(240 days)
No
The summary describes standard image processing for display and recording, but does not mention any AI or ML capabilities for analysis, interpretation, or other functions.
Yes
The device is used for "diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system," indicating a therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states that the system is "designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system". The term "diagnosis" directly indicates a diagnostic purpose.
No
The device is described as a "Pancreaticobiliary Video System" consisting of both a "Single-use Video Pancreaticobiliary Scope" (hardware) and a "PB Digital Controller" (hardware with software). The description details physical characteristics and performance of both hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pancreaticobiliary Video System is an endoscopic system used for direct visualization within the pancreatic biliary system. It collects images from inside the body using a camera and displays them for diagnostic and treatment purposes.
- Lack of Specimen Analysis: The device does not analyze specimens taken from the body. It is used for direct observation of internal anatomy.
Therefore, while it is a medical device used for diagnosis and treatment, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.
The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.
The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.
Product codes
FBN, NTN, KQM
Device Description
Pancreaticobiliary Video System consists of:
Single-Use Video Pancreaticobiliary Scope:
- CDS11001
- CDS11002
- CDS11003
- CDS11004
- CDS11005
- CDS22001 ●
- CDS22002
- CDS22003
- CDS22004
- CDS22005
PB Digital Controller:
- BS-W-100
The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device.
The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Insertion port
- Suction port
- Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope
The light emitted by the cold light source located in the handle is transmitted to the distal end of the pancreaticobiliary scope through the glass fiber, and irradiates the human tissue from the distal end. CMOS and glass fiber are located at the same position at the distal end. CMOS transmits the collected image information to the PB Digital Controller through cable, and the PB Digital Controller displays the image on the display after processing.
CMOS and optical components are identical for all specifications of products. - Working channel port
- Lever which can lock the control
The Single-Use Video Pancreaticobiliary Scope have different size as follows:
- Maximum insertion portion width
- Effective working length
- Minimum accessories channel width
The PB Digital Controller has the following physical and performance characteristics:
- Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen
- Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope
- Can connect to an external monitor
- Reusable device
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pancreatic biliary system, hepatic ducts
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
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
Performance testing was conducted to demonstrate the essential performance of the proposed device Pancreaticobiliary Video System and confirmed that the proposed device works as intended with the compatible devices.
The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
- Diameter
- Working length
- Working channel diameter
- Liquid injection and aspiration
- Field of view
- Resolution
- Articulation direction
- Articulation angle A
- Surface and edges
- Leakage
- Attachment to duodenoscope reliability
- Duodenoscope compatibility
- Irrigation pump compatibility
- Accessory compatibility
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. A oneyear aging test was performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices"
Biocompatibility testing was performed 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".
Electrical performance was performed in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", IEC 60601-2-18:2009 "Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment", 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"
No animal study is included in this submission.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
February 16, 2023
Micro-Tech (Nanjing) Co., Ltd Sally He RA Engineer No. 10 Gaoke Third Road Nanjing National Hi-tech Industrial Development Zone Nanjing, Jiangsu 210032 CHINA
Re: K221784
Trade/Device Name: Single-use Video Pancreaticobiliary Scope, PB Digital Controller Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBN, NTN, KQM Dated: August 26, 2022 Received: January 17, 2023
Dear Sally He:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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.
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known)
Device Name Pancreaticobiliary Video System
Indications for Use (Describe)
The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.
The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.
The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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."
3
Image /page/3/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks, giving them a bold and modern look. A registered trademark symbol (®) is positioned in the upper right corner of the logo. The logo is simple, clean, and easily recognizable.
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K221784
1. Date of Preparation: 2023-02-08
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Sally He
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
3. Identification of Proposed Device
Trade Name: Single-use Video Pancreaticobiliary Scope, PB Digital Controller
Common Name: Pancreaticobiliary Video System
Regulatory Information
Device Classification Name: Endoscope and accessories
Classification regulation: 876.1500(FBN, NTN, FET), 874.4160(KQM)
Class and Review Panel: Class II, Gastroenterology/Urology (FBN, NTN, FET)
Class I, General and plastic surgery (KQM)
Product code: FBN, KQM, NTN, FET
4
Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are interconnected and have a three-dimensional appearance, suggesting depth and solidity. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
4. Identification of Predicate Device and Reference Device
Predicate Device:
510(k) Number: K142922
Product Name: SpyGlass DS Direct Visualization System
Manufacturer: Boston Scientific Corporation.
Reference Device:
510(k) Number: K200483
Product Name: SpyGlass Discover Digital System
Manufacturer: Boston Scientific Corporation.
5. Indications for Use
The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.
The Single-use Video Pancreaticobiliary Scope is used in combination with the PB Digital Controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.
The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.
Device Description 6.
Pancreaticobiliary Video System consists of:
Single-Use Video Pancreaticobiliary Scope:
- CDS11001
- CDS11002
- CDS11003
- CDS11004
- CDS11005
5
Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a clean and modern design.
- CDS22001 ●
- CDS22002
- CDS22003
- CDS22004
- CDS22005
PB Digital Controller:
- BS-W-100
The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device.
The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Insertion port
- Suction port
- Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope
The light emitted by the cold light source located in the handle is transmitted to the distal end of the pancreaticobiliary scope through the glass fiber, and irradiates the human tissue from the distal end. CMOS and glass fiber are located at the same position at the distal end. CMOS transmits the collected image information to the PB Digital Controller through cable, and the PB Digital Controller displays the image on the display after processing.
CMOS and optical components are identical for all specifications of products.
- Working channel port
- Lever which can lock the control
The Single-Use Video Pancreaticobiliary Scope have different size as follows:
- Maximum insertion portion width
- Effective working length
- Minimum accessories channel width
6
Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A registered trademark symbol (®) is located in the upper right corner of the logo.
The PB Digital Controller has the following physical and performance characteristics:
- Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen
- Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope
- Can connect to an external monitor
- Reusable device
7. Comparison of Technological Characteristics
The Pancreaticobiliary Video System substantially equivalent device materials, design, configuration,
sterilization process and intended use as those featured in the predicate device SpyGlass DS Direct
Visualization System (K142922) and SpyGlass Discover Digital System (K200483).
Comparison to Predicate Device and Reference Device:
Table 1 Substantial Equivalence Comparison between Proposed Single-Use Video Pancreaticobiliary
| Proposed Device | Predicated Device | Reference Device | ||
|---|---|---|---|---|
| Characteristics | Single-Use | |||
| Video | ||||
| Pancreaticobiliary Scope | SpyGlass DS Access | |||
| and Delivery Catheter | ||||
| (K142922) | SpyGlass Discover | |||
| Digital Catheter | ||||
| (K200483) | Remark | |||
| Product Code | FBN, KQM, NTN | FBN, KQM, NTN | FBM,KQM, NTN | Same |
| Class | II | II | II | Same |
| Regulation | ||||
| Description | Pancreaticobiliary Scope | |||
| (flexible or rigid) and | ||||
| accessories | Pancreaticobiliary Scope | |||
| (flexible or rigid) and | ||||
| accessories | Pancreaticobiliary | |||
| Scope (flexible or rigid) | ||||
| and accessories | Same | |||
| Regulation | ||||
| number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Illumination | ||||
| Source | LED | LED | LED | Same |
| Indication | ||||
| for | ||||
| Use | The Single-use Video | |||
| Pancreaticobiliary Scope | ||||
| is used in combination | ||||
| with the PB Digital | ||||
| Controller, which is | ||||
| designed to provide | ||||
| imaging for the diagnosis | ||||
| and treatment application | ||||
| of endoscopic surgery | ||||
| process of pancreatic | ||||
| biliary system, and | Intended to provide | |||
| direct visualization and | ||||
| to guide both optical and | ||||
| accessory devices for | ||||
| diagnostic and | ||||
| therapeutic applications | ||||
| during endoscopic | ||||
| procedures in the | ||||
| pancreatico-biliary | ||||
| system including the | ||||
| hepatic ducts. | The Spyglass Discover | |||
| Digital Catheter is | ||||
| intended to provide | ||||
| direct visualization and | ||||
| to guide both optical and | ||||
| accessory devices for | ||||
| diagnostic and | ||||
| therapeutic applications | ||||
| during endoscopic | ||||
| procedures in the | ||||
| pancreatico-biliary | Similar | |||
| Proposed Device | Predicated Device | Reference Device | ||
| Characteristics | Single-Use | |||
| Video | ||||
| Pancreaticobiliary Scope | SpyGlass DS Access | |||
| and Delivery Catheter | ||||
| (K142922) | SpyGlass Discover | |||
| Digital Catheter | ||||
| (K200483) | Remark | |||
| provide working channel | ||||
| for other diagnosis and | ||||
| treatment accessories. | system including the | |||
| hepatic ducts. | ||||
| Operating | ||||
| method | ERCP, PTC | ERCP | LCBDE, PTC, Open | |
| Surgical procedure | Similar | |||
| Working length | 2200mm | |||
| 800mm | ||||
| 650mm | ||||
| 600mm | ||||
| 400mm | 2140mm | 650mm | Similar | |
| Images Sensor | CMOS | CMOS | CMOS | Same |
| Reusability | Single-Use | Single-Use | Single-Use | Same |
| Sterile | Yes | Yes | Yes | Same |
| Anatomic sites | Pancreatic biliary system | Pancreatic biliary system | Pancreatic | |
| biliary | ||||
| system | Same | |||
| Target | ||||
| population | Adults | Adults | Adults | Same |
| Rx-only | Yes | Yes | Yes | Same |
| Tip Diameter | 3.7mm | |||
| 3.1mm | 3.5mm | 3.5mm | Similar | |
| Shaft Diameter | 3.9mm | |||
| 3.2mm | 3.6mm | 3.6mm | Similar | |
| Working | ||||
| Channel | ||||
| Diameter | 2.0mm | |||
| 1.2mm | 1.2mm | 1.2mm | Similar | |
| Proposed Device | Predicated Device | Reference Device | ||
| Characteristics | Single-Use | |||
| Video | ||||
| Pancreaticobiliary Scope | SpyGlass | |||
| DS Access | ||||
| and Delivery Catheter | ||||
| (K142922) | SpyGlass | |||
| Discover | ||||
| Digital | ||||
| Catheter | ||||
| (K200483) | Remark | |||
| Minimum | ||||
| Duodenoscope | ||||
| Working | ||||
| channel | 4.2mm | |||
| 3.7mm | 4.2mm | Not | ||
| used | ||||
| through | ||||
| duodenoscope | Similar | |||
| Minimum | ||||
| Sheath Working | ||||
| Channel | 4.0mm | |||
| 3.3mm | Not used through sheath | 3.6mm | Similar | |
| Deflection | 4way | |||
| ≥45° | 4way | |||
| ≥30 ° | 4way | |||
| ≥30 ° | Greater | |||
| Direction | ||||
| of | ||||
| View | 0 | 0 | 0 | Same |
| Field of view | 120 | 120 | 120 | Same |
| Resolution | 12.7lines/mm | |||
| @5mm | ||||
| object distance | 7.13 lines/mm | |||
| @5mm | ||||
| object distance | Unknown | Greater | ||
| Biocompatibilit | ||||
| y | Comply with ISO 10993-1 | Comply with ISO 10993- | ||
| 1 | Comply with ISO 10993-1 | Same | ||
| Shelf Life | 2 Years | 2 Years | 2 Years | Same |
| Electrical | ||||
| Performance | Comply with | |||
| ANSI AAMI ES60601-1 | ||||
| IEC60601-1-2 | ||||
| IEC 60601-2-18 | Comply with | |||
| ANSI AAMI ES60601-1 | ||||
| IEC60601-1-2 | ||||
| IEC 60601-2-18 | Comply with | |||
| ANSI AAMI ES60601-1 | ||||
| IEC60601-1-2 | ||||
| IEC 60601-2-18 | Same |
Scope and Predicate/Reference Device
7
Image /page/7/Picture/1 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional design. The letters are white and stand out against a blue background. A registered trademark symbol is located in the upper right corner of the logo.
8
Image /page/8/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right, creating a sense of depth. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
Table 2 Substantial Equivalence Comparison between Proposed PB Digital Controller and
| Characteristics | Proposed Device | Predicate/Reference Device | ||
|---|---|---|---|---|
| PB Digital Controller | Predicated Device | Reference Device | Remark | |
| SpyGlass DS Digital | ||||
| Controller(K142922) | SpyGlass Discover | |||
| Digital | ||||
| Controller(K200483) | ||||
| Product Code | FBN,FET | FBN | FBN | PB Digital |
| Controller is | ||||
| Characteristics | Proposed Device | Predicated Device | Reference Device | Remark |
| PB Digital Controller | SpyGlass DS Digital | |||
| Controller(K142922) | SpyGlass Discover | |||
| Digital | ||||
| Controller(K200483) | ||||
| Class | II | II | II | a video |
| processor | ||||
| regulated | ||||
| under FET. | ||||
| Regulation | ||||
| Description | Pancreaticobiliary Scope | |||
| (flexible or rigid) and | ||||
| accessories | ||||
| Endoscopic Video | ||||
| Imaging | ||||
| System/Component, | ||||
| Gastroenterology-Urology | Pancreaticobiliary Scope | |||
| (flexible or rigid) and | ||||
| accessories | Pancreaticobiliary | |||
| Scope (flexible or rigid) | ||||
| and accessories | Same | |||
| PB Digital | ||||
| Controller is | ||||
| one | ||||
| component | ||||
| of | ||||
| endoscopic | ||||
| Video | ||||
| Imaging | ||||
| System | ||||
| Regulation | ||||
| number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Indication | ||||
| for | ||||
| Use | The PB Digital Controller | |||
| can be used together with | ||||
| the Single-use Video | ||||
| Pancreaticobiliary Scope | ||||
| of Micro-Tech to process | ||||
