(231 days)
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.
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.
The provided text describes a 510(k) premarket notification for an Olympus bronchoscope (BF-MP190F) and single-use biopsy forceps (FB-433D). The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing, rather than presenting a study where a device's performance is measured against predefined acceptance criteria. Therefore, the requested information, which pertains to such a performance study and acceptance criteria specific to an AI/algorithm-based device, is largely not available in this document.
Here's an analysis of what information is available or implied, and what is not:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not describe specific numerical acceptance criteria or performance metrics for the device (e.g., sensitivity, specificity, accuracy). Instead, it lists various non-clinical tests conducted to demonstrate safety and effectiveness. The acceptance criteria for these tests are generally implied to be "meeting established in-house criteria" or compliance with specific ISO/ASTM standards (e.g., ISO 14971 for risk analysis, ISO 10993 for biocompatibility, etc.). These are related to manufacturing and safety, not diagnostic or clinical accuracy.
2. Sample sized used for the test set and the data provenance
- Not Available. The document outlines a series of non-clinical tests (e.g., thermal safety, mechanical durability, forceps operation, dimension, package integrity, software validation, EMC, electrical safety, reprocessing validation, sterilization validation, shelf-life testing). These typically involve a small number of physical samples of the devices themselves, performed in a lab setting, rather than a "test set" of clinical data with human subjects or patient samples. The concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Available. Since this is a non-clinical evaluation of hardware and accessories, there is no "ground truth" establishment in the sense of expert clinical diagnosis or interpretation. The tests assess the physical and functional characteristics of the device against engineering specifications and safety standards.
4. Adjudication method for the test set
- Not Applicable/Not Available. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus on clinical ground truth, which is not part of this device's evaluation as described.
5. 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
- Not Applicable. This document describes a bronchoscope and biopsy forceps, which are physical medical instruments. It does not describe an AI or algorithm-driven device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. As mentioned above, this document does not concern an algorithm-driven device.
7. The type of ground truth used
- Not Applicable/Not Available. For the non-clinical tests performed, "ground truth" would be established by objective measurements and compliance with engineering specifications, safety standards, and performance test protocols (e.g., a "thermal safety test" would have an objective temperature limit). It does not involve expert consensus, pathology, or outcomes data in the context of clinical performance.
8. The sample size for the training set
- Not Applicable. This document does not pertain to an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not Applicable. This document does not pertain to an AI/machine learning device that would require a training set.
Summary based on the provided text:
The submission focuses on demonstrating substantial equivalence of a new bronchoscope and biopsy forceps to previously cleared predicate devices, primarily through engineering and safety evaluations. The modifications include changes in the bronchoscope's CCD unit position, outer diameter, instrument channel size, optical properties, and materials, as well as additional sterilization methods. For the biopsy forceps, changes relate to compatible devices, maximum diameter and length, and cup size/material.
The "study" in this context refers to a series of non-clinical tests designed to verify that these modifications do not raise new safety or effectiveness concerns and that the devices comply with relevant international standards.
| Acceptance Criteria (Implied by Tests) | Reported Device Performance |
|---|---|
| BF-MP190F Bronchoscope: | |
| Complies with ISO 14971:2007 (Risk Management) | Risk analysis carried out, and design verification tests identified and performed based on this assessment. |
| Complies with ISO 10993-1, -5, -10 (Biocompatibility) | Biocompatibility testing performed. |
| Meets thermal safety requirements | Thermal safety test performed. |
| Meets mechanical durability requirements | Mechanical durability test performed. |
| Software functions as intended (FDA Guidance "Software Contained in MD") | Software validation activities performed. |
| Complies with electromagnetic compatibility (IEC 60601-1-2) | Electromagnetic compatibility confirmed. |
| Complies with electrical safety (AAMI ANSI ES60601-1) | Electric safety confirmed. |
| Complies with reprocessing validation (FDA Guidance "Reprocessing MD") | Reprocessing validation (cleaning, manual/automated high-level disinfection, sterilization) performed. |
| Complies with ethylene oxide sterilization residuals (ISO 10993-7) | Combined with FB-433D. |
| Complies with ethylene oxide sterilization (ISO 11135) | Combined with FB-433D. |
| FB-433D Biopsy Forceps: | |
| Complies with ISO 14971:2007 (Risk Management) | Risk analysis carried out, and design verification tests identified and performed based on this assessment. |
| Complies with ISO 10993-1, -5, -10, -11 (Biocompatibility) | Biocompatibility testing performed. |
| Maintains proper function with compatible endoscope | Forceps operation with compatible endoscope test performed. |
| Meets dimensional specifications | Dimension of each part of the forceps test performed. |
| Meets general durability requirements | General durability test performed. |
| Package integrity maintained | Integrity of the package test performed. |
| Complies with ethylene oxide sterilization (ISO 11135) | Sterilization validation carried out (Method Half-cycle approach). |
| Complies with ethylene oxide sterilization residuals (ISO 10993-7) | Combined with BF-MP190F. |
| Meets shelf-life and packaging requirements (ASTM F1980, AAMI/ANSI/ISO 11607) | Shelf-life testing conducted based on accelerated aging test, with 3-year aging test planned. Requirements on packaging for terminally sterilized medical device met. |
This submission is a traditional 510(k) for a physical medical device, not an AI/ML-driven device, so many of the requested categories related to algorithm performance, training data, and expert review of clinical cases are not applicable.
