(273 days)
The RF Passive Attenuator/Splitter Model I 100 I 200 and Cutting/Coagulating Electrode Model R 10 is indicated for the cutting and coagulation of the tissue. This device is intended for use by qualified medical personnel in the use of electrosurgery.
RF Passive Attenuator/Splitter Model I 100, I 200 and Cutting/Coagulating Electrode Model R 10.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain any specific acceptance criteria or reported device performance metrics for the RF Passive Attenuator/Splitter (PAS) and Loop Electrode. The letter is a 510(k) clearance stating substantial equivalence to a predicate device, which focuses on device type, indications for use, and regulatory compliance rather than detailed performance specifications.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a test set sample size or data provenance is available in this document.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
No information about experts or ground truth establishment is provided.
4. Adjudication Method for the Test Set:
No information regarding an adjudication method is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No information about a MRMC study or its effect size is present in this document.
6. Standalone (Algorithm Only) Performance:
This device is a hardware component (RF Passive Attenuator/Splitter and Loop Electrode), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable and not discussed.
7. Type of Ground Truth Used:
No information regarding the type of ground truth used is provided. As this is a hardware device clearance, the "ground truth" would likely relate to electrical safety, performance specifications, and clinical effectiveness demonstrated in predicate devices, rather than a diagnostic ground truth.
8. Sample Size for the Training Set:
This device is a hardware component. The concept of a "training set" is not applicable here as it refers to data used to train AI models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is a hardware device.
{0}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thomas C. Wehman, Ph.D. President and Chief Operating Officer Advanced Closure Systems 910 W. Maude Avenue Sunnyvale, California 94086
AUG 27 1997
Re: K964779
Trade Name: Model I 100 and 200 RF Passive Attenuator/Splitter (PAS) and Model QL 10 Loop Electrode Regulatory Class: II Product Code: GEI Dated: May 28, 1997 Received: June 2, 1997
Dear Dr. Wehman:
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, Farts 800 to 895. A substantially equivalent determination assurves compliance with the current Good Manufacturing Practice requirements , 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
{1}------------------------------------------------
Page 2 - Thomas C. Wehman, Ph.D.
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.
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,
A. Coello
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known):
K 964779
Device name: …………………
RF Passive Attenuator/Splitter . . . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Model I 100, I 200 and Cutting/Coagulating Electrode Model R 10.
Indications for Use:
The RF Passive Attenuator/Splitter Model I 100 I 200 and Cutting/Coagulating Electrode Model R 10 is indicated for the cutting and coagulation of the tissue.
This device is intended for use by qualified medical personnel in the use of electrosurgery.
Contraindications for Use:
The use of the RF Passive Attenuator/Splitter Model I 100, I 200 and Cutting/Coagulating Electrode Model R 10 is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best of the interest of the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| OR Over-The-Counter Use | |
| (Optional Format 1-2-96)(Division Sign-Off) | |
| Division of General Restorative Devices | K964779 |
| 510(k) Number | 150-100259 Rev. 1 |
Proprietary Data: This document and the information consