(203 days)
No
The summary describes a standard fiberscope and its associated equipment, focusing on physical characteristics, safety, and performance testing. There is no mention of AI, ML, image processing, or any software features that would suggest the use of such technologies for analysis or diagnosis.
No.
The device is indicated for endoscopic diagnosis within the nasal and nasopharyngeal lumen, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is "intended for endoscopic diagnosis."
No
The device description and performance studies clearly indicate this is a physical fiberscope with associated hardware components, not a software-only device. The "Software Verification and Validation Testing: Not applicable and not performed" section further confirms this.
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 directly visualizing internal body structures.
- Device Description: The description reinforces the use of a fiberscope for direct visualization.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis. This device is used inside the body for direct observation.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device itself (durability, image quality, safety, reprocessing), not on the analytical or clinical performance of a diagnostic test performed on a specimen.
Therefore, the RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is a medical device used for direct visualization and diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.
Product codes
EOB
Device Description
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the 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
Non-Clinical Bench Testing:
- Thermal Safety: compliance to Protection against excessive temperature and other safety hazards of IEC 60601-2-18:2009-08.
- Composite Durability: retention of safety and effectiveness against stresses expected in use-life.
- Color Performance: confirmed as substantially equivalent to the predicate devices.
- Image Intensity Uniformity: confirmed as substantially equivalent to the predicate devices.
- Resolution: similar to predicate device and does not raise new issues of safety or effectiveness.
- Photobiological Safety: compliance to IEC 62471:2006-07 which confirms light emitted is low enough not to cause injury to the skin and eye.
- Direction of View: compliance to ISO 8600-1 and consistent with design specifications.
- Field of View: compliance to ISO 8600-1 and consistent with design specifications.
Biocompatibility Evaluation: conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1.
Sterilization, Shelf Life, Reprocessing: Validated as safe and effective for reprocessing with Manual Cleaning (FlexClean895, Endozime AW, Endozime AW with pre-soaking), Manual Disinfection (2-3.5% glutaraldehyde), OER-Pro (K103264), OER-Mini (K120357), OER-Elite (K201920), and Sterilization with EO Gas.
Electrical Safety: compliance with IEC 60601-1:2005+A1:2012 and IEC 60601-2-18:2009.
Software Verification and Validation Testing: Not performed as the device does not contain any software.
Risk Analysis: performed in accordance with ISO 14971:2007.
Clinical Testing: Not applicable and not performed.
Key Metrics
Not Found
Predicate Device(s)
RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 (K181240)
Reference Device(s)
OER-Pro (K103264), OER-Mini (K120357), OER-Elite (K201920)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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December 28, 2022
Olympus Medical Systems Corp. % Steven Keenan Program Manager, Regulatory Affairs Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K221660
Trade/Device Name: Rhino-Laryngofiberscope Olympus ENF Type XP Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: November 21, 2022 Received: November 21, 2022
Dear Steven Keenan:
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.
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
1
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 (OS) 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 mediation-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,
Joyce C. Lin -S
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
2
Indications for Use
510(k) Number (if known) K221660
Device Name
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP
Indications for Use (Describe)
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K221660 - 510(k) Summary
For
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP
| General Information | |
|---|---|
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP. |
| 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan | |
| 192-8507 | |
| Phone: (+81) 42-642-2694 | |
| Fax: (+81) 42-642-2307 | |
| Establishment Registration Number: 8010047 | |
| Manufacturer: | Aizu Olympus Co., Ltd., |
| 500 Muranishi, Niidera, Monden-machi, | |
| Aizuwakamatsu-shi, Fukushima 965-8520, | |
| Japan | |
| Phone: (+81) 242-28-2111 | |
| Fax: (+81) 242-26-4234 | |
| Establishment Registration Number: 9610595 | |
| 510(k) Submitter: | Olympus Corporation of the Americas |
| 800 West Park Drive | |
| Westborough, MA 01518 USA | |
| Establishment Registration Number: | 2429304 |
| Contact Person: | Steven Keenan |
| Program Manager | |
| Mobile: (508)-523-5004 | |
| Email: Steven.Keenan@olymus.com | |
| Date Prepared: | June 3, 2022 |
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Device Description
| Model No. | Device/Trade Name | Product Classification |
|---|---|---|
| ENF-XP | RHINO-LARYNGOFIBERSCOPE | |
| OLYMPUS ENF TYPE XP | EOB (874.4760) |
Classification Name: Generic/Common Name: Regulation Number: Regulatory Class: Product Codes: Review Panel:
Nasopharyngoscope (flexible or rigid) and accessories Rhino-Laryngo Fiberscope 874.4760 Class II EOB Ear Nose & Throat
Predicate Device
| Predicate Device | 510(k) No. |
|---|---|
| RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 | K181240 |
Product Description
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.
