(57 days)
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.
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.
This document is a 510(k) summary for a medical device (electrosurgical tip protector/cleaner) from 1997. It describes the device, its intended use, and its technological characteristics, primarily comparing it to predicate devices to establish substantial equivalence.
Based on the provided text, there is no acceptance criteria or a study proving the device meets acceptance criteria in the way typically understood for modern AI/ML medical devices. This document predates the widespread use of such devices and the specific regulatory guidance around their performance evaluation. Instead, the submission relies on establishing "substantial equivalence" to existing, legally marketed predicate devices.
Therefore, most of the requested fields cannot be populated as there were no explicit performance studies or acceptance criteria defined in this submission as would be expected for a contemporary AI device.
Here's an attempt to address your request based only on the provided text, noting where information is absent:
Acceptance Criteria and Device Performance
For this 1997 510(k) submission, the "acceptance criterion" is implicitly demonstrating substantial equivalence to predicate devices. There are no specific quantitative performance metrics defined for this type of electrosurgical tip cleaner in the document.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate devices (Devon Cautery Tip Polisher, Product - K803055 and similar products on the market) in terms of: - Intended Use - Technological Characteristics (materials, design, abrasive surface) | The "Cygnus Electrosurgical Tip Protector" is stated to have the "same intended use" as predicate devices and "similar devices products currently cleared for marketing." The "composition and technological characteristics" are stated to be "the same as those for the predicate devices." Descriptive performance information is stated to show "that the materials of which the Cygnus product is made, is nearly identical to those of similar products currently on the market." The #60 Aluminum Oxide Impregnated Vinyl Grit Sheet abrasive surface is stated to have "proven to be effective" for over fifteen years in existing products. |
Detailed Study Information (Based on provided text):
Since this is a 510(k) submission for a non-AI/ML device based on substantial equivalence, the following sections either do not apply or the information is not present in the provided text.
- Sample size used for the test set and the data provenance: Not applicable. There was no specific "test set" for performance evaluation in the context of an AI/ML device. Substantial equivalence was based on direct comparison of characteristics and known performance of similar materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a test set in this context.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission was the established safety and effectiveness of the predicate devices and the known properties of the materials used.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Summary of Approach in the Document:
The 510(k) submission relies on the "510(k) Substantial Equivalence Decision-Making Process." The argument for substantial equivalence is based on:
- Identical Intended Use: The device is for cleaning electrosurgical instrument tips, which is the same as predicate devices.
- Similar Technological Characteristics: The materials (polyurethane ester foam, aluminum oxide grit sheet, adhesive, X-ray detectable rod) used are either the same as or nearly identical to those in predicate and currently marketed devices.
- Known Efficacy of Materials: The abrasive material (#60 Aluminum Oxide Impregnated Vinyl Grit Sheet) has a proven history of effectiveness for over fifteen years.
- Manufacturing and Sterilization: These processes are consistent with established medical device practices.
The submission is essentially a comparison report rather than a performance study with defined acceptance criteria and human-involved evaluations for an AI solution.
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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.
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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.
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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
§ 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.