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.

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.

AI/ML Overview

This document is a 510(k) Summary for the Olympus AIRWAY MOBILESCOPE MAF-DM2, MAF-GM2, and MAF-TM2. It details a premarket notification for these devices, asserting their substantial equivalence to previously marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

Table of acceptance criteria and the reported device performance:

The document does not explicitly list a table of quantifiable acceptance criteria with corresponding performance results. Instead, it states that "design verification tests and their acceptance criteria were identified and performed as a result of this risk management" (Section 7.8). The performance data section describes various types of tests conducted, implying that the devices met the acceptance criteria for each test type.

Here's a summary of the types of performance tests conducted:

Test Type	Objective/Purpose	Reported Performance (Implicit)
Reprocessing Validation Testing	Validate reprocessing instructions and methods.	Conducted as per FDA guidance, implies successful validation.
Biocompatibility Testing	Assess biological compatibility with human tissue.	Conducted as per ISO 10993-1, included cytotoxicity, intracutaneous, and sensitization tests, implies satisfactory results.
Software Verification and Validation Testing	Ensure software performs as intended and meets specifications.	Conducted as per FDA guidance for software and cybersecurity, implies successful verification and validation.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing	Ensure compliance with electrical safety and EMC standards.	Complies with ANSVAAMI ES 60601-1:2005/(R)2012, A1:2012, IEC 60601-2-18:2009, and IEC 60601-1-2:2014.
Bench Performance Testing	Ensure the device performs as intended and meets design specifications.	Conducted for: Mechanical durability, Thermal safety, Depth of field, Direction of view, Image performance resolution, Signal to noise ratio, Dynamic range, Photobiological safety, Color performance, Image intensity uniformity. Implies all tests met design specifications.
Risk Management	Identify and mitigate risks, inform design verification tests and acceptance criteria.	Performed in accordance with ISO 14971:2007.
Human Factors Validation	Assess usability and human-device interaction.	Conducted in accordance with FDA Guidance, implies satisfactory results.

Sample size used for the test set and the data provenance:

The document does not specify sample sizes for any of the test sets (e.g., number of devices tested for mechanical durability or image performance). All tests appear to be in-vitro bench tests performed on the physical devices or their components. No information is provided regarding the country of origin of the data, but given a major manufacturing site is in Japan (Aizu Olympus Co., Ltd., Fukushima, Japan), some testing may have occurred there. The data is prospective in the sense that it was generated for this specific submission to demonstrate equivalence of the new devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The performance data consists of engineering and safety tests rather than clinical evaluations requiring expert interpretation of ground truth (e.g., medical image diagnosis).
Adjudication method for the test set:

This information is not provided. As the tests are largely objective engineering and safety assessments, a formal adjudication method for ground truth establishment as seen in clinical studies is not applicable.
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 MRMC comparative effectiveness study was conducted. The device is a bronchoscope, a direct observation tool, and not an AI-powered diagnostic system that would typically undergo such a study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No standalone algorithm performance study was done. The device is a medical imaging instrument (bronchoscope), not an algorithm or AI. All performance is inherently "human-in-the-loop" as it is operated by a healthcare professional.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the engineering and safety tests performed (e.g., depth of field, resolution, electrical safety), the "ground truth" would be the design specifications established by the manufacturer and relevant international and national standards (e.g., IEC, ISO, AAMI). For example, a depth of field test would compare the measured depth of field to the specified acceptable range.
The sample size for the training set:

Not applicable. The devices are physical medical instruments (bronchoscopes), not AI/ML models that require a training set.
How the ground truth for the training set was established:

Not applicable. As above, the devices are hardware instruments and do not involve AI/ML training sets.

Summary

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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.

