(63 days)
The Golden Tip™ Electro-Surgical Probe is an electrocautery electrode and intended for use in open surgical procedures.
The Golden Tip™ Electro-Surgical Probe is a conventional electrosurgical instrument to which is applied electrical energy in the form of a radio-frequency signal for purposes of cauterizing or cutting during a surgical procedure.
The provided text describes the submission for a 510(k) premarket notification for "The Golden Tip™ Electro-Surgical Probe." This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving performance against them in the way a clinical trial for a novel, high-risk device might.
Therefore, many of the requested categories in your prompt are not applicable or cannot be fully answered from the provided text. This device is an electrosurgical probe, which is a common, well-understood technology, and the submission emphasizes non-clinical testing and comparison to existing products.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Electrode Functional Performance: Proper function, no damage at recommended power levels during cutting and cauterizing. | Performed properly on beef steaks, chicken breasts, and beef liver steaks. No electrode damage occurred. | This is a pass/fail criterion based on observation during simulated use. The specific "power levels" are not quantified. |
| Assembly Testing: Proper assembly into common electrosurgical pencils; appropriate removal force; satisfactory force required to separate electrode tip from shaft. | Assembled properly into Valley Lab, Aspen Labs, Birtcher, Conmed, and other standard 3-terminal receiver pencils. Exhibited appropriate removal force. Met performance requirements satisfactorily for tip/shaft separation. | Criteria are qualitative ("properly," "appropriate," "satisfactorily") and indicate compliance with design intent. Specific force values are not provided. |
| Electrical Insulation: Meet ANSI/AAMI HF-18/1993, Section 4.2.5.4 requirements for insulation at low and radio frequencies. | Passed all test requirements for electrical insulation at both low frequency and radio frequency. | This is a pass/fail criterion against a recognized standard. |
| Safety and Effectiveness (General): No design characteristics violating Reviewer Guidance or resulting in safety hazards. | None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. | General compliance statement based on the sum of testing. |
| Substantial Equivalence: Equivalent in intended use, design, material, and technology to predicate device (MegaDyne). | Concluded to be substantially equivalent in intended use, design, material, and technology as the MegaDyne ElectroSurgery Electrode. | This is the overarching "acceptance criterion" for a 510(k) submission. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Functional Testing: Not specified as a numerical count of probes. It refers to "All Golden Tip™ Electro-Surgical Probes" and various "steaks" and "breasts." This suggests a qualitative, rather than large statistical, sample.
- Data Provenance: The tests were conducted "in the laboratory" and "on dogs" (pre-clinical performance). This indicates prospective testing, likely in the USA (given the submission to the FDA). No information on the country of origin of the biological samples or dogs themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document does not mention experts being used to establish a "ground truth" for the non-clinical tests described. The assessment of proper function, assembly, and insulation would have been based on engineering measurements, observations by technicians, and adherence to standards.
- The "pre-clinical performance was tested on dogs, using surgical procedures." While this implies the involvement of animal surgeons or veterinarians, their specific number or qualifications are not stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This type of formal adjudication process (e.g., for interpreting images or clinical outcomes) is not applicable to the non-clinical tests described. The results are likely direct measurements or observations against predefined technical specifications or functional requirements.
5. 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
- No MRMC study was conducted. This device is a surgical instrument, not an imaging analysis AI or diagnostic tool. The concept of "human readers improving with AI" is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical electrosurgical probe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical functional tests: The "ground truth" was the physical behavior of the device (cutting, cauterizing, not sticking, not damaging) and performance against engineering specifications (assembly, electrical insulation).
- For the pre-clinical dog tests: The "ground truth" would be the observed surgical and physiological effects in the animal model, likely assessed by the veterinary surgical team against expected outcomes for electrosurgery. Specific details are not provided beyond "testing specifications were met."
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
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FEB 1 1999
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Exhibit #1 3 Pages
510 (K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
1. Submitter's Identification:
Joshua Urueta, M.D. President/CEO Amada Surgical Inc. 7010 S. Santa Clara Avenue Tucson, AZ 85706
Date Summary Prepared:
November 24, 1998
2 . Name of the Device:
The Golden Tip™ Electro-Surgical Probe
3. Predicate Device Information:
The Golden Tip™ Electro-Surgical Probe is "substantially equivalent" to: 1) Valley Lab Coated Electrodes, K#962044, 2) Davis-Bayonet ™ Electrodes, K#96402, 3) MegaDyne ElectroSurgery Electrode, K#903302, MegaDyne Medical Products, Inc.
