(16 days)
Not Found
No
The description focuses on basic signal processing and display, with no mention of AI, ML, or advanced image analysis beyond simple conversion. The performance studies are standard electrical safety and software validation, not studies typically associated with AI/ML model performance.
No
The device processes and displays signals from an endoscope; it does not mention any therapeutic action or intervention.
No
This device is described as a video processor that receives and processes image signals from a digital endoscope and outputs them to a medical monitor for display. Its purpose is to process signals for display, not to provide a diagnosis.
No
The device description explicitly states it is a "video processor" and mentions electrical safety and EMC testing, which are associated with hardware components, not software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to process signals from an endoscope for display on a monitor. This is a function related to visualizing internal body structures, not analyzing samples taken from the body (in vitro).
- Device Description: The description focuses on processing image signals from a digital endoscope and displaying them. It explicitly states there is no direct/indirect patient contact material and no sterilization is required, which is typical for devices that interact with the body externally or indirectly for visualization purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate the visualization of internal anatomy during an endoscopic procedure.
N/A
Intended Use / Indications for Use
"This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor."
Product codes
FET
Device Description
"The Medical Video Endoscope Image Processor PV210 is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from digital endoscope and outputs signals to a medical monitor to display. PV210 has integrated software to control the operation of the device. PV210 is a reusable device and do not require sterilization before use, as there is no direct/in-direct patient contact material. It needs to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual. The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures."
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscope signals
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"skilled physicians trained in clinical endoscopic techniques and procedures", "hospital or qualified medical institution"
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)
"Bench testing as identified below was conducted to verify and validate that the product performs as intended."
"The following bench testing conducted for the subject device PV210 demonstrates substantial equivalence in safety:
Electrical safety: Electrical safety of the system was evaluated in accordance with IEC 60601-1:2012, and AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 C1:2009/(R)2012 C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-2-18:2009. According to the test result, the subject device conforms to the requirements of the above standards.
Electromagnetic compatibility (EMC): Electromagnetic compatibility was evaluated in accordance with IEC 60601-1-2:2007. According to the test result, the subject device conforms to the requirements of the above standard.
Software Verification and Validation testing: Software verification and validation testing were conducted. According to the test result, the subject device conforms to software and system requirements. Bench testing of performance specifications were completed and demonstrate that the device met all requirements."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2019
Zhuhai Pusen Medical Technology Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. Warren, NJ 07059
Re: K190648
Trade/Device Name: Pusen™ Eview™M Medical Video Endoscope Image Processor, Model PV210 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: March 11, 2019 Received: March 13, 2019
Dear Dave Yungvirt:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Angel A. Solergarcia -S
for Benjamin R. Fisher, Ph.D.
Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190648
Device Name
Pusen™ Eview™M Medical Video Endoscope Image Processor, Model PV210
Indications for Use (Describe)
This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Traditional 510(k)
Image /page/3/Picture/2 description: The image shows the logo for Zhuhai Pusen Medical Technology Co., Ltd. The logo consists of the word "PUSEN" in a stylized, sans-serif font, with rounded corners and a light blue color. Below the word "PUSEN" is the text "Zhuhai Pusen Medical Technology Co., Ltd." in a smaller, gray font.
510(k) SUMMARY
1. Submitter's Name, Address and Phone and Fax Number
Zhuhai Pusen Medical Technology Co., Ltd.
5/F, Building 1, No 33, Keji San Road, High-tech Zone, Tangjiawan Town, 519085 Zhuhai, Guangdong, PRC.
Phone: 86-07566880096
Fax: 86-07566880401
Contact Person: Ms. Wang ChangShen
Manager, Regulatory Affairs Phone: 86-07566880865
Date prepared: February 22, 2019
Device: 2.
Pusen ™ Eview™ Medical Video Endoscope Image Processor Trade name:
Model Number: PV210
Common name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
21 CFR 876.1500 Endoscope and accessories. Class II Classification:
Product Code: FET
Predicate Device: 3.
Trade name: Image 1 SPIES
Premarket Notification: K131953
4. Device description:
4
Image /page/4/Picture/1 description: The image shows the logo for PUSEN, a medical technology company based in Zhuhai. The logo is in a sans-serif font and is a light blue color. Below the logo is the text "Zhuhai Pusen Medical Technology Co., Ltd."
Traditional 510(k)
The Medical Video Endoscope Image Processor PV210 is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from digital endoscope and outputs signals to a medical monitor to display.
PV210 has integrated software to control the operation of the device.
PV210 is a reusable device and do not require sterilization before use, as there is no direct/in-direct patient contact material. It needs to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual.
The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.
5. Indications for Use
This equipment has been designed to be used to process signals from an endoscope and convert it to a signal that can be displayed on the monitor.
Comparison of Technological Characteristics 6.
The predicate and subject devices are both video processors that can be used for the visualization of endoscopic procedures, while the predicate device can work with camera head, therefore it can also be used for microscopic procedures. There are similarities and differences in the technological characteristics.
These similarities are:
- Have the same intended use in endoscopic procedures. .
- . Have similar functions such as: light source control, enhancement control, white balance, zoom and HD video output.
- . Are used in conjunction with digital endoscope and medical monitor.
- Reusable
- . Powered by main line
These differences are:
- . the predicate supports both camera head and digital endoscope while the subject only supports digital endoscope
- . the predicate supports image and video storage while the subject is not capable of storage
- . the predicate supports display brightness control while the subject only supports
5
Image /page/5/Picture/1 description: The image shows the word "PUSEN" in a stylized, sans-serif font. The letters are a light blue color. Below the word "PUSEN" is the text "Zhuhai Pusen Medical Technology Co., L" in a smaller, sans-serif font. The text is also a light blue color.
predetermined display brightness setting which cannot be adjusted
- . The predicate supports 3G-SDI and DVI-D video output formats while the subject supports SDI, DVI-D, VGA and VIDEO output formats.
- . The predicate incorporates an external keyboard to control the system operation while the subject does not have an external keyboard, it is equipped with buttons on front panel to control the system operation.
The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness. Bench testing as identified below was conducted to verify and validate that the product performs as intended.
Non-Clinical Performance Data 7.
The following bench testing conducted for the subject device PV210 demonstrates substantial equivalence in safety:
Electrical safety
Electrical safety of the system was evaluated in accordance with IEC 60601-1:2012, and AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 C1:2009/(R)2012 C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-2-18:2009.
According to the test result, the subject device conforms to the requirements of the above standards.
Electromagnetic compatibility (EMC)
Electromagnetic compatibility was evaluated in accordance with IEC 60601-1-2:2007. According to the test result, the subject device conforms to the requirements of the above standard.
Software Verification and Validation testing
Software verification and validation testing were conducted.
According to the test result, the subject device conforms to software and system requirements.
Bench testing of performance specifications were completed and demonstrate that the device met all requirements.
8. Conclusion:
The subject device is substantially equivalent to the predicate device and does not raise any questions of safety and effectiveness.