(69 days)
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
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.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, or any of the other requested details regarding a medical device. The document is a 510(k) Summary for an "Irrigation/Suction Handle with sheath" from 1996, and it explicitly states:
- "No performance data was obtained."
- "No clinical tests were performed."
The document focuses on establishing substantial equivalence to previously marketed devices based on technological characteristics and intended use, rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, I cannot populate the requested table or answer any of the questions about a study showing the device meets acceptance criteria.
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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.
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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
§ 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.