(256 days)
No
The summary describes standard image processing and display technology without mentioning any AI or ML capabilities.
No.
The device is used for diagnosis, observation, intubation, and management (which can include endoscopic treatment), but its primary function is visualization and access, not direct therapy. The "endoscopic treatment" mentioned for the MAF-TM2 suggests a capability for therapeutic procedures, but the device itself is a tool for facilitating those procedures rather than being a therapeutic device inherently. It helps in managing the airway, including accessing it for treatment, but it doesn't administer treatment on its own.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is designed for "airway management, which includes diagnosis and observation to access airway anatomy."
No
The device description explicitly states it comprises hardware components including a 3.5" monitor, LED light source, battery, and recording features, making it a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "airway management, which includes diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management." This involves direct visualization and intervention within the body.
- Device Description: The description details an "all in one mobile endoscope" that provides visual access to the airway.
- Mechanism: The device uses optical imaging transmitted through fiber bundles to a sensor and displayed on a monitor. This is a direct imaging technique, not an in vitro test.
- Lack of In Vitro Activity: There is no mention of the device being used to examine samples (like blood, urine, tissue) outside of the body to provide diagnostic information. IVD devices are specifically designed for testing biological samples in vitro.
The device is an endoscope used for direct visualization and procedures within the airway, which falls under the category of medical devices used for diagnosis and treatment in vivo.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with a Suction Pump and other ancillary equipment for airway management, which includes diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management.
This instrument has been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Product codes
EOO
Device Description
The AIRWAY MOBILESCOPE OLYMPUS MAF-DM2/GM2/TM2 are all in one mobile endoscopes that enables efficient airway management. These endoscopes comprises a 3.5" monitor, LED light source, battery and recording features in a handy single unit, which enable observation without peripherals or cables, allowing them to be used in Intensive Care Unit (ICU), Operating Room (OR) and emergency procedures and so on.
The following items are components and accessories to be marketed with the AIRWAY MOBILESCOPE OLYMPUS MAF-DM2/GM2/TM2.
- -MH-364 Cap for MAF-DM2/GM2
- -MAJ-1077 Suction Cleaning Adapter for MAF-DM2/GM2
- MAJ-222 Suction Cleaning Adapter for MAF-TM2 -
Principle of Operation
Basic principle: The subject devices employ the following principles to obtain observation images of objective part: Light provided from LED in the control section of the endoscope is transmitted to the distal end of insertion section through light guide fiber bundles in order to illuminate the objective part. The optical image obtained in the distal end is transmitted through the image guide fiber bundles to a Complimentary metal-oxide semiconductor (CMOS) image sensor/processor built in the camera unit which is installed on the top of the control section. The CMOS image sensor/processor converts the optical image into electronic/video signal. The endoscopic image is displayed on the LCD monitor which is provided in the camera section.
Technological characteristics: The technological characteristics of subject devices are basically identical to the predicate devices and the differences of them are described in Section 12. The key characteristics of the subject devices are described below.
- . Incorporate a 3.5-inch monitor to enable observation and control operations in a single view. The monitor is capable of adjustment range from 0 to 90°, which allows physician to tilt the screen to a suitable angle for viewing.
- . Both still images and movies can be recorded on a SD card for easy referencing and management. Images can be transferred easily to a PC for additional processing.
- . Instead of mechanical shutter, exposure is adjusted appropriately by switching the LED off in synchronization with shutter signals from the camera section when still image is taken.
- . Chemical immersion is available under the condition of loading SD card and battery.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway anatomy
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)
The following performance data were provided in support of the substantial equivalence determination.
