(309 days)
No
The summary describes a standard endoscopic system with image capture and display capabilities, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to be used for "diagnostic and therapeutic endoscope procedures", which implies it can be used for therapeutic purposes. The device description also states it is for "endoscopic evaluation of, or intervention in," the specified body cavities, with "intervention" indicating a therapeutic action.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for visualization during "diagnostic and therapeutic endoscope procedures," directly indicating its use in diagnostic contexts.
No
The device description clearly outlines hardware components including a single-use endoscope with a CMOS imager and illumination source, and a video console. The performance studies also include testing for biocompatibility, electrical safety, and mechanical properties, which are associated with hardware components.
Based on the provided information, the Peregrine Endoscopy System 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 and therapeutic 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 flexible endoscope with a camera, light source, and working channel for direct examination of anatomical structures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to provide diagnostic information. IVD devices are specifically designed for these purposes.
The Peregrine Endoscopy System is a medical device used for in vivo (within the living body) visualization and intervention.
N/A
Intended Use / Indications for Use
The Peregrine Endoscopy System is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
Product codes
EOB
Device Description
The Peregrine Endoscopy System is a single-use flexible ENT (ear, nose & throat) endoscope (provided sterile) which allows the user to steer through the anatomy and visualize it. The device is used in patients in whom endoscopic evaluation of, or intervention in, the ear, airways, nose, and sinus cavities is indicated.
The modified Peregrine endoscopy system consists of:
- A Single-use Endoscope - includes a distal CMOS imager, an illumination source, and a working channel which enables irrigation and suction. The endoscope is provided sterile. The multi-use handle and the endoscope attachment cable, which were separate components in the cleared 3NT Endoscopy System, are now an integral part of the single-use endoscope, thus eliminating all multi-use components from the system.
- A Video Console (formerly named Camera Control Unit, or CCU) which includes a video board and a tablet-based display, connects to the endoscope through the endoscope cable to receive video images from the endoscope and display them.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video images from endoscope
Anatomical Site
internal cavities of the ear, airways, nose and sinus cavities
Indicated Patient Age Range
Not Found
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
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Peregrine Endoscopy System was conducted in accordance with ISO 10993-1: 2018 "Biological evaluation of medical devices" and 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" Guidance for Industry and Food and Drug Administration Staff. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
Test results verify that the Peregrine Endoscopy System complies with the same biocompatibility requirements as the predicate device and hence substantial equivalence is determined.
Electrical safety and electromagnetic compatibility (EMC)
The Peregrine Endoscopy System passed the electrical safety tests IEC 60601-1:2012 and IEC 60601-2-18:2009.
The electromagnetic compatibility of the Peregrine Endoscopy System was tested per IEC 60601-1-2:2014.
Test results verify that the Peregrine Endoscopy System complies with the same electrical safety and EMC requirements as the predicate device and hence substantial equivalence is determined.
Software Verification and Validation testing
Software verification and validation testing were conducted and documentation was conducted in accordance with IEC 62304:20006 Medical device software – software life cycle processes and as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The Level of Concern of 3NT Console Software is defined as Moderate.
The Level of Console Software is defined as Moderate.
Peregrine Endoscopy System has the same level of concern as the predicate device and the software was validated following the same standard requirements and FDA guidelines, hence substantial equivalence is demonstrated.
Bench testing
The following tests were conducted with the Peregrine Endoscopy System:
- Peregrine Scope Functionality and Simulated use, 3NT Console: The Peregrine Endoscopy System passed all the functionality and simulated use tests. The tests passed and all acceptance criteria were met.
- Functionality and dimensions verification: The Peregrine Endoscopy System and the predicate device have the same indications for use, which were verified by the described test. Substantial equivalence is demonstrated.
- Photobiological safety: Testing was based on IEC 62471:2006 – Photobiological safety of lamps and lamp systems, under clinically realistic worst-case conditions. The Peregrine Endoscopy System is assigned the Exempt Group classification based on this testing.
- Display Color Gamut Measurement: Peregrine system provides good coverage of both sRGB (99.7%) and AdobeRGB (91.7%) color spaces.
