(242 days)
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.
The Medical Endoscope Image Processing System is a portable hysteroscope. It includes a sterile single use disposable Electronic Hysteroscope and a reusable Medical Endoscope Image Processor. The Disposable Electronic Hysteroscope contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and two channels for infusion of irrigating fluid and aspiration of tissue. The Disposable Electronic Hysteroscope is sterilized and packaged in a sealed pouch. The Medical Endoscope Image Processor is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the Disposable Electronic Hysteroscope. The Medical Endoscope Image Processor contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or start/stop a video of the procedure, a video processor, microcontrollers, and firmware.
The provided text is a 510(k) summary for a medical device called the "Medical Endoscope Image Processing System." This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines various non-clinical performance tests.
*However, the document does not contain information about studies evaluating the device's performance against specific acceptance criteria for diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance.
The "Summary of Non-Clinical Performance Testing" section details tests related to:
- Software validation: Ensuring the software conforms to user needs and intended purposes. This is a general statement about software development practices, not specific performance metrics.
- Biocompatibility testing: Proving the device is safe for biological contact (e.g., non-cytotoxic, non-irritating).
- Safety, Electrical Safety, and Electromagnetic Compatibility (EMC): Compliance with relevant IEC standards.
- Sterility: Verification of the sterilization method.
- Cleaning and Disinfection: Protocols for reusable components.
- Packaging/Shelf Life: Validation of shelf life and package integrity.
These are all crucial for device safety and functionality but do not measure diagnostic or clinical performance in the way requested by the prompt (e.g., accuracy against ground truth, impact on human reader performance).
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth for a diagnostic AI/algorithm.
The document's conclusion states: "Based on the verification and validation as documented in the non-clinical performance testing, the Medical Endoscope Image Processing System was found to have a safety and effectiveness profile that is similar to the predicate device." This reinforces that the focus was on non-clinical aspects for 510(k) clearance, not necessarily a clinical performance study involving diagnostic accuracy metrics.
In summary, the provided text does not contain the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria for analytical or clinical performance.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 1, 2021
Jiangsu Jiyuan Medical Technology Co., Ltd. % Yuling Chen Consultant Microkn Business Consulting (Shanghai) Co., Ltd Room 1219, Block A, No 3699, Gonghexin Road, Jingan District Shanghai, 200435 China
Re: K210270
Trade/Device Name: Medical Endoscope Image Processing System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: August 25, 2021 Received: August 25, 2021
Dear Yuling Chen:
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.
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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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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. 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210270
Device Name
Medical Endoscope Image Processing System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Residential Use (SINGLE FAMILY Only) Please see |
|---|
| Other Use: See Instructions in CFR |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510K summary
According to the requirements Per 21 CFR §807.92, the following information is provided sufficient detail to understand the basis for a determination of substantial equivalence.
| Company: | Jiangsu Jiyuan Medical Technology Co., Ltd. |
|---|---|
| Address: | No. 48 CECEP (Taizhou) Environmental ProtectionTechnology Industry Park, No.59 Meilan Road, HailingDistrict, Taizhou, Jiangsu, ChinaPostcode: 225300 |
| Date Prepared | September 30, 2021 |
| Device Name: | Medical Endoscope Image Processing System |
| Common Name | Medical Endoscope Image Processing System |
| Regulation Number | 21 CFR 884.1690 |
| Regulation Name | Hysteroscope and accessories |
| Product Code | HIH |
| Product Code Name | Hysteroscope (And Accessories) |
| Regulatory Class | II |
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| PredicateDevice: | Hysteroscope System (K181545) manufactured byShanghai AnQing Medical Instrument CO., Ltd. Thepredicate device has not been subject to any designrelated recalls. |
|---|---|
| LegalManufacturer: | Jiangsu Jiyuan Medical Technology Co., Ltd.No. 48 CECEP (Taizhou) Environmental ProtectionTechnology Industry Park, No.59 Meilan Road, HailingDistrict, Taizhou ,Jiangsu,ChinaPostcode: 225300 |
| Consultant | |
| Company | Microkn Business Consulting (Shanghai) Co., Ltd. |
| Address | Room 1219, Block A, No 3699, Gonghexin Road,Jingan District, Shanghai, China |
| Contact Person | Yuling Chen |
| Telephone | +86 15021397762 |
| Yuling.chen@microkn.com |
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1.Indications for use
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.