- Reprocessing validation testing: Reprocessing instruction and reprocessing method validation testing for the AIRWAY MOBILESCOPE MAF-DM2/GM2/TM2 were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
- Biocompatibility testing: Biocompatibility testing for the AIRWAY MOBILESCOPE MAF-DM2/GM2/TM2 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the Colony Assay
- Intracutaneous Study in Rabbits
- Guinea Pig Maximization Sensitization Test
- Software verification and validation testing: Software verification and validation testing for the AIRWAY MOBILESCOPES, MAF-DM2/MAF-GM2/ MAF-TM2 were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the AIRWAY MOBILESCOPES, MAF-DM2/ MAF-GM2/ MAF-TM2. The system complies with the ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
- Performance testing - Bench: Bench testing for the AIRWAY MOBILESCOPES, MAF-DM2/ MAF-GM2/ MAF-TM2 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
- Mechanical durability test
- Thermal safety test
- Depth of field test
- Direction of view test
- Image performance resolution test
- Signal to noise ratio test
- Dynamic range test
- Photobiological safety test
- Color performance test
- Image intensity uniformity test
- Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
- Risk management: Risk management for the AIRWAY MOBILESCOPES, MAF-DM2/ MAF-GM2/ MAF-TM2 was performed in accordance with ISO 14971:2007 and human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices". The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, 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 and 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 blue.
January 26, 2021
Olympus Medical Systems Corp. % Sheri Musgnung Regulatory Affairs Manager Olympus Corporation of the America 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610
Re: K201300
Trade/Device Name: Airway Mobilescope Olympus MAF-DM2, Airway Mobilescope Olympus MAF-GM2, Airway Mobilescope Olympus MAF-TM2 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOO Dated: December 28, 2020 Received: December 29, 2020
Dear Sheri Musgnung:
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.
1
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 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 medical devices and radiation-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 Malvina B. Eydelman, M.D. Director 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)
Device Name
AIRWAY MOBILESCOPE OLYMPUS MAF-DM2, AIRWAY MOBILESCOPE OLYMPUS MAF-GM2, AIRWAY MOBILESCOPE OLYMPUS MAF-TM2
Indications for Use (Describe)
This instrument has been designed to be used with a Suction Pump and other ancillary equipment for airway management, which includes diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management.
This instrument has been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. There is a small registered trademark symbol to the right of the "S". A thin yellow line is underneath the word.
January 26, 2021 K201300
510(k) Summary
1. GENERAL INFORMATION
- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Person: Sheri L. Musgnung Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung@olympus.com
- Manufacturing site: Aizu Olympus Co., Ltd., 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
2. DEVICE IDENTIFICATION
- Device Name: AIRWAY MOBILESCOPE
- Model Name: OLYMPUS MAF-DM2 OLYMPUS MAF-GM2 OLYMPUS MAF-TM2
- Common Name: AIRWAY MOBILESCOPE
- 874.4680 ■ Regulation Number:
- Regulation Name: Bronchoscope (flexible or rigid) and accessories
- Regulatory Class: II
- Product Code: EOQ (Bronchoscope (Flexible or rigid))
- Classification Panel: Ear, Nose and Throat
510(k) Summary Page 1 of 11
4
Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced and appear to be a sans-serif font. A thin, horizontal yellow line is located beneath the word. The registered trademark symbol is located to the right of the letter "S".
3. PREDICATE DEVICE
■ Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| TRACHEAL INTUBATION | ||
| FIBERVIDEOSCOPE | ||
| LF-Y0004 and LF-Y0005 | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K082720 |
Reference device
As for the AIRWAY MOBILESCOPE OLYMPUS MAF-DM2, a reference device is being utilized to support the substantial equivalence discussion regarding the image capture system.
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| OLYMPUS LF-TP AND LF-DP | ||
| TRACHEAL INTUBATION | ||
| FIBERSCOPES, ACCESSORIES | ||
| AND ANCILLARY EQUIPMENT | Olympus Optical Co., Ltd. | K981543 |
4. DEVICE DESCRIPTION
■ General Description of the subject device
The AIRWAY MOBILESCOPE OLYMPUS MAF-DM2/GM2/TM2 are all in one mobile endoscopes that enables efficient airway management. These endoscopes comprises a 3.5" monitor, LED light source, battery and recording features in a handy single unit, which enable observation without peripherals or cables, allowing them to be used in Intensive Care Unit (ICU), Operating Room (OR) and emergency procedures and so on.
