← Product Code [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ) · K172726 # EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D (K172726) _Olympus Medical Systems Corp. · EOQ · Apr 30, 2018 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K172726 ## Device Facts - **Applicant:** Olympus Medical Systems Corp. - **Product Code:** [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ.md) - **Decision Date:** Apr 30, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4680 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic ## Intended Use EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. Single Use Biopsy Forceps FB-433D: The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. ## Device Story The BF-MP190F is a flexible video bronchoscope used for endoscopic diagnosis and treatment in the respiratory organs, specifically the peripheral tracheobronchial tree. It functions as part of an Olympus video system, including a light source, monitor, and documentation equipment. The device captures visual data via a CCD sensor located in the control section (moved from the distal end compared to the predicate) and transmits it to the video system for physician viewing. The device features a smaller outer diameter and narrower instrument channel than the predicate BF-Q190 to facilitate access to peripheral airways. The FB-433D biopsy forceps is a single-use mechanical accessory inserted through the bronchoscope channel to collect tissue samples. Both devices are used in healthcare facilities by trained clinicians. The bronchoscope provides real-time visualization to guide diagnostic and therapeutic procedures, potentially benefiting patients by enabling minimally invasive access to peripheral lung tissue. ## Clinical Evidence Bench testing only. No clinical data provided. Testing included risk analysis (ISO 14971), biocompatibility (ISO 10993), thermal safety, mechanical durability, software validation, electromagnetic compatibility (IEC 60601-1-2), and reprocessing validation. ## Technological Characteristics Bronchoscope: CCD sensor (control section), 90° FOV, 2-50mm DOF, 0° view, 600mm working length, 3.7mm insertion tube diameter. Materials: stainless steel distal tip, resin insertion tube, rubber bending section, glass lens, epoxy adhesive. Sterilization: Ethylene oxide, Hydrogen peroxide. Biopsy Forceps: Mechanical, stainless steel cups/coil, 1150mm length, 1.5mm diameter. Sterilization: Ethylene oxide. Standards: ISO 14971, ISO 10993, IEC 60601-1, IEC 60601-2-18, ASTM F1980, ISO 11135. ## Regulatory 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. ## Predicate Devices - OLYMPUS BF-Q190 EVIS EXERA III BRONCHOVIDEOSCOPE ([K121959](/device/K121959.md)) - DISPOSABLE BIOPSY FORCEPS FB-49C ([K950636](/device/K950636.md)) ## Reference Devices - EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F ([K033225](/device/K033225.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 30, 2018 Olympus Medical Systems Corp. % Daphney Germain-Kolawole Senior Project Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Re: K172726 Trade/Device Name: EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: March 29, 2018 Received: March 30, 2018 Dear Daphney Germain-Kolawole: 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. {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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely yours. Eric A. Mann -S 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K172726 Device Name EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F Single Use Biopsy Forceps FB-433D #### Indications for Use (Describe) #### - EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor. EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. - Single Use Biopsy Forceps FB-433D The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope. | 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 displays the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the phrase "Your Vision, Our Future" is written in a smaller, blue font. # 510(k) SUMMARY BRONCHOFIBERVIDEOSCOPE BF-MP190F Single Use Biopsy Forceps FB-433D April 27, 2018 #### 1. General Information | ■ Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
192-8507
Establishment Registration No: 8010047 | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ■ Official Correspondent: | Daphney Germain-Kolawole
Senior Project Manager, Regulatory Affairs
Olympus Corporation of the Americas
3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 484-896-5691
FAX: 484-896-7128
Email: daphney.germain-kolawole@olympus.com | | ■ Manufacturer: | AIZU OLYMPUS CO., LTD.
500 Muranishi, Niidera Monden-Machi
Aizuwakamatsu-shi Fukushima, JAPAN 965-8520
Establishment Registration No.: 9610595
Aomori Olympus Co., Ltd.
