(75 days)
The Subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.
The Aaron SlickTip Solid Laparoscopic Electrode is a sterile, single use solid laparoscopic electrode. It utilizes an insulated stainless steel laparoscopic electrode with the same coating as cleared under K974735. It is an accessory to an electrosurgical generator.
This document is a 510(k) premarket notification for the Aaron SlickTip Solid Laparoscopic Electrode. It declares substantial equivalence to previously cleared devices rather than presenting novel performance data based on a new study. Therefore, the information requested about acceptance criteria, study design, and performance metrics is generally not applicable in the context of this specific regulatory submission.
However, I can extract information related to the device comparison and the regulatory determination.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
This section is Not Applicable in the traditional sense for a 510(k) submission asserting substantial equivalence. 510(k)s often don't establish new, quantifiable performance criteria for the device itself but rather demonstrate that the new device is as safe and effective as a predicate device. The "acceptance criteria" here implicitly refer to demonstrating equivalence in design, operation, intended use, materials, components, and performance claims to the listed predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Claim) |
|---|---|
| Substantial Equivalence to Predicate Devices | The Aaron SlickTip Solid Laparoscopic Electrode is IDENTICAL to the Resistick Solid Laparoscopic Electrodes (K971621) with the coating cleared under K974735. It is substantially equivalent to the MegaDyne K913281, the Valleylab K904560, the Conmed K942892, and the WJ Surgical Hi-Tip Laparoscopic electrodes in design, operation, intended use, materials, components and performance claims. |
| Safety - No new hazards | Hazard analysis evaluations were performed on the Aaron SlickTip Solid Laparoscopic Electrode. Test results indicated that there are no new hazards presented with the use of the Aaron SlickTip Solid Laparoscopic Electrode as compared with the predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a separate "test set" with a number of units. The testing appears to be on the device itself for hazard analysis and to confirm its performance characteristics relative to predicates, rather than on a patient population.
- Data provenance: Not specified. It's implied that testing was conducted internally by Aaron Medical Industries, Inc., as part of their product development and regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is Not Applicable. The determination of "ground truth" through expert consensus or clinical outcomes is typical for diagnostic algorithms or subjective assessments. For a medical device like a laparoscopic electrode, the ground truth for its function is typically based on engineering specifications, material properties, and performance against established benchmarks or predicate devices. The "ground truth" for safety and efficacy in this context is established by comparison to legally marketed predicate devices, as assessed by the FDA.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is Not Applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images). For the hazard analysis and substantial equivalence claim of this device, a formal adjudication method as described is not relevant.
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:
This is Not Applicable. This device is a surgical tool, not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant to its regulatory review.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is Not Applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is based on the established safety and effectiveness of the predicate devices. The new device is considered safe and effective if it performs with the same intended use and performance characteristics as the predicate devices and introduces no new safety concerns. This is demonstrated through engineering comparison, materials assessment, and hazard analysis, rather than clinical outcome data for a novel device.
8. The sample size for the training set:
This is Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in this submission.
9. How the ground truth for the training set was established:
This is Not Applicable for the same reason as point 8.
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2/10/99
KG84239
AARON MEDICAL INDUSTRIES, INC. Aaron SlickTip Solid Laparoscopic Electrodes
510(K) NOTIFICATION
510(k) SAFETY AND EFFECTIVENESS SUMMARY
TRADE NAME: Aaron SlickTip Solid Laparoscopic Electrode COMMON NAME: Laparoscopic Electrode CLASSIFICATION NAME: General and Plastic Surgery (21 CFR 878.4400)
The Aaron SlickTip Solid Laparoscopic Electrode is a sterile, single use solid laparoscopic electrode. It utilizes an insulated stainless steel laparoscopic electrode with the same coating as cleared under K974735. It is an accessory to an electrosurgical generator.
The Aaron SlickTip Solid Laparoscopic Electrode, is intended to be used, in laparoscopic electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for single use.
The Aaron SlickTip Solid Laparoscopic Electrode is IDENTICAL to the Resistick Solid Laparoscopic Electrodes by Aaron Medical Industries, Inc, cleared under K971621 dated June 20, 1997 with the coating cleared under K974735. It is substantially equivalent to the MegaDyne K913281, the Valleylab K904560, the Conmed K942892 and the WJ Surgical Hi-Tip Laparoscopic electrodes in design, operation, intended use, materials, components and performance claims.
Testing which has been performed on the Aaron SlickTip Solid Laparoscopic Electrode indicates that the devices are substantially equivalent in their performance and method of operation.
Hazard analysis evaluations were performed on the Aaron SlickTip Solid Laparoscopic Electrode. Test results indicated that there are no new hazards presented with the use of the Aaron SlickTip Solid Laparoscopic Electrode as compared with the predicate devices.
In conclusion, the Aaron SlickTip Solid Laparoscopic Electrode is substantially equivalent to the predicate devices, the MegaDyne K913281, the Conmed K942892, the Aaron Medical Industries, Inc Resistick Solid Laparoscopic Electrode K971621, with the Aaron Medical Industries, Inc coating cleared under K974735, the Valleylab K904560 and the WJ Surgical Hi-Tip Laparoscopic electrodes.
Submitted By: J. Robert Saron President & CEO Official Correspondent
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Mr. J. Robert Saron President and Chief Executive Officer, Official Correspondent Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710
Re: K984239
Trade Name: Slicktip Solid Laparoscopic Electrodes Regulatory Class: II Product Code: GEI Dated: November 25, 1998 Received: November 27, 1998
Dear Mr. Saron:
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 - Mr. J. Robert Saron
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 vour 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,
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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Page 1 _______________________________________________________________________________________________________________________________________________________________________ of 1__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _
Device Name: SlickTip Solid Laparoscopic Electrodes
Indications For Use:
. .
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The Subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K984239 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
§ 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.