The following items are components and accessories to be marketed with the AIRWAY MOBILESCOPE OLYMPUS MAF-DM2/GM2/TM2.
- -MH-364 Cap for MAF-DM2/GM2
- -MAJ-1077 Suction Cleaning Adapter for MAF-DM2/GM2
- MAJ-222 Suction Cleaning Adapter for MAF-TM2 -
Principle of Operation
Basic principle
The subject devices employ the following principles to obtain observation images of objective part:
5
Light provided from LED in the control section of the endoscope is transmitted to the distal end of insertion section through light guide fiber bundles in order to illuminate the objective part. The optical image obtained in the distal end is transmitted through the image guide fiber bundles to a Complimentary metal-oxide semiconductor (CMOS) image sensor/processor built in the camera unit which is installed on the top of the control section. The CMOS image sensor/processor converts the optical image into electronic/video signal. The endoscopic image is displayed on the LCD monitor which is provided in the camera section.
Technological characteristics
The technological characteristics of subject devices are basically identical to the predicate devices and the differences of them are described in Section 12. The key characteristics of the subject devices are described below.
- . Incorporate a 3.5-inch monitor to enable observation and control operations in a single view. The monitor is capable of adjustment range from 0 to 90°, which allows physician to tilt the screen to a suitable angle for viewing.
- . Both still images and movies can be recorded on a SD card for easy referencing and management. Images can be transferred easily to a PC for additional processing.
- . Instead of mechanical shutter, exposure is adjusted appropriately by switching the LED off in synchronization with shutter signals from the camera section when still image is taken.
- . Chemical immersion is available under the condition of loading SD card and battery.
5. INDICATIONS FOR USE
AIRWAY MOBILESCOPE OLYMPUS MAF-DM2 and AIRWAY MOBILESCOPE OLYMPUS MAF-GM2
This instrument has been designed to be used with a Suction Pump and other ancillary equipment for airway management, which includes diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management.
AIRWAY MOBILESCOPE OLYMPUS MAF-TM2
This instrument has been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.
6
6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The AIRWAY MOBILESCOPE OLYMPUS MAF-DM2/GM2/TM2 has the same technological characteristics and design as the predicate device except for the following new features:
- 3.1 mm distal end diameter of MAF-DM2
- Changes on optical system parameters
- Design change of camera section
All other technological characteristics of both the subject and predicate devices are identical. For details of the comparison, see Table.5.1, 5.2 and 5.3. Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
| Subject Device | Predicate Device (PD) | |
|---|---|---|
| Item | MAF-TM2 | LF-Y0005 |
| General Information | ||
| 510(k) Number | K201300 | K082720 |
| Indications for Use | This instrument has been | |
| designed to be used with a | ||
| Suction Pump and | ||
| EndoTherapy accessories | ||
| and other ancillary | ||
| equipment for airway | ||
| management, which | ||
| includes endoscopic | ||
| treatment, diagnosis, and | ||
| observation to access airway | ||
| anatomy, | ||
| endotracheal/endobronchial | ||
| intubation and management. | These instruments have been | |
| designed to be used with a | ||
| Suction Pump and | ||
| EndoTherapy accessories | ||
| and other ancillary | ||
| equipment for airway | ||
| management, which | ||
| includes endoscopic | ||
| treatment, diagnosis, and | ||
| observation to access airway | ||
| anatomy, | ||
| endotracheal/endobronchial | ||
| intubation and management. | ||
| Regulation Number | 874.4680 | 874.4680 |
| Regulation Name | Bronchoscope (flexible or | |
| rigid) and accessories | Bronchoscope (flexible or | |
| rigid) and accessories | ||
| Regulatory Class | II | II |
Table 5.1 Comparison between MAF-TM2 and LF-Y0005
7
Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. There is a registered trademark symbol to the right of the word.