2. Description of the Device
The Medical Endoscope Image Processing System is a portable hysteroscope. It includes a sterile single use disposable Electronic Hysteroscope and a reusable Medical Endoscope Image Processor. The Disposable Electronic Hysteroscope contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and two channels for infusion of irrigating fluid and aspiration of tissue. The Disposable Electronic Hysteroscope is sterilized and packaged in a sealed pouch. The Medical Endoscope Image Processor is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the Disposable Electronic Hysteroscope. The Medical Endoscope Image Processor contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or start/stop a video of the procedure, a video processor, microcontrollers, and firmware.
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3. Principles of Operation
The disposable electronic hysteroscope is composed of a handle, an insertion part (including a bending part), an operation part, two connectors and a connecting wire. The disposable electronic hysteroscope is used in conjunction with Jiyuan's medical endoscope image processing system. It is used in the hospital to perform endoscopic surgery in the clinic, to collect and transmit the state of internal operation area to the medical endoscope image processing system, and then display the state of internal operation area on the medical endoscope image processing system. The front end of the hysteroscope is a camera component, and both sides of the camera are LED, and the brightness of the LED can be adjusted through the medical endoscope image processing system. The inner diameter of the instrument channel is 2.0mm, and the biopsy forceps can enter the human body through this channel for sampling and other operations. The head bending angle is 16°. The knob of the operating part can be rotated freely from left to right and 360° from left to right. The water inlet and outlet channels are smooth and well-sealed without water leakage phenomenon. Hence It can meet the needs of uterine dilation and attraction during the endoscopic surgery.
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4. Comparison to Predicate Device
The subject and predicate devices have the same intended use – viewing of the cervical canal and uterine cavity for diagnostic and operative procedures;
The subject and predicative device have different technological characteristics as evidenced by the table below, such as energy source, maximum insertion diameter (Tip) , hysteroscope direction of view, and image resolution, etc. The differences in technological characteristics do not raise different questions of safety or effectiveness.
(Please refer to table 005-01 and 005-02 for details).
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| Table 005-01_Descriptive Comparison | ||||
|---|---|---|---|---|
| SerialNumber | ITEM | Proposed Device | Predicate deviceHysteroscopeSystem | Discussion |
| ClassificationProduct Code | HIH | HIH | ||
| 510(k) number | K210270 | K181545 | ||
| 01 | Indications foruse | The MedicalEndoscope ImageProcessing System isintended to be used forviewing of the adultcervical canal anduterine cavity for thepurpose of performingdiagnostic andoperative procedures. | The HysteroscopeSystem is intended tobe used to permitviewing of the cervicalcanal and uterine cavityfor the purpose ofperforming diagnosticand surgicalprocedures. Note:Hysteroscopes areused as tools to accessthe uterine cavity andare not, in and ofthemselves, a methodof surgery.Generally recognizedindications fordiagnostichysteroscopy include: | SE |
| Table 005-01_Descriptive Comparison | ||||
| SerialNumber | ITEM | Proposed Device | Predicate deviceHysteroscopeSystem | Discussion |
| ClassificationProduct Code | HIH | HIH | • Amenorrhea• Pelvic painGenerally recognizedindications foroperative hysteroscopyinclude:• Directed endometrialbiopsy• Polypectomy• Submucousmyomectomy• Transection ofintrauterine adhesions• Transection ofintrauterine septa• Endometrial | |
| 510(k) number | K210270 | K181545 | ||
