(84 days)
Not Found
No
The description focuses on mechanical grasping and retrieval under direct visualization, with no mention of AI/ML terms or functions.
No
The device is used to retrieve foreign bodies and excised tissue; it does not treat or cure a disease or condition.
No
Explanation: The device description states its purpose is to retrieve foreign bodies and excised tissue; there is no mention of analysis or diagnosis.
No
The device description clearly states it consists of a flexible shaft and a proximal control handle, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "retrieve foreign bodies, excised tissue, etc., endoscopically." This describes a procedure performed within the body (in vivo) for retrieval purposes.
- Device Description: The description details a mechanical device for grasping and retrieving objects under endoscopic visualization. This is a surgical/interventional tool, not a device used to examine samples outside the body (in vitro).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components of an IVD.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical retrieval during an endoscopic procedure.
N/A
Intended Use / Indications for Use
The Olympus basket graspers are intended to be used to retrieve foreign bodies, excised tissue, etc., endoscopically.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Olympus basket graspers are designed to retrieving foreign body, excised tissue, etc., under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the grasping basket.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Olympus FG Basket Grasper Forceps (K955063)
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
> \ \ \ X96
JUL 18 1996 510(k) SUMMARY
FOR OLYMPUS FG BASKET GRASPING FORCEPS
| Device Name: | Olympus FG-16/17/18/19/22/23/24-1 Grasping Forceps
(Urology) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Basket Graspers |
| Classification Name: | Endoscope and Accessories
21 CFR 876.1500, Class II |
| Predicate Device: | Olympus pre-Amendment and 510(k) cleared grasping forceps
Olympus FG Basket Grasper Forceps (K955063) |
| Contact Person: | Barry Sands
Olympus America, Inc.
Medical Instrument Division
2 Corporate Center Drive
Melville, NY 11747-3157
(516) 844-5474 |
| Summary Preparation Date: | March 18, 1996 |
| Statement of Intended Use: | The Olympus basket graspers are intended to be used to retrieve
foreign bodies, excised tissue, etc., endoscopically. |
| Device Description: | The Olympus basket graspers are designed to retrieving foreign
body, excised tissue, etc., under endoscopic visualization.
These forceps consist of a flexible shaft and a proximal control
handle. Operation of the proximal control handle actuates the
grasping basket. |