(186 days)
No
The summary describes a mechanically scanning ultrasound endoscope and its intended use for imaging and guided procedures. There is no mention of AI or ML in the device description, intended use, or the sections specifically checked for these terms. The focus is on the mechanical design and imaging capabilities.
No
The device is used for imaging and guided aspiration, which are diagnostic and procedural functions, not therapeutic.
Yes
The device is intended for "endoscopic ultrasound imaging" and "Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) to acquire submucosal tissue," which are diagnostic procedures to visualize and sample internal tissues to aid in diagnosis.
No
The device description clearly details a physical endoscope with specific dimensions and a scanning mechanism, indicating it is a hardware device.
Based on the provided text, the Olympus GF-UM30P Ultrasonic Endoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for imaging and guided procedures (FNA) within the gastrointestinal tract and surrounding organs. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue samples to diagnose or monitor conditions.
- Device Description: The description details an endoscope, which is inserted into the body. It uses ultrasound technology to image internal structures. This is consistent with an in vivo diagnostic and procedural device, not an in vitro diagnostic device.
- Anatomical Site: The specified anatomical sites are internal organs and structures, not biological specimens being analyzed in a lab.
Therefore, the Olympus GF-UM30P Ultrasonic Endoscope is an in vivo medical device used for diagnostic imaging and guided procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Olympus GF-UM30P Ultrasonic Endoscope is intended to be used in combination with the Ultrasound System, EU-M20, for endoccopic ultrasound inaging of the gastrointestinal tract wall, billiary and pancreatic duct, and surrounding organs. This instrument also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) to acquire submucosal tissue.
Product codes
Not Found
Device Description
In examining the GI tract, endoscopic ultrasound may be indicated. The conventional type ultrasound endoscope does not provide the capability for ultrasonic guidance of endoscopic accessories (i.e. biopsy forceps, aspiration biopsy needles, etc.) The mechanically radially scanning GF-UM30P ultrasound endoscope provides this capability since the direction of the sonographic scan coincides with the geometric plane in which the accessory enters.
The subject devices operates in B mode using the de-aerated water immersion or balloon contact method and offers a 250° scan. The outer diameter of the insertion tube is 11.7 mm and it's working length is 1265 mm.
Both subject and predicate devices have similar design, construction, intended use, and method of operation. The only difference between the two is that the subject device's scanning plane is parallel, rather than perpendicular, to the axis of the insertion tube. The Olynpus Endoscopic Ultrasound System. EU-M20, received marketing clearance in the 510(k) # K926514.
The MAJ-213 Balloon will be provided clean and should be EtO sterilized before use. The balloon is intended for single use only and should be discarded after use. All other components and related ancillary equipment of the subject device will be marketed non sterile and can be reprocessed as described in the Instruction Manuals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
gastrointestinal tract wall, billiary and pancreatic duct, and surrounding organs
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ATTACHMENT I
510(K) SUMMARY
OLYMPUS GF TYPE UM30P ULTRASONIC ENDOSCOPE
Device Name: Olympus GF-UM30P Ultrasonic Endoscope and related ancillary equipment
Olympus Ultrasonic Endoscopes Common/Usual Name:
Classification Name: Endoscope and Accessories
GF/JF/CF-UM20 (K926514) Predicate Devices:
Submitted By: Mr. Subhash Patel Olympus America Inc. (Contact Person) Regulatory Affairs 2 Corporate Center Drive Melville, NY 11747 (516) 844-5481
Summary Preparation Date: January 27, 1997 (revised)
Statement of Intended Use:
The Olympus GF-UM30P Ultrasonic Endoscope is intended to be used in combination with the Ultrasound System, EU-M20, for endoccopic ultrasound inaging of the gastrointestinal tract wall, billiary and pancreatic duct, and surrounding organs. This instrument also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) to acquire submucosal tissue.
Device Descripton
In examining the GI tract, endoscopic ultrasound may be indicated. The conventional type ultrasound endoscope does not provide the capability for ultrasonic guidance of endoscopic accessories (i.e. biopsy forceps, aspiration biopsy needles, etc.) The mechanically radially scanning GF-UM30P ultrasound endoscope provides this capability since the direction of the sonographic scan coincides with the geometric plane in which the accessory enters.
The subject devices operates in B mode using the de-aerated water immersion or balloon contact method and offers a 250° scan. The outer diameter of the insertion tube is 11.7 mm and it's working length is 1265 mm.
Both subject and predicate devices have similar design, construction, intended use, and method of operation. The only difference between the two is that the subject device's scanning plane is parallel, rather than perpendicular, to the axis of the insertion tube. The Olynpus Endoscopic Ultrasound System. EU-M20, received marketing clearance in the 510(k) # K926514.
The MAJ-213 Balloon will be provided clean and should be EtO sterilized before use. The balloon is intended for single use only and should be discarded after use. All other components and related ancillary equipment of the subject device will be marketed non sterile and can be reprocessed as described in the Instruction Manuals.