(183 days)
Not Found
No
The device description and performance studies focus on the physical and optical properties of a traditional rod lens sinuscope, with no mention of software, image processing, or AI/ML capabilities.
No.
The AED Sinuscope is an endoscope used for visualization during medical procedures, not for treatment.
No
The device description indicates it is a reusable rod lens sinuscope used for visualization in surgical procedures, not for diagnosis. Its intended use is described for procedures, not for identifying a disease or condition.
No
The device description clearly outlines physical hardware components made of surgical grade stainless steel, glass, and Ultem, and mentions reprocessing and sterilization, indicating it is a physical medical device, not software-only.
Based on the provided information, the AED Sinuscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for use in surgical procedures (otolaryngology, Head and Neck, rhinology, endoscopic plastic and reconstructive surgery). IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical instrument used for visualization inside the body. It's a scope for direct observation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory testing.
The AED Sinuscope is a surgical endoscope used for visualization during procedures, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EOB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sinus and nasal passages
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ).
Reprocessing: 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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
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
2
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
3
8827BS AED Sinuscope 2.7mm diameter, 30° Angle of View, 100mm working length
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.
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:
4
| Attribute | Proposed
Device
(current Submission) | Predicate
Device
K142249 |
|---------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Light
Transmission | Fiberoptics | Fiberoptics |
| Light Source | External, connected via light post to light guide connector | External, connected via light post to light guide connector |
| Image
Transmission | 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 |
| Working
Channel | 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.
5
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
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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.
7
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