Comparison of Technological Characteristics
Table 5-1 compares RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP to the predicate device with respect to intended use, technological characteristics, and principle of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
Table 5-1: Comparison of the technological characteristics of ENF-XP to predicate device
| Feature/
Technological
Characteristics | Subject Device
ENF-XP | Predicate Device
ENF-GP2 | Comparison |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| Device Name | RHINO-
LARYNGOFIBE
RSCOPE
OLYMPUS ENF
TYPE XP | Rhino-Laryngo
Fiberscope ENF-
GP2 | Different model names. |
| Regulatory Decision | This submission | K181240 | N/A |
| Feature/
Technological
Characteristics | Subject Device
ENF-XP | Predicate Device
ENF-GP2 | Comparison |
| Product Code | EOB | EOB | Same as predicate. |
| Regulation Number | 874.4760 | 874.4760 | Same as predicate. |
| Regulation Name | Nasopharyngosco
pe (flexible or
rigid) and
accessories | Nasopharyngosco
pe (flexible or
rigid) and
accessories | Same as predicate. |
| Intended Use | RHINO-
LARYNGOFIBE
RSCOPE
OLYMPUS ENF
TYPE XP is
intended to be
used with an
Olympus video
system center,
documentation
equipment,
display monitor,
and other
ancillary
equipment for
endoscopic
diagnosis.
RHINO-
LARYNGOFIBE
RSCOPE
OLYMPUS ENF
TYPE XP is
indicated for use
within the nasal
and
nasopharyngeal
lumen. | 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. | Similar to predicate. Device name
and model number are now
included in the Indications for Use
statement. The intended use is
identical to predicate. |
| Feature/
Technological
Characteristics | Subject Device
ENF-XP | Predicate Device
ENF-GP2 | Comparison |
| Mode of Action | When observing
nasal or
nasopharyngeal
lumen, the light
emitted from light
source enters into
the 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
illuminated image
reflected into
objective lens is
sent to the
eyepiece section
by image fiber
bundles. The
observer can
observe the image
directly in the
eyepiece section
or alternatively,
the image can be
observed on a
monitor generated
by a video
processor and a
camera head
attached on the
eyepiece. | When observing
nasal or
nasopharyngeal
lumen, the light
emitted from light
source enters into
the 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
illuminated image
reflected into
objective lens is
sent to the
eyepiece section
by image fiber
bundles. The
observer can
observe the image
directly in the
eyepiece section
or alternatively,
the image can be
observed on a
monitor generated
by a video
processor and a
camera head
attached on the
eyepiece. | Same as predicate. |
| Optical System Parameters | | | |
| Field of View | 75° | 85° | Although the field of view is
different from PD, the area within
the view can be adjusted by the
advance or retreat of the endoscope.
Therefore, the difference in FOV
does not affect the safety and
effectiveness of the subject device. |
| Direction of View | 0° (Forward
viewing) | 0° (Forward
viewing) | Same as predicate. |
| Feature/
Technological
Characteristics | Subject Device
ENF-XP | Predicate Device
ENF-GP2 | Comparison |
| Depth of Field | 2.5-50 mm | 5-50 mm | The increased range of depth of
field covers the PD's depth of field.