- Peregrine Scope Visual and Dimensions: The Peregrine Endoscopy System passed all the visual and dimensions inspections. The test passed and all acceptance criteria were met.
- Peregrine Scope Mechanical Properties Verification: The tests passed and all acceptance criteria were met.
- Peregrine Scope System Image Quality Performance: The Peregrine Endoscopy System image is accurate and well reflects the observed items in terms of color accuracy. The tests passed and all acceptance criteria were met. The Peregrine Endoscopy System image quality was found to be superior to that of the predicate device.
- Peregrine Scope Optical performance and MTF: The tests passed and all acceptance criteria were met. The Peregrine Endoscopy System optical performance was found to be equal or better than these of the predicate device
- Geometric distortion: Geometric distortion was measured. The test met the predefined criteria.
- Peregrine Scope Labeling Verification and 3NT Console label verification: Peregrine Labels and IFU found to include all information required by regulatory requirements and risks mitigations.
- Transportation and Shelf life: The test passed and all acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
July 23, 2021
3NT Medical Ltd. % Orly Maor Company Consultant Orly Maor 25 A Sirkin Street Kfar Saba, 4442156 Israel
Re: K202727
Trade/Device Name: Peregrine Endoscopy System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: June 23, 2021 Received: June 23, 2021
Dear Orly Maor:
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 (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 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/cdrl-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 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
2
Indications for Use
510(k) Number (if known) K202727
Device Name Peregrine Endoscopy System
Indications for Use (Describe)
Peregrine Endoscopy System is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic 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
3NT Medical Ltd. Peregrine Endoscopy System K202727
1. SUBMITTER
3NT Medical Ltd. 22 Hamelacha Street, PO Box 11384, Rosh Ha'ayin 4809169, Israel Tel: +972.73.7154056 Fax: +972.73.7154058
Contact Person
Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: +972-9-7453607 Fax: +972-153-9-7453607 oram.ma@gmail.com Date Prepared: July 20, 2021
2. DEVICE
Name of Device- Peregrine Endoscopy System Regulation Number- 21 CFR 874.4760 Regulation Name- Nasopharyngoscope (flexible or rigid) and accessories Regulatory class- class II Product Code- EOB Classification Panel- Ear Nose and Throat
3. PREDICATE DEVICE
510(k) Number- K162916 Name of Device- 3NT Endoscopy System Regulation Number- 21 CFR 874.4760 Regulation Name- Nasopharyngoscope (flexible or rigid) and accessories Regulatory class- class II Product Code- EOB Classification Panel- Ear Nose and throat
Reference Device
510(k) Number- K192305 Name of Device- Colibri Endoscopy System Regulation Number- 21 CFR 874.4760 Regulation Name- Nasopharyngoscope (flexible or rigid) and accessories
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Regulatory class- class II Product Code- EOB Classification Panel- Ear Nose and throat
4. DEVICE DESCRIPTION
The Peregrine Endoscopy System is a single-use flexible ENT (ear, nose & throat) endoscope (provided sterile) which allows the user to steer through the anatomy and visualize it. The device is used in patients in whom endoscopic evaluation of, or intervention in, the ear, airways, nose, and sinus cavities is indicated.
The modified Peregrine endoscopy system consists of:
- A Single-use Endoscope - includes a distal CMOS imager, an illumination source, and a working channel which enables irrigation and suction. The endoscope is provided sterile. The multi-use handle and the endoscope attachment cable, which were separate components in the cleared 3NT Endoscopy System, are now an integral part of the single-use endoscope, thus eliminating all multi-use components from the system.
- A Video Console (formerly named Camera Control Unit, or CCU) which includes a video ● board and a tablet-based display, connects to the endoscope through the endoscope cable to receive video images from the endoscope and display them.
5. INDICATIONS FOR USE
The Peregrine Endoscopy System is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Ear, nose, and throat endoscopic visualization of the anatomy for diagnosis and therapeutic procedures is the technological principle for both the subject and predicate devices. The subject and predicate devices are based on the same technological elements:
- Endoscope - used to visualize the same target anatomies. The endoscope includes a suction/irrigation channel.
