(254 days)
Not Found
No
The summary mentions "image processing circuit and software" but does not include any terms like AI, ML, DNN, or provide details about training or test data sets, which are typical indicators of AI/ML use in medical devices.
Yes
The device is designed to be used with "endo-therapy accessories such as a biopsy forcens and other ancillary equipment for endoscopic surgery," indicating its role in therapeutic procedures like biopsies and surgery.
No
The device is primarily intended for endoscopic surgery and visualization, as stated by its use with "endo-therapy accessories such as a biopsy forcens and other ancillary equipment for endoscopic surgery." While it displays images, its primary role is not to diagnose conditions but to facilitate surgical procedures and provide visual guidance.
No
The device description explicitly states that the system consists of both a Single-use Video Ureterorenoscope (hardware) and a Medical Video Processor (which includes hardware components like a power circuit and image processing circuit, in addition to software). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic surgery within urinary tract and interior of the kidney" and for "enhancing and displaying the image of the field of view of the endoscope". This describes a device used for direct visualization and surgical procedures within the body, not for testing samples outside the body.
- Device Description: The description details a system consisting of an endoscope and a video processor used for imaging and providing functional supply for the endoscope. This aligns with an endoscopic system for internal examination and intervention.
- Anatomical Site: The anatomical site is the "urinary tract and interior of the kidney," which are internal body locations.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples) in vitro (outside the body) to provide diagnostic information. The device's function is to provide visual information and facilitate procedures in vivo.
Therefore, this device falls under the category of an endoscopic system for internal visualization and surgical assistance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Medical Video Endoscope System has been designed to be used with endo-therapy accessories such as a biopsy forcens and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.
Medical Video Processor is intended to be used in conjunction with the endoscopes to enhance and display the image of the field of view of the endoscope on the monitor, and also provides functional supply for the endoscope.
Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.
Product codes (comma separated list FDA assigned to the subject device)
FGB
Device Description
Medical Video Endoscope System is consist of a Single-use Video Ureterorenoscope and a Medical Video Processor. The proposed device has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
The Single-use Video Ureterorenoscope is a single use device. The Single-use Video Ureterorenoscope is consist of distal end, bending section, insertion portion, operational portion and connection portion. The Single-use Video Ureterorenoscope is a single-channel endoscope. Only one instrument channel is in the distal end of the endoscope.
The Medical Video Processor is a reusable device. The Medical Video Processor is composed of a power circuit, an image processing circuit and software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract and interior of the kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
Test results demonstrated compliance with various ISO and ASTM standards, and IEC standards for biological evaluation, electrical safety, and optical properties.
Biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous irritation) was performed on patient-contact components with results showing no negative impacts.
Software verification and validation testing were conducted per FDA guidance.
Bench performance testing included optical performance testing (Photobiological safety, Color reproduction, Resolution, Depth of Field of view, Noise, Geometric distortion, Intensity uniformity, Image frame frequency and system delay) which showed similar performance to the predicate device (K172098).
Physical/functional performance testing included irrigation valve leakage test.
Endoscope and video processor use-life testing showed that the optical performance of the aged single-use endoscope was similar to un-aged, and the video processor maintained its performance after accelerated aging and running, supporting a six-year use-life statement.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 3, 2023
HUGER Medical Instrument Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K230475
Trade/Device Name: Medical Video Endoscope System Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: September 26, 2023 Received: September 27, 2023
Dear Diana Hong:
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
Page 3
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,
Mark J. Antonino -S
Mark J. Antonino, M.S. 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)
Device Name
Medical Video Endoscope System
Indications for Use (Describe)
Medical Video Endoscope System has been designed to be used with endo-therapy accessories such as a biopsy forcens and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.
Medical Video Processor is intended to be used in conjunction with the endoscopes to enhance and display the image of the field of view of the endoscope on the monitor, and also provides functional supply for the endoscope.
Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.
| 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)
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Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 02/16/2023
-
- Sponsor Identification
HUGER Medical Instrument Co., Ltd.
