(81 days)
Not Found
No
The device description focuses on basic visualization, recording, and display technology. There is no mention of AI/ML terms, image processing beyond simple display/recording, or any description of training or test data sets which would be expected for an AI/ML component.
Yes.
The device's intended use includes providing visual guidance during therapeutic procedures such as directed biopsy, submucosal myomectomy, and transection of intrauterine adhesions and septa. It is also used for therapeutic procedures in the urinary bladder.
Yes
Explanation: The device is intended for visualization during diagnostic procedures such as assessment of abnormal bleeding, pelvic pain, amenorrhea, infertility, and confirmation of intrauterine foreign bodies. It also permits viewing of the urinary bladder for diagnostic purposes.
No
The device description clearly states it is a handheld, battery-operated portable hysteroscope with on-board hardware components like a camera, LED illumination, display, microelectronics, and firmware. It also includes a separate hardware Recording Module.
Based on the provided information, the LiNA OperaScope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- 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.
- LiNA OperaScope Function: The LiNA OperaScope is a device used for direct visualization of internal anatomical structures (cervical canal, uterine cavity, and urinary bladder). It is an imaging device used in vivo (within the living body) during diagnostic and therapeutic procedures.
- No Sample Analysis: The device does not analyze samples taken from the body. It provides a visual output of the internal anatomy.
Therefore, the LiNA OperaScope falls under the category of a medical device used for visualization and intervention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope could offer visualization include:
- Assessment of abnormal bleeding, pelvic pain, amenorrhea and abnormal findings from hysterosalpingogram
- Assessment of infertility and pregnancy wastage
- Confirmation of the presence of intrauterine foreign body
- Assist in locating submucosal fibroids and polyps targeted for removal
- Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa.
The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
HIH, FAJ
Device Description
The LiNA OperaScope is a handheld, battery-operated portable hysteroscope which allows direct viewing of the cervical canal and uterine cavity via the on-board LCD display. If the user wants to capture images and/or record video sequences utilizing a USB stick, a Recording Module is available, which connects to the device via the HDMI cable. The LiNA OperaScope can also be connected to an external monitor via the HDMI cable. External monitors are not provided by LiNA Medical ApS and therefore, monitors are not the subject of this 510(k) submission.
The LiNA OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a non- sterile reusable unit. The LiNA OperaScope contains a miniature Complimentary Medical Oxide Semiconductor (CMOS) camera and a Light-Emitting Diode (LED) illumination at the tip, a channel for infusion of irrigating fluid and a channel for fluid outflow, a display), microelectronics, firmware and single use batteries for powering the device. The Recording Module contains microelectronics, software, controls for recording pictures and video sequences, USB port for storage of pic/video, HDMI port for connection of the LiNA OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal, uterine cavity, adult female urinary bladder
Indicated Patient Age Range
Adult female
Intended User / Care Setting
Trained Medical Professionals - Gynecologists/Urologists
Hospitals and Physician Offices
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)
Non-Clinical Performance Data:
The LiNA OperaScope underwent safety and optical performance testing, meeting requirements for overall design, sterilization, biocompatibility, and electrical safety. It passed tests according to internal, national, and international standards, including:
- Field of view and direction of view per ISO 8600-3
- Maximum width of insertion portion per ISO 8600-4
- Biocompatibility testing per ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12
- EO and ECH residual testing per ISO 10993-7
- Electromagnetic Compatibility per EN/IEC 60601-1-2 (EMC and Immunity)
- Electrical Safety per AAMI/ANSI ES60601-1 and EN 60601-2-18
- Sterilization Validation per ISO 11135 (Ethylene Oxide – OperaScope), ISO 11137-1 and ISO 11137-2 (Radiation - OperaScope Batteries) and maintenance of sterilization per ISO 11737-2.
- Mechanical testing for bending (displacement), tensile strength and torque.
- Spatial Resolution utilizing ISO 3334 (test chart No. 2)
- Visualization and illumination study to determine the adequacy of imaging while in use in the uterine cavity utilizing a hysteroscopy simulator.
- In-flow and out-flow fluid delivery, including leak testing
- Fuctionality testing to verify compatibility of instruments and accessories with respect to dimensions
- Shelf-Life and Simulated shipping conditions per ASTM D4169
- Battery lifetime
- Software Validation and Verification per IEC 62304
- FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices [Moderate Level of Concern Applied to the OperaScope]
- FDA's guidance document Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for 510(K), including section V(E)(6b)/distortion characteristics.
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.
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January 17, 2020
LiNA Medical ApS % Kevin MacDonald Regulatory Consultant MacDonald Consulting 4297 D Street Sacramento, CA 95819
Re: K193007
Trade/Device Name: LiNA OperaScope Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: Class II Product Code: HIH, FAJ Dated: November 13, 2019 Received: November 18, 2019
Dear Kevin Macdonald:
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
1
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 (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 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,
Jason R. Roberts, Ph.D. Acting 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) K193007
Device Name LiNA OperaScope
Indications for Use (Describe)
The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope could offer visualization include:
- Assessment of abnormal bleeding, pelvic pain, amenorthea and abnormal findings from hysterosalpingogram
- · Assessment of infertility and pregnancy wastage
- · Confirmation of the presence of intrauterine foreign body
- Assist in locating submucosal fibroids and polyps targeted for removal
· Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa.
The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary K193007
1. Submitter's Name and Address:
LiNA Medical ApS Formervangen 5 DK-2600 Glostrup, Denmark Jarosław Mrówczyński Regulatory Affairs Manager Email: jmr@lina-medical.com Tel.: +48 61 222 8643
2. Submission Correspondent
Kevin MacDonald Regulatory Consultant 4297 D Street Sacramento, CA 95819 Office Phone: (415) 609-9875
3. Date Prepared
January 17, 2020
4. Device Identification
| Trade/Proprietary Name: | LiNA OperaScope |
|---|---|
| Common/Usual Name: | Hysteroscope/Cystoscope |
| Classification: | 21 CFR 884.1690 Hysteroscope and Accessories |
| Product Code: | HIH, Hysteroscope and Accessories |
| FAJ, Cystoscope and Accessories, Flexible/Rigid | |
| Device Class: | Class II |
| Classification Panel: | Obstetrics/Gynecology |
| Gastroenterology/Urology |
5. Legally Marketed Predicate Devices
There are no design-related recalls for these legally marketed predicate devices.
5
6. Indications for Use Statement
The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope could offer visualization include:
- . Assessment of abnormal bleeding, pelvic pain, amenorrhea and abnormal findings from hysterosalpingogram
- . Assessment of infertility and pregnancy wastage
- . Confirmation of the presence of intrauterine foreign body
- Assist in locating submucosal fibroids and polyps targeted for removal
- . Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa.
The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.
7. Device Description
The LiNA OperaScope is a handheld, battery-operated portable hysteroscope which allows direct viewing of the cervical canal and uterine cavity via the on-board LCD display. If the user wants to capture images and/or record video sequences utilizing a USB stick, a Recording Module is available, which connects to the device via the HDMI cable. The LiNA OperaScope can also be connected to an external monitor via the HDMI cable. External monitors are not provided by LiNA Medical ApS and therefore, monitors are not the subject of this 510(k) submission.
The LiNA OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a non- sterile reusable unit. The LiNA OperaScope contains a miniature Complimentary Medical Oxide Semiconductor (CMOS) camera and a Light-Emitting Diode (LED) illumination at the tip, a channel for infusion of irrigating fluid and a channel for fluid outflow, a display), microelectronics, firmware and single use batteries for powering the device. The Recording Module contains microelectronics, software, controls for recording pictures and video sequences, USB port for storage of pic/video, HDMI port for connection of the LiNA OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.
Model Numbers
| Ref. number | Description |
|---|---|
| OP-201-6 | LiNA OperaScope™ with HDMI cable and |
| on-board LCD – 6 units | |
| OP-RM-1 | LiNA OperaScopeTM Recording Module |
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8. Predicate Comparison
The table below compares the LiNA OperaScope to the predicate devices with respect to the indications for use and technological characteristics:
| Manufacturer | LiNA Medical ApS | LiNA Medical ApS | CooperSurgical, Inc. | Technology
Overview | | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | OperaScope
(K193007) | OperaScope
(K171113) | Endosee System
(K190639) | | Handheld battery-operated sterile and
disposable single-use hysteroscope and
cystoscope, which can be used for both
diagnostic and therapeutic gynecological
procedures.
Non-Sterile/Reusable Recording Module
with software, USB port for storage of
pictures and video, HDMI ports (2) for
connection to handpiece (hysteroscope /
cystoscope) and external monitor and
input port for external 9V DC power
supply. | Same as Subject Device | Handheld battery-operated
hysteroscope consisting of a reusable
handle and a sterile, disposable,
diagnostic cannula. |
| Common Name | Hysteroscope, Cystoscope | Hysteroscope | Hysteroscope,Cystoscope | Cannula Type | Rigid | Same as Subject Device | Flexible |
| Product Code | HIH, FAJ | HIH | HIH, FAJ | Patient Contact
Materials | Compliant with ISO 10993 | Same as Subject Device | Same as Subject Device |
| Regulation
Number | 884.1690
876.1500 | 884.1690 | 884.1690
876.1500 | Working Channel | Yes | Same as Subject Device | Same as Subject Device |
| Regulation
Name | Hysteroscope and Accessories
Gastroenterology/Urology Device | Hysteroscope and Accessories | Hysteroscope and Accessories
Gastroenterology/Urology Device | Maximum
Insertion Portion
Width | 4.3 mm | Same as Subject Device | 4.5mm |
| Indications for
Use | The LiNA OperaScope is intended for
use in visualization of the cervical canal
and uterine cavity during diagnostic and
therapeutic gynecological procedures.