| Specification | ||
|---|---|---|
| Insertion section | Outer Diameter of Distal End | $φ$ 5.1mm |
| Outer Diameter of Insertion Tube | $φ$ 5.2mm | |
| Angulation UP/DOWN | 180°/130° | |
| Inner Diameter of Instrument Channel | $φ$ 2.6mm | |
| Working Length | 600 mm | |
| Image capture system | Field of View | 90° |
| Depth of Field | 3-50 mm | |
| Direction of View | 0° (Forward viewing) | |
| Image Sensor | CMOS | |
| Video processor | Built in the camera section | |
| Camera Section | Monitor | LCD of the camera section |
| LCD | 3.5"TFT | |
| Operation | Image: Operation panel | |
| Battery/card cover | Image: Battery/card cover | |
|
| | | |
| | | |
| | | |
| | | |
| | | |
8
Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. There is a thin, curved, yellow line underneath the word. The registered trademark symbol is located to the right of the word.
| Item | Subject Device | Predicate Device (PD) | |
|---|---|---|---|
| MAF-GM2 | LF-Y0004 | ||
| General Information | |||
| 510(k) Number | K201300 | K082720 | |
| Indications for Use | This instrument has been | ||
| designed to be used with a | |||
| Suction Pump and other | |||
| ancillary equipment for | |||
| airway management, which | |||
| includes diagnosis and | |||
| observation to access airway | |||
| anatomy, | |||
| endotracheal/endobronchial | |||
| intubation and management. | These instruments have been | ||
| designed to be used with a | |||
| Suction Pump and | |||
| EndoTherapy accessories and | |||
| other ancillary equipment for | |||
| airway management, which | |||
| includes endoscopic | |||
| treatment, diagnosis, and | |||
| observation to access airway | |||
| anatomy, | |||
| endotracheal/endobronchial | |||
| intubation and management. | |||
| Regulation Number | 874.4680 | 874.4680 | |
| Regulation Name | Bronchoscope (flexible or | ||
| rigid) and accessories | Bronchoscope (flexible | ||
| or rigid) and accessories | |||
| Regulatory Class | II | II | |
| Specification | |||
| Insertion section | Outer Diameter of | ||
| Distal End | φ3.9mm | φ3.9mm | |
| Outer Diameter of | |||
| Insertion Tube | φ4.1mm | φ4.1mm | |
| Angulation | |||
| UP/DOWN | 120°/120° | 120°/120° | |
| Inner Diameter of | |||
| Instrument | |||
| Channel | φ1.5mm | φ1.5mm | |
| Working Length | 600 mm | 600 mm | |
| Image capture | |||
| system | Field of View | 90° | 90° |
| Depth of Field | 4-50 mm | 4-50 mm | |
| Direction of View | 0° (Forward viewing) | 0° (Forward viewing) | |
| Image Sensor | CMOS | CCD | |
| Camera section | Video processor | Built in the camera section | Built in the camera section |
| Monitor | LCD of the camera section | LCD of the camera section | |
| LCD | 3.5"TFT | 2.5"TFT | |
| Operation | |||
| Battery/card cover |
Table 5.2 Comparison between MAF-GM2 and LF-Y0004
9
Image /page/9/Picture/0 description: The image features the word "OLYMPUS" in bold, dark blue letters. A registered trademark symbol is located to the right of the word. A yellow and orange gradient line is located underneath the word.