248-1 Okkonoki 2-chome Kuroishi-shi,
Aomori, Japan 036-0357
Establishment Registration No.: 9614641 | | 2. Device Identification | | | ■ Device Trade Name and
Model number (if
applicable): | ·EVIS EXERA III BRONCHOFIBERVIDEOSCOPE
OLYMPUS BF-MP190F
·Single Use Biopsy Forceps FB-433D | | ■ Common Name: | ·Bronchoscope, its accessories and ancillary equipment
·Single Use Biopsy Forceps | | ■ Regulation Number: | 874.4680 | | ■ Regulation Name: | Bronchoscope (flexible or rigid) and accessories | | ■ Regulatory Class: | II | | ■ Classification Panel: | Ear Nose & Throat | Page 1 of 10 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line. Below the line, the words "Your Vision, Our Future" are written in smaller, blue letters. #### ■ Product Code: EOQ; Bronchoscope (Flexible Or Rigid) EOB; Nasopharyngoscope (Flexible Or Rigid) #### 3. Predicate Device/ Reference devices Information [EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F] Predicate device | Device Trade Name | Common Name | Applicant | 510(k) No. | |------------------------------------------------------------|----------------------------------------------------------------|-------------------------------------|------------| | OLYMPUS BF-Q190
EVIS EXERA III
BRONCHOVIDEOSC
OPE | Bronchoscope, its
accessories and
ancillary
equipment | OLYMPUS
MEDICAL
SYSTEMS CORP. | K121959 | #### Reference device | Device Trade Name | Common Name | Applicant | 510(k) No. | |--------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------|------------| | EVIS EXERA
BRONCHOFIBERVID
EOSCOPE OLYMPUS
BF TYPE XP160F | Bronchoscope, its
accessories and
ancillary equipment | OLYMPUS
OPTICAL CO.,
LTD. | K033225 | # [Single Use Biopsy Forceps FB-433D] | Device Trade Name | Common Name | Applicant | 510(k) No. | |-------------------------------------|-----------------------------------------|-------------------------|------------| | DISPOSABLE BIOPSY
FORCEPS FB-49C | OLYMPUS
DISPOSABLE
BIOPSY FORCEPS | Olympus America
Inc. | K950636 | The predicate devices have not been subject to a design-related recall. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller, lighter font. #### 4. Device Description #### [EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F] The BF-MP190F is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The BF-MP190F is indicated for use within the airways and tracheobronchial tree. The BF-MP190F is a flexible video endoscope used for endoscopic diagnosis and treatment within the respiratory organs and a modification of the BF-Q190 which was previously cleared under K121959. The BF-MP190F has been designed to be applicable for diagnosis and treatment in the peripheral portion of the tracheobronchial trees compared to the predicate model. The basic principle, the user interface and operation for the bronchoscopic procedure of the BF-MP190F is identical to the predicate BF-Q190. #### [Single Use Biopsy Forceps FB-433D] The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. Identical to the predicate device, the subject device is inserted into the channel of an endoscope to collect tissue with the pair of forceps which is equipped at the distal end of the subject device. Then users withdraw the subject device from the channel and collect samples. #### 5. Indications for Use # [EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F] This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. #### [Single Use Biopsy Forceps FB-433D] The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. #### 6. Comparison of Technological Characteristics [EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F] Compared to the proposed predicate device, the subject device, EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, incorporated the following modifications: - Function of narrow band imaging is unavailable - - -Position of the CCD unit is changed from distal end to control section - -Outer diameter of the insertion portion is shorter - -Instrument channel size is narrower - -Material of distal end and light guide lens in insertion portion has been altered {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line, and below that is the text "Your Vision, Our Future" in a smaller, blue font. - -The optical properties are changed to accommodate to the narrowed insertion portion - Additional sterilization methods for reprocessing - Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device. A side-by-side comparison of the subject device and the predicate device is provided below. | Item | | | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | BF-MP190F #K172726 | BF-Q190 # K121959 | | Indications for use | This instrument is intended to be
used with an Olympus video
system center, light source,
documentation equipment,
monitor, EndoTherapy accessories
(such as a biopsy forceps), and
other ancillary equipment for
endoscopy and endoscopic
surgery. This instrument is
indicated for use within the
airways and tracheobronchial tree. | This instrument is intended to be
used with an Olympus video
system center, light source,
documentation equipment,
monitor, EndoTherapy
accessories (such as a biopsy
forceps), and other ancillary
equipment for endoscopy and
endoscopic surgery. This
instrument is indicated for use
within the airways and
tracheobronchial tree. | | Common name | BRONCHOSCOPE | BRONCHOSCOPE | | Regulation number | 874.4680 | 874.4680 | | Regulation name | Bronchoscope (flexible or rigid)
and accessories | Bronchoscope (flexible or rigid)
and accessories | | Regulatory class | II | II | | Classification panel | Ear Nose & Throat | Ear Nose & Throat | | Product code | EOQ,EOB | EOQ,EOB,NWB | | Environment of use | Healthcare facility/hospital | Healthcare facility/hospital | | Single/repeat use | Repeat use | Repeat use | | Sterile/non-sterile | Marketed as non-sterile | Marketed as non-sterile | | Sterilization method | Ethylene oxide; Hydrogen
peroxide | Ethylene oxide; Hydrogen
peroxide | | Energy source | Electricity | Electricity | | Field of View | 90° | 120° | | Depth of Field | 2-50mm | 3-100mm | | Direction of View | 0°(Forward viewing) | 0°(Forward viewing) | | Image sensor | CCD (in the control section) | CCD (in the distal end) | | NBI observation | Not available | Available | | Item | | | | | BF-MP190F #K172726 | BF-Q190 # K121959 | | Angulation
UP/DOWN | UP:210°, DOWN:130° | UP:210°, DOWN:130° | | Working Length | 600mm | 600mm | | Inner Diameter of
Instrument Channel | φ1.7mm | φ2.0mm | | Outer Diameter of Distal
End | φ3.0mm | φ4.8mm | | Outer Diameter of
Insertion Tube | φ3.7mm | φ6.0mm | | High frequency
accessories | Not compatible | Compatible | | Material composition of
main patient-contact | Material composition of main
patient-contact parts | Material composition of main
patient-contact parts | | parts and duration and
type of contact | Distal tip: Stainless steel
Insertion tube: Resin
Bending rubber: Rubber
Lens: Glass
Adhesive: Epoxy
Surface-contacting device in
contact with mucosal membranes.