| Table 005-01 Descriptive Comparison | ||||
| SerialNumber | ITEM | Proposed Device | Predicate deviceHysteroscopeSystem | Discussion |
| ClassificationProduct Code | HIH | HIH | ||
| 510(k) number | K210270 | K181545 | ||
| 02 | SystemComponents | The medical endoscope system is composed of disposable electronic hysteroscope and medical endoscope image processor. | The Hysteroscope System consists of a sterile single-use disposable Rigid Hysteroscope and video processor for clinical image processing. | Similar, with difference in wording, while the actual indications are the same. |
| 03 | Optical Image | CMOS | CMOS | SE |
| 04 | ImageResolution | 160,000 pixels | 100,000 pixels | Difference 1 |
| 05 | IlluminationLight Source | LED | LED | SE |
| 06 | Inflow and outflow channel for saline instillation | Inflow and outflow channels separately. | Inflow and outflow channels separately . | SE |
| 07 | Cannula tipdesign | The head bending angle is $16\pm3^\circ$ . | Angled shaft proximal to tip: Straight: 0°Curved tip:22° | Difference 2 |
| Table 005-01_Descriptive Comparison | ||||
| SerialNumber | ITEM | Proposed Device | Predicate deviceHysteroscopeSystem | Discussion |
| HIH | ||||
| ClassificationProduct Code | HIH | |||
| 510(k) number | K210270 | K181545 | ||
| 08 | 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. | 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. | SE |
| 09 | Maximum InsertionDiameter (Tip) | 4.8mm | 4.0 to 6.4mm depending on model | Difference 3 |
| 10 | Shaft/Cannula Length | 200mm±3% | 260mm | Difference 4 |
| 11 | Energy Source | Hysteroscopy is powered by medical endoscope image processor:5VImage processor for medical endoscope:100-240V ,40VA | Hysteroscope: 5VVideo Processor: 5V 2A | Difference 5 |
| Table 005-01_Descriptive Comparison | ||||
| SerialNumber | ITEM | Proposed Device | Predicate deviceHysteroscopeSystem | Discussion |
| ClassificationProduct Code | HIH | HIH | ||
| 510(k) number | K210270 | K181545 | ||
| 12 | Sterilization | The DisposableElectronicHysteroscope isprovided sterilized byEO. No re-sterilizationis permitted. VideoProcessor: Non-Sterile | The RigidHysteroscope isprovided sterilized byEO. No re-sterilizationis permitted. VideoProcessor: Non-Sterile | SE |
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K210270 Page 9 of 16
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| Table 005-02 Analysis of Differences | ||||
|---|---|---|---|---|
| SN | ITEM | Proposed Device | Predicate deviceHysteroscopeSystem | Reason |
| Difference1 | ImageResolution | 160,000 pixels | 100,000 pixels | The higher image resolutionallows the operator to see thetissue more clearly. |
| Table 005-02 Analysis of Differences | ||||
| Cannula tip | The head | Angled shaft proximal | The slightly smaller angle | |
| Difference | design | bending | to tip: Straight: 0° | allows for more flexible use of |
| 2 | angle is | Curved tip:22° | the hysteroscope. | |
| 16±3°. | ||||
| Maximum | 4.8mm | 4.0 to 6.4mm | Submission product contains | |
| Difference | Insertion | depending on model | 2mm instrument working | |
| 3 | Diameter (Tip) | channel. | ||
| Shaft/Cann ula Length | 200mm±3 % | 260mm | According to the design of the human uterine cavity and vagina depth, 200mm is enough to meet the inspection and surgical operation; too long may cause improper operation to damage the endometrium of the uterine cavity | |
| Difference 4 | ||||
| Table 005-02 Analysis of Differences | ||||
| Difference5 | EnergySource | Hysteroscopy ispowered bymedicalendoscopeimageprocessor:5VImageprocessorfor medicalendoscope:100-240V ,40VA | Hysteroscope: 5VVideo Processor: 5V2A | Submission product haspassed the IEC 60601-1-2:2014, IEC 60601-1:2005+A1:2012 andIEC 60601-2-18:2009,thesame as predicate device.Sothis difference doesn't raiseany safety or effectivenessissue. |
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5. Summary of Non-Clinical Performance Testing
The following performance data were provided to support substantial equivalence to the predicate device.
