(167 days)
KD-1/2, PK, KD-6G
Not Found
No
The device description focuses on mechanical and electrical components for endoscopic sphincterotomy and does not mention any AI/ML related terms or functionalities.
Yes
The device is used to perform endoscopic sphincterotomy, which is a medical procedure to treat a condition. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a sphincterotome, designed to perform endoscopic sphincterotomy, which is a therapeutic cutting procedure, not a diagnostic one.
No
The device description clearly outlines physical components like a control handle, flexible catheter-like tube, distal end knife wire, and electrical connections, 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 "perform endoscopic sphincterotomy of the papilla of Vater." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a surgical instrument with a knife wire for cutting tissue. This is consistent with a surgical device, not a device used to examine specimens in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used directly on the patient's tissue during a surgical procedure.
N/A
Intended Use / Indications for Use
The KD sphincterotomes and the predicated devices are all
designed specifically to perform endoscopic sphincterotomy of
the papilla of Vater
Product codes
Not Found
Device Description
The KD sphincterotomes and the predicated devices are all
designed specifically to perform endoscopic sphincterotomy of
the papilla of Vater. The KD sphincterotomes consist of three
primary parts: a proximal end control handle, a flexible catheter-
like tube, and a distal end knife wire. The catheter shaft contains
a thin steel wire that exits the catheter shaft for a short length and
then re-enters the shaft. The exposed wire is referred to as the
knife wire. The knife wire may be either tensioned or pushed to
position the wire for cutting. This is accomplished by
maneuvering the control handle slider accordingly. The
detachable control handle contains the electrical connections
which permit the knife wire to be connected to an electrosurgical
generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
papilla of Vater
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 KD-1/2 pre-Amendment Diathermic Cutters, Olympus PK Papillotomy Knives, and Olympus KD-6G Sphincterotomes
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
955247
510(k) Summary for Olympus KD Series of Sphincterotome
APR 30 1996
| Device Name: | Olympus KD Sphincterotome |
|---|---|
| Common/Usual Name: | Sphincterotome |
| Classification Name: | Endoscope Electrosurgical Unit and Accessories |
| 21 CFR 876.4300 | |
| Predicate Devices: | Olympus KD-1/2 pre-Amendment Diathermic Cutters, Olympus |
| PK Papillotomy Knives, and Olympus KD-6G Sphincterotomes | |
| Contact Person: | Barry Sands |
| Olympus America, Inc. | |
| Medical Instrument Division | |
| 2 Corporate Center Drive | |
| Melville, NY 11747-3157 | |
| (516) 844-5474 | |
| Summary Preparation Date: | 6 October 1995 |
| Statement of Intended Use: | The KD sphincterotomes and the predicated devices are all |
| designed specifically to perform endoscopic sphincterotomy of | |
| the papilla of Vater | |
| Device Description: | The KD sphincterotomes and the predicated devices are all |
| designed specifically to perform endoscopic sphincterotomy of | |
| the papilla of Vater. The KD sphincterotomes consist of three | |
| primary parts: a proximal end control handle, a flexible catheter- | |
| like tube, and a distal end knife wire. The catheter shaft contains | |
| a thin steel wire that exits the catheter shaft for a short length and | |
| then re-enters the shaft. The exposed wire is referred to as the | |
| knife wire. The knife wire may be either tensioned or pushed to | |
| position the wire for cutting. This is accomplished by | |
| maneuvering the control handle slider accordingly. The | |
| detachable control handle contains the electrical connections | |
| which permit the knife wire to be connected to an electrosurgical | |
| generator. |