Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
Device Facts
| Record ID | K221631 |
|---|---|
| Device Name | Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V |
| Applicant | Olympus Medical Systems Corp. |
| Product Code | EOQ · Ear, Nose, Throat |
| Decision Date | Sep 26, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
Indications for Use
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management. The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Device Story
Olympus LF-P (fiberscope) and LF-V (videoscope) are flexible endoscopes for airway management. LF-P uses fiber-optic bundles; LF-V uses video technology. Both devices are inserted into the airway to provide visualization for intubation and anatomical observation. They connect to Olympus video system centers, light sources, and monitors. Operated by clinicians in clinical settings, these devices assist in navigating the airway to facilitate endotracheal or endobronchial tube placement. The visual output allows the physician to guide the scope and tube accurately, reducing the risk of airway trauma and improving intubation success rates. The devices are designed for integration with standard endoscopic ancillary equipment.
Clinical Evidence
No clinical or animal testing was performed. Substantial equivalence was established through non-clinical bench testing, including electrical safety (IEC 60601-1, 60601-1-2, 60601-2-18), photobiological safety (IEC 62471), performance testing (ISO 8600, durability, color, image intensity, resolution), and biocompatibility (ISO 10993-1, 5, 10).
Technological Characteristics
Flexible endoscopes for airway visualization. LF-P is a fiberscope; LF-V is a videoscope. Features include 120° angulation range, forward viewing (0°). LF-P distal diameter 1.8mm; LF-V distal diameter 3.8mm. Connectivity via Olympus video system centers. Sterilization/reprocessing follows FDA guidance. Materials evaluated per ISO 10993.
Indications for Use
Indicated for airway management, including endoscopic observation to access airway anatomy, and endotracheal/endobronchial intubation and management in patients requiring such procedures.
Regulatory Classification
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 LF-TP AND LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment (K981543)
Reference Devices
- Tracheal Intubation Fibervideoscope LF-Y0004 and LF-Y0005 (K082720)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 26, 2022
Olympus Medical Systems Corp. % Brenda Geary Manager, Regulatory Affairs Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K221631
Trade/Device Name: Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: August 19, 2022 Received: August 19, 2022
Dear Brenda Geary:
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 Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices 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) K221631
Device Name
Tracheal Intubation Fiberscope OLYMPUS LF-P VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
#### Indications for Use (Describe)
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in blue, with a registered trademark symbol next to it. Below the word is a yellow and orange graphic. To the right of the word "OLYMPUS" is the alphanumeric code "K221631".
Date Prepared: June 3, 2022
# 510(k) Summary
# A. SPONSOR INFORMATION
| 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho, Hachioji-shi,<br>Tokyo, Japan 192-8507 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Brenda Geary<br>Olympus Corporation of the Americas<br>800 West Park Drive<br>Westborough, MA 01581<br>Cell: (928) 707-2852<br>Email: brenda.geary@olympus.com |
Official Correspondent: Brenda Geary
# B. DEVICE IDENTIFICATION
| ■ Device Name(s): | TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P<br>VISERA TRACHEAL INTUBATION VIDEOSCOPE<br>OLYMPUS LF TYPE V |
|-------------------------|-----------------------------------------------------------------------------------------------------------|
| ■ Model Name(s): | OLYMPUS LF-P, OLYMPUS LF-V |
| ■ Common Name: | Tracheal Intubation Videoscope |
| ■ Regulation Number: | 874.4680 |
| ■ Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| ■ Regulatory Class: | II |
| ■ Product Code: | EOQ: Bronchoscope (Flexible or Rigid) |
| ■ Classification Panel: | Division of Dental and ENT Devices (DHT1B) |
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### C. PREDICATE DEVICES
#### 1 Predicate device for LF-P
| Device Name | 510(k) Submitter | 510(k) No. |
|-------------------------------------------------------------------------------------------------|------------------------------|------------|
| PREDICATE | | |
| OLYMPUS LF-TP AND LF-DP Tracheal Intubation<br>Fiberscopes, Accessories and Ancillary Equipment | Olympus Optical Co.,<br>Ltd. | K981543 |
#### Predicate devices for LF-V .
| Device Name | 510(k) Submitter | 510(k) No. |
|-------------------------------------------------------------------------------------------------|----------------------------------|------------|
| PREDICATE | | |
| OLYMPUS LF-TP AND LF-DP Tracheal Intubation<br>Fiberscopes, Accessories and Ancillary Equipment | Olympus Optical Co.,<br>Ltd. | K981543 |
| REFERENCE PREDICATE | | |
| Tracheal Intubation Fibervideoscope LF-Y0004 and LF-<br>Y0005 | Olympus Medical<br>Systems Corp. | K082720 |
#### D. DEVICE DESCRIPTION
#### LF-P Device Description
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
#### LF-V Device Description
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
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# E. INDICATIONS FOR USE
#### LF-P Indications for Use
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
#### LF-V Indications for Use
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
### F. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
| | SUBJECT DEVICE:<br>LF-P Tracheal Intubation Fiberscope | PRIMARY PREDICATE:<br>LF-DP Tracheal Intubation Fiberscopes<br>(K981543) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Olympus Medical | SAME |
| Classification<br>& Regulation<br>Number | Class II<br>21 CFR §874.4680 | SAME |
| Product Code | EOQ - Bronchoscope (Flexible or Rigid) | SAME |
| Intended Use | The TRACHEAL INTUBATION<br>FIBERSCOPE OLYMPUS LF-P has been<br>designed to be used with an Olympus video<br>system center, documentation equipment,<br>display monitor and other ancillary equipment<br>for airway management, which includes<br>endoscopic observation to access airway<br>anatomy, endotracheal/endobronchial<br>intubation and management. | These instruments have been designed to be<br>used with a Suction Pump and other ancillary<br>equipment for airway management, which<br>includes observation to access airway anatomy,<br>endotracheal/endobronchial intubation and<br>management. Do not use these instruments for<br>any purpose other than their intended use. |
| Field of View | 75° | 90° |
| Direction of<br>View | 0° (Forward viewing) | SAME |
| Depth of<br>Field | 2-50mm | 3-50mm |
| Optimum<br>Working<br>Distance | 7.0mm | 6.0mm |
| Insertion<br>Tube<br>Diameter | Distal end size: ø 1.8mm<br>Flexible tube outer Diameter: ø 2.2mm | Distal end size: ø 3.1mm<br>Flexible tube outer Diameter: ø 3.1mm |
| Insertion<br>section | 600mm | SAME |
#### LF-P Tracheal Intubation Fiberscope
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| | SUBJECT DEVICE:<br>LF-P Tracheal Intubation Fiberscope | PRIMARY PREDICATE:<br>LF-DP Tracheal Intubation Fiberscopes<br>(K981543) |
|--------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------|
| Working<br>Length | | |
| Angulation<br>Range | Up 120° / Down 120° | SAME |
| Light Guide<br>(LG) Cable<br>Configuration | Not detachable | Detachable |
# LF-V Tracheal Intubation Videoscope
| | SUBJECT DEVICE:<br>LF-V Tracheal Intubation<br>Videoscope | PRIMARY PREDICATE:<br>LF-DP Tracheal<br>Intubation Fiberscopes<br>(K981543) | REFERENCE PREDICATE:<br>LF-Y0004 Tracheal Intubation<br>Fibervideoscope (K082720) |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Olympus Medical | Olympus Medical | Olympus Medical |
| Classification<br>& Regulation<br>Number | Class II<br>21 CFR §874.4680 | SAME | SAME |
| Product Code | EOQ - Bronchoscope<br>(Flexible or Rigid) | SAME | SAME |
| Intended Use | The VISERA TRACHEAL<br>INTUBATION<br>VIDEOSCOPE OLYMPUS<br>LF TYPE V has been<br>designed to be used with a<br>video system center, light<br>source, documentation<br>equipment, display monitor,<br>suction pump, and other<br>ancillary equipment for<br>airway management which<br>includes endoscopic<br>observation to access airway<br>anatomy,<br>endotracheal/endobronchial<br>intubation and management. | These instruments have<br>been designed to be used<br>with a Suction Pump and<br>other ancillary equipment<br>for airway management,<br>which includes observation<br>to access airway anatomy,<br>endotracheal/endobronchial<br>intubation and management.<br>Do not use these<br>instruments for any purpose<br>other than their intended<br>use. | These instruments have been<br>designed to be used with a<br>Suction Pump and<br>EndoTherapy accessories and<br>other ancillary equipment for<br>airway management, which<br>includes endoscopic treatment,<br>diagnosis, and observation to<br>access airway anatomy,<br>endotracheal/endobronchial<br>intubation and management. |
| Field of View | 120° | 90° | 90° |
| Direction of<br>View | 0° (Forward viewing) | SAME | SAME |
| Depth of Field | 3-50mm | SAME | 4-50 mm |
| Optimum<br>Working<br>Distance | 9.0mm | 6.0mm | 9.5mm |
| Insertion<br>Tube<br>Diameter | Distal end size: ø 3.8mm<br>Flexible tube outer<br>Diameter: ø 4.1mm | Distal end size: ø 3.1mm<br>Flexible tube outer<br>Diameter: ø 3.1mm | Distal end size: ø 3.9mm<br>Flexible tube outer Diameter: ø<br>4.1mm |
| Insertion<br>section<br>Working<br>Length | 600mm | SAME | SAME |
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| | SUBJECT DEVICE:<br>LF-V Tracheal Intubation<br>Videoscope | PRIMARY PREDICATE:<br>LF-DP Tracheal<br>Intubation Fiberscopes<br>(K981543) | REFERENCE PREDICATE:<br>LF-Y0004 Tracheal Intubation<br>Fibervideoscope (K082720) |
|--------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Angulation<br>Range | Up 120° / Down 120° | SAME | SAME |
| Light Guide<br>(LG) Cable<br>Configuration | Not detachable | Detachable | None |
# G. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
- General
- ISO 14971 (Medical devices Application of risk management to medical I devices)
- Non-Clinical Bench Testing ●
Electrical Testing:
- IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- 트 IEC 60601-1-2 (Medical electrical equipment - Part 1-2: Collateral Standard: Electromagnetic disturbances - Requirements and tests)
- I IEC 60601-2-18 (Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment)
- IEC 62471 (Photobiological safety of lamps and lamp systems)
Performance Testing:
- I ISO 8600 (Endoscopes - Medical endoscopes and endotherapy devices, Part 1: General requirements)
- Composite durability
- I Color performance
- 트 Image intensity uniformity (IIU)
- Field of View and Direction of View
- 트 Resolution
#### Reprocessing:
- FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- Biocompatibility ●
- ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and 트 testing within a risk management process)
- I ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- 트 ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for skin
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sensitization)
#### Clinical Performance Data .
Clinical and animal testing were not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
# H. CONCLUSION
In summary the LF-P and LF-V are substantially equivalent to the predicate devices and present no new questions of safety or effectiveness.