4 . Device Description:
The Golden Tip™ Electro-Surgical Probe is a conventional electrosurgical instrument to which is applied electrical energy in the form of a radio-frequency signal for purposes of cauterizing or cutting during a surgical procedure.
5. Intended Use:
The Golden Tip™ Electro-Surgical Probe is an electrocautery electrode and intended for use in open surgical procedures.
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Comparison to Predicate Devices: 6.
The Golden Tip™ Electro-Surgical Probe is substantially equivalent to electro surgical probes currently marketed by manufacturers holding 510(k) clearance. Predicate devices currently marketed include electro-surgical electrodes with various coatings such as silicone and/or a nickel-phosphorous matrix. The Golden Tip™ Electro-Surgical Probe intended to be marketed by Amada Surgical Inc. offers a gold and teflon coating.
Discussion of Similarities and Differences:
The Golden Tip™ Electro-Surgical Probe is similar in intended use, principle of operations, etc. to the MegaDyne Medical Products, Inc. Electrosurgery electrode, K#903302. Intended use of the MegaDyne device is "Electrocautery Electrode for Surgical Procedures." The Golden Tip™ coated electrode blade is gold and teflon coated and is substantially equivalent to the MegaDyne teflon coated electrode.
The Golden Tip™ is similar in structural design to the MegaDyne probe with the exception that the Golden Tip™ uses a gold and teflon coated tip. This process allows for better electrical conductivity to cut flesh and cauterize, while allowing easy passage of the blade through the flesh without sticking and permitting easier cleaning of the blade while reducing surgery time.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Golden Tip™ Electro-Surgical Probe in the intended environment of use is supported by testing that was conducted in accordance with the FDA October 1993 Draft "510(k) Guideline for General Surgical Electrosurgical Devices", which outlines performance requirements.
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards.
1. Electrode Functional Testing:
Functional tests were performed on beef steaks, chicken breasts and beef liver steaks in the laboratory. All Golden Tip™ Electro-Surgical Probes performed properly and no electrode damage occurred at recommended power levels.
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2. Assembly Testing:
All Golden Tip™ Electro-Surgical Probes are assembled properly into the following electrosurgical pencils:
Valley Lab, Aspen Labs, Birtcher, Conmed, and other pencils (handswitch universal) that utilize the standard 3-terminal receiver. All have exhibited an appropriate removal force. The force required to separate the Electrode Tip from the Electrode Shaft have met performance requirements satisfactorily.
We certify that the Golden Tip™ Electro-Surgical Probe is designed to meet all applicable requirements of the ANSI/AAMI HF-18/1993 specifically, Section 4.2.5.4, American National Standard for Electrosurgical Devices. Electrode insulation was tested at both low frequency and radio frequency typical of electrosurgical generators. The electrical insulation testing passed all test requirements.
Discussion of Clinical Tests Performed: 8 .
Pre-clinical performance was tested on dogs, using surgical procedures and testing specifications were met.
9. Conclusions:
Golden Tip™ Electro-Surgical Probe, is substantially The equivalent in intended use, design, material and technology as the MegaDyne ElectroSurery Electrode. Thus, when compared to the predicate device, the Golden Tip™ Electro-Surgical Probe does not incorporate any changes in intended use, method of operation, material or design that could affect safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in black, creating a silhouette effect against a white background.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1999
Ms. Susan D. Goldstein-Falk Official Correspondent Amada Surgical, Inc. c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K984275
Trade Name: The Golden Tip™ Electro-Surgical Probe Regulatory Class: II Product Code: GEI Dated: November 24, 1998 Received: November 30, 1998
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Susan D. Goldstein-Falk
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT A
Page 1 of -
510(k) NUMBER (IF KNOWN):
The Golden Tip™ Electro-Surgical Probe DEVICE NAME:
INDICATIONS FOR USE:
The Golden Tip™ Electro-Surgical Probe is an electrocautery electrode and intended for use in open surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter-Use (Optional Format 1-2-96)
seef
Division Sign-Off)
(Division Sign-Off) vision of General Restorati
§ 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.