(57 days)
No
The device description and intended use clearly describe a passive, physical cleaning pad for electrosurgical instruments. There is no mention of any software, data processing, or learning capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device's intended use is to clean surgical instruments, not to directly treat a medical condition or ailment in a patient.
No
Explanation: The device is described as a surface for cleaning the tips of electrosurgical instruments, not for diagnosing any medical condition.
No
The device description clearly outlines physical components (polyurethane ester foam, grit sheet, adhesive, X-Ray detectable rod) and manufacturing processes (lamination, sterilization), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing a surface for cleaning electrosurgical instrument tips during surgery. This is a physical cleaning function performed on a surgical instrument, not a diagnostic test performed on a biological sample.
- Device Description: The description details the physical components of the device (foam, grit sheet, adhesive, X-Ray detectable rod). There is no mention of reagents, assays, or any components designed to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's health status
- Using laboratory procedures
The device is a surgical accessory used to maintain the functionality of another surgical instrument.
N/A
Intended Use / Indications for Use
The primary purpose of the device is to provide a convenient and effective surface for cleaning the tips of electrosurgical cutting and coagulation instruments. The design of the pad is such that the device may be used during surgery and in conjunction with the electrosurgical instrument.
Product codes
Not Found
Device Description
The body of the device is constructed of a polyurethane ester foam. A grit sheet is laminated to the top surface of the foam, and a pressure sensitive adhesive and release liner laminated to the base of the pad. An X-Ray detectable rod is placed between the pressure sensitive adhesive and the foam. The device is available in three sizes. Each pad is individually wrapped and sterilized for use. Sterilization will be by Gamma Ray or ETO and will be conducted and certified by a contract sterilization firm.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
M. SAFE MEDICAL DEVICES ACT OF 1990 STATEMENT OF SAFETY AND EFFECTIVENESS.
FEB 1 4 1997 "510(k) Summary" December 1, 1996 Contact person: Shaun Sweeney (203) 265-9550 phone (203) 265-9961 fax
"Cygnus Electrosurgical Tip Protector" Trade Name : Electrosurgical, Cautery Tip Cleaner Common Name: Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories (per 21 CFR section 878.4400).
Predicate device: Manufacturer Devon Industries, CA
Devon Cautery Tip Polisher, Product -510(k) Number - K803055
General and Plastic Surgery Device Panel Classification - Class II Requlatory Citation - 21 CFR ch 1 (4-1-95)
M.1 Product Description
The body of the device is constructed of a polyurethane ester foam. A grit sheet is laminated to the top surface of the foam, and a pressure sensitive adhesive and release liner laminated to the base of the pad. An X-Ray detectable rod is placed between the pressure sensitive adhesive and the foam. The device is available in three sizes. Each pad is individually wrapped and sterilized for use. Sterilization will be by Gamma Ray or ETO and will be conducted and certified by a contract sterilization firm.
м.2 Intended Use of the Device
The primary purpose of the device is to provide a convenient and effective surface for cleaning the tips of electrosurgical cutting and coagulation instruments. The design of the pad is such that the device may be used during surgery and in conjunction with the electrosurgical instrument.
1
Instructions for Use м.3
- Peel open sterile pouch and remove device. 1.
- Remove pressure sensitive adhesive from base of pad. 2.
- Affix the polishing pad to a drape, mayo stand or 3. the most convenient surface area.
- Stroke electrosurgical blade across the abrasive 4 . surface to clean.
- After use, dispose of pad in a Biohazards container. 5.
M.4 Technological Characteristics
The technological characteristics of the Cygnus Electrosurgical Tip Cleaner are identical to the predicate devices listed as well as a number of other manufacturers producing this type of product. The self-adhering pad design makes the device convenient and flexible to use. As an abrasive surface, the #60 Aluminum Oxide Impregnated Vinyl Grit Sheet has been in use for over fifteen years and has proven to be effective.
- The "510(k) Substantial Equivalence" Decision-Making M - 5 Process (detailed) from ODE Guidance Memorandum #86-3 was followed.
These products have the same intended use (namely to A. be used as an abrasive cleaning pad) as the predicate They also have the same intended use as similar devices. products currently cleared for marketing by the 510(k) process.
The composition and technological characteristics for B. the new Cyqnus device are the same as those for the predicate devices.
Descriptive performance information provided shows C. that the materials of which the Cygnus product is made, is nearly identical to those of similar products currently on the market.
Sufficiently precise specifications for the materials D. of which Cygnus products are constructed have been supplied. These specifications are summarized including comparison with comparative materials.
E. Characteristics of the material used in construction was compared to that of Sybron Medical Products (now marketed by ConMed, Devon Industries and C.R. Bard.
F. Thus, we believe we have supplied sufficient data to show that the CYGNUS products are substantially equivalent to the originally classified device under (CFR 778.4400) and to devices currently on the market, cleared by the 510(k) process.
2
Having followed the "510(k) Substantial Equivalence" Decision-Making process we feel we have supplied sufficient data to show that the Cyqnus Device is substantially equivalent to the originally classified device under (CFR 778.440) and to predicate devices currently being marketed. Your prompt attention to this premarket notification--510(k) will be sincerely appreciated. If there are questions or clarification needed, please call me at 201-827-9333.
Sincerely yours,
Ben Sweeney
Shaun Sweeney Regulatory Affairs Manager