827) | |
| | | | This difference does not
alter the intended use. |
| | | Sheath | |
| Rigid/Flexible
Sheath | Flexible and rigid sheaths
available:
Flexible sheath (LUMINELLE
●
DTx 360° Rotatable
Disposable Sheath) contains
a PEEK
(polyetheretherketone)
hypotube for flexibility.
Rigid sheath (LUMINELLE
●
DTx 360° Rotatable
Disposable Sheath Rigid and
LUMINELLE Dx 360°
Rotatable Disposable Sheath
(Diagnostic)) contains a 304
stainless steel inner tube for
rigidity. | Flexible and rigid sheaths
available:
Flexible sheath (LUMINELLE
●
DTx 360° Rotatable Disposable
Sheath) contains a PEEK
(polyetheretherketone)
hypotube for flexibility.
Rigid sheath (LUMINELLE DTx
●
360° Rotatable Disposable
Sheath Rigid) contains a 304
stainless steel inner tube for
rigidity. | The rigidity of the
LUMINELLE DTx
Hysteroscopy System is
identical to the rigidity of
the LUMINELLE DTx 360°
Rotatable Diagnostic
Sheath Rigid of the
previously cleared
LUMINELLE DTx
Hysteroscopy System
(K190827). |
| Sheath | Rotatable sheath with a curved | Rotatable sheath with a curved tip | The sheath manipulation of |
| manipulation | tip | | the LUMINELLE DTx
Hysteroscopy System is
identical to the sheath
manipulation of the
previously cleared
LUMINELLE DTx
Hysteroscopy System
(K190827). |
| Item | Subject Device | Predicate Device | Comparison |
| Sheath
Channels | LUMINELLE DTx
Hysteroscopy System
LUMINELLE DTx 360°
Rotatable Disposable Sheath
and LUMINELLE DTx 360°
Rotatable Disposable Sheath
Rigid - 4 Channels; one for the
scope, two for fluid
management, and one for
operative instruments.
LUMINELLE Dx 360° Rotatable
Disposable Sheath
(Diagnostic) - 2 Channels that
merge into a single channel; one
for the scope and one for fluid
management that merge
through a funnel to become a
single channel. | LUMINELLE DTx Hysteroscopy
System (K190827)
4 Channels; one for the scope, two
for fluid management, and one for
operative instruments. | The sheath channels of the
LUMINELLE DTx
Hysteroscopy System are
different from the sheath
channels of the previously
cleared LUMINELLE DTx
Hysteroscopy System
(K190827). This difference
only limits the intended use
and does not raise different
questions of safety and
effectiveness. This
difference does not alter
the intended use. |
| Instrument
Channel
Diameter | LUMINELLE DTx 360°
Rotatable Disposable Sheath
and LUMINELLE DTx 360°
Rotatable Disposable Sheath
Rigid - 5 Fr (1.7 mm)
LUMINELLE Dx 360° Rotatable
Disposable Sheath
(Diagnostic) - Not applicable.
There is no instrument channel. | 5 Fr. (1.7 mm) | There is no instrument
channel in the LUMINELLE
DTx Hysteroscopy System
compared to the 5 Fr.
instrument channel
diameter of the previously
cleared LUMINELLE DTx
Hysteroscopy System
(K190827). This difference
only limits the intended use
and does not raise different |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx
Hysteroscopy System | LUMINELLE DTx Hysteroscopy
System (K190827) | |
| | | | questions of safety and
effectiveness. This
difference does not alter
the intended use. |
| Sheath Fluid
Management | LUMINELLE DTx 360°
Rotatable Disposable Sheath
and LUMINELLE DTx 360°
Rotatable Disposable Sheath
Rigid - 2 fluid channels (inflow
and outflow), with manual
manipulation of fluid flow by
attaching gravity-fed or
pressurized bag of distending
medium
LUMINELLE Dx 360° Rotatable
Disposable Sheath
(Diagnostic) - 1 fluid channel
(inflow), with manual
manipulation of fluid flow by
attaching gravity-fed or
pressurized bag of distending
medium | 2 fluid channels (inflow and
outflow), with manual manipulation
of fluid flow by attaching gravity-
fed or pressurized bag of
distending medium | The sheath fluid
management of the
LUMINELLE DTx
Hysteroscopy System is
different from that of the
previously cleared
LUMINELLE DTx
Hysteroscopy System
(K190827). This difference
only limits the intended use
and does not raise different
questions of safety and
effectiveness. This
difference does not alter
the intended use. |
| Sheath
Reprocessing | No reprocessing required - the
LUMINELLE DTx 360°
Rotatable Disposable Sheath,
LUMINELLE DTx 360°
Rotatable Disposable Sheath | No reprocessing required - the
LUMINELLE DTx 360° Rotatable
Disposable Sheath and
LUMINELLE DTx 360° Rotatable
Disposable Sheath Rigid are | The sheath reprocessing of
the LUMINELLE DTx
Hysteroscopy System is
identical to the sheath
reprocessing of the |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx
Hysteroscopy System | LUMINELLE DTx Hysteroscopy
System (K190827) | |
| | Rigid, and LUMINELLE Dx 360°
Rotatable Disposable Sheath
(Diagnostic) are single-use
disposable and are provided
sterile. | single-use disposable and are
provided sterile. | previously cleared
LUMINELLE DTx
Hysteroscopy System
(K190827). |
| Scope and
Sheath
Connection | LUMINELLE DTx 360°
Rotatable Disposable Sheath
and LUMINELLE DTx 360°
Rotatable Disposable Sheath
Rigid - The Insertion Tube of
the Scope inserts through the
scope channel of the Operative
Introducer Manifold and slides
through the Operative Introducer
Tube. The Operative Introducer
tube fully inserts into the 360°
RotoSheath until the
components snap together.
LUMINELLE Dx 360° Rotatable
Disposable Sheath
(Diagnostic) - The Insertion
Tube of the Scope inserts
through the scope channel of
the Introducer Manifold. The
Introducer Manifold snaps
together with the 360°
RotoSheath. | The Insertion Tube of the Scope
inserts through the scope channel
of the Operative Introducer
Manifold and slides through the
Operative Introducer Tube. The
Operative Introducer tube fully
inserts into the 360° RotoSheath
until the components snap
together. | The scope and sheath
connection for the
LUMINELLE DTx
Hysteroscopy System is
different from that of the
previously cleared
LUMINELLE DTx
Hysteroscopy System
(K190827). This difference
only limits the intended use
and does not raise different
questions of safety and
effectiveness. This
difference does alter the
intended use. |
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Testing
UVision performed the following testing of the LUMINELLE DTx Hysteroscopy System as used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) accessory, to ensure its continued performance, safety, and effectiveness:
- A sterilization adoption was performed for the LUMINELLE Dx 360° Rotatable . Disposable Sheath in accordance with AAMI TIR28:2016. Product adoption and Process Equivalence for Ethylene Oxide Sterilization to confirm that the previously performed sterilization validation is also applicable to the LUMINELLE Dx 360° Rotatable Disposable Sheath. To substantiate the conclusion that the processes are equivalent, microorganism characterization, and EO residuals testing was performed. Results demonstrated that the LUMINELLE Dx 360° Rotatable Disposable Sheath sterilization may be adopted into the existing validation protocol.
- . An accelerated aging shelf life study was performed for packaged LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) to confirm the 13 month shelf life of the sheaths. After accelerating aging in accordance with ASTM F1980-16, visual inspection was performed to inspect for product damage caused by the aging process, and functional design verification was performed to verify that the documented inputs met the documented outputs. All samples met specifications after aging.
- Distribution simulation testing in accordance with ASTM D4169-16, Distribution Cycle 13: . Assurance Level I was performed for the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). This testing consisted of seal strength testing in accordance with ASTM F88-15 and bubble leak testing in accordance with ASTM F2096-11 to confirm that the packaging maintained a sterile barrier throughout the normal transportation and distribution of the device. Packages were confirmed to maintain integrity following simulated distribution.
- Usability and design validation testing was repeated for the LUMINELLE DTx ● Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) to confirm that the sheath performs according to its intended use in in vivo models, the user is able to operate the system as intended, and the product conforms to user needs. Devices met predefined acceptance criteria.
- Sensitization and irritation testing was performed for the final finished LUMINELLE Dx ● 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-10:2016 to confirm that the Sheath does not induce sensitization or irritation. Results demonstrate the device is not irritating or sensitizing.
- . Cytotoxicity testing was performed for the final finished LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) in accordance with ISO 10993-5:2009 to confirm that the Sheath does not induce cytotoxicity. Results demonstrate the device is not cytotoxic.
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Substantial Equivalence Discussion and Conclusion
The intended use for LUMINELLE DTx Hysteroscopy System is identical to the intended use of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) with only a limitation in the intended use when used with the new accessory. LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). This limitation is a subset of the predicate indications, and so does not represent a new intended use. The technological characteristics of the subject LUMINELLE DTx Hysteroscopy System are different as compared to the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) in that the subject device includes the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic). However, the addition of this accessory does not raise different questions of safety and effectiveness. Performance testing demonstrates that the subject device, LUMINELLE DTx Hysteroscopy System, is as safe and effective as the previously cleared LUMINELLE DTx Hysteroscopy System (K190827). Therefore, the subject device, LUMINELLE DTx Hysteroscopy System, is substantially equivalent to the predicate LUMINELLE DTx Hysteroscopy System (K190827).