Building 26A, No. 3825, Xinzhuan Highway, Dongjing Town, Songjiang District, 201619, Shanghai, China.
Establishment Registration Number: Not yet registered.
Contact Person: Lei Lu Position: Compliance Manager Tel: +86-021-67626235 Fax: +86-021-67691721 Email: lulei@huger.cn
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
5
4. Identification of Proposed Device
Trade Name: Medical Video Endoscope System; Common Name: Flexible Urology Endoscope System
Regulation Name: Endoscope and Accessories Classification: II Product Code: FGB Regulation Number: 21CFR 876.1500 Review Panel: Gastroenterology/Urology
Indications for Use:
Medical Video Endoscope System has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopic surgery within urinary tract and interior of the kidney.
Medical Video Processor is intended to be used in conjunction with the endoscopes to enhance and display the image of the field of view of the endoscope on the monitor, and also provides functional supply for the endoscope.
Single-use Video Ureterorenoscope is intended to connect with Medical Video Processor to provide video imaging.
Device Description:
Medical Video Endoscope System is consist of a Single-use Video Ureterorenoscope and a Medical Video Processor. The proposed device has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
| System | Component | Model |
|---|---|---|
| Medical | ||
| Endoscope System | Video | |
| Single-use | ||
| Ureterorenoscope | SVU-220 | |
| Medical Video Processor | VEP-220 |
| Table 1 Product Model | ||||
|---|---|---|---|---|
| -- | -- | -- | ----------------------- | -- |
The Single-use Video Ureterorenoscope is a single use device. The Single-use Video Ureterorenoscope is consist of distal end, bending section, insertion portion, operational portion and connection portion. The Single-use Video Ureterorenoscope is a single-channel endoscope. Only one instrument channel is in the distal end of the endoscope.
6
The Single-use Urology Videoscope is sterilized by Ethylene Oxide Gas to achieve a SAL of 106 and supplied sterility maintenance which could maintain the sterility of the device during the shelf life of three vears.
The Medical Video Processor is a reusable device. The Medical Video Processor is composed of a power circuit, an image processing circuit and software.
-
న్. Identification of Predicate Device
510(k) Number: K172098 Product Name: Medical Video Endoscope system -
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
-
A ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dve Penetration
-
ISO 8600-1:2015 Endoscopes-Medical endoscopes and endotherapy devices - Part 1: General requirements
-
A ISO 8600-3:1997/Amd1:2003 Optics and optical instruments -Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
-
ISO 8600-4:2014 Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance, including the US National Differences
-
A IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic disturbances - Requirements and tests
-
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
7
-
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- A ISO 14971:2019 Medical Devices - Application of risk management to medical devices
-
IEC 62471:2006 Photobiological safetv of lamps and lamp systems
Biocompatibilitv testing
The contact level of the proposed device is mucosal membrane, and the contact duration is limited contact ( Cytotoxicity,
- A Sensitization,
-
Intracutaneous irritation,
Software verification and validation testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Bench performance testing
Optical performance testing
-
Photobiological safety test according to IEC 62471: 2006;
Color reproduction, Resolution, Depth of Field of view, Noise, Geometric distortion, A Intensity uniformity, Image frame frequency and system delay testing compared with the predicate device (K172098). The test results show that the performance of the proposed device is similar to the predicate device.
Physical/functional performance testing
Irrigation valve leakage test was performed on the proposed device.
Endoscope and video processor use-life testing
The optical performance comparison test was conducted on the un-aged Single-use Video Ureterorenoscope and aged Single-use Video Ureterorenoscope. The test results demonstrate that the optical performance of the aged endoscope is similar as those of the un-aged endoscope.