In addition, although the subject
device is compatible with various
processors, light sources, and
camera heads, this specification is
not affected by the variation of the
systems. |
| | Bending Section | | |
| Angulation range | Up 130° / Down
130° | Up 130° / Down
130° | Same as predicate. |
| | Insertion section | | |
| Insertion Tube
Diameter – Distal
End | 1.8 mm | 3.1 mm | The difference in tube diameter of
the distal end for the subject
device does not alter or change the
indications for use or result in a
new intended use. |
| Insertion Tube
Diameter –
Flexible Outer
Diameter | 2.2mm | 3.5mm | The difference in flexible outer
diameter of the insertion tube for
the subject device does not alter or
change the indications for use or
result in a new intended use. |
| Insertion Section
Working Length | 300 mm | 300 mm | Same as predicate. |
| | Connection to Light Source | | |
| Configuration | Light Guide (LG)
cable is not
detachable | LG cable is
detachable | Cable configuration does not
directly affect the safety and
effectiveness of the subject device. |
| | Venting Connector | | |
| Venting
Connector
Position | On LG connector | On control body | Venting connector position does
not directly affect the safety and
effectiveness of the subject device. |
| | Sterilization | | |
| EO | Available | Available | Same as predicate. |
| | Other | | |
| Suction Function | Not provided | Not provided | Same as predicate. |
| Total Length | 530 mm | 550 mm | Due to the difference in the shape
of the control section, the subject
device has a 20mm shorter total
length compared with the predicate
device. This difference does not
alter or change the indications for
use or result in a new intended use. |
| Feature/
Technological
Characteristics | Subject Device
ENF-XP | Predicate Device
ENF-GP2 | Comparison |
| Compatible
Processor | OTV-S200/S300
(with light source
function) | OTV-SC/SC2
OTV-S7V
CV-170
OTV-S7Pro
OTV-S190 | Compatibility of ENF- XP with OTV-
S200/S300 was demonstrated with
bench performance testing in Section
18 confirm that these additional
processors do not raise any new
questions of safety or effectiveness. |
| Compatible Light
Source | OTV-S200/S300
(with light source
function) | CLV-S190
CLV-S40Pro
CLH-SC
CLL-V1
CLL-S1
CV-170 | Compatibility of ENF- XP with OTV-
S200/S300 (with light source
function) was demonstrated with
bench performance testing in Section
18 confirm that these additional light
sources do not raise any new
questions of safety or effectiveness. |
| Compatible
Monitor | OEV-262H
LMD-X310ST*
*This can only be
combined with
OTV-S300. | OEV-141
OEV-142
OEV-143
OEV-201
OEV-202
OEV-203
OEV-181H
OEV-191
OEV-191H
OEV-261H | Compatibility of ENF- XP with OEV-
262H and LMD-X310ST was
demonstrated with bench performance
testing in Section 18 confirm that
these additional monitors do not raise
any new questions of safety or
effectiveness. |
| Compatible
Camera Head | CH-S200-XZ-EA
CH-S200-XZ-EB | OTV-S7H-1NA-
10E/12E
OTV-S7H-
1N/1NA
OTV-S7ProH-
HD-10E/12E | Compatibility of ENF- XP with CH-
S200-XZ-EA and CH-S200-XZ-EB
camera heads was demonstrated with
bench performance testing in Section
18 confirm that these additional
camera heads do not raise any new
questions of safety or effectiveness. |
5
OLYMPUS®
Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP
6
OLYMPUS®
Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP
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8
Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP
Indications for Use
RHINO-LARYNGOFIBROSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBROSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.
Compliance to Voluntary Standards
The following voluntary standards have been applied to the subject devices respectively:
| Standard | |
|---|---|
| ANSI AAMI ES 60601- | |
| 1:2005+A1:2012 | Medical electrical equipment – Part 1: General |
| requirements for basic safety and essential performance | |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process |
| ISO 10993-5:2009 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization |
| ISO 10993-12:2012 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials |
| ISO 10993-17:2002 | Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-18:2020 | Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process |
| ISO 11135:2014 | Sterilization of health care products – Ethylene Oxide – requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-7: 2008 | Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019) |
| ISO 14971:2007 | Medical Devices – Application of risk management to medical devices |
| FDA Device Specific Guidance | |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff | |
| FDA Guidance Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | |
| Guidance for the Content of Premarket Submissions for Software contained in Medical Devices | |
| FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices |
9
Summary of Performance Testing
The following performance testing was conducted in support of the substantial equivalence determination.
