(15 days)
Not Found
No
The document explicitly states that AI, DNN, or ML are not mentioned, and there is no description of training or test sets, performance studies, or key metrics typically associated with AI/ML devices. The device description focuses on hardware modifications and image display technology.
Yes
The intended use explicitly states the device is for "observation, diagnosis, and treatment." Since treatment is mentioned, the device has therapeutic capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is designed for "observation, diagnosis, and treatment within the nasal and nasopharyngeal lumens." The "Device Description" also reiterates that it is "intended for observation, diagnosis, and treatment."
No
The device description clearly states it is a flexible endoscope with physical components (instrument channel, CCD based system) and is intended for physical insertion and observation. 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 is for "observation, diagnosis, and treatment within the nasal and nasopharyngeal lumens." This describes a device used directly on or within the patient's body for visualization and intervention.
- Device Description: The device is described as a "flexible endoscope." Endoscopes are instruments used to look inside the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is clearly an in vivo device, meaning it is used within a living organism, rather than an in vitro device, which is used outside of a living organism.
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 therapy accessories and other equipment for observation, diagnosis and transnasal therapeutic treatment within the nasal and nasopharyngeal lumens.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The VISERA Rhino-Laryngovideoscope Olympus ENF type VT, hereafter referred to as ENF-VT, is a flexible endoscope intended to provide images of the nasal and nasopharyngeal lumens.
The modifications that were made are:
- Field of view is wider. l
- Instrument channel inner diameter is smaller. -
- Instrument changed to a CCD based system, allowing endoscopic image display on a video monitor.
- Improved resolution -
- Improved resolution
The subject device is not compatible with a miniature light source, whereas the predicate device -ાંડ - ,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and nasopharyngeal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
SEP 2 1 2005
510(k) SUMMARY
VISERA Rhino-Laryngovideoscope Olympus ENF type VT
August 26, 2005
General Information 1
| ■ Applicant | Olympus Medical Systems Corp.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Establishment Registration No.: 8010047 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent | Laura Storms-Tyler
Executive Director,
Regulatory Affairs & Quality Assurance
Olympus America Inc.
Two Corporate Center Drive,
Melville, NY 11747-9058, USA
Phone: 631-844-5688
FAX: 631-844-5554
Email: Laura.storms-tyler@olympus.com
Establishment Registration No.: 2429304 |
| ■ Manufacturer | Aizu Olympus Co., Ltd.
500 Aza Muranishi, Oaza-Iidera, Monden-cho, |
500 Aza-Muranishi, Ooaza-lidera, Monden-cho,
Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595
Device Identification 2
| Device Name | VISERA Rhino-Laryngovideoscope Olympus ENF type VT |
|---|---|
| Common Name | Nasopharyngoscope |
| Regulation No: | 21 CFR 874.4760 |
| Regulation Name: | Nasopharyngoscope (flexible or rigid) and accessories |
| Regulatory Class: | II |
| Product Code: | EOB |
| Prescription Status: | Prescription device |
| Performance Standards: | None established under Section 514 of FDCA. |
1
Image /page/1/Picture/0 description: The image contains a sequence of characters that appear to be handwritten. The characters are 'Kos 2452'. The writing style is cursive, and the characters are connected. The image is in black and white.
Predicate Device Information 3
| Device Name | Rhino-Laryngofiberscope Olympus XENF-TP |
|---|---|
| 510(k) No: | K013591 |
| Decision Date: | 12/26/2001 |
Device Description ব
The VISERA Rhino-Laryngovideoscope Olympus ENF type VT, hereafter referred to as ENF-VT, is and The VISERA Knino-Laryngovicessope Olympos EN. Type V., Hersament within the nasal and nasopharyngeal lumens.
The modifications that were made are:
- Field of view is wider. l
- Instrument channel inner diameter is smaller. -
- Instrument changed to a CCD based system, allowing endoscopic image display on a video monitor.
- Improved resolution -
- Improved resolution
The subject device is not compatible with a miniature light source, whereas the predicate device -ાંડ - ،
5 Intended Use
This instrument has been designed to be used with an Olympus video system center, light souncent This institutient has been designed to be acou therapy accessories, and other and documentation equipment, alsployment within the nasal and nasopharyngeal lumens.
This intended use is identical to the predicate device, the Rhino-Laryngofiberscope Olympus XENF-TP.
Conclusion 6
The VISERA Rhino-Laryngovideoscope Olympus ENF type VT has the following similarities to the predicate device:
- 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 patient contacting materials as for the Olympus predicate devices. -
In summary, the ENF-VT described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Olympus Medical Systems Corporation c/o Laura Storms-Tyler Executive Director Olympus America, Inc. Regulatory Affairs and quality Assurance Two Corporate Center Drive PO Box 9058 Melville, NY 11747-9058
Re: K052452
KU52432
Trade/Device Name: VISERA Rhino-Laryngovideoscope Olympus ENF type VT Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: September 1, 2005 Received: September 7, 2005
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained in the may arranger started in interests a referenced above and nave determined the arrest as a recess marketed in interstate for use stated in the enclosure) to legally manative provide in one of the Enderal Food. Device commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while toproval applicians of the Act . The and Cosmetic Act (Act) that do not require approvial controls) provisions of the Act. The You may, therefore, market the device, seeject to since general registration, listing of
general controls provisions of the Act include requirements for annual registration, general controls provisions of the Fist list increases of the adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) this child be sites).
may be subject to such additional controls. Existing major regalation FDA may may be subject to such additional connolor Entrological of 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Securer be found in the Code of Poderal Regarning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a but can and other requirements of the Act
that FDA has made a determination that your device complies with on must that FDA has made a decemination administered by other Federal agencies. You must or any Federal Statutes and regulations administers of a fimited to: registration and listing (21 l comply with all the Act Stequirements, morams manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 800); god a frapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
The start of the same of the same of the same of your device to a legal This letter will allow you to begin marketing your artice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales on the premarket notification. The FDA inding of substantial equivalians 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), please
rs the latest of the most of an 11 companses and the regulation entitled If you desire specific advice for your ac 1100 cm ... Also, please note the regulation entitled, and the regulation entitled, would contact the Office of Complance at (301) 627 07 (21CFR Patt 807.97). You may obtain " Misbranding by relerence to premarket notified.com