The types of procedures where the LiNA
OperaScope could offer visualization
include:
•
Assessment of abnormal bleeding,
pelvic pain, amenorrhea and
abnormal findings from
hysterosalpingogram
•
Assessment of infertility and
pregnancy wastage
•
Confirmation of the presence of
intrauterine foreign body
•
Assist in locating submucosal
fibroids and polyps targeted for
removal
•
Provide visual guidance during
directed biopsy, submucosal
myomectomy, polypectomy,
transection of intrauterine
adhesions and septa.
The LiNA OperaScope can also be used
to permit viewing of the adult female
urinary bladder through minimally
invasive approach by utilizing natural
orifices for the purpose of performing
diagnostic and therapeutic procedures. | The LiNA OperaScope is
intended for use in
visualization of the cervical
canal and uterine cavity during
diagnostic and therapeutic
gynecological procedures.
The types of procedures where
the OperaScope could offer
visualization include:
• Assessment of abnormal
bleeding, pelvic pain,
amenorrhea and abnormal
findings from
hysterosalpingogram
• Assessment of infertility and
pregnancy wastage
• Confirmation of the presence
of intrauterine foreign body
• Assist in locating submucosal
fibroids and polyps targeted for
removal
• Provide visual guidance during
directed biopsy, submucosal
myomectomy, transection of
intrauterine adhesions and
septa. | The Endosee® System is used to
permit viewing
of the adult cervical canal and
uterine cavity for the purpose of
performing 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
The Endosee® System can also be
used to permit viewing of the adult
urinary bladder through a minimally
invasive approach by utilizing
natural orifices to access the
diagnostic site. | Illumination Light
Source | LED at tip of cannula | Same as Subject Device | Same as Subject Device |
| Intended Users | Trained Medical Professionals -
Gynecologists/Urologists | Gynecologists | Same as Subject Device | Field of View | 100° | Same as Subject Device | Same as Subject Device |
| Site of Use | Hospitals and Physician Offices | Same as Subject Device | Same as Subject Device | Pre-bend tip | 20° $\pm$ 5° | Same as Subject Device | 20° $\pm$ 3° |
| Shelf Life | 12 months | Same as Subject Device | 6 months | | | | |
| Image Display | LCD on handheld device and connection
to
external monitor | Same as Subject Device | LCD on handheld device | | | | |
7
The LiNA OperaScope has the same or similar indications for use and technological characteristics as compared to the predicate devices. The are no different questions of safety and effectiveness.
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the LiNA OperaScope and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, LiNA completed a number of non-clinical performance tests. The LiNA OperaScope meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The LiNA OperaScope was subjected to safety and optical performance testing in accordance with the FDA's "Hysteroscopes and Gynecological Laparoscopes Submission Guidance for a 510(k)" (March 7, 1996).
The LiNA OperaScope passed all applicable testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Field of view and direction of view per ISO 8600-3
- . Maximum width of insertion portion per ISO 8600-4
- . Biocompatibility testing per ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12
- . EO and ECH residual testing per ISO 10993-7
8
- Electromagnetic Compatibility per EN/IEC 60601-1-2 (EMC and Immunity)
- Electrical Safety per AAMI/ANSI ES60601-1 and EN 60601-2-18
- Sterilization Validation per ISO 11135 (Ethylene Oxide – OperaScope), ISO 11137-1 and ISO 11137-2 (Radiation - OperaScope Batteries) and maintenance of sterilization per ISO 11737-2.
- . Mechanical testing for bending (displacement), tensile strength and torque.
- . Spatial Resolution utilizing ISO 3334 (test chart No. 2)
- . Visualization and illumination study to determine the adequacy of imaging while in use in the uterine cavity utilizing a hysteroscopy simulator.
- . In-flow and out-flow fluid delivery, including leak testing
- . Fuctionality testing to verify compatibility of instruments and accessories with respect to dimensions
- Shelf-Life and Simulated shipping conditions per ASTM D4169
- . Battery lifetime
- Software Validation and Verification per IEC 62304
- FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices [Moderate Level of Concern Applied to the OperaScope]
- . FDA's guidance document Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for 510(K), including section V(E)(6b)/distortion characteristics.
10. Clinical Performance Data
Not Applicable
11. Conclusion
The LiNA OperaScope, as designed and manufactured, is substantially equivalent to the predicate devices.