The AED Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.

Device Description

The AED Sinuscope is a reusable rod lens sinuscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem.

AED Sinuscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view).

The AED Sinuscope is reusable and provided non-sterile. It must be cleaned and sterilized prior to use.

AI/ML Overview

The provided document describes the AED Sinuscope, a reusable rigid rod lens sinuscope, and its substantial equivalence to a predicate device (Schoelly Sinuscope) for 510(k) clearance.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Temperature Testing	Meet requirements specified in IEC 60601-2-18: Medical Electrical Equipment - Part 2: Particular Requirements For The Basic Safety And Essential Performance Of Endoscopic Equipment. Edition 3.0 2009-08 (Surface temperatures at various locations over time).	"The device was measured for surface temperatures at various locations over time and found to meet the requirements specified in IEC 60601-2-18."
Optical Parameter Testing	Meet minimum requirements defined in internal specifications and as specified in ISO 8600-3:1997 and ISO 8600-3: Amendment 1: 2003 standards (specifically for field of view and direction of view).	"The device was tested for all relevant optical parameters and found to meet the minimum requirements defined in internal specifications and as specified in the ISO 8600-3:1997 and ISO 8600-3: Amendment 1: 2003 standards (field of view, direction of view)."
Reprocessing: Cleaning	Validated in accordance with AAMI TIR12:2010 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers), AAMI TIR30:2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices) and FDA Guideline on General Principles of Process Validation, January 2011, Rev 1.	"The cleaning study has been performed in accordance with AAMI TIR12:2010... AAMI TIR30:2011... and FDA Guideline on General Principles of Process Validation..."
Reprocessing: Sterilization	Validated in accordance with ISO 14937:2009 (Sterilization of health care products - General requirements for characterization of sterilizing agent and the development, validation and routine control of a sterilization process for medical devices), ANSI/AAMI/ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of sterilization process for medical devices), AAMI TIR 12:2010 (Designing, testing and labeling reusable medical devices for reprocessing in health care facilities) and ISO 17665-2:2009 (Sterilization of health care products - Moist heat - Part 2: Guidance of the application of ISO 17665-1).	"The sterilization study has been performed in accordance with ISO 14937:2009... ANSI/AAMI/ISO 17665-1:2006... AAMI TIR 12:2010... and ISO 17665-2:2009."

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical performance testing for the device itself (temperature, optical parameters, reprocessing). It does not mention a "test set" in the context of patient data, imaging data, or human interpretation. Therefore, phrases like "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable to the type of device and testing described. The tests were performed on the device prototypes/production samples in a lab environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the document describes physical and reprocessing performance testing of a medical device, not a diagnostic algorithm that requires expert-established ground truth from medical images or patient data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as points 2 and 3. The testing involves objective measurements against established technical standards, not subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes the testing of a physical medical device (sinuscope), not an AI algorithm intended to assist human readers. Therefore, there is no mention of "human readers" or "AI assistance" in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described are the specified technical standards and internal specifications. For example:

Temperature Testing: Ground truth is defined by the limits and requirements of IEC 60601-2-18.
Optical Parameter Testing: Ground truth is defined by the minimum requirements in ISO 8600-3:1997 and Amendment 1:2003, and internal specifications.
Reprocessing: Ground truth for cleaning efficacy and sterilization assurance is defined by the requirements and methodologies outlined in the various AAMI and ISO standards (e.g., AAMI TIR12, AAMI TIR30, ISO 14937, ANSI/AAMI/ISO 17665-1).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical instrument, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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510(K) Summary

General Information

Preparation Date:	June 23, 2017
Owner's Name:	National Advanced Endoscopy Devices, Inc.Registration: 9027397
Address:	22134 Sherman Way

USA

Telephone Number: Fax Number: Contact Person:

Subject Device Name:

Trade Name Common/Usual Name: Classification Name:

	21 CFR 874.4760; Class II
Predicate Device Name:	Schoelly Sinuscope
Trade Name:	Schoelly Sinuscope
Common/Usual Name:	Sinuscope
Classification Name:	EOB- Nasopharyngoscope (flexible or rigid) and accessories
	21 CFR 874.4760; Class II
Premarket Notification:	K142249, Schoelly Fiberoptic GmbH, SE date January 27, 2015

EOB- Nasopharyngoscope (flexible or rigid) and accessories

Canoga Park, CA 91303

(818) 227-2720

(818) 227-2724

AED Sinuscope

Sinuscope

Gayle Butler

Premarket Notification:

Device Description:

5700 Series AED Sinuscopes

5700A AED Sinuscope 4.0mm diameter, 0° Angle of View, 175mm working length

5700AXS AED Sinuscope 4.0mm diameter, 0° Angle of View, 50mm working length

5700BAED Sinuscope 4.0mm diameter, 30° Angle of View, 175mm working length

5700CAED Sinuscope 4.0mm diameter, 70° Angle of View, 175mm working length

5700F AED Sinuscope 4.0mm diameter, 45° Angle of View, 175mm working length

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5727 Series AED Sinuscopes

5727A AED Sinuscope 2.7mm diameter, 00 Angle of View, 175mm working length
5727AX AED Sinuscope 2.7mm diameter, 0° Angle of View, 100mm working length

