(49 days)
Not Found
No
The summary does not mention any AI or ML capabilities, image processing, or provide details about training or test sets, which are typical indicators of AI/ML use in medical devices. The description focuses on the device's hardware and its similarity to predicate devices.
No.
The device is described for diagnosis, observation, and endoscopic treatment for airway management, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instruments are designed for "airway management, which includes diagnosis, and observation endoscopic treatment." This clearly indicates a diagnostic purpose.
No
The device description explicitly states it is an "all-in-one cordless endoscope" that includes hardware components like a light source, video processor, and video monitor.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for "airway management, which includes diagnosis, and observation endoscopic treatment. to access airway anatomy, endotracheal/endobronchial intubation and management." This involves direct visualization and intervention within the body, not the examination of samples taken from the body (which is the hallmark of IVD).
- Device Description: The description details an "all-in-one cordless endoscope" with light source, video processor, and video monitor functions. This aligns with an endoscopic device used for internal examination.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
The device is an endoscope used for direct visualization and procedures within the airway.
N/A
Intended Use / Indications for Use
These instruments have been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes diagnosis, and observation endoscopic treatment. to access airway anatomy, endotracheal/endobronchial intubation and management.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 are all-in-one cordless endoscopes with great portability which include light source, video processor, and video monitor functions.
The new endoscopes are basically identical to each predicate device shown in Table 14-1 in intended use, and similar in specifications, performance and materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway anatomy
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
6082720
510(k) SUMMARY
NOV - 5 2008
TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005
September 8, 2008
1 General Information
-
트 Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 북 Official Correspondent: Stacy Abbatiello Kluesner, RAC
Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 Fax: 484-896-7128 Email:stacy.kluesner@olympus.com Establishment Registration No: 2429304 -
Aizu Olympus Co., Ltd. Manufacturer: 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No: 9610595
Device Identification 2
월
| | Device Trade Name: | TRACHEAL INTUBATION FIBERVIDEOSCOPE
LF-Y0004 and LF-Y0005 |
|--|-----------------------|--------------------------------------------------------------|
| | Common Name: | TRACHEAL INTUBATION FIBERVIDEOSCOPE |
| | Regulation Number: | 21 CFR 874.4680 |
| | Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| | Regulatory Class: | II |
| | Classification Panel: | Ear Nose & Throat |
| | Product Code: | EOQ - Bronchoscope (Flexible Or Rigid) |
1
3 Predicate Device Information
The following table shows the primary components of the subject devices and the devices to which we claim substantial equivalence (predicate devices).
| Table 14-1. Primary Components & Predicate Devices | |||||||
|---|---|---|---|---|---|---|---|
| ---------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
| Subject Devices
(Part of this submission) | Predicate Devices | PD's
510(k) No. |
|-------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------|
| TRACHEAL INTUBATION
FIBERVIDEOSCOPE LF-Y0004 | Olympus LF-DP Tracheal Intubation
Fiberscope | K981543 |
| TRACHEAL INTUBATION
FIBERVIDEOSCOPE LF-Y0005 | EVIS EXERA BRONCHOFIBERVIDEO
SCOPE OLYPUS BF TYPE XP160F
Olympus Bronchoscope BF-XT40 | K033225
K023984 |
Device Description ব
The TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 are all-in-one cordless endoscopes with great portability which include light source, video processor, and video monitor functions.
The new endoscopes are basically identical to each predicate device shown in Table 14-1 in intended use, and similar in specifications, performance and materials.
ട് Indications for Use
These instruments have been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes diagnosis, and observation endoscopic treatment. to access airway anatomy, endotracheal/endobronchial intubation and management.
б Comparison of Technological Characteristics
The TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 are basically identical to the predicate device in intended use, and similar in specifications except for the all-in-one unit, outer diameter, and optical system. Comparison between the subject and predicate devices is shown in Table 14-2.
2
Talions : TRACHEAL MTUBATION FIBERVIDEOSCOPE LE-Y0004 and LF-Y000
Trelicate Devices : TRACHEAL NEWS : Present : Prove and LE-Y000
Predicate Devices : TRACHEAL MTUBERVIOR
| Specifications | Subject Device
LF-Y0004 | Subject Device
LF-Y0005 | Predicate Device
LF-DP | Predicate Device
BF-XP160F | Predicate Device
BF-XT40 |
|----------------------------------------|------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------|
| Field of View | 90° | 90° | 90° | 90° | 120° |
| Depth of Field | 4-50mm | 3-50mm | 3-50mm | 2-50mm | 3-50mm |
| Direction of View | 0° (Forward viewing) | 0° (Forward viewing) | 0° (Forward viewing) | 0° (Forward viewing) | 0°(Forward viewing) |
| Outer Diameter
of Distal End | φ3.9mm | φ5.1mm | φ3.1mm | φ2.8mm | φ6.1mm |
| Outer Diameter
of Insertion
Tube | φ4.1mm | φ5.2mm | φ3.1mm | φ2.8mm | φ6.2mm |
| Angulation
UP/DOWN | UP : 120°
DOWN : 120° | UP : 180°
DOWN : 130° | UP : 120°
DOWN : 120° | UP : 180°
DOWN : 130° | UP : 180°
DOWN : 130° |
| Working Length | 600mm | 600mm | 600mm | 600mm | 550mm |
| Source of
examination
light | These are built-in
functions of the
endoscope. | These are built-in
functions of the
endoscope. | External Light Source
Unit | External Light Source
Unit | External Light
Source Unit |
| Video
Processor | | | External Video System
Center Unit (when
connected via Video
Converter Unit) | External Video
System Center Unit | External Video
System Center Unit
(when connected
via Video Converter
Unit) |
| Monitor | | | External Video Monitor
Unit | External Video Monitor
Unit | External Video
Monitor Unit |
3/4
3
7
.
When compared to the predicate device, the TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
:
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Olympus Medical System Corporation c/o Stacy Abbatiello Kluesner Olympus America, Inc 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034
NOV - 5 2008
Re: K082720
Trade/Device Name: Tracheal Intubation Fiberscope LF-Y0004 and LF-Y0005 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOQ Dated: September 16, 2008 Received: September 23, 2008
Dear Ms. Kluesner:
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.
5
Page 2 - Stacy Abbatiello Kluesner
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 10(t) marketed predicate device results in a classification for your device and thus, perrorits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Melvina B. Esguerra, M.D.
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
6
Indications for Use
510(k) Number (if known):
Device Name: TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004, LF-Y0005 Indications For Use:
These instruments have been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concur
(Division Sign-Off)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Number K082720
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