(143 days)
Not Found
No
The description focuses on a mechanical guide sheath and its use with existing imaging modalities and accessories, with no mention of AI/ML capabilities for image analysis, guidance, or other functions.
No.
The device description states it is used for "performing diagnostic and therapeutic procedures" and helps guide accessories or probes to targeted lesions. However, the device itself is a "Guide Sheath" and acts as an accessory to guide other instruments, rather than directly performing a therapeutic intervention. It facilitates therapeutic procedures but is not a therapeutic device in itself.
Yes
The 'Device Description' states that the Guide Sheath is "for performing diagnostic and therapeutic procedures" and helps "guide the ultrasonic probe precisely to the targeted lesions repeatedly" for diagnostic purposes. The 'Input Imaging Modality' section also lists X-ray and Ultrasound, both of which can be used for diagnostic imaging.
No
The device description explicitly states it consists of a tube sheath and a fluoro tip, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to guide instruments within the respiratory organs for diagnostic and therapeutic procedures. This is an in vivo (within a living organism) procedure, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description focuses on the physical components and how it facilitates the placement of other instruments within the body.
- Input Imaging Modality: While it uses X-ray and Ultrasound, these are imaging modalities used during the procedure on the patient, not for analyzing samples outside the body.
- Anatomical Site: The device is used within the respiratory organs of a patient.
- Predicate Device: The predicate device listed is a Cytology Brush, which is used to collect cells from the body, but the guide sheath itself is not performing the diagnostic analysis of those cells.
IVD devices are typically used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device is a tool used inside the body to facilitate other procedures.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area within the respiratory organs.
Product codes
EOQ
Device Description
Olympus Medical Systems Corp., intends to introduce the Guide Sheath for use in the respiratory organs. This Guide Sheath,XBO1-836-13 has been designed to be used with Olympus bronchoscopes with 2.8 mm instrument channel, accessories and ultrasonic probe unit for performing diagnostic and therapeutic procedures. The Guide Sheath allows physicians to advance the endo-therapy accessories or guide the ultrasonic probe precisely to the targeted lesions repeatedly.
This Guide Sheath, XBO1-836-13 consists of tube sheath and piece of flouro tip, which shows the distal end position when X-ray was monitored. The following is the specification of the Guide Sheath:
| Specifications | Dimension (m) |
|---|---|
| Outer Diameter | 2.7 |
| Inner Diameter | 2.1 |
| Sheath Length | 900 |
| Channel Size (Minimum φ) | 2.8 |
| Fluoro Tip for X-ray monitor | Provided |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
respiratory organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
Olympus sponsored prospective clinical evaluation of the subject device which support the safe and effective use of the subject device for its intended use.
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
§ 874.4680 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
January 23 , 2006
SMDA 510(k) SUMMARY "Olympus Guide Sheath, XBO1-836-13 "
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.
A. GENERAL INFORMATION
| 1. Applicant : | Olympus Medical Systems Corporation
2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan
Registration number :8010047 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Official Correspondent : | Laura Storm-Tyler
Executive Director, Regulatory Affairs and Quality Assurance
Olympus America Inc.
Two Corporate Center Drive, Melville, NY 11747-9058, USA
TEL 631-844-5688
FAX 631-844-5554
Registration Number :2429304 |
| 3. Manufacturer : | Aomori Olympus Co., Ltd.
2-248-1 Okkonoki Kuroishi-shi, Aomori-ken,
036-0357, Japan
Registration Number : 9614641 |
B. DEVICE IDENTIFICATION
| 1. Common/Usual Name : | Bronchoscope accessory |
|---|---|
| 2. Device Name : | Olympus Guide Sheath, XBO1-836-13 |
| 3. Classification Name : | 874.4680, class II , EOQ |
C. PREDICATE DEVICES
| Device Name | 510(k) # | Manufacturer | Class | Product
Code |
|---------------------------------------------------|----------|-------------------------|-------|-----------------|
| Cytology Brush: BC-14/15/16C
(EVIS 200 System) | #K931154 | Olympus
Corporation. | II | EOQ |
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D. SUMMARY DESCRIPTION OF THE DEVICE
1. Summarv
Olympus Medical Systems Corp., intends to introduce the Guide Sheath for use in the respiratory organs. This Guide Sheath,XBO1-836-13 has been designed to be used with Olympus bronchoscopes with 2.8 mm instrument channel, accessories and ultrasonic probe unit for performing diagnostic and therapeutic procedures. The Guide Sheath allows physicians to advance the endo-therapy accessories or guide the ultrasonic probe precisely to the targeted lesions repeatedly.
2. Materials
The patient contacting materials used as components of the Guide Sheath are identical to legally Marketed Olympus products.
E. SUMMARY
In summary, the Guide Sheath, XBO1-836-13 is basically identical to the predicate device in performance, materials and specifications. The subject device differs from the predicate device relative to the intended use.
F. INTENDED USE OF THE DEVICE
This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the targeted area within the respiratory organs.
G. TECHNOLOGICAL CHARACTERISTICS
This Guide Sheath, XBO1-836-13 consists of tube sheath and piece of flouro tip, which shows the distal end position when X-ray was monitored. The following is the specification of the Guide Sheath:
| Specifications | Dimension (m) |
|---|---|
| Outer Diameter | 2.7 |
| Inner Diameter | 2.1 |
| Sheath Length | 900 |
| Channel Size (Minimum $\phi$ ) | 2.8 |
| Fluoro Tip for X-ray monitor | Provided |
H. CLINICAL DATA
Olympus sponsored prospective clinical evaluation of the subject device which support the safe and effective use of the subject device for its intended use.
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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 eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2006
Olympus Medical Systems Corporation c/o Ms. Laura Storm-Tyler Two Corporate Center Dr. Melville, NY 11747-9058
Re: K060243
Trade/Device Name: Olympus Guide Sheath. XBO1-836-13 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories (flexible or rigid) Regulation Class: II Product Code: EOQ Dated: May 30, 2006 Received: May 31, 2006
Dear Ms. Storm-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.
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Page 2 - Ms. Laura Storm-Tyler
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 Iogally marketed predicate device results in a classification for your device and thus, perceits your evice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note (21 cm regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
M.B. Eychler-SiMD
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
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Indications for Use Statement
510(k) Number (if known) :
Device Name: Olympus Guide Sheath, XBO1-836-13
Indications for Use :
This instrument has been designed to be used with Olympus bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area within the respiratory organs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Karen t. Baker
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K060243
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