(221 days)
No
The description focuses on standard optical imaging and signal processing, with no mention of AI or ML algorithms for image analysis or other functions.
No
Explanation: The device is intended for viewing the cervical canal and uterine cavity for diagnostic and operative procedures, not for providing a therapeutic effect itself.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures." This clearly indicates its use in diagnostics.
No
The device description explicitly details hardware components such as a handle, insertion portion, camera module, LED light source, and cables, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Single-Use Video Hysteroscope is a medical device used for direct visualization of the cervical canal and uterine cavity. It uses optical imaging to provide real-time video of the internal anatomy.
- Intended Use: The intended use is for "viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures." This involves direct observation and potentially surgical intervention, not the analysis of samples taken from the body.
While the device involves image processing, this is for displaying the visual information obtained from the direct observation, not for analyzing biological samples.
Therefore, the Single-Use Video Hysteroscope falls under the category of a medical device used for visualization and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The devices is suitable for professional healthcare facility environments such as hospitals and clinics.
Product codes (comma separated list FDA assigned to the subject device)
HIH
Device Description
The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity and it is provided sterile (sterilized by EO) and intended for single use only.
The Single-Use Video Hysteroscope is composed of a handle part, including the video cable interface, working channel port and instrument channel port, and an insertion portion, of which a camera module and LED light source are integrated inside the distal tip. There are two models of The Single-Use Video Hysteroscope, RP-G-C24 and RP-G-C0101. The model RP-G-C24 is identical to RP-G-C0101 except for the direction of view, width size of insertion port and width size of instrument channel, as shown in the table below:
| Spec. | Model | RP-G-C24 | RP-G-C0101 |
|---|---|---|---|
| Direction of View | 22° | 30° | |
| Maximum width of insertion portion | 5.5mm(16.7Fr) | 4.8mm(14.4Fr) | |
| Minimum width of instrument channel | 2.3mm(6.9Fr) | 2.0mm(6.0Fr) |
The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Endoscopic Video Image Processor where it is restored after processing and finally displayed on the screen of Endoscopic Video Image Processor. The materials used in construction of the insertion of Hysteroscope are lowdensity polyethylene (LDPE), Polyether-polyamide block copolymers (PEBAX), and polycarbonate (PC). The insertion portion is considered to contact a breached or compromised surface for a duration of less than 24 hours. The biocompatibility evaluation was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The handle does not contact the patient.
The Single-Use Video Hysteroscope shall be used in conjunction with REDPINE Endoscopic Video Image Processor, which has been cleared under another 510(k) (K221158) to process the images collected by the video endoscope and send it to the display screen, as well as to provide power to the hysteroscope.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Cervical canal and uterine cavity
Indicated Patient Age Range
Adult
Intended User / Care Setting
Professional healthcare facility environments such as hospitals and clinics.
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)
Summary of Non-clinical Performance
All non-clinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate device and reference device. Tests setup and execution were performed in accordance with applicable standards. Results of the testing demonstrate compliance to the standards and matching the performance of subject device to the reference device. The following performance data were provided in support of the substantial equivalence determination.
A Biocompatibility
The biocompatibility evaluation for the Single-Use Video Hysteroscope was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The insertion portion of Single-Use Video Hysteroscope is considered to contact a breached or compromised surface for a duration of less than 24 hours; therefore, the following tests are considered and passed:
| Test | Testing Summary |
|---|---|
| Cytotoxicity test (ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, Annex C) | Pass-Non-cytotoxic |
| Skin Sensitization test (ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization, GPMT) | Pass-Non-irritation |
| Intracutaneous test (ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization) | Pass-Non-sensitization |
| Acute Systemic Toxicity test (ISO 10993-11:2017 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity) | Pass-Non-acutely toxic |
A Electrical Safety and Electromagnetic Compatibility
Electrical safety and EMC testing were conducted on the Hysteroscope System and the device complies with the following standards:
- AAMI ES 60601-1:2005 + AMD1:2012 + AMD2:2021 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-2-18: 2009 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment.
- IEC 60601-1-2: 2014 + A1: 2020 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests.
A Photobiological safety
The subject device was tested according to the following FDA recognized standards:
- IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems.
A Sterilization Validation
The EO sterilization of the Single-Use Video Hysteroscope has been validated according to the following applicable standards:
- ISO11135:2014+A1:2018 Sterilization of medical device- validation and routine control of ethylene oxide sterilization
- ISO 11737-2:2019 Sterilization of Medical Device-Microbiological methods part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- USP Bacterial endotoxins test
A Shelf Life and Sterile Barrier System (Packaging)
Shelf Life and Sterile Barrier System of the Single-Use Video Hysteroscope has been validated according to the following applicable standards:
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO11607-1:2019 Packaging for terminally sterilized Medical Device Part 1: Requirement for materials, sterile barrier systems and packaging systems
- ISO11607-2:2019 Packaging for terminally sterilized Medical Device Part 2: Validation Requirement for forming, sealing and assembly process
- ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
A Performance Data - Bench
The following performance data were provided in support of the substantial equivalence, as shown in the table below.
The optical performance testing was conducted in accordance with applicable parts of ISO 8600-1:2015, ISO 8600-3:2019, ISO 12233-2017, ISO15739-2017 and ISO/CIE 11664-4 standards, and the mechanical performance testing was conducted in accordance with applicable parts of ISO 8600-1:2015, ISO 8600-4:2014, YY/T 1028-2023 standards. The field of view was measured according to the test method in the article: Wang et al., "Endoscope field of view measurement." Biomedical Optics Express 8, no. 3 (2017): 1441-1454, and geometric distortion was measured according to section 3 of the article: Wang, et al., "Development of the local magnification method for quantitative evaluation of endoscope geometric distortion." Journal of Biomedical Optics 21, no. 5 (2016): 056003. The tensile strength of each joint in the insertion portion should be greater than 15 N and be free of any breakage, splitting, or deformation.
| Test category | Test item |
|---|---|
| Optical performance | Direction of view |
| Resolution | |
| Depth of Field | |
| Field of view | |
| Geometric Distortion | |
| Signal-To-Noise Ratio | |
| Dynamic Range | |
| Image Intensity Uniformity (IIU) | |
| Color Performance | |
| Surface Safety (Surface and Edges) | |
| Mechanical performance | Basic Size |
| Water Supply System | |
| Sealing Performance | |
| Tensile strength |
A Performance Data – Animal
N/A, no animal studies are available for the subject device.
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.
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2024
Guangzhou Red Pine Medical Instrument Co.,Ltd. Xiangfei Li Regulatory Affairs Manager 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District Guangzhou, Guangdong 510200 China
Re: K232003
Trade/Device Name: Single-Use Video Hysteroscope: RP-G-C24. RP-G-C0101 Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: January 9, 2024 Received: January 9, 2024
Dear Xiangfei Li:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232003
Device Name Single-Use Video Hysteroscope: RP-G-C24, RP-G-C0101
Indications for Use (Describe)
The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures
The devices is suitable for professional healthcare facility environments such as hospitals and clinics.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY
510(k) Number: K232004
I. SUBMITTER
Name: Guangzhou Red Pine Medical Instrument Co., Ltd. Address: 12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District, 510000 Guangzhou City, Guangdong Province, PEOPLE'S REPUBLIC OF CHINA Name of contact person: Xiangfei Li Tel: +86 20-38315611 Fax: +86 20-38315611 E-mail: regulation@gzredpine.com Date prepared: February 5, 2024
II. Proposed Device
Submission Number: K232003 Trade/Device Name: Single-Use Video Hysteroscope: RP-G-C24, RP-G-C0101 Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulation class: II Review Panel: Obstetrics/Gynecology Product code: HIH
III. Predicate Device
510(k) Number: K202445 Device name: Hystero-V Hysteroscope Applicant: Hysterovue, Inc. Regulation number:21 CFR 884.1690
5
Regulation Name: Hysteroscope and accessories Regulation class: II Review Panel: Obstetrics/Gynecology Product code: HIH Note: This predicate device has not been subject to a design-related recall.
IV. Reference Device
510(k) Number: K210270 Device name: Medical Endoscope Image Processing System Applicant: Jiangsu Jiyuan Medical Technology Co., Ltd Regulation number:21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulation class: II Review Panel: Obstetrics/Gynecology Product code: HIH Note: This reference device has not been subject to a design-related recall.
V. Indications for use
Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
The device is suitable for professional healthcare facility environments such as hospitals and clinics.