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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 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

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Indications for Use

510(k) Number (if known)

K201300

Device Name

AIRWAY MOBILESCOPE OLYMPUS MAF-DM2, AIRWAY MOBILESCOPE OLYMPUS MAF-GM2, AIRWAY MOBILESCOPE OLYMPUS MAF-TM2

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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3. PREDICATE DEVICE

■ Predicate device

Device name	510(k) Submitter	510(k) No.
TRACHEAL INTUBATIONFIBERVIDEOSCOPELF-Y0004 and LF-Y0005	OLYMPUS MEDICALSYSTEMS 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-DPTRACHEAL INTUBATIONFIBERSCOPES, ACCESSORIESAND ANCILLARY EQUIPMENT	Olympus Optical Co., Ltd.	K981543

4. DEVICE DESCRIPTION

■ General Description of the subject device

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:

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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

AIRWAY MOBILESCOPE OLYMPUS MAF-TM2

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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 beendesigned to be used with aSuction Pump andEndoTherapy accessoriesand other ancillaryequipment for airwaymanagement, whichincludes endoscopictreatment, diagnosis, andobservation to access airwayanatomy,endotracheal/endobronchialintubation and management.	These instruments have beendesigned to be used with aSuction Pump andEndoTherapy accessoriesand other ancillaryequipment for airwaymanagement, whichincludes endoscopictreatment, diagnosis, andobservation to access airwayanatomy,endotracheal/endobronchialintubation and management.
Regulation Number	874.4680	874.4680
Regulation Name	Bronchoscope (flexible orrigid) and accessories	Bronchoscope (flexible orrigid) and accessories
Regulatory Class	II	II

Table 5.1 Comparison between MAF-TM2 and LF-Y0005

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	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

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Item		Subject Device	Predicate Device (PD)
		MAF-GM2	LF-Y0004
General Information
510(k) Number		K201300	K082720
Indications for Use		This instrument has beendesigned to be used with aSuction Pump and otherancillary equipment forairway management, whichincludes diagnosis andobservation to access airwayanatomy,endotracheal/endobronchialintubation and management.	These instruments have beendesigned to be used with aSuction Pump andEndoTherapy accessories andother ancillary equipment forairway management, whichincludes endoscopictreatment, diagnosis, andobservation to access airwayanatomy,endotracheal/endobronchialintubation and management.
Regulation Number		874.4680	874.4680
Regulation Name		Bronchoscope (flexible orrigid) and accessories	Bronchoscope (flexibleor rigid) and accessories
Regulatory Class		II	II
Specification
Insertion section	Outer Diameter ofDistal End	φ3.9mm	φ3.9mm
	Outer Diameter ofInsertion Tube	φ4.1mm	φ4.1mm
	AngulationUP/DOWN	120°/120°	120°/120°
	Inner Diameter ofInstrumentChannel	φ1.5mm	φ1.5mm
	Working Length	600 mm	600 mm
Image capturesystem	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

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	Item	Subject Device	Predicate Device (PD)	ReferenceDevice(RD)
		MAF-DM2	LF-Y0004	LF-DP
	General Information
	510(k)Number	K201300	K082720	K981543
	Indicationsfor Use	This instrument hasbeen designed to beused with a SuctionPump and otherancillary equipment forairway management,which includesdiagnosis andobservation to accessairway anatomy,endotracheal/endobronchialintubation andmanagement.	These instruments havebeen designed to beused with a SuctionPump and EndoTherapyaccessories and otherancillary equipment forairway management,which includesendoscopic treatment,diagnosis, andobservation to accessairway anatomy,endotracheal/endobronchialintubation andmanagement.	Olympus LF-TP andF-DP TrachealIntubation Fiberscope,accessories andancillary equipmentare intended forairway managementwhich includesendoscopicobservation to assessairway anatomy,endotracheal/endobronchialintubation, andmanagement.
	RegulationNumber	874.4680	874.4680	874.4680
	RegulationName	Bronchoscope (flexibleor rigid) andaccessories	Bronchoscope (flexibleor rigid) and accessories	Bronchoscope(flexible or rigid)and accessories
	RegulatoryClass	II	II	II
Specification
Insertion section	OuterDiameter ofDistal End	φ3.1mm	φ3.9mm	φ3.1mm
	OuterDiameter ofInsertionTube	φ3.1mm	φ4.1mm	φ3.1mm

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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

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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.

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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.

Regulation Number and Section

§ 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.