| the image collected by the | ||||
| scope and transmit it to the | ||||
| display. | The SpyGlass DS Digital | |||
| Controller is intended to | ||||
| provide illumination and | ||||
| receive, process, and | ||||
| output images from the | ||||
| SpyScope DS Access and | ||||
| Delivery Catheter for | ||||
| diagnostic and | ||||
| therapeutic applications | ||||
| during endoscopic | ||||
| procedures in the | ||||
| pancreaticobiliary | ||||
| system including the | ||||
| hepatic ducts. | The Spyglass Discover | |||
| Digital Controller is | ||||
| intended to provide | ||||
| illumination and receive, | ||||
| process, and output | ||||
| images from the | ||||
| Spyglass Discover | ||||
| Digital Catheter for | ||||
| diagnostic and | ||||
| therapeutic applications | ||||
| during endoscopic | ||||
| procedures in the | ||||
| pancreaticobiliary | ||||
| system including the | ||||
| hepatic ducts. | Similar | |||
| Proposed Device | Predicated Device | Reference Device | ||
| Characteristics | PB Digital Controller | SpyGlass DS Digital | ||
| Controller(K142922) | SpyGlass Discover | |||
| Digital | ||||
| Controller(K200483) | Remark | |||
| Video Formats | PAL and NTSC | PAL and NTSC | PAL and NTSC | Same |
| Video Outputs | DVI, CVBS | S-Video, VGA, DVI | S-Video, VGA, DVI | Similar |
| Characteristics | Proposed Device | Predicated Device | Reference Device | |
| PB Digital Controller | SpyGlass DS Digital | |||
| Controller(K142922) | SpyGlass | |||
| Discover | ||||
| Digital | ||||
| Controller(K200483) | Remark | |||
| White | ||||
| Balancing | Automatic | Automatic | Automatic | Same |
| Brightness | ||||
| Control | 5 settings | 5 settings | 5 settings | Same |
| Separate | ||||
| monitor | Yes | Yes | Yes | Same |
| Energy | ||||
| used/Power | ||||
| source | Yes | Yes | Yes | Same |
| Reusability | Reusable | Reusable | Reusable | Same |
| Rx-only | Yes | Yes | Yes | Same |
| Shelf Life | 5 Years | 5 Years | 5 Years | Same |
| Electrical | ||||
| Performance | Comply with | |||
| ANSI AAMI ES60601-1 | ||||
| IEC60601-1-2 | ||||
| IEC 60601-2-18 | Comply with | |||
| ANSI AAMI ES60601-1 | ||||
| IEC60601-1-2 | ||||
| IEC 60601-2-18 | Comply with | |||
| ANSI AAMI ES60601-1 | ||||
| IEC60601-1-2 | ||||
| IEC 60601-2-18 | Same |
Predicate/Reference Device
9
Image /page/9/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be part of a single, solid shape. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
10
Image /page/10/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A small registered trademark symbol is visible in the upper right corner of the logo. The logo has a clean and modern design.
8. Performance Data
Performance testing was conducted to demonstrate the essential performance of the proposed device Pancreaticobiliary Video System and confirmed that the proposed device works as intended with the compatible devices.
The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
-
Diameter
-
Working length
-
Working channel diameter
-
Liquid injection and aspiration
-
Field of view
-
Resolution
-
Articulation direction
11
Image /page/11/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly, giving the logo a dynamic look. A registered trademark symbol (®) is positioned in the upper right corner of the logo.
- Articulation angle A
-
Surface and edges
-
Leakage
-
Attachment to duodenoscope reliability
- A Duodenoscope compatibility
-
Irrigation pump compatibility
-
Accessory compatibility
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. A oneyear aging test was performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices"
Biocompatibility testing was performed 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".
Electrical performance was performed in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", IEC 60601-2-18:2009 "Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment", 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"
12
Image /page/12/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
9. Animal Study
No animal study is included in this submission.
10. Clinical Study
No clinical study is included in this submission.
11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Pancreaticobiliary Video System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device SpyGlass DS Direct Visualization System under K142922 and reference device SpyGlass Discover Digital System under K200483, the subject device is as safe, as effective, and performs as well as the predicate/reference device.