Although the subject device lacks integrated biopsy functionality compared to the predicate device, the intended use of both is the same. In addition, the indications for use is the same for the subject and reference device.
VI. Description of the Device
The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity and it is provided sterile (sterilized by EO) and intended for single use only.
6
The Single-Use Video Hysteroscope is composed of a handle part, including the video cable interface, working channel port and instrument channel port, and an insertion portion, of which a camera module and LED light source are integrated inside the distal tip. There are two models of The Single-Use Video Hysteroscope, RP-G-C24 and RP-G-C0101. The model RP-G-C24 is identical to RP-G-C0101 except for the direction of view, width size of insertion port and width size of instrument channel, as shown in the table below:
| Spec. | Model | RP-G-C24 | RP-G-C0101 |
|---|---|---|---|
| Direction of View | 22° | 30° | |
| Maximum width of insertion portion | 5.5mm(16.7Fr) | 4.8mm(14.4Fr) | |
| Minimum width of instrument channel | 2.3mm(6.9Fr) | 2.0mm(6.0Fr) |
The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Endoscopic Video Image Processor where it is restored after processing and finally displayed on the screen of Endoscopic Video Image Processor. The materials used in construction of the insertion of Hysteroscope are lowdensity polyethylene (LDPE), Polyether-polyamide block copolymers (PEBAX), and polycarbonate (PC). The insertion portion is considered to contact a breached or compromised surface for a duration of less than 24 hours. The biocompatibility evaluation was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation
of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The handle does not contact the patient.
7
The Single-Use Video Hysteroscope shall be used in conjunction with REDPINE Endoscopic Video Image Processor, which has been cleared under another 510(k) (K221158) to process the images collected by the video endoscope and send it to the display screen, as well as to provide power to the hysteroscope.
8
VII. Comparison with the Predicate Devices
> Comparison of Indications with the Predicate Devices
Regarding the indications for use, although the subject device lacks integrated biopsy functionality compared to the intended use of both of them are the same.
> Comparison of Technological Characteristics with the Predicate Devices
Subjective device and the predicate device have intended use. The subject and predicate device have similar technological characteristics as evidenced by the table below. All differences have been discussed in detail and chat these differences in technological characteristics do not raise new questions regarding safety or effectiveness of the subject device.
a. The following basic technological elements are the same or similar for the subject and predicate devices:
| Table VI Descriptive Comparison | ||||
|---|---|---|---|---|
| Item | Subject Device | |||
| Hysteroscope System | Predicate device | |||
| Hystero-V hysteroscope | Reference device | |||
| Medical Endoscope Image | ||||
| Processing System | Discussion | |||
| 510(k) number | K232003 | K202445 | K210270 | |
| Classification | ||||
| Product Code | HIH | HIH | HIH | same |
9
K232003 Page 6 of 14
| Indications
for use | Single-Use Video Hysteroscope
is intended to be used for
viewing of the adult cervical
canal and uterine cavity for the
purpose of performing
diagnostic and operative
procedures. | The Hystero-V hysteroscope is
intended to be used to permit
viewing of the cervical canal and
uterine cavity for the purpose of
performing diagnostic procedures
and to obtain an endometrial tissue
sample (biopsy) in an outpatient or
office setting. | The Medical Endoscope Image
Processing System is intended to
be used for viewing of the adult
cervical canal and uterine cavity
for the purpose of performing
diagnostic and operative
procedures. | Difference 1 |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Route of
Advancement | Advanced to uterine cavity via
the cervical canal | Advanced to uterine cavity via the
cervical canal | Advanced to uterine cavity via the
cervical canal | Same |
| Site of use | Hospitals and physician offices | Hospitals and physician offices | Hospitals and physician offices | Same |
| | Device Features | | | |
| Components | The hysteroscope system is
composed of Single-Use Video
Hysteroscope and endoscopic
video image processor. | Reusable handle with video screen
Attachable cannula with a working
channel along its length and an
illumination source and camera at its
tip | The medical endoscope system is
composed of disposable electronic
hysteroscope and medical
endoscope image processor. | Difference 2 |
| Cannula Outer | RP-G-C24:5.5mm | | | |
| Diameter | RP-G-C0101:4.8mm | 4.25mm | 4.8mm | Difference 3 |
| Cannula Total
Length | 270mm±3% | 254mm | 200mm±3% | Difference 4 |
| Illumination
light source | LED | LED | LED | Same |
| Image
transmission | Transmits images are
transmitted to the user by the
video processor with a CMOS
chip at the distal end of the
endoscope and the image
showing on a monitor. | Image transmitted from a video
camera at the tip of the cannula to
a video monitor on the handle | Transmits images are transmitted
to the user by the video processor
with a CMOS chip at the distal
end of the endoscope and the
image showing on a monitor. | Same |
| LCD Display
Size | 10.1 inches | 3.5 inches (diagonal)
on the handle | The image processor of reference
device with no display (It is
connected by an external display
to display images) | Difference 5 |
| Optical Image | CMOS | CMOS | CMOS | Same |
| Image
Resolution | 160,000 pixels | Unknown | 160,000 pixels | Same as the
reference device |
| Field of View | 120° | 140° | 120° | Same as the
reference device;
similar to the
predicate device |
| Depth of field | RP-G-C24: 3 to 50 mm
RP-G-C0101: 5 to 50 mm | 5 to 50 mm | 3 to 50 mm | Model RP-G-C24
is the same as the
reference device;
RP-G-C0101 is
the same as the
predicate device |
| Direction of
view from
center axis | RP-G-C24:22°
RP-G-C0101:30° | 30° | 16±3° | Difference 6 |
| Adjust
brightness of
illumination | Press the Brightness +/- button
in the Processor to adjust to the
appropriate brightness level. | Adjust by depressing a button on
the handle to change settings | The brightness of the LED can be
adjusted with a button on the
medical endoscope image
processing system | Same |
| Capture still
images or
video images
during the | Capture images or video during
procedure by the image
processor | Capture still images or video during
procedure by depressing a camera
button on the handle | Capture images or video during
procedure by the image processor | Same |
| procedure | | | | |
| Duration of
use | ≤ 24 hours | ≤ 24 hours | ≤ 24 hours | Same |
| Sterilization | The Endoscopic Video Image
Processor is not sterile.
The Single-Use Video
Hysteroscopes is sterile
following exposure to ethylene
oxide (EO) | The handle is not provided sterile.
The handle is cleaned and
disinfected following company
instructions.
Disposable cannula is sterile
following exposure to
ethylene oxide (EO) and is
single use; it is disposed after
the procedure following the
institution's procedures. | Video Processor: Non-Sterile
The Disposable Electronic
Hysteroscope is provided sterilized
by EO.
Re-sterilization is not permitted. | Same |
| Tissue contact
materials | Compliant with ISO 10993 | Compliant with ISO 10993 | Compliant with ISO 10993 | Same |
10
K232003
Page 7 of 14
11
K232003
Page 8 of 14
12
K232003
13
b. Discussion on differences between the subject and the predicate device Difference 1 Indication for use
Although the subject device lacks integrated biopsy functionality compared to the predicate device, the intended use of both is the same. In addition, the indications for use is the same for the subject and reference device.
Difference 2 Components
Regarding Components, both the subject and reference device are composed of a singleuse (disposable) endoscope and an image processor (for displaying imaging). The difference from the predicate device is that the image processor (video screen) and reusable handle of the predicate device are designed as one, and the handle is connected to the insertion part, while the handle and insertion part of the subject device and the reference device are integrated (which are single use), and the handle is connected to the image processor. These differences do not raise different questions of safety and effectiveness.
Difference 3 Cannula outer diameter
The diameter of the hysteroscope is usually in the range of 4-6 mm; thus there are no new risks associated with 4.8 or 5.5 mm diameter.
Difference 4 Cannula total length
Longer cannula length does not affect the safety and effectiveness of the product.
Difference 5 LCD display size
Larger screen size does not affect the safety and performance of the product.
Difference 6 Direction of view from center axis
The difference in this parameter has only a minor effect on the observed image and does not affect the effectiveness of its use.
VIII. Summary of Non-clinical Performance
All non-clinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate device and reference device. Tests setup and execution were performed in accordance with applicable standards. Results of the testing
14
demonstrate compliance to the standards and matching the performance of subject device to the reference device. The following performance data were provided in support of the substantial equivalence determination.
