(161 days)
Not Found
No
The summary describes standard image processing for visualization and display, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms for automated analysis or interpretation.
No.
Explanation: The device is described as being "intended to visualize the internal cavities...during diagnostic endoscope procedures," indicating its purpose is for diagnosis and visualization, not for treating or interveining in a disease or condition.
Yes
The device description and intended use explicitly state that the Zsquare ENT-Flex endoscope is for "diagnostic endoscope procedures" and is intended to "visualize the internal cavities of the ear, airways, nose and sinus cavities" to aid in diagnosis.
No
The device description clearly outlines multiple hardware components including an endoscope (with disposable and reusable parts), a console with various units (illumination, camera control, monitor, keyboard, footswitch, cart), and associated cables. While there is mention of image processing and software verification/validation, the core functionality and components are hardware-based.
Based on the provided information, the Zsquare ENT-Flex endoscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic endoscope procedures." This describes a device used for direct visualization within the body, not for examining specimens in vitro (outside the body).
- Device Description: The description details a system for capturing and displaying images from within the body. It involves a physical endoscope inserted into the patient.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information about a patient's health status based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Zsquare ENT-Flex endoscope is a medical device used for direct visualization during a diagnostic procedure performed in vivo (within the body).
N/A
Intended Use / Indications for Use
Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic endoscope procedures.
Product codes
EOB
Device Description
Zsquare ENT-Flex endoscope is a flexible, high-resolution endoscope with a narrow insertion diameter composed of a Single-Use Shell, provided sterile, that fully encompasses a reusable Imaging Core. The Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose, and sinus cavities during diagnostic endoscope procedures. The endoscope is to be used with a Console provided by Zsquare in a hospital or clinic environment. This device is designed to reduce the need for high-level disinfection and/or sterilization between patients by providing a sterile disposable Single-Use Shell that is used in combination with a reusable Imaging Core.
The Zsquare ENT-Flex system consists of a/an:
• Endoscope comprised of a:
• Disposable Single-Use Shell that is comprised of the handle, the steering mechanism, and the steerable shaft (imaging fiber, illumination fiber and distal optics). It is the only part that contacts the patient and physician's soiled hands and is disposed of at the end of the procedure.
• Reusable Imaging Core, which is a hand-held multi-use unit containing the optical system that is composed of a lens array and a camera. At the end of a procedure, the Imaging Core is disengaged from the Shell and cleaned with ethanol wipes.
- Console comprised of a/an:
- Illumination Unit
- Camera Control Unit (CCU)
- Monitor/Screen
- Keyboard with touchpad
- Footswitch
- Cart
The console enables the image-processing. A data cable connects to the endoscope and transfers the video data to the image-processing unit. The image is transferred and displayed on a graphical user interface (i.e.: monitor).
Power is supplied to the camera contained in the Imaging Core by a cable from the CCU. A second cable is connected to the illumination source to control the illumination.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear, airways, nose, and sinus cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or clinic environment.
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 included Image Parameter Testing (Including ISO 8600), Shaft Dimensional Visual Inspection and Mechanical Properties, Zsquare ENT-Flex Illumination Source (ZEIS) HW & Optical Performance Testing, Reusable to Console Mating Cycles Testing, Reusable to Disposable Mating Cycles Testing, IP Testing of the Imaging Core, Color Performance Test, Glass to Glass Latency Testing.
STERILIZATION, PACKAGING & SHELF-LIFE Sterilization validation of the Single-Use Shell was tested according to Sterilization ISO 11135.
The shelf life of the Zsquare ENT-Flex Shell (use before date) is established through an accelerated aging study according to ISO 11607.
Testing of the the product after transportation/environmental and shelf-life simulation showed that the sterile barrier packaging integrity is maintained, thus assuring maintenance of the product sterility assurance level (SAL) of 10-6.
Core requires Intermediate The Imaging Level Disinfection, and this process kills pathogenic and other microorganisms by physical or chemical means.
The reprocessing validation was conducted, according to ST-724-2021/P Manual Cleaning Intermediate Level Disinfection Validation.
BIOCOMPATIBILITY Biocompatibility assessments were performed in accordance with the appropriate risk category requirements, as defined in ISO 10933-1.
SOFTWARE Software verification and validation testing was performed to demonstrate that the software in the subject device meets design specifications.
ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY General requirements for basic safety and essential performance IEC 60601-1. Electrical safety for endoscopes in IEC 60601-2-2018. Electromagnetic compatibility testing per IEC 60601-1-2. Photobiological safety per IEC 62471.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
3NT endoscopy system (K162916), Ambu aScope 4 RhinoLaryngo Slim (K191080)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 14, 2022
Zsquare, Ltd Liat Diamant-Porat CEO, LDP Consulting Ltd. 43 Hasivim Street Petah Tikva, 4959501 Israel
Re: K220004
Trade/Device Name: Zsquare ENT-Flex Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: Mav 4, 2022 Received: May 10, 2022
Dear Liat Diamant-Porat:
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.
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
1
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-safety-reportingcombination-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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220004
Device Name Zsquare ENT-Flex
Indications for Use (Describe)
Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic endoscope procedures.
**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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510(k) SUMMARY
| Owner's Name & Address | Zsquare, Ltd
43 Hasivim Street
Petah Tikva, Israel 4959501
Phone: +972-3-698-7600 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Liat Diamant Porat, LL.B, B.Sc
LDP Consulting Ltd.
44 Hey Beiyar Street
Tel-Aviv, Israel
liat@ldp-consulting.com
+972-50-525-2099 |
| Date | June 09, 2022 |
| Trade Name | Zsquare ENT-Flex |
| Common / Classification Name | Ear & Nose Surgery |
| Product Code | EOB |
| Classification | Class II |
| Predicate Device | 3NT endoscopy system (K162916), Ambu aScope 4
RhinoLaryngo Slim (K191080) |
| Device Description | Zsquare ENT-Flex endoscope is a flexible, high-resolution endoscope with a narrow insertion diameter composed of a Single-Use Shell, provided sterile, that fully encompasses a reusable Imaging Core. The Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose, and sinus cavities during diagnostic endoscope procedures. The endoscope is to be used with a Console provided by Zsquare in a hospital or clinic environment. This device is designed to reduce the need for high-level disinfection and/or sterilization between patients by providing a sterile disposable Single-Use Shell that is used in combination with a reusable Imaging Core.
The Zsquare ENT-Flex system consists of a/an:
• Endoscope comprised of a:
• Disposable Single-Use Shell that is comprised of the handle, the steering mechanism, and the steerable shaft (imaging fiber, illumination fiber and distal optics). It is the only part that contacts the patient and physician's soiled hands and is disposed of at the end of the procedure.
• Reusable Imaging Core, which is a hand-held multi-use unit containing the optical system that is composed of a lens array and a camera. At the end |
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of a procedure, the Imaging Core is disengaged from the Shell and cleaned with ethanol wipes.
- · Console comprised of a/an:
- o Illumination Unit
- o Camera Control Unit (CCU)
- o Monitor/Screen
- Keyboard with touchpad
- o Footswitch
- o Cart
The console enables the image-processing. A data cable connects to the endoscope and transfers the video data to the image-processing unit. The image is transferred and displayed on a graphical user interface (i.e.: monitor).
Power is supplied to the camera contained in the Imaging Core by a cable from the CCU. A second cable is connected to the illumination source to control the illumination.
Indications for use Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose, and sinus cavities during diagnostic endoscope procedures.
Technological Characteristics
| Optics Performance: | |
|---|---|
| Field of View | 93° (air) |
| Direction of View | Forward view |
| Depth of Field | 3.5 – 50 mm |
| Optimal working distance | 7 mm |
| Insertion Tube Diameter | 2.3mm |
| Insertion Tube Working Length | 290 mm |
| Articulation | 130° |
| Reusability | Single-use disposable unit, reusable imaging unit |
Non-Clinical Performance Data
PERFORMANCE - BENCH TESTING
Bench testing included Image Parameter Testing (Including ISO 8600), Shaft Dimensional Visual Inspection and Mechanical Properties, Zsquare ENT-Flex Illumination Source (ZEIS) HW & Optical Performance Testing, Reusable to Console Mating Cycles Testing, Reusable to Disposable Mating Cycles Testing, IP Testing of the Imaging Core, Color Performance Test, Glass to Glass Latency Testing.
STERILIZATION, PACKAGING & SHELF-LIFE Sterilization validation of the Single-Use Shell was tested according to Sterilization ISO 11135.
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The shelf life of the Zsquare ENT-Flex Shell (use before date) is established through an accelerated aging study according to ISO 11607.
Testing of the the product after transportation/environmental and shelf-life simulation showed that the sterile barrier packaging integrity is maintained, thus assuring maintenance of the product sterility assurance level (SAL) of 10-6.
Core requires Intermediate The lmaging Level Disinfection, and this process kills pathogenic and other microorganisms by physical or chemical means.
The reprocessing validation was conducted, according to ST-724-2021/P Manual Cleaning Intermediate Level Disinfection Validation.
BIOCOMPATIBILITY
Biocompatibility assessments were performed in accordance with the appropriate risk category requirements, as defined in ISO 10933-1.
SOFTWARE
Software verification and validation testing was performed to demonstrate that the software in the subject device meets design specifications.
ELECTROMAGNETIC COMPATIBILITY AND ELECTRICAL SAFETY
General requirements for basic safety and essential performance IEC 60601-1. Electrical safety for endoscopes in IEC 60601-2-2018. Electromagnetic compatibility testing per IEC 60601-1-2. Photobiological safety per IEC 62471.
Substantial Equivalence The Zsquare ENT-Flex endoscope has similar indications for use and technological features to the predicate devices, the 3NT Endoscopy System and Ambu aScope 4 RhinoLaryngo Slim. These devices are single-use endoscopes, designed to visualize the internal cavities of ear, airways, nose, and sinus cavities. The the endoscopes are supplied sterile and should not be reused. The 3NT Endoscopy System contains an integrated working channel that allows irrigation through a single channel, whereas the Zsquare ENT-Flex endoscope and the Ambu endoscope do not contain a working channel, however, this difference does not introduce hazards and does not raise questions of safety or effectiveness. The Zsquare ENT-Flex endoscope device has the same basic
6
device design as the 3NT Endoscopy System and Ambu aScope 4 RhinoLaryngo Slim predicate devices. The principle of operation is similar between the devices, as is the expected workflow, and most of the device features.
All devices include a single-use unit connected to a reusable unit, and a CCU. All endoscopes provide a singleuse, sterile distal unit, which is disposed of at the end of the procedure. All single-use distal units are ETO sterilized. All single-use disposable distal units include the insertion tube that is in direct contact with the patient. The 3NT endoscope is composed of a multi-use handle (includes controls for anqulation of the endoscope tip) that engages the single-use insertion tube. The Zsquare ENT-Flex disposable unit completely encompasses the Imaging Core and includes a handle so that the physicians' sterile hands come in contact only with the disposable unit (images are captured with a foot switch) to minimize crosscontamination. The Ambu endoscope is entirely disposable, however is for use with the Ambu aView 2 Advance that requires disinfection by wipes (that are on lsopropyl alcohol 70-80 %, Isopropyl based alcohol/Ammonium Chloride or Isopropyl alcohol/Ethanol.) The Ambu endoscope contains optics and illumination. At the end of the procedure the single-use endoscope unit (or the whole endoscope for Ambu) in all devices is disengaged and disposed of; the Imaging Core of Zsquare is cleaned with a lint-free cloth dampened with 70% isopropyl alcohol, which is considered intermediate level sterilization, as it is not exposed to contamination. It is similar to the reprocessing recommendations for the reusable Ambu monitor. The 3NT multi use unit is reprocessed and autoclaved between patients since the physician holds the handle during the procedure. The Zsquare illumination system includes an external illumination source and illumination fiber in the shaft similar to the 3NT; the only difference is that the Zsquare illumination source is separate from the CCU and the 3NT illumination source is embedded in the CCU. The Ambu illumination system is two LED lights embedded in the tip. The Zsquare endoscope contains an optical system within the Imaging Core that is composed of a lens array and a camera that is connected to a console (control unit), which includes an image/video processor and a white LED light source. Similarly, the 3NT endoscope is composed of a multi-use handle that engages the single-use insertion tube and a Camera control unit (CCU) which includes a video processor and a white LED light source. The 3NT CCU includes an attachment cable which connects to the single-use endoscope, receives video images from the endoscope, and delivers LED light to the endoscope. The Ambu aScope 4 RhinoLaryngo Slim is to be used with the
Ambu® aView™ 2 Advance, the
separately sold
7
equivalent of the CCU unit. In all devices the video data is processed in a separate image-processing unit. The minor differences in technological characteristics do not raise new types of safety or effectiveness questions. Performance testing and validations confirm that these differences do not adversely impact performance. Therefore, the proposed device is substantially equivalent to the predicate devices.
Conclusions
Based on the comparison of intended use, indications for use, technological characteristics and performance testing, Zsquare Ltd. believes that the Zsquare ENT-Flex is substantially equivalent to its predicates.