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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.
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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 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
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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)
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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, Japan192-8507Establishment Registration No: 8010047 |
|---|---|
| ■ Official Correspondent: | Daphney Germain-KolawoleSenior Project Manager, Regulatory AffairsOlympus Corporation of the Americas3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-5691FAX: 484-896-7128Email: daphney.germain-kolawole@olympus.com |
| ■ Manufacturer: | AIZU OLYMPUS CO., LTD.500 Muranishi, Niidera Monden-MachiAizuwakamatsu-shi Fukushima, JAPAN 965-8520Establishment Registration No.: 9610595Aomori Olympus Co., Ltd.248-1 Okkonoki 2-chome Kuroishi-shi,Aomori, Japan 036-0357Establishment Registration No.: 9614641 |
| 2. Device Identification | |
| ■ Device Trade Name andModel number (ifapplicable): | ·EVIS EXERA III BRONCHOFIBERVIDEOSCOPEOLYMPUS 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 |
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■ 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-Q190EVIS EXERA IIIBRONCHOVIDEOSCOPE | Bronchoscope, itsaccessories andancillaryequipment | OLYMPUSMEDICALSYSTEMS CORP. | K121959 |
Reference device
| Device Trade Name | Common Name | Applicant | 510(k) No. |
|---|---|---|---|
| EVIS EXERABRONCHOFIBERVIDEOSCOPE OLYMPUSBF TYPE XP160F | Bronchoscope, itsaccessories andancillary equipment | OLYMPUSOPTICAL CO.,LTD. | K033225 |
[Single Use Biopsy Forceps FB-433D]
| Device Trade Name | Common Name | Applicant | 510(k) No. |
|---|---|---|---|
| DISPOSABLE BIOPSYFORCEPS FB-49C | OLYMPUSDISPOSABLEBIOPSY FORCEPS | Olympus AmericaInc. | K950636 |
The predicate devices have not been subject to a design-related recall.
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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
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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 beused with an Olympus videosystem center, light source,documentation equipment,monitor, EndoTherapy accessories(such as a biopsy forceps), andother ancillary equipment forendoscopy and endoscopicsurgery. This instrument isindicated for use within theairways and tracheobronchial tree. | This instrument is intended to beused with an Olympus videosystem center, light source,documentation equipment,monitor, EndoTherapyaccessories (such as a biopsyforceps), and other ancillaryequipment for endoscopy andendoscopic surgery. Thisinstrument is indicated for usewithin the airways andtracheobronchial 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; Hydrogenperoxide | Ethylene oxide; Hydrogenperoxide |
| 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 | |
| AngulationUP/DOWN | UP:210°, DOWN:130° | UP:210°, DOWN:130° |
| Working Length | 600mm | 600mm |
| Inner Diameter ofInstrument Channel | φ1.7mm | φ2.0mm |
| Outer Diameter of DistalEnd | φ3.0mm | φ4.8mm |
| Outer Diameter ofInsertion Tube | φ3.7mm | φ6.0mm |
| High frequencyaccessories | Not compatible | Compatible |
| Material composition ofmain patient-contact | Material composition of mainpatient-contact parts | Material composition of mainpatient-contact parts |
| parts and duration andtype of contact | Distal tip: Stainless steelInsertion tube: ResinBending rubber: RubberLens: GlassAdhesive: EpoxySurface-contacting device incontact with mucosal membranes.The contact duration is limitedexposure (i.e. contact is up to 24hours). | Distal tip: PolymerInsertion tube: ResinBending rubber: RubberLens: PolymerAdhesive: EpoxySurface-contacting device incontact with mucosal membranes.The contact duration is limitedexposure (i.e. contact is up to 24hours). |
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[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.