1. Non-Clinical Bench Testing
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| Item | Contents |
|---|---|
| Thermal Safety | Thermal safety performance test verified compliance to Protection |
| against excessive temperature and other safety hazards of IEC 60601-2- | |
| 18:2009-08. | |
| Composite Durability | The durability test against composite stress of mechanical and chemical |
| stress demonstrates the subject device retains its safety and effectiveness | |
| against the stresses expected in its use-life. | |
| Color Performance | The color performance of the subject devices is confirmed as |
| substantially equivalent to the predicate devices. | |
| Image Intensity | |
| Uniformity | The image intensity uniformity of the subject devices is confirmed as |
| substantially equivalent to the predicate devices. | |
| Resolution | The resolution of the subject device is similar to predicate device and |
| does not raise new issues of safety or effectiveness. | |
| Photobiological Safety | The photobiological safety test verified compliance to IEC 62471:2006- |
| 07 and confirms the light emitted from subject devices connected to each | |
| light source is low enough not to cause injury to the skin and eye. | |
| Direction of View | The direction of view test verified compliance to ISO 8600-1 and |
| confirms that the subject device is consistent with the design | |
| specifications and does not introduce new questions related to safety and | |
| effectiveness. | |
| Field of View | The field of view test verified compliance to ISO 8600-1 and confirms |
| that the subject device is consistent with the design specifications and | |
| does not introduce new questions related to safety and effectiveness. |
2. Animal Test
Animal testing was not applicable and not performed.
3. Biocompatibility Evaluation
Biocompatibility testing was 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". There have been no changes that have impacted the established biocompatibility profile and the Biological Risk associated with this device is acceptable for intended use.
4. Sterilization, Shelf Life, Reprocessing
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP and its reusable accessories are not sterilized before shipment. Before using the instrument for the first time and after using the endoscopes, the devices are reprocessed according to the instructions given in the subject endoscope's companion Reprocessing Manual. All cleaning, disinfection, and sterilization methods were validated pursuant to the FDA guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015. The reprocessing validation was conducted
11
pursuant to the same FDA guidance document. ENF-XP is validated as safe and effective for reprocessing with the following:
- Manual Cleaning using FlexClean895 ●
- Manual Cleaning using Endozime AW ●
- Manual Cleaning with pre-soaking using Endozime AW
- . Manual Disinfection (2-3.5% glutaraldehyde)
- OER-Pro (K103264)
- . OER-Mini (K120357)
- OER-Elite (K201920)
- Sterilization with EO Gas
5. Electrical Safety
Electrical safety testing has been confirmed for the subject devices. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP was found to be in compliance with the relevant requirements as noted below. Electromagnetic compatibility (EMC) testing was not applicable and not performed.
- IEC 60601-1:2005+A1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- . IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
6. Software Verification and Validation Testing
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP does not contain any software and therefore software testing was not performed.
7. Risk Analysis
Risk management has been performed in accordance with ISO 14971:2007. In the risk management process, Olympus determined that additional human factors validation testing was not required for the subject device in accordance with the FDA Guidance. "Applying Human Factors and Usability Engineering to Medical Devices" since the risk analysis made to the currently marketed device did not identify any unacceptable use-related risks. Refer to the risk management table for the RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP. To date, with respect to perceivable conditions in which the device would be subjected to a worst-case environment for human error scenario, Olympus believes that the outcomes of these risks are considered acceptable within the context of ISO 14971:2007 and that all potential risks have been mitigated to the lowest form.
8. Clinical Testing
Clinical testing was not applicable and not performed.
Substantial Equivalence
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OLYMPUS
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is substantially equivalent to the legally marketed predicate device, ENF-GP2 (K181240). Olympus claims substantial equivalence to the predicate devices based on evaluation of the on similarities in indications for use, design, materials, technological characteristics, and operational characteristics. Differences are summarized in Table 5-1 above.
Conclusion
In summary, the indications for use and technological characteristics of the RHINO-LAR YNGOFIBERSCOPE OLYMPUS ENF TYPE XP device do not raise different questions of safety and effectiveness as compared to the predicate device. The performance testing demonstrate that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device.