A use-life verification was conducted to determine the image system's use life. After accelerating aging and running, the qualitative was conducted on the video processor. The test results demonstrate that the performance of the proposed system doesn't reduced after accelerating aging and the use-life statement of six years are accepted. In addition, the quantitative optical performance comparison testing was conducted on the new image processor and the image processor after accelerating aged and
8
running. The test results demonstrate that the optical performance of the image process after accelerating aged and running is similar as those of the new one.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate Device
K172098 | Remark |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product Code | FGB | FGB | Same |
| Regulation No. | 876.1500 | 876.1500 | Same |
| Class | II | II | Same |
| Indication for Use | Medical Video Endoscope
System has been designed to be used with endo-therapy
accessories such as a biopsy
forceps and other ancillary
equipment for endoscopy and
endoscopic surgery within urinary
tract and interior of the kidney.
Medical Video Processor is
intended to be used in
conjunction with the endoscopes
to enhance and display the image
of the field of view of the
endoscope on the monitor, and
also provides functional supply
for the endoscope.
Single-use Video
Ureterorenoscope is intended to
connect with Medical Video
Processor to provide video imaging. | The instrument has been
designed to be used with
endo-therapy accessories such
as a biopsy forceps and other
ancillary equipment for
endoscopy and endoscopic
surgery within urinary tract and
interior of the kidney. | Similar |
| Single use/ Reuse | Endoscope: Single use | Endoscope: Single use | Same |
Table 2 SE Comparison
9
| Video Processor: Reuse | Image Processor: Reuse | ||
|---|---|---|---|
| Sterile | Yes for disposable endoscope | Yes for disposable endoscope | Same |
| Anatomical Site | Urinary tract and interior of the kidney | Urinary tract and interior of the kidney | Same |
| Where used | Hospital | Hospital | Same |
| Main Configuration | Single-use Video | ||
| Ureterorenoscope | |||
| Medical Video Processor | Uscope (single-use endoscope) | ||
| Eview (touch PC with data processing center) | Similar | ||
| Label/Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Single-use video Ureterorenoscope | |||
| Scope type | Flexible | Flexible | Same |
| Field of view | 120° | 120° | Same |
| Direction of view | 0° | 0° | Same |
| Depth of field | 2-100mm | 3-50mm | Different |
| Sensor type | CMOS | CMOS | Same |
| Max. outer | |||
| diameter of | |||
| insertion section | 2.9mm | 3.2mm | Similar |
| Up/down deflection | Up:270° Down: 270° | Up:270° Down: 270° | Same |
| Work length | 700mm | 650mm | Similar |
| Minimum | |||
| instrument channel | |||
| width | 1.2mm | 1.0mm | Similar |
| Product | |||
| Performance | Comply with ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 8600-7 | Comply with ISO 8600-1 | Different |
| Patient-contact component and material | |||
| Bending section | Thermoplastic Polyurethane (TPU) | Sheath SUS 304 and PEBAX | |
| Insertion section | Thermoplastic Polyurethane (TPU) | Controllable portion SUS 304, covered with silicone rubber | |
| Distal End Section | Polycarbonate (PC) | Distal tip ABS | Different |
| CMOS Front End | Glass | Working channel Fluorinated ethylene propylene | |
| Instrument channel | Pebax and Barium sulfate | / | |
| Tuohy Borst Valve | Polycarbonate (PC) and | ||
| Assembly | Polyethylene copolymer | ||
| UV Glue | Epoxy resin | ||
| Cytotoxicity: ISO 10993-5 | Cytotoxicity: ISO 10993-5 | ||
| Biocompatibility | Sensitization: ISO 10993-10 | Sensitization: ISO 10993-10 | Same |
| Irritation: ISO 10993-10 | Irritation: ISO 10993-10 | ||
| Sterilization | |||
| Method | EO sterilization | EO sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Medical Video Processor | |||
| Illumination source | LED | LED | Same |
| Power supply | AC: 100-240V±10% 50/60 Hz | AC: 100-240V 50/60 Hz | Same |
| Dimension | 320(W)×96(H)×370(D) mm | 315(W)×187(H)×308 (D) mm | Different |
| Weight | 9Kg | 4.3 Kg | Different |
| Input power | 50VA | Unknown | Different |
| Video signal output | DVI | HDMI | Different |
| Auto white balance | Automatically adjusted | Automatically adjusted | Same |
| Communication | |||
| with endoscope | Provided | Provided | Same |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Particular | |||
| requirements | Comply with IEC 60601-2-18 | Comply with IEC 60601-2-18 | Same |
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Similar Analysis 1-Indication for Use
The indication for use of the proposed device is different from that of the predicate device in expression. The indications for use of the proposed device are provided in the form of system's indications for use, video processor's indications for use and disposable endoscope's indications for use. The predicate device only provides the whole system's indications for use. The expression of the indications for use of the proposed device provides the indications for use of video processor and disposable endoscope. Many cleared endoscope systems adopted this expression form of indications for use. Both devices are used for endoscopic diagnosis and therapies within the urinary system. Based on above analysis, the indication for use of the proposed device and the predicate device is only different in expression. Therefore, the difference will not affect the new safety and effectiveness of the proposed device.