The contact duration is limited
exposure (i.e. contact is up to 24
hours). | Distal tip: Polymer
Insertion tube: Resin
Bending rubber: Rubber
Lens: Polymer
Adhesive: Epoxy
Surface-contacting device in
contact with mucosal membranes.
The contact duration is limited
exposure (i.e. contact is up to 24
hours). | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Underneath the line is the text "Your Vision, Our Future". # [Single Use Biopsy Forceps FB-433D] Compared to the predicate device, the proposed subject device, Single Use Biopsy Forceps FB-433D, mainly has the following technical differences: - -Compatible devices - -Maximum diameter and length of insertion portion - -Cup and its rigid portion size and material. Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device. A side by side comparison of the subject device and the predicate device is provided below. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line, and below that is the text "Your Vision, Our Future". | Item |
Single Use Biopsy Forceps
FB-433D #K172726 |
FB-49C #K950636 | |----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The biopsy forceps has been
designed specifically to collect
tissue endoscopically for
examination in conjunction with a
flexible bronchoscope. | The Olympus Disposable Biopsy
Forceps are specifically designed
to collect tissue endoscopically
for examination in conjunction
with flexible bronchoscopes and
rhino-laryngoscopes. | | Common name | OLYMPUS DISPOSABLE
BIOPSY FORCEPS | N/A | | Regulation number | 874.4680 | 874.4680 | | Regulation name | Bronchoscope (flexible or rigid)
and accessories | Bronchoscope (flexible or rigid)
and accessories | | Regulatory class | II | II | | Classification panel | Ear Nose & Throat | Ear Nose & Throat | | Product code | EOQ | EOQ | | Environment of use | Healthcare facility/hospital | Healthcare facility/hospital | | Single/repeat use | Single use | Single use | | Sterile/non-sterile | Sterile | Sterile | | Sterilization method | Ethylene oxide | Ethylene oxide | | Energy source | Mechanical | Mechanical | | Maximum insertion
portion diameter | $φ$ 1.5 mm | $φ$ 1.8 mm | | Working length | 1150 mm | 1050 mm | | Cup shape and size | Oval shaped portion
Maximum diameter: $φ$ 1.5 mm | Oval shaped portion
Maximum diameter: $φ$ 1.8mm | | Sheath type | Metal coil | Metal coil | | Material composition of
main patient-contact
parts and duration and
type of contact | Material composition of main
patient-contact parts

Cups: Stainless metal
Coil sheath: Stainless metal

Surface-contacting device in
contact with mucosal membranes.
The contact duration is limited
exposure (i.e. contact is up to 24
hours) | Material composition of main
patient-contact parts

Cups: Stainless metal
Coil sheath: Stainless metal

Surface-contacting device in
contact with mucosal membranes.
The contact duration is limited
exposure (i.e. contact is up to 24
hours) | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line. Below the line is the text "Your Vision, Our Future" in a smaller, blue font. #### 7. Summary of non-clinical testing The technological characteristic differences between the predicate devices and the subject devices have been confirmed that they are substantially equivalent through the following tests and standards. ·Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment. (For BRONCHOFIBERVIDEOSCOPE BF-MP190F and Single Use Biopsy Forceps FB-433D) · Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process` issued on June 16 2016. (For BRONCHOFIBERVIDEOSCOPE BF-MP190F and Single Use Biopsy Forceps FB-433D) ·Performance testing was carried out to demonstrate the safety and the effectiveness of the subject device. # [EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F] - Thermal safety test - - -Mechanical durability test [Single Use Biopsy Forceps FB-433D] - Forceps operation with the compatible endoscope - - -Dimension of each part of the forceps - -General durability - Integrity of the package - •The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005. (For EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F) ·Electromagnetic compatibility, electric safety, and thermal safety had been confirmed. (For EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F) ·The reprocessing validation test (cleaning, manual and automated high-level disinfection and sterilization) was performed in accordance with the FDA guidance "Guidance for Industry and FDA Staff - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling issued on March 17, 2015" (For EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F) {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line, and below that is the text "Your Vision, Our Future". #### •Sterilization validation Sterilization validation was carried out with Method Half-cycle approach in accordance with ISO 11135:2014. (For Single Use Biopsy Forceps FB-433D) ·Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. Three-year aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test. The requirements on packaging for terminally sterilized medical device per AAMI/ANSI/ISO 11607-1/2 had also been met. (For the Single Use Biopsy Forceps FB-433D) The following standards have been applied to the subject devices. | Standard No. | Standard Title | Subject devices | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | ISO 14971 Second Edition:
2007-03-01 | Medical Devices - Application Of
Risk Management To Medical
Devices | • EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F
• Single Use Biopsy Forceps
FB-433D | | ISO 10993-1 Fourth
Edition:2009-10-15 | Biological Evaluation Of Medical
Devices - Part1: Evaluation And
Testing Within A Risk
Management Process [Including:
Technical Corrigendum 1 (2010)] | • EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F
• Single Use Biopsy Forceps
FB-433D | | AAMI ANSI ISO
10993-5:2009/(R)2014 | Biological Evaluation Of Medical
Devices - Part5: Tests For In Vitro
Cytotoxicity | • EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F
• Single Use Biopsy Forceps
FB-433D | | ISO 10993-10 Third
Edition: 2010-08-01 | Biological Evaluation Of Medical
Devices - Part 10: Tests For
Irritation And Skin Sensitization | • EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F
• Single Use Biopsy Forceps
FB-433D | | ISO 10993-11 Second
Edition 2006-08-15 | Biological Evaluation Of Medical
Devices, Part 11: Tests For
Systemic Toxicity | • Single Use Biopsy Forceps
FB-433D | | AAMI ANSI
ES60601-1:2005/(R)2012
and A1:2012 | Medical Electrical Equipment -
Part 1: General Requirements for
Basic Safety And Essential
Performance + Amendment 1: 2012 | • EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F | | IEC 60601-1-2 Edition 4.0:
2014-02 | Medical Electrical Equipment -
Part 1-2: General Requirements for
Safety - Collateral standard:
Electromagnetic Compatibility - | • EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F | | Standard No. | Standard Title | Subject devices | | | Requirements and Tests | | | IEC 60601-2-18 Edition
3.0: 2009-08 | Medical Electrical Equipment -
Part 2-18: Particular Requirements
For The Basic Safety And Essential
Performance Of Endoscopic
Equipment. | • EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F | | ASTM E1837-96
(Reapproved 2014) | Standard Test Method to Determine
Efficacy of Disinfection Processes
for Reusable Medical Devices
(Simulated Use Test) | • EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F | | ISO 10993-7 Second
edition 2008-10-15 | Biological evaluation of medical
devices - Part 7: Ethylene oxide
sterilization residuals [Including:
Technical Corrigendum 1 (2009)] | EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F
•Single Use Biopsy Forceps
FB-433D | | ISO 11135 Second Edition
2014 | Sterilization Of Health-Care
Products: Ethylene Oxide –
Requirements For The
Development, Validation And
Routine Control Of A Sterilization
Process For Medical Devices. | • EVIS EXERA III
BRONCHOFIBERVIDEOSCO
PE OLYMPUS BF-MP190F
•Single Use Biopsy Forceps
FB-433D | | ASTM F1980-16 | Standard Guide For Accelerated
Aging Of Sterile Barrier Systems
For Medical Devices | •Single Use Biopsy Forceps
FB-433D | | AAMI/ANSI/ISO 11607-1 | Packaging for terminally sterilized
medical devices - Part 1:
Requirements for materials, sterile
barrier systems and packaging
systems [Including: Amendment 1
(2014)] | •Single Use Biopsy Forceps
FB-433D | | AAMI/ANSI/ISO
11607-2 | Packaging for terminally sterilized
medical devices - Part 2: Validation
requirements for forming, sealing
and assembly processes [Including:
Amendment 1 (2014)] | •Single Use Biopsy Forceps
FB-433D | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, horizontal, yellow line, and below that is the text "Your Vision, Our Future". # 8. Conclusion The EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, yellow line, and below that is the text "Your Vision, Our Future". and Single Use Biopsy Forceps FB-433D are substantially equivalent to their proposed predicate devices, respectively. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K172726](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K172726) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com