(86 days)
Not Found
No
The summary describes a standard endoscope and its intended use, with no mention of AI, ML, or advanced image processing beyond basic video capture.
No.
The device is described as an endoscope for observation and an instrument for endoscopic surgery, but the provided text does not mention any therapeutic function of the device itself. The mention of "endo-therapy accessories(such as a biopsy forceps)" suggests that other tools, not the device itself, would be used for therapy.
Yes
The device is described as an "endoscope for observation within nasal and nasopharyngeal lumen," which implies it is used to visualize internal body structures for diagnostic purposes. It works with a video system, further supporting its role in providing visual information for diagnosis.
No
The device description clearly states it is an "endoscope" and describes physical components like a light source and light cable, 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 describes the device as an instrument for endoscopy and endoscopic surgery within the thoracic and abdominal cavities. This involves direct visualization and potentially therapeutic interventions within the body.
- Device Description: The device is described as an endoscope for observation within nasal and nasopharyngeal lumen. This is a tool for direct visualization of internal body structures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The device is clearly intended for direct visualization and potentially intervention within the body, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
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, video monitor, endo-therapy accessories(such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
This subject device "XENF-DP Rhino-Laryngofiberscope" is the endoscope for observation within nasal and nasopharyngeal lumen. This endoscope enables two ways of light source, detachable and single use battery powered and light cable source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and nasopharyngeal lumen
thoracic and abdominal cavities
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.
#K955403, #K950103, #K930215, #K915857
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
510(k) SUMMARY
JAN 3 0 2002
K013617 1/2
LTF-240 Pleuravideoscope, its accessories and ancillary equipment
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section807.92.
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 :
Address, Phone and Fax
Olympus Optical Co., Ltd. 2-3-1 Shinjuku Monolis Nishi-shinjuku Shinjuku-ku, Tokyo, 163-0914 Japan 810047 2951 Ishikawa-cho Hachioii-shi. Tokyo 192-8507 Japan TEL 81-426-42-5177 FAX 81-426-46-5613
Ms.Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631)844-5688 FAX (631) 844-5416
B. Device Name, Common Name
-
- Device Name :
-
- Common/Usual Name :
-
- Classification Name :
LTF-240 Pleuravideoscope, its accessories and ancillary equipment
Video Scope for Pleuravideoscope
21CFR 884.1720 21CFR 876.1500
1
C. Predicate Devices:
| Model | Device Description &
410(k)#/Date of Cleared | Manufacturer | Class |
|------------------------------------------|-------------------------------------------------|-----------------------|-------|
| OES Laparo-Thoracoscope
LTF-V | #K955403 | Olympus Optical Co., | II |
| Laparoscope,
Hand Instruments | #K950103 | Olympus America, Inc. | II |
| Flexible Trocar Tubes | #K930215 | Olympus Optical Co., | II |
| Flexible Tip
Thoracoscope/Laparoscope | #K915857 | Olympus Optical Co., | II |
Summary Description of the Device D.
1. Summary
This subject device "XENF-DP Rhino-Laryngofiberscope" is the endoscope for observation within nasal and nasopharyngeal lumen. This endoscope enables two ways of light source, detachable and single use battery powered and light cable source.
2. Design
"XENF-DP Rhino-Laryngofiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601-1 and IEC60601-2-18.
3. Materials
There are no new patient-contacting materials. All of patient contact materials are cleared by previous 510(k) submissions.
Intended Use of the device E.
This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, and other ancillary equipment of endoscopic diagnosis with the nasal and nasopharyngeal lumen.
F. Technological Characteristics
This endoscope does not have special technological characteristics, when compared to the predicate device.
G. Reason for not requiring clinical data
The subject device, LTF-240, is basically identical to the LTF-V laparoscopic thoracoscope, which is a flexible endoscope indicated for use in the thoracic and abdominal cavities, with the exception being that the LTF-V is not indicated for electrosurgery applications.
Historically, electrosurgery within the thoracic and abdominal cavities has been performed using a rigid endoscope. The use of the subject device, which is a flexible endoscope, should present no differences in safety or efficacy when compared to the predicate devices for electrosurgical applications.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Olympus Optical Company, Ltd. c/o Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747
Re: K013617
Trade/Device Name: LTF-240 Pleuravideoscope, accessories and ancillary equipment Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 1, 2001 Received: November 5, 2001
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to may 20, 2015, 10:10 accordance with the provisions of the Federal Food, Drug, de rices that have occh require approval of a premarket approval application (PMA). and Cosmetion (110. (110.) that the device, subject to the general controls provisions of the Act. The r ou may, dierelove, manier the act include requirements for annual registration, listing of general controls provisions of vactice, 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 If your device is etablined too as controls. Existing major regulations affecting your device can may oe subject to back additions, 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 r lease be deviced that I Dr mination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I odolar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fart 6077, laboring (21 CFR Part 820); and if applicable, the electronic for the qualis) by becam (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms. Laura Storms-Tyler
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maing of substantial equivalence of your device to a legally premits that in the Pro Pro maining of casion 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 If you desire specific advice for your witto diagnostic devices), please contact the Office of additionally 21 CHC Fur 80711 Additionally, for questions on the promotion and advertising of Compliance at (301) 591 1037. Transe Compliance at (301) 594-4639. Also, please note the your dovice, prease occident by reference to premarket notification" (21CFR Part 807.97). Tegulation chitted, "Nisoranaing of esponsibilities under the Act may be obtained from the Oincl general information on your responsional 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,
Miriam C. Provost
Cor Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
OLYMPUS!
Indication for Use Statement
510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________ Not assigned y LTF-240 Pleuravideoscope, its accessories and Device Name: ancillary equipment.
Indications for Use:
This instrument has been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories(such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities.
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K013617
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
(Prescription 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)