- Video console and Software used to display the image received from the endoscope. ●
The changes from the cleared 3NT Endoscopy System include:
- Change in the Single use endoscope (size, shape, electronics) ●
- Change in the Software (to support updated hardware)
- Adding an integrated tablet-based video display and user interface
- Package change- to accommodate the above modifications.
None of the above changes alter the fundamental scientific technology of the device or otherwise raise new types of safety or effectiveness questions. The changes generally simplify operation for the user by making device components that were previously reusable single-use, eliminating the need for reprocessing, as well as improving ergonomics and upgrading optical components
5
for enhanced resolution. Testing demonstrates that none of these changes adversely impact performance, supporting substantial equivalence,
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Peregrine Endoscopy System was conducted in accordance with ISO 10993-1: 2018 "Biological evaluation of medical devices" and 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" Guidance for Industry and Food and Drug Administration Staff. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
Test results verify that the Peregrine Endoscopy System complies with the same biocompatibility requirements as the predicate device and hence substantial equivalence is determined.
Electrical safety and electromagnetic compatibility (EMC)
The Peregrine Endoscopy System passed the electrical safety tests IEC 60601-1:2012 and IEC 60601-2-18:2009.
The electromagnetic compatibility of the Peregrine Endoscopy System was tested per IEC 60601-1-2:2014.
Test results verify that the Peregrine Endoscopy System complies with the same electrical safety and EMC requirements as the predicate device and hence substantial equivalence is determined.
Software Verification and Validation testing
Software verification and validation testing were conducted and documentation was conducted in accordance with IEC 62304:20006 Medical device software – software life cycle processes and as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The Level of Concern of 3NT Console Software is defined as Moderate.
The Level of Console Software is defined as Moderate.
Peregrine Endoscopy System has the same level of concern as the predicate device and the software was validated following the same standard requirements and FDA guidelines, hence substantial equivalence is demonstrated.
Bench testing
The following tests were conducted with the Peregrine Endoscopy System:
| Test | Results and Substantial Equivalence discussion |
|---|---|
| Peregrine Scope Functionality and | |
| Simulated use, 3NT Console | The Peregrine Endoscopy System passed all the functionality and |
| simulated use tests. | |
| The tests passed and all acceptance criteria were met. |
6
| Test | Results and Substantial Equivalence discussion |
|---|---|
| Functionality and dimensions | |
| verification | The Peregrine Endoscopy System and the predicate device have the same |
| indications for use, which were verified by the described test. Substantial | |
| equivalence is demonstrated. | |
| Photobiological safety | Testing was based on IEC 62471:2006 – Photobiological safety of lamps |
| and lamp systems, under clinically realistic worst-case conditions. The | |
| Peregrine Endoscopy System is assigned the Exempt Group classification | |
| based on this testing. | |
| Display Color Gamut | |
| Measurement | Peregrine system provides good coverage of both sRGB (99.7%) and |
| AdobeRGB (91.7%) color spaces. | |
| Peregrine Scope Visual and | |
| Dimensions | The Peregrine Endoscopy System passed all the visual and dimensions |
| inspections. The test passed and all acceptance criteria were met. | |
| Peregrine Scope Mechanical | |
| Properties Verification | The tests passed and all acceptance criteria were met. |
| Peregrine Scope System Image | |
| Quality Performance | The Peregrine Endoscopy System image is accurate and well reflects the |
| observed items in terms of color accuracy. | |
| The tests passed and all acceptance criteria were met. | |
| The Peregrine Endoscopy System image quality was found to be superior | |
| to that of the predicate device. | |
| Peregrine Scope Optical | |
| performance and MTF | The tests passed and all acceptance criteria were met. |
| The Peregrine Endoscopy System optical performance was found to be | |
| equal or better than these of the predicate device | |
| Geometric distortion | Geometric distortion was measured. The test met the predefined criteria. |
| Peregrine Scope Labeling | |
| Verification and 3NT Console | |
| label verification | Peregrine Labels and IFU found to include all information required by |
| regulatory requirements and risks mitigations. | |
| Transportation and Shelf life | The test passed and all acceptance criteria were met. |
8. CONCLUSIONS
From the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as the 3NT Endoscopy System we concluded that the Peregrine Endoscopy System is substantially equivalent to the predicate device.