(185 days)
Not Found
No
The description focuses solely on the mechanical components and intended use of a balloon catheter for ultrasonic imaging, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is described as a balloon sheath used for intraluminal ultrasonic imaging, which is a diagnostic procedure, not a therapeutic one.
Yes
The device performs "intraluminal ultrasonic imaging" which is a diagnostic function used to visualize and assess the gastrointestinal tract wall and surrounding organs.
No
The device description clearly outlines physical components like a balloon, insertion tube, adapter, connector body, rings, and an irrigation port. It is a physical medical device, 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 for "intraluminal ultrasonic imaging of the gastrointestinal tract wall and surrounding organs." This describes a diagnostic imaging procedure performed in vivo (within the living body) to visualize structures.
- Device Description: The device is a balloon sheath designed to be used with an ultrasonic probe. It facilitates the ultrasonic imaging process by providing a medium (water-filled balloon) for better sound transmission and visualization within the gastrointestinal tract.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information about a physiological or pathological state. This device does not perform any analysis on bodily specimens.
Therefore, the MH-246R Balloon Sheath is an accessory used in an in vivo diagnostic imaging procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The balloon sheath MH-246R is designed to be used with the Olympus Ultrasonic Probe UM-2R/3R for intraluminal ultrasonic imaging of the gastrointestinal tract wall and surrounding organs.
Product codes
Not Found
Device Description
The MH-246R Balloon Catheter consists of two section section and connector section. The insertion section is constructed of a balloon with the light shielding cover, insertion tube, and adapter. The connector section consists of a connector body, probe lock ring, sheath lock ring, and irrigation port.
The insertion section is connected to the connector body through a sheath locking ring, while the ultrasonic probe is inserted into the balloon sheath through a probe locking ring. The water filled syringe is connected to the irrigation port via an extension tube and three-way stopcock. The insertion section with the balloon will be provided sterile and intended for single use only. The connector section can be reused after proper cleaning and sterilization as outlined in the instruction manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic imaging
Anatomical Site
gastrointestinal tract wall 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
510 (k) SUMMARY
SEP 16 1996
OLYMPUS MH-246R BALLOON SHEATH
| Device Name: | Olympus MH-246R Balloon Sheath |
|---|---|
| Common/Usual Name: | Balloon Sheath |
| Classification Name: | Endoscope and Accessories |
| Predicate Devices: | Olympus |
| GF-UM2/EU-M2 K872027 | |
| GF-UM-3/EU-M3 K882061 | |
| EUS-20 System K926514 | |
| Submitted By: | |
| (Contact Person) | Mr. Barry Sands |
| Olympus America Inc. | |
| Endoscope Division | |
| Two Corporate Center Drive | |
| Melville, New York 11747-3157 | |
| (516) 844-5474 | |
| Summary Preparation Date: | February 23, 1996 |
Statement of Intended Use
The balloon sheath MH-246R is designed to be used with the Olympus Ultrasonic Probe UM-2R/3R for intraluminal ultrasonic imaging of the gastrointestinal tract wall and surrounding organs.
Device Description
The MH-246R Balloon Catheter consists of two section section and connector section. The insertion section is constructed of a balloon with the light shielding cover, insertion tube, and adapter. The connector section consists of a connector body, probe lock ring, sheath lock ring, and irrigation port.
The insertion section is connected to the connector body through a sheath locking ring, while the ultrasonic probe is inserted into the balloon sheath through a probe locking ring. The water filled syringe is connected to the irrigation port via an extension tube and three-way stopcock. The insertion section with the balloon will be provided sterile and intended for single use only. The connector section can be reused after proper cleaning and sterilization as outlined in the instruction manual.
1
K 96/048
General Safety
When compared to the predicate devices, Olympus MH-246R Balloon Sheath does not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness.