(29 days)
XENF-TP (K# 013591)
None
No
The summary describes a standard endoscopic device with improved resolution and a change in the optical system from image guide to CCD. There is no mention of AI, ML, or any related concepts like image processing beyond basic signal conversion.
Yes
The intended use explicitly states "treatment" and "endo-therapy accessories," indicating it's used for therapeutic purposes, not solely diagnostic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is designed for "endoscopic diagnosis and treatment within the nasal and nasapharyngeal lumens," indicating its diagnostic purpose. This is further supported by the "Device Description" which reiterates its use for "endoscopic diagnosis and treatment."
No
The device description explicitly states it is an "instrument" with an "optical system" modified from an "image guide to CCD," indicating it is a hardware device with physical components for image acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic diagnosis and treatment within the nasal and nasapharyngeal lumens." This describes a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The description focuses on the optical system and its use in endoscopy, which is an in-vivo procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the nasal and nasapharyngeal lumens.
Product codes
EOB
Device Description
The subject device is used for endoscopic diagnosis and treatment within the nasal and nasapharyngeal lumens. The optical system is modified from the image guide to CCD and the resolution is improved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and nasapharyngeal lumens
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
XENF-TP (K# 013591)
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
MAY 0-1 2002
SMDA 510(k) SUMMARY
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
A. Submitter's Name, Address, Phone and Fax Numbers
| Name & Address of manufacturer: | Olympus Optical Co., Ltd. |
|---|---|
| 2-3-1 Shinjuku Monolis Nishi-Shinjuku, | |
| Shinjuku-ku Tokyo, Tokyo 163-0914 | |
| Japan | |
| Registration No.: | 8010047 |
| Address, Phone and Fax Numbers: | 2951 Ishikawa-Cho, |
| Hachioji-shi, Tokyo 192-8507 | |
| Japan | |
| TEL 81-426-42-2891 | |
| FAX 81-426-46-5613 |
B. Name of Contact Person
| Name: | Laura Storms-Tyler |
|---|---|
| Address, Phone and Fax Numbers: | Olympus America Inc. |
| Two Corporate Center Drive | |
| Melville, New York 11747-3157 | |
| TEL: (631) 844-5688 | |
| FAX: (631) 844-5416 |
C. Device Name, Common Name, Classification Name and Predicate Devices
| Trade Name: | VISERA RHINO-LARYNGOVIDEOSCOPE
OLYMPUS ENF-TYPE V |
|-------------------|---------------------------------------------------------------------------|
| Common Name: | Nasopharyngoscope (flexible) and accessories |
| Classification: | 21 CFR 874.4760 Nasopharyngoscope (flexible) and
accessories, Class II |
| Predicate Device: | XENF-TP (K# 013591) |
D. Description of the Device(s)
The subject device is used for endoscopic diagnosis and treatment within the nasal and nasapharyngeal lumens. The optical system is modified from the image guide to CCD and the resolution is improved.
1
Following is the comparison table between the subject ENF-V and the predicate XENF-TP.
| Specifications | Subject Device | Predicate Device |
|---|---|---|
| ENF-V | XENF-TP | |
| Field of view | 90° | 85° |
| Direction of view | 0° (Forward) | 0° (Forward) |
| Depth of field | 5-50 mm | 3-50 mm |
| Insertion tube working length | 365mm | 365mm |
| Insertion tube outer diameter | $\phi$ 3.9mm | $\phi$ 5.0mm |
| Bending section angulation range | Up 130°, Down130° | Up 130°, Down130° |
| Total length | 593mm | 620mm |
| Optical system | CCD | Image guide |
| Resolution (Max, Minimum) | 12.6 Lines/mm | |
| 12.6 Lines/mm | 5.62 Lines/mm | |
| 0.70 Lines/mm |
ー
- Field of view is wider. -
- Total length is shorter.
- Optical system is CCD which provides observation on a monitor.
- Resolution is improved. -
The subject device, ENF-V, has the following similarities to the predicate device which has received 510(k) clearance.
- The same intended use .
- The same operating principle except for the optical system ●
- The same reprocessing method .
- The same basic endoscope design except for the optical system .
- The same body contacting materials 8
In summary, the subject device, ENF-V, described in this substantially equivalent to the predicate device_
E. Intended Use of the Device(s)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasapharyngeal lumens.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0-1 2002
Olympus America Inc. c/o Laura Storms-Tyler Two Corporate Center Drive Melville, NY 11747
Re: K021073
Trade/Device Name: Olympus ENF Type V Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible) and accessories Regulatory Class: Class II Product Code: EOB Dated: March 29, 2002 Received: March 2, 2002
Dear Ms. Storms-Tyler:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Laura Storms-Tyler
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematicate 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 additionally 21 (301) 594-4613. Additionally, for questions on the promotion and advertising of Compinance at (301) 29 - 1 t 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
Indications for Use Statement
K021073 510(k) Number(if known): ___Not assigned yet. Device Name: YISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
Indications for Use:
This instrument has been designed to be used with an Olympus vadeo system source, documentation equipment, display monitor, and other center, light ancillary equipment for endoscopic diagnosis within the nasal and nasopharyngeal lumens.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Analyst |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, Nose and Throat Devices | |
| Prescription Use | ✓ |
| (Prescription 21 CFR 801.109) | OR |
| 510(k) Number: K021073 | |
| Over-The-Counter Use |
(Optional Format 1-2-96)