5727AXS AED Sinuscope 2.7mm diameter, 0° Angle of View, 50mm working length

5727BAED Sinuscope 2.7mm diameter, 30° Angle of View, 175mm working length

5727BS AED Sinuscope 2.7mm diameter, 30° Angle of View, 100mm working length

8800 Series AED Sinuscopes

8800A AED Sinuscope 4.0mm diameter, 0° Angle of View, 175mm working length

8800AXS AED Sinuscope 4.0mm diameter, 0° Angle of View, 50mm working length

8800BAED Sinuscope 4.0mm diameter, 30° Angle of View, 175mm working length 8800CAED Sinuscope 4.0mm diameter, 70° Angle of View, 175mm working length

8800F AED Sinuscope 4.0mm diameter. 45° Angle of View. 175mm working length

8827 Series AED Sinuscopes

8827A AED Sinuscope 2.7mm diameter, 0° Angle of View, 175mm working length

8827AX AED Sinuscope 2.7mm diameter, 0° Angle of View, 100mm working length

8827AXS AED Sinuscope 2.7mm diameter, 0° Angle of View, 50mm working length

8827BAED Sinuscope 2.7mm diameter, 30° Angle of View, 175mm working length

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8827BS AED Sinuscope 2.7mm diameter, 30° Angle of View, 100mm working length

AED Sinuscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view).

The AED Sinuscope is reusable and provided non-sterile. It must be cleaned and sterilized prior to use.

Technological Characteristics

To view the sinus and nasal passages the distal end of the sinuscope with a light source attached is passed into a nasal passage. Images are transmitted to the eyepiece which is typically attached to a camera so the images received through the sinuscope can be displayed on a video screen.

Technical parameters of the AED Sinuscope are characterized by the optical view -Direction of View (0° - 70°) and the Field of View (70°). The AED Sinuscopes are available in two different lengths for the insertion tube: 4mm diameter and 2.7mm diameters with working lengths that vary from 50mm, 100mm and 175mm.

The AED Sinuscope differs from the predicate device Schoelly Sinuscope (K142249):

. The Schoelly Sinuscope comes in a 2.0mm as well as 2.7mm and 4.0mm diameters. The AED Sinuscope comes in 2.7mm and 4.0mm diameters.
The Schoelly Sinuscope comes in 110mm, 175mm and 187mm working . lengths. The AED Sinuscope comes in 50mm, 100mm and 175mm working lengths.

The different diameters and workings lengths do not change the same basic design or use of the AED Sinuscope. The same basic mechanical design, operating principles and indications for use are the same for both devices.

A detailed comparison of the technological characteristics with the predicate device is shown in the table below:

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Attribute	ProposedDevice(current Submission)	PredicateDeviceK142249
LightTransmission	Fiberoptics	Fiberoptics
Light Source	External, connected via light post to light guide connector	External, connected via light post to light guide connector
ImageTransmission	Rigid Rod Lens	Rigid Rod Lens
Diameter	4mm, 2.7mm	4mm, 2.7mm, 2.0mm
Direction of View	0° - 70°	0° - 70°
Field of View	70°	80° - 100°
Image Display	Camera/monitor connected via the eyepiece of the sinuscope	Camera/monitor connected via the eyepiece of the sinuscope
Working Length	50mm, 100mm, 175mm	110mm, 175mm, 187mm
WorkingChannel	None	None
Single Use/Reusable	Reusable	Reusable
Reprocessing	Cleaning, sterilization (steam)	Cleaning, sterilization (steam, STERRAD®)
Materials
Insertion Tube (outer surface)	stainless steel	stainless steel
Insertion Part (distal surface)	stainless steel, glass	stainless steel, glass
Fiberoptics	glass/acrylic	glass/acrylic
Lens bonding	epoxy	epoxy
Temperature Testing	IEC 60601-2-18 compliant	IEC 60601-2-18 complaint
Packaging	Case with foam insert	Case with foam insert

Technological Characteristics of the Proposed Device and the Predicate Device

Indications for Use

The AED Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery.

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Non-clinical Performance Testing

Temperature testing: The device was measured for surface temperatures at various locations over time and found to meet the requirements specified in IEC 60601-2-18: Medical Electrical Equipment - Part 2: Particular Requirements For The Basic Safety And Essential Performance Of Endoscopic Equipment. Edition 3.0 2009-08

Optical parameter testing: The device was tested for all relevant optical parameters and found to meet the minimum requirements defined in internal specifications and as specified in the ISO 8600-3:1997 and ISO 8600-3: Amendment 1: 2003 standards (field of view, direction of view ).

Reprocessina

The AED Sinuscope is the subject of completed reprocessing validations including manual cleaning and steam sterilization.

The cleaning study has been performed in accordance with AAMI TIR12:2010 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers), AAMI TIR30:2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices) and FDA Guideline on General Principles of Process Validation, January 2011, Rev 1.

The sterilization study has been performed in accordance with ISO 14937:2009 (Sterilization of health care products - General requirements for characterization of sterilizing agent and the development, validation and routine control of a sterilization process for medical devices), ANSI/AAMI/ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of sterilization process for medical devices),AAMI TIR 12:2010 (Designing, testing and labeling reusable medical devices for reprocessing in health care facilities) and ISO 17665-2:2009 (Sterilization of health care products - Moist heat - Part 2: Guidance of the application of ISO 17665-1).

Conclusion

The AED Sinuscope meets all the pre-determined acceptance criteria to demonstrate substantial equivalence to the predicate device.

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 1, 2017

National Advanced Endoscopy Devices. Inc. Gayle Butler Compliance Officer 22134 Sherman Way Canoga Park, CA 91303

Re: K170285

Trade/Device Name: AED Sinuscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: June 29, 2017 Received: July 3, 2017

Dear Gayle Butler:

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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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.