(69 days)
1 pre enact., 2
Not Found
No
The summary describes a mechanical device for irrigation and suction, with no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
This device is for irrigation, suction, and viewing a sinus cavity; it is not intended to treat or cure a disease or condition.
No
Explanation: The device is described as a handle for irrigation, suction, and holding a telescope to view the sinus cavity. Its function is to facilitate procedures, not to diagnose conditions.
No
The device description clearly states it is a "Sinus Irrigation / Suction Handle and the accompanying sheath," which are physical hardware components used for irrigation, suction, and holding a telescope. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a surgical instrument used within the sinus cavity for irrigation, suction, and holding a telescope for viewing. It is used in vivo (within a living organism), not in vitro (in a test tube or lab setting).
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information based on biological markers. Its function is procedural and visualization-based.
Therefore, this device falls under the category of a surgical instrument rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Sinus Irrigation / Suction Handle and the accompanying sheath are used to provide a means for rities mass frightin - Subtron - Subtity, a means of suction from the same cavity and a holder for a 4.0mm telescope to view the sinus cavity.
The Sinus Irrigation / Suction Handle can be used in conjunction with laser procedures and may be used with warm (heated) irrigation solutions. One such procedure is the VideoHydrascopic technique developed by Daniel Schuman. MD
Product codes
Not Found
Device Description
The irrigation / suction handle with sheath allows the insertion of a 4 0mm telescope and provides the physician the ability to view, apply irrigation fluids, and suction the cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
No performance data was obtained.
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.
1 pre enact., 2
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
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
NOV 26 1996 11963757
510(k) Summary of Safety and Effectiveness
| Submitted by: | |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | IL 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | September 13. 1996 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | ( 847 ) 913 1113 |
| FAX number (include area code): | ( 847 ) 913 0924 |
| Product Information: | |
| Trade name: | Irrigation/Suction Handle with sheath |
| Model number: | Handle - 8475.221. Sheath - 8475.032 |
| Common name: | Sinus irrigator / suction device |
| Classification name: | irrigator. sinus |
| Information on devices to which substantial equivalence is claimed: |
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre enact. | 1 Suction / irrigation handle 8475.25 | 1 Richard Wolf M.I.C. |
| 2 | 2 Suction / irrigation handle 8475.26 | 2 Richard Wolf M.I.C. |
| 3 | ||
| 4 | ||
| 5 | ||
| 6 |
1.0 Description
The irrigation / suction handle with sheath allows the insertion of a 4 0mm telescope and provides the physician the ability to view, apply irrigation fluids, and suction the cavity.
1
2.0 Intended Use
The Sinus Irrigation / Suction Handle and the accompanying sheath are used to provide a means for rities mass frightin - Subtron - Subtity, a means of suction from the same cavity and a holder for a 4.0mm telescope to view the sinus cavity.
The Sinus Irrigation / Suction Handle can be used in conjunction with laser procedures and may be used with warm (heated) irrigation solutions. One such procedure is the VideoHydrascopic technique developed by Daniel Schuman. MD
3.0 Technological Characteristics
There are no new technological characteristics for the irrigation / suction handle.
4.0 Substantial Equivalence
The irrigation / suction handle is substantially equivalent to prior suction / irrigation handle sold by Richard Wolf Medical Instruments Corporation. The predicate devices are listed in the information box above.
5.0 Performance Data
No performance data was obtained.
6.0 Clinical Tests
No clinical tests were performed.
7.0 Conclusions Drawn
The irrigation / suction handle is substantially equivalent to products currently marketed. particularly devices sold by Richard Wolf.
By:
Robert J. Cacace
Robert L. Casarsa Quality Assurance Manager
Date: Sept 13, 96