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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 ForcepsFB-433D #K172726 | FB-49C #K950636 |
|---|---|---|
| Indications for use | The biopsy forceps has beendesigned specifically to collecttissue endoscopically forexamination in conjunction with aflexible bronchoscope. | The Olympus Disposable BiopsyForceps are specifically designedto collect tissue endoscopicallyfor examination in conjunctionwith flexible bronchoscopes andrhino-laryngoscopes. |
| Common name | OLYMPUS DISPOSABLEBIOPSY 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 insertionportion diameter | $φ$ 1.5 mm | $φ$ 1.8 mm |
| Working length | 1150 mm | 1050 mm |
| Cup shape and size | Oval shaped portionMaximum diameter: $φ$ 1.5 mm | Oval shaped portionMaximum diameter: $φ$ 1.8mm |
| Sheath type | Metal coil | Metal coil |
| Material composition ofmain patient-contactparts and duration andtype of contact | Material composition of mainpatient-contact partsCups: Stainless metalCoil sheath: Stainless metalSurface-contacting device incontact with mucosal membranes.The contact duration is limitedexposure (i.e. contact is up to 24hours) | Material composition of mainpatient-contact partsCups: Stainless metalCoil sheath: Stainless metalSurface-contacting device incontact with mucosal membranes.The contact duration is limitedexposure (i.e. contact is up to 24hours) |
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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)
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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 OfRisk Management To MedicalDevices | • EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F• Single Use Biopsy ForcepsFB-433D |
| ISO 10993-1 FourthEdition:2009-10-15 | Biological Evaluation Of MedicalDevices - Part1: Evaluation AndTesting Within A RiskManagement Process [Including:Technical Corrigendum 1 (2010)] | • EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F• Single Use Biopsy ForcepsFB-433D |
| AAMI ANSI ISO10993-5:2009/(R)2014 | Biological Evaluation Of MedicalDevices - Part5: Tests For In VitroCytotoxicity | • EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F• Single Use Biopsy ForcepsFB-433D |
| ISO 10993-10 ThirdEdition: 2010-08-01 | Biological Evaluation Of MedicalDevices - Part 10: Tests ForIrritation And Skin Sensitization | • EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F• Single Use Biopsy ForcepsFB-433D |
| ISO 10993-11 SecondEdition 2006-08-15 | Biological Evaluation Of MedicalDevices, Part 11: Tests ForSystemic Toxicity | • Single Use Biopsy ForcepsFB-433D |
| AAMI ANSIES60601-1:2005/(R)2012and A1:2012 | Medical Electrical Equipment -Part 1: General Requirements forBasic Safety And EssentialPerformance + Amendment 1: 2012 | • EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F |
| IEC 60601-1-2 Edition 4.0:2014-02 | Medical Electrical Equipment -Part 1-2: General Requirements forSafety - Collateral standard:Electromagnetic Compatibility - | • EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F |
| Standard No. | Standard Title | Subject devices |
| Requirements and Tests | ||
| IEC 60601-2-18 Edition3.0: 2009-08 | Medical Electrical Equipment -Part 2-18: Particular RequirementsFor The Basic Safety And EssentialPerformance Of EndoscopicEquipment. | • EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F |
| ASTM E1837-96(Reapproved 2014) | Standard Test Method to DetermineEfficacy of Disinfection Processesfor Reusable Medical Devices(Simulated Use Test) | • EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F |
| ISO 10993-7 Secondedition 2008-10-15 | Biological evaluation of medicaldevices - Part 7: Ethylene oxidesterilization residuals [Including:Technical Corrigendum 1 (2009)] | EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F•Single Use Biopsy ForcepsFB-433D |
| ISO 11135 Second Edition2014 | Sterilization Of Health-CareProducts: Ethylene Oxide –Requirements For TheDevelopment, Validation AndRoutine Control Of A SterilizationProcess For Medical Devices. | • EVIS EXERA IIIBRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F•Single Use Biopsy ForcepsFB-433D |
| ASTM F1980-16 | Standard Guide For AcceleratedAging Of Sterile Barrier SystemsFor Medical Devices | •Single Use Biopsy ForcepsFB-433D |
| AAMI/ANSI/ISO 11607-1 | Packaging for terminally sterilizedmedical devices - Part 1:Requirements for materials, sterilebarrier systems and packagingsystems [Including: Amendment 1(2014)] | •Single Use Biopsy ForcepsFB-433D |
| AAMI/ANSI/ISO11607-2 | Packaging for terminally sterilizedmedical devices - Part 2: Validationrequirements for forming, sealingand assembly processes [Including:Amendment 1 (2014)] | •Single Use Biopsy ForcepsFB-433D |
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8. Conclusion
The EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F
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and Single Use Biopsy Forceps FB-433D are substantially equivalent to their proposed predicate devices, respectively.
§ 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.