Peregrine Endoscopy System is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.

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.

AI/ML Overview

Based on the provided text, the Peregrine Endoscopy System is a medical device, and the document is a 510(k) summary for its premarket notification to the FDA. This document does not describe an AI medical device or a study involving AI assistance for human readers.

Therefore, many of the requested points, such as sample sizes for test/training sets, blinding, adjudication methods, number of experts for ground truth, MRMC studies, standalone AI performance, and AI-specific ground truth establishment, are not applicable to this document. The document describes a traditional medical device (an endoscope system) and its performance against acceptance criteria largely focused on safety, electrical compatibility, software validation, and bench testing.

Here's an analysis based on the information available in the document:

1. A table of acceptance criteria and the reported device performance

The document provides a table summarizing bench testing, but it doesn't explicitly list specific quantitative acceptance criteria alongside the numeric results for all tests. Instead, it generally states "The tests passed and all acceptance criteria were met" or "substantial equivalence is determined."

Test Category	Reported Device Performance and Substantial Equivalence Discussion
Biocompatibility Testing	• Conducted per ISO 10993-1:2018 and FDA guidance. • Tests included: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity. • Result: Complies with same biocompatibility requirements as predicate device, hence substantial equivalence determined.
Electrical Safety and Electromagnetic Compatibility (EMC)	• Electrical safety: Passed IEC 60601-1:2012 and IEC 60601-2-18:2009. • EMC: Tested per IEC 60601-1-2:2014. • Result: Complies with same electrical safety and EMC requirements as predicate device, hence substantial equivalence determined.
Software Verification and Validation	• Conducted per IEC 62304:2006 and FDA guidance for software in medical devices. • Level of Concern: Moderate (same as predicate device). • Result: Software validated following same standard requirements and FDA guidelines, hence substantial equivalence demonstrated.
Bench Testing	• Peregrine Scope Functionality and Simulated use, 3NT Console: Passed all functionality and simulated use tests. All acceptance criteria were met. • Functionality and dimensions verification: Verified same indications for use as predicate. Substantial equivalence demonstrated. • Photobiological safety: Based on IEC 62471:2006. Assigned Exempt Group classification under clinically realistic worst-case conditions. • Display Color Gamut Measurement: Provides good coverage of sRGB (99.7%) and AdobeRGB (91.7%) color spaces. • Peregrine Scope Visual and Dimensions: Passed all visual and dimensions inspections. All acceptance criteria were met. • Peregrine Scope Mechanical Properties Verification: Tests passed and all acceptance criteria were met. • Peregrine Scope System Image Quality Performance: Image is accurate, well reflects observed items in terms of color accuracy. Tests passed and all acceptance criteria were met. Image quality found to be superior to predicate device. • Peregrine Scope Optical performance and MTF: Tests passed and all acceptance criteria were met. Optical performance found to be equal or better than predicate device. • Geometric distortion: Measured, met predefined criteria. • Peregrine Scope Labeling Verification and 3NT Console label verification: Labels and IFU include all required information and risk mitigations. • Transportation and Shelf life: Test passed and all acceptance criteria were met.

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified in terms of patient data. For bench testing, it refers to the number of devices or components tested. The document does not provide raw numbers but implies enough for a statistically sound conclusion for the type of testing performed (e.g., "The Peregrine Endoscopy System passed all the functionality and simulated use tests.").
Data Provenance: The tests are "bench tests," meaning they were conducted in a controlled lab environment on the device itself, not on patient data. The company is based in Israel (3NT Medical Ltd., Rosh Ha'ayin, Israel).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the document describes performance data for a medical device (endoscopy system), not an AI algorithm. Ground truth, in the context of diagnostic AI, refers to confirmed disease status, which isn't relevant here. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., passing electrical safety tests, meeting specified dimensions, or achieving certain image quality parameters).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This relates to human expert consensus for diagnostic tasks, which is not relevant to the acceptance criteria for an endoscope system.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document does not mention an MRMC study or any study involving human readers or AI assistance. The device is an endoscope system, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical endoscope system, not a standalone AI algorithm. While it has software, its "performance" is tied to its function as a visualization tool, not independent algorithmic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's acceptance is based on compliance with established international and national standards (e.g., ISO, IEC, FDA guidelines) for medical device performance, safety, and functionality, as verified through bench testing. For example:
- Biocompatibility: Conformance to ISO 10993-1.
- Electrical Safety: Conformance to IEC 60601-1, IEC 60601-2-18.
- EMC: Conformance to IEC 60601-1-2.
- Software V&V: Conformance to IEC 62304.
- Physical/Optical Properties: Meeting predefined engineering specifications and visual/dimensional inspections.
- Image Quality: Objective measurements like sRGB/AdobeRGB coverage, MTF, and color accuracy, likely against defined benchmarks for endoscopic visualization.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The software mentioned underwent verification and validation, but this refers to traditional software engineering V&V, not machine learning model training.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for an AI/ML model in this document.

Summary

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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

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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

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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)
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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 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

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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 andSimulated use, 3NT Console	The Peregrine Endoscopy System passed all the functionality andsimulated use tests.The tests passed and all acceptance criteria were met.

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Test	Results and Substantial Equivalence discussion
Functionality and dimensionsverification	The Peregrine Endoscopy System and the predicate device have the sameindications for use, which were verified by the described test. Substantialequivalence is demonstrated.
Photobiological safety	Testing was based on IEC 62471:2006 – Photobiological safety of lampsand lamp systems, under clinically realistic worst-case conditions. ThePeregrine Endoscopy System is assigned the Exempt Group classificationbased on this testing.
Display Color GamutMeasurement	Peregrine system provides good coverage of both sRGB (99.7%) andAdobeRGB (91.7%) color spaces.
Peregrine Scope Visual andDimensions	The Peregrine Endoscopy System passed all the visual and dimensionsinspections. The test passed and all acceptance criteria were met.
Peregrine Scope MechanicalProperties Verification	The tests passed and all acceptance criteria were met.
Peregrine Scope System ImageQuality Performance	The Peregrine Endoscopy System image is accurate and well reflects theobserved 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 superiorto that of the predicate device.
Peregrine Scope Opticalperformance and MTF	The tests passed and all acceptance criteria were met.The Peregrine Endoscopy System optical performance was found to beequal or better than these of the predicate device
Geometric distortion	Geometric distortion was measured. The test met the predefined criteria.
Peregrine Scope LabelingVerification and 3NT Consolelabel verification	Peregrine Labels and IFU found to include all information required byregulatory 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.

Regulation Number and Section

§ 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.