5.1 Software
The software embedded in the Medical Endoscope Image Processing System is a moderate level of concern. The software was comprehensively verified and validated in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical devices.
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Software development activities included establishing detailed software requirements, detailed design specification, trace the requirements to software verification and validation testing, source code reviews, unit testing, system testing, and defect tracking to ensure the software conforms to the user needs and intended purposes.
5.2 Biocompatibility testing
Biocompatibility testing for the Disposable Electronic Hysteroscope was performed in accordance with the recommendations of ISO 10993-1, Biological Evaluation of Medical Device - Part 1: Evaluation and Testing. The results of these tests are listed in the table below:
| Biocompatibility testing summary | |||
|---|---|---|---|
| Test | Testing Summary | ||
| Cytotoxicity | Pass-Non-cytotoxic | ||
| Irritation test | Pass-Non-irritation | ||
| Sensitization test | Pass-Non-sensitization | ||
| Intracutaneous reactivity test | Pass-Non-intracutaneous reactivity | ||
| Systemic Toxicity test (Acute) | Pass-Non-toxic | ||
| Pyrogen test | Pass-Non-pyrogenicity |
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5.3 Safety, Electrical Safety, and Electromagnetic Compatibility (EMC)
Safety, Electrical Safety, and EMC testing were conducted on the Medical Endoscope Image Processing System in accordance with IEC 60601-1 for Basic Safety and Essential Performance, IEC 60601-1-2 for Electromagnetic Disturbances, IEC 60601-2-18 for Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment.
5.4 Sterility
The Disposable Electronic Hysteroscope is provided sterile. The method employed for the sterilization of the Disposable Electronic Hysteroscope is Ethylene oxide sterilization according to the EN ISO 11135:2014 sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. All sterilized Reservoir Patches met the standard of EN ISO 11135:2014 to assurance a sterility assurance level (SAL) of 10-6.
5.5 Cleaning and Disinfection
The Medical Endoscope Image Processor is reusable. The device needs to be cleaned and disinfected before and after each use. The 75% medical alcohol should be used to thoroughly disinfect the surface of the machine head, including corners and connectors.
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5.6 PACKAGING/SHELF LIFE
Simulated shipping testing, accelerated aging testing, and sterility package validation were carried out to support the shelf life of the Disposable Electronic Hysteroscope. Testing results demonstrated that the life of the Disposable Electronic Hysteroscope is 3 years.
The packaging of the Disposable Electronic Hysteroscope was validated for a shelf life of 36 months according to the requirements of ISO 11607-1:2009, ASTM F1980-16, ASTM F88/F88M-15, ASTM D 3078-02, ASTM F1929-15 and ASTM F1140/F1140M-13.
Shipping distribution tests for the Disposable Electronic Hysteroscope and Medical Endoscope Image Processor were conducted per ASTM D4169-16 to simulate shipping hazard exposure climate conditioning, vehicle stacking, vehicle vibration, loose load vibration, and drop to conduct relative tests. Results demonstrated that package integrity for the Disposable Electronic Hysteroscope and Medical Endoscope Image Processor were maintained following shipping and distribution.
The shelf life of the medical endoscope image processor is the same as its service life, which is 5 years. The main components that affect the service life of the product are switching power supply and PCB, and the main factors that determine the service life of these components are temperature and humidity. The service life of the medical endoscope image processor
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was evaluated using an accelerated constant stress life test at elevated temperature and humidity. During testing, normal operation and static storage are performed alternately. Accelerated life test results and risk analysis support that the product can be used for up to 5 years.
6. Summary
Based on the verification and validation as documented in the non-clinical performance testing, the Medical Endoscope Image Processing System was found to have a safety and effectiveness profile that is similar to the predicate device.
7. Conclusion
The subject and predicate devices have the same intended use. Although there are differences in the technological characteristics of the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. Results of performance testing have demonstrated that the subject device is as safe and effective as the the predicate device.
§ 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.