(147 days)
Not Found
No
The device description and performance studies focus on the physical components, optical performance, and safety testing of a fiberscope, with no mention of AI/ML algorithms or data processing for image analysis or diagnosis.
No
This device is for endoscopic diagnosis within the nasal and nasopharyngeal lumen, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This instrument is intended to be used... for endoscopic diagnosis." The device description further elaborates on how it enables observation of the nasal and nasopharyngeal lumen, which is a diagnostic activity.
No
The device description clearly outlines physical components like an eyepiece section, control section, connector section, and insertion section, which are hardware elements of an endoscope. The performance studies also include hardware-specific testing like electrical safety, thermal safety, and durability.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "endoscopic diagnosis" within the nasal and nasopharyngeal lumen. This involves direct visualization of the anatomical site.
- Device Description: The description details a fiberscope used for observing internal body structures using light and image transmission.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device described is a medical endoscope used for direct visualization in vivo (within the body).
N/A
Intended Use / Indications for Use
This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.
ENF-GP2 is mainly consisted of four functional parts:
- eyepiece section that observes endoscopic images
- control section that operates endoscope such as controlling angulation to guide insertion and observation
- connector section that links with light source -
- insertion section that goes through and contacts with nasal and nasopharyngeal lumen under light guide.
When observing nasal or nasopharyngeal lumen, the light emitted from light source comes into fiberscope via apparatus on connector section and is eventually transmitted and released from examination light outlet in the distal end to supply light by optical fiber bundles. Subsequently the enlighten image reflexed into objective lens is grasped and sent to evepiece section by image fiber bundles, and observer can observe the image in eyepiece section or alter the imaging position by means of operations on control section, such as manipulation by UP/DOWN angulation control lever to adjust the bending section. Each section works collectively to perform observation within nasal and nasopharyngeal lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and nasopharyngeal lumen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Reprocessing validation testing: Reprocessing instruction and reprocessing method validation testing for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 were conducted and documentation was provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".
- Biocompatibility testing: Biocompatibility testing for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 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".
- Performance testing - Bench: Bench testing for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 as listed below was conducted. Electrical safety test has been performed to verify the compliance to ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012. IEC60601-2-18:2009, thermal safety test has been performed to verify the compliance to "PROTECTION AGAINST EXCESSIVE TEMPARATURES AND OTHER SAFETY HAZARDS" of IEC 60601-2-18:2009-08, durability test has been performed to verify the safety and effectiveness considering the supposed usage and operating environment and optical performance test has been performed to verify the safety and effectiveness from optical perspective.
- Electrical Safety followed by ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC60601-2-18:2009
- Thermal safety test
- Mechanical durability test
- Optical performance test
- Performance testing - Animal: No animal study was performed to demonstrate substantial equivalence.
- Performance testing - Clinical: No clinical study was performed to demonstrate substantial equivalence.
- Risk analysis: Risk analysis for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007 and the 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 analysis assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
October 4, 2018
Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K181240
Trade/Device Name: Rhino-Larvngo Fiberscope Olympus ENF-GP2 Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: August 31, 2018 Received: September 4, 2018
Dear Sheri L. 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.
1
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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Srinivas Nandkumar -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) K181240
Device Name RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2
Indications for Use (Describe)
This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.
| 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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) SUMMARY RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2
October 1, 2018
1 General Information
| ■ Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,
Japan
Establishment Registration No: 8010047 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent: | Sheri L. Musgnung
Manager, Regulatory Affairs
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 |
| ■ Manufacturer: | Aizu Olympus Co., Ltd.
500 Muranishi, Niidera, Monden-Machi,
Aizuwakamatsu- Shi, Fukushima, 965-8520, Japan
Establishment Registration No.: 9610595 |
4
2 Device Identification
| ■ Device Trade Name: | RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 |
|---|---|
| ■ Common Name: | RHINO-LARYNGO FIBERSCOPE |
| ■ Regulation Number: | 874.4760 |
| ■ Regulation Name: | Nasopharyngoscope (flexible or rigid) and accessories |
| ■ Regulatory Class: | II |
| ■ Classification Panel: | Ear Nose and Throat |
| ■ Product Code: | EOB |
3 Predicate Device Information
| ■ Device Name: | XENF-TP Rhino-Laryngofiberscope, its accessories and
ancillary equipment |
|----------------|-----------------------------------------------------------------------------|
| ■ Common Name: | Fiber Scope for Rhino-Laryngo |
| ■ Applicant | OLYMPUS MEDICAL SYSTEMS CORP. |
| ■ 510(k) No. | K013591 |
5
4 Device Description
This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.