A Biocompatibility
The biocompatibility evaluation for the Single-Use Video Hysteroscope was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The insertion portion of Single-Use Video Hysteroscope is considered to contact a breached or compromised surface for a duration of less than 24 hours; therefore, the following tests are considered and passed:
| Biocompatibility testing summary | |
|---|---|
| Test | Testing Summary |
| Cytotoxicity test (ISO 10993-5:2009 Biological | |
| evaluation of medical devices - Part 5: Tests for in vitro | |
| cytotoxicity, Annex C) | Pass-Non-cytotoxic |
| Skin Sensitization test (ISO 10993-10:2010 Biological | |
| evaluation of medical devices - Part 10: Tests for | |
| irritation and sensitization, GPMT) | Pass-Non-irritation |
| Intracutaneous test (ISO 10993-10:2010 Biological | |
| evaluation of medical devices - Part 10: Tests for | |
| irritation and sensitization) | Pass-Non-sensitization |
| Acute Systemic Toxicity test (ISO 10993-11:2017 | |
| Biological evaluation of medical devices – Part 11: Tests | |
| for systemic toxicity) | Pass-Non-acutely toxic |
A Electrical Safety and Electromagnetic Compatibility
Electrical safety and EMC testing were conducted on the Hysteroscope System and
the device complies with the following standards:
- AAMI ES 60601-1:2005 + AMD1:2012 + AMD2:2021 Medical electrical
15
equipment - Part 1: General requirements for basic safety and essential performance. • IEC 60601-2-18: 2009 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment. • IEC 60601-1-2: 2014 + A1: 2020 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests.
A Photobiological safety
The subject device was tested according to the following FDA recognized standards: • IEC 62471:2006 Medical electrical equipment, Photobiological safety of lamps and lamp systems.
A Sterilization Validation
The EO sterilization of the Single-Use Video Hysteroscope has been validated according to the following applicable standards:
• ISO11135:2014+A1:2018 Sterilization of medical device- validation and routine control of ethylene oxide sterilization
· ISO 11737-2:2019 Sterilization of Medical Device-Microbiological methods part 2: Tests of sterility performed in the validation of a sterilization process
• ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• USP Bacterial endotoxins test
A Shelf Life and Sterile Barrier System (Packaging)
Shelf Life and Sterile Barrier System of the Single-Use Video Hysteroscope has been validated according to the following applicable standards:
• ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• ISO11607-1:2019 Packaging for terminally sterilized Medical Device Part 1:
Requirement for materials, sterile barrier systems and packaging systems
16
• ISO11607-2:2019 Packaging for terminally sterilized Medical Device Part 2: Validation Requirement for forming, sealing and assembly process
• ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
A Performance Data - Bench
The following performance data were provided in support of the substantial equivalence, as shown in the table below.
The optical performance testing was conducted in accordance with applicable parts of ISO 8600-1:2015, ISO 8600-3:2019, ISO 12233-2017, ISO15739-2017 and ISO/CIE 11664-4 standards, and the mechanical performance testing was conducted in accordance with applicable parts of ISO 8600-1:2015, ISO 8600-4:2014, YY/T 1028-2023 standards. The field of view was measured according to the test method in the article: Wang et al., "Endoscope field of view measurement." Biomedical Optics Express 8, no. 3 (2017): 1441-1454, and geometric distortion was measured according to section 3 of the article: Wang, et al., "Development of the local magnification method for quantitative evaluation of endoscope geometric distortion." Journal of Biomedical Optics 21, no. 5 (2016): 056003. The tensile strength of each joint in the insertion portion should be greater than 15 N and be free of any breakage, splitting, or deformation.
| Test category | Test item |
|---|---|
| Optical | |
| performance | Direction of view |
| Resolution | |
| Depth of Field | |
| Field of view | |
| Geometric Distortion |
17
| Signal-To-Noise Ratio | |
|---|---|
| Dynamic Range | |
| Image Intensity Uniformity (IIU) | |
| Color Performance | |
| Surface Safety (Surface and Edges) | |
| Mechanical | |
| performance | Basic Size |
| Water Supply System | |
| Sealing Performance | |
| Tensile strength |
A Performance Data – Animal
N/A, no animal studies are available for the subject device.
IX. Clinical Evidence
N/A.
X. Conclusion
In conclusion, the technological characteristics, features, specifications, and intended use of the subject device are substantially equivalent to the predicate device quoted above. The differences between the subjective device and the predicate device do not raise new questions of safety and effectiveness. Performance testing demonstrated that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device.