Similar Analysis 2- Main Configuration
The main configuration of the proposed device is different with the predicate device. However, it's just the different name. The Single-use Video Ureterorenoscope of the proposed device and the Uscope of the predicate device have the same function and the Medical Video Processor of the proposed device and the view of the predicate device have function. Therefore, the
11
difference will not affect the safety and effectiveness of the proposed device.
Different Analysis 3 - Depth of Field
The proposed device has a wider range of depth of field than the predicate device to give physicians more options for diagnosis and treatment based on the patient's condition. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Similar Analysis 4- Max. outer diameter of insertion section
The max. outer diameter of insertion of the proposed device is similar to that of the predicate device. The out diameter of the proposed device is 2.9mm, and the out diameter of the predicate device is 3.2mm. The proposed device was complied with the requirements of ISO 8600 series standards. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Similar Analysis 5- Work length
The work length of the proposed device is similar as that of the predicate device. The work length of the proposed device is 700mm, and the work length of the predicate device is 650mm. The proposed device was complied with the requirements of ISO 8600 series standards. Therefore, this difference does not raise new problems on safety and effectiveness of proposed device.
Similar Analysis 6- Min. inner diameter instrument channel
The minimum instrument channel width of the proposed device is similar to that of the predicate device. The instrument channel inner diameter of the proposed device is 1.2mm, and the instrument channel inner diameter of the predicate device is 1.0mm. The device was tested per ISO 8600 standard, which can prove that the performance of the proposed endoscope is comply with ISO 8600 standards. Endoscopes with different sizes can be applied to different size of surgical instruments. This difference on minimum instrument channel width between the proposed device and predicate devices does not affect the safety and effectiveness of the proposed device.
Different Analysis 7- Product Performance
The performance tests of the proposed device follow more standards than those of the predicate device, ISO 8600-3, ISO 8600-4 and ISO 8600-7. And the performance test result of the proposed device meets the requirements of ISO 8600-1, ISO 8600-4 and ISO 8600-7. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Different Analysis 8- Patient-contact component and material
The patient-conduct component and material of the proposed device is different with the predicate device. However, the biocompatibility tests were conducted on the proposed device and the test result showed that the proposed device does not raise the adverse effect on the material. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
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Different Analysis 9-Dimension and weight
The dimension and weight for the proposed image processor is different from predicate image processor. However, the dimension and weight difference is just in physical specification and this difference will not raise new issues in safety and effectiveness.
Different Analysis 10- Input power
The input power for the predicate image processor is unknown. However, the input power of proposed image processor complies with IEC 60601-1 standard, the difference in input power is just the difference in device design. Therefore, this difference on input power is considered not affect the safety and effectiveness of the proposed device.
Different Analysis 11-Video Signal Output
The types of video signal output are different between proposed image processor and predicate image processor. The proposed device has DVI interface, the predicate device has HDMI interface. The image quality of DVI output and HDMI output of the proposed device and predicative device have been tested in the quantitative image quality testing. The test results demonstrate that there is no difference in image quality between the two products. Therefore, the difference on video signal output will not affect the safety and effectiveness of the proposed device.
9. Substantially Equivalent (SE) Conclusion
The proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K172098.