10
| | Item | Subject Device | Predicate Device (PD) | Reference
Device(RD) |
|-------------------|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | MAF-DM2 | LF-Y0004 | LF-DP |
| | General Information | | | |
| | 510(k)
Number | K201300 | K082720 | K981543 |
| | Indications
for Use | This instrument has
been designed to be
used with a Suction
Pump and other
ancillary equipment for
airway management,
which includes
diagnosis and
observation to access
airway anatomy,
endotracheal/
endobronchial
intubation and
management. | These instruments have
been designed to be
used with a Suction
Pump and EndoTherapy
accessories and other
ancillary equipment for
airway management,
which includes
endoscopic treatment,
diagnosis, and
observation to access
airway anatomy,
endotracheal/
endobronchial
intubation and
management. | Olympus LF-TP and
F-DP Tracheal
Intubation Fiberscope,
accessories and
ancillary equipment
are intended for
airway management
which includes
endoscopic
observation to assess
airway anatomy,
endotracheal/
endobronchial
intubation, and
management. |
| | Regulation
Number | 874.4680 | 874.4680 | 874.4680 |
| | Regulation
Name | Bronchoscope (flexible
or rigid) and
accessories | Bronchoscope (flexible
or rigid) and accessories | Bronchoscope
(flexible or rigid)
and accessories |
| | Regulatory
Class | II | II | II |
| Specification | | | | |
| Insertion section | Outer
Diameter of
Distal End | φ3.1mm | φ3.9mm | φ3.1mm |
| | Outer
Diameter of
Insertion
Tube | φ3.1mm | φ4.1mm | φ3.1mm |
11
Image /page/11/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. A registered trademark symbol is located to the right of the word.
| Image capture system | Angulation UP/DOWN | 120°/120° | 120°/120° | 120°/120° |
|---|---|---|---|---|
| Inner Diameter of Instrument Channel | φ1.2mm | φ1.5mm | φ1.2mm | |
| Working Length | 600 mm | 600 mm | 600 mm | |
| Field of View | 90° | 90° | 90° | |
| Depth of Field | 2-50 mm | 4-50 mm | 3-50 mm | |
| Direction of View | 0° (Forward viewing) | 0° (Forward viewing) | 0° (Forward viewing) | |
| Image Sensor | CMOS | CCD | CCD | |
| Camera section | Video processor | Built in the camera section | Built in the camera section | Built in the camera section |
| Monitor | LCD of the camera section | LCD of the camera section | LCD of the camera section | |
| LCD | 3.5"TFT | 2.5"TFT | 2.5"TFT | |
| Operation | Image: Operation panel 1 | Image: Operation panel 2 | ||
| Battery/card cover | Image: Battery/card cover 1 | Image: Battery/card cover 2 |
12
7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Reprocessing validation testing
Reprocessing instruction and reprocessing method validation testing for the AIRWAY MOBILESCOPE MAF-DM2/GM2/TM2 were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
2) Biocompatibility testing
Biocompatibility testing for the AIRWAY MOBILESCOPE MAF-DM2/GM2/TM2 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the Colony Assay ।
- Intracutaneous Study in Rabbits ।
- Guinea Pig Maximization Sensitization Test ।
3) Software verification and validation testing
Software verification and validation testing for the AIRWAY MOBILESCOPES, MAF-DM2/MAF-GM2/ MAF-TM2 were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
4) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the AIRWAY MOBILESCOPES, MAF-DM2/ MAF-GM2/ MAF-TM2. The system complies with the ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC.
5) Performance testing - Bench
Bench testing for the AIRWAY MOBILESCOPES, MAF-DM2/ MAF-GM2/ MAF-TM2 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.
13
Image /page/13/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly condensed and have a clean, modern sans-serif font. Below the word "OLYMPUS" is a horizontal bar of yellow color, which appears to be a design element associated with the brand logo.
- Mechanical durability test
- Thermal safety test
- Depth of field test
- Direction of view test
- Image performance resolution test
- Signal to noise ratio test
- Dynamic range test
- Photobiological safety test
- Color performance test
- Image intensity uniformity test
6) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
7) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
8) Risk management
Risk management for the AIRWAY MOBILESCOPES, MAF-DM2/ MAF-GM2/ MAF-TM2 was performed in accordance with ISO 14971:2007 and human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices". The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.
8. CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the AIRWAY MOBILESCOPES, MAF-DM2/ MAF-GM2/ MAF-TM2 raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, effectiveness, and performance.