(178 days)
No
The description focuses on the mechanical function of grasping forceps and does not mention any computational or analytical capabilities.
No
The device is described as grasping forceps for tissue manipulation and foreign body retrieval, which are diagnostic or procedural tools, not therapeutic in nature. There is no indication it treats or cures a disease or condition.
No
Explanation: The device is described as grasping forceps used for grasping tissue, retrieving foreign bodies, and excised tissue endoscopically. Its "Intended Use / Indications for Use" and "Device Description" clearly state its function as a tool for physical manipulation and retrieval, not for diagnosing conditions or analyzing medical data.
No
The device description clearly outlines physical components like a flexible shaft, proximal control handle, and distal tip grasping jaws, 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 is to "grasp tissue and/or retrieve foreign body, and excised tissue endoscopically." This describes a physical manipulation of tissue and objects within the body, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a mechanical device with a flexible shaft, handle, and grasping jaws. This aligns with a surgical or procedural tool, not a diagnostic assay or instrument that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples), performing chemical reactions, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical for grasping and retrieval during an endoscopic procedure.
N/A
Intended Use / Indications for Use
The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body, and excised tissue endoscopically.
Product codes
Not Found
Device Description
The Olympus FG-6/7/8/9/42/47-1 grasping forceps are designed for grasping tissue and/or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.
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)
Olympus Pre-Amendment and 510(k) cleared grasping forceps, Olympus FG-Series Rat tooth Grasping Forceps (K955051)
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
K962474
510(k) SUMMARY FOR DEC 20 1996 olympus fg grasping forceps
| Device Name: | Olympus FG-4/14/20/21/22/26/32/38/40/##-1 Grasping Forceps
(Urology) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Grasping Forceps |
| Classification Name: | Endoscope and Accessories
21 CFR 876.1500, Class II |
| Predicate Device: | Olympus Pre-Amendment and 510(k) cleared grasping forceps
Olympus FG-Series Rat tooth Grasping Forceps (K955051) |
| Contact Person: | Barry Sands
Olympus America, Inc.
Endoscope Division
2 Corporate Center Drive
Melville, NY 11747-3157
(516) 844-5474 |
| Summary Preparation Date: | June 17, 1996 |
| Statement of Intended Use: | The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended
to be used to grasp tissue and/or retrieve foreign body, and
excised tissue endoscopically. |
| Device Description: | The Olympus FG-6/7/8/9/42/47-1 grasping forceps are designed
for grasping tissue and/or retrieving foreign body, and excised
tissue under endoscopic visualization. These forceps consist of
a flexible shaft and a proximal control handle. Operation of the
proximal control handle actuates the distal tip grasping jaws. |