(57 days)
Not Found
No
The summary describes a standard endoscope and does not mention any AI or ML capabilities, image processing, or related performance metrics.
Yes
The device description states that the endoscope is equipped with an “instrument channel, so this device is suitable for treatment within the nasal and nasopharyngeal lumen using recommended ancillary equipment.” This indicates a therapeutic function beyond just diagnosis.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the instrument is designed for "endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen."
No
The device description explicitly states it is an "endoscope" and describes physical components like an instrument channel and compatibility with light sources, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen." This describes a procedure performed directly on the patient's body, not on samples taken from the body.
- Device Description: The description confirms it's an endoscope used for "treatment and observation within the nasal and nasopharyngeal lumen." This is a medical device used for visualization and intervention within a body cavity.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on these types of samples.
Therefore, this device is a medical device used for direct examination and treatment within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Fiberscope:
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, document, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen.
Miniature Light Source:
MAJ-524 is a detachable battery powered Miniature Light Source, which has been designed to be used with the XENF-TP.
FB-56D-1
These instruments have been designed to be used with an Olympus endoscope to collect tissue within the nasal and nasopharyngeal lumen.
FG-53SX-1
These instruments has been designed to be used with an Olympus endoscope to retrieve foreign bodies, calculi or resected tissue from the nasal and nasopharyngeal lumen.
BC-201C/ BC-8C/BC-10C
These instruments has been designed to be used with an Olympus endoscope to collect tissue specimens within the nasal and nasopharyngeal lumen.
NM-101C-0427 / NM-201L-0423 / NM-201L-0525
These instruments has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection within the nasal and nasopharyngeal lumen.
PW-6C-1/MAJ-929
These instruments has been designed to be used with an Olympus endoscope for spraying medications in the nasal and nasopharyngeal lumen.
Product codes
EOB
Device Description
This subject device "XENF-TP Rhino-Laryngofiberscope" is an endoscope used for treatment and observation within the nasal and nasopharyngeal lumen. This endoscpe can be used with two types of light sources, detachable with an reusable battery powered and light cable source. This device is equipped instrument channel, so this device is suitable for treatment within the nasal and nasopharyngeal lumen using recommended ancillary equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
510(k) SUMMARY
XENF-TP Rhino-Laryngo fiberscope, its accessories and ancillary equipment
This summary of 510(k) safety and effectiveness information is being submitted in rnis Sammary of U.S. (1) in the requirements of SMDA 1990 and 21 CFR, Section 807.92.
Japan 8010047
Japan
A. Submitter's Name, Address, Phone and Fax Number
1. Manufacturer of the subject device
Name & Address of Manufacturer;
Registration No : Address, Phone and Fax Number of R&D Department Endoscope Division
2 Name of Contact Person Name :
Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631)844-5688 FAX (631) 844-5416
Olympus Optical Co, Ltd.
2951 Ishikawa-cho
TEL 81-426-42-5177 FAX 81-426-46-5613
Shinjuku-ku, Tokyo, 163-0914
Hachioji-shi, Tokyo 192-8507
2-3-1 Shinjuku Monolis Nishi-shinjuku
Address, Phone and Fax :
B. Device Name, Common Name
-
Device Name :
-
Common/Usual Name :
accessories and ancillary equipment
XENF-TP Rhino-Laryngofiberscope, its
Fiber Scope for Rhino-Laryng Fiberscope
- Classification Name :
21CFR 876.1500 21 CFR 868.5530 21 CFR 874.4760
1
C. Predicate Devices:
| Model | Device Description &
510(k)#/ Date Cleared | Manufacturer |
|---------------------------------------------------------|-----------------------------------------------|-------------------------------------|
| Pentax Naso-Pharyngo-
Laryngoscope
FNL-15P2/15RP2 | #K921707
07/01/1992 | Pentax Precision
Instrument Corp |
| Laparoscope,
Hand Instruments | #K950103
03/06/1995 | Olympus America,Inc. |
| LF-TP/DP | #K981543
08/06/1998 | Olympus Optical Co., |
D. Summary Description of the Device
1. Summary
This subject device "XENF-TP Rhino-Laryngofiberscope" is an endoscope used for treatment and observation within the nasal and nasopharyngeal lumen. This endoscpe can be used with two types of light sources, detachable with an reusable battery powered and light cable source. This device is equipped instrument channel, so this device is suitable for treatment within the nasal and nasopharyngeal lumen using recommended ancillary equipment.
2. Design
"XENF-TP Rhino-Laryngofiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601 -1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18.
3. Materials
There are no new patient-contacting materials. All of patient contact materials are cleared by previous 510(k) submissions such as LF-TP/DP.
E. Intended Use of the device
This instruments has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, Endo-Therapy accessories and other ancillary equipment for endoscpic diagnosis and treatment within the nasal and nasopharyngeal lumen. Do not use this instrument for any purpose other than its intended use.
F. Technological Characteristics
This endoscope does not have special technological characteristics compared to the predicate device.
G. Reason for not requiring clinical data
Compared to the predicate devices, "XENF-TP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Treatment and observation within nasal and nasopharyngeal lumen have been done widely, and established its safety and effectiveness, therefore clinical data is not necessary for its evaluation of safety and efficacy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "U.S. Department of Health & Human Services - USA" around the perimeter. Inside the circle is an emblem of three stylized lines that resemble an eagle or bird in flight. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 6 2001
Olympus Optical Co., Ltd. c/o Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, NY 11747
Re: K013591
Trade/Device Name: XENF-TP Rhino-Laryngofiberscope, its accessories and ancillary equipment
Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope Regulatory Class: Class II Product Code: EOB Dated: October 29, 2001 Received: October 30, 2001
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indication for Use Statement
510(k) Number(if known): Not assigned yet. Device Name: XENF-TP Rhino-Larvngofiberscope, its accessories and ancillary equipment.
Indications for Use:
Fiberscope:
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, document, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen.
Miniature Light Source:
MAJ-524 is a detachable battery powered Miniature Light Source, which has been designed to be used with the XENF-TP.
FB-56D-1
These instruments have been designed to be used with an Olympus endoscope to collect tissue within the nasal and nasopharyngeal lumen.
FG-53SX-1
These instruments has been designed to be used with an Olympus endoscope to retrieve foreign bodies, calculi or resected tissue from the nasal and nasopharyngeal lumen.
BC-201C/ BC-8C/BC-10C
These instruments has been designed to be used with an Olympus endoscope to collect tissue specimens within the nasal and nasopharyngeal lumen.
NM-101C-0427 / NM-201L-0423 / NM-201L-0525
These instruments has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection within the nasal and nasopharyngeal lumen.
PW-6C-1/MAJ-929
These instruments has been designed to be used with an Olympus endoscope for spraying medications in the nasal and nasopharyngeal lumen.
en. Analyst /qn
Division Sign-Off
(Division Sign-Oll
Division of Ophthalmic Ear,
Nose and Throat Devises
K0135
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C Prescription Use_
OR
Over-The-Counter Use
(Prescription 21 CFR 801.109)
(Optional Format 1-2-96)