ENF-GP2 is mainly consisted of four functional parts:
- eyepiece section that observes endoscopic images
- control section that operates endoscope such as controlling angulation to guide insertion and observation
- connector section that links with light source -
- insertion section that goes through and contacts with nasal and nasopharyngeal lumen under light guide.
When observing nasal or nasopharyngeal lumen, the light emitted from light source comes into fiberscope via apparatus on connector section and is eventually transmitted and released from examination light outlet in the distal end to supply light by optical fiber bundles. Subsequently the enlighten image reflexed into objective lens is grasped and sent to evepiece section by image fiber bundles, and observer can observe the image in eyepiece section or alter the imaging position by means of operations on control section, such as manipulation by UP/DOWN angulation control lever to adjust the bending section. Each section works collectively to perform observation within nasal and nasopharyngeal lumen.
5 Indications for Use
This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.
6
6 Comparison of Technological Characteristics
Compared to the predicate device, the subject device RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 has similar technological characteristics except for the following differences:
- Changes on optical system parameters
- Configuration modification and material change of eyepiece section and control section
- Dimension and material change on insertion section
- Removal of instrumental channel structure
- Extension of reprocessing methods
Detailed information is provided in the following table.
7
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) Premarket Notification RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2, K181240
| Features |
RHINO-LARYNGO FIBERSCOPE
OLYMPUS ENF-GP2 |
XENF-TP Rhino-Laryngofiberscope,
its accessories and ancillary
equipment, K013591 |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | This instrument is intended to be used
with an Olympus light source,
documentation equipment, display
monitor and other ancillary equipment
for endoscopic diagnosis. This
instrument is indicated for use within
the nasal and nasopharyngeal lumen. | This instrument has been designed to
be used with an Olympus light source
or an Olympus miniature light source,
documentation equipment, display
monitor. Endotherapy accessories and
other ancillary equipment for
endoscopic diagnosis and treatment
within the nasal and nasopharyngeal
lumen. Do not use this instrument for
any purpose other than its intended
use. |
| Field of view | 85° | 85° |
| Direction of view | 0°(forward viewing) | 0°(forward viewing) |
| Depth of field | 5-50mm | 3-50mm |
| Configuration and
material change of
eyepiece and control
section | Image: RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 eyepiece and control section | Image: XENF-TP Rhino-Laryngofiberscope eyepiece and control section |
| Features |
RHINO-LARYNGO FIBERSCOPE
OLYMPUS ENF-GP2 |
XENF-TP Rhino-Laryngofiberscope,
its accessories and ancillary
equipment, K013591 |
| Outer diameter of distal end | φ3.1mm | φ4.8mm |
| Outer diameter of insertion tube | φ3.5mm | φ5.0mm |
| Working length of insertion section | 300mm | 365mm |
| Angulation angle | 130° | 130° |
| Channel for therapy accessories | none | Incorporated |
| Construction of objective lens and light guide lens | Image: Diagram of objective lens and light guide lens with labels 1. objective lens and 2. light guide lens | Image: Diagram of light guide lenses, objective lens, and instrument channel with labels 1. light guide lenses, 2. objective lens, and 3. instrument channel |
| Total length | 550mm | 620mm |
| Reprocess with OER-Pro | available | unavailable |
| Sterilization with STERRAD | available | unavailable |
| Sterilization with V-PRO | available | unavailable |
8
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) Premarket Notification RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2, K181240
9
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 RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 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 RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 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".
3) Performance testing - Bench
Bench testing for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 as listed below was conducted. Electrical safety test has been performed to verify the compliance to ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012. IEC60601-2-18:2009, thermal safety test has been performed to verify the compliance to "PROTECTION AGAINST EXCESSIVE TEMPARATURES AND OTHER SAFETY HAZARDS" of IEC 60601-2-18:2009-08, durability test has been performed to verify the safety and effectiveness considering the supposed usage and operating environment and optical performance test has been performed to verify the safety and effectiveness from optical perspective.
- Electrical Safety followed by ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC60601-2-18:2009
- Thermal safety test
- Mechanical durability test
- Optical performance test
4) Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
5) Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
6) Risk analysis
Risk analysis for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 was
10
conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007 and the 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 analysis assessment.
8 Conclusion
When compared to the predicate device, the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 does not cause any significant changes in intended use and technical characteristics that could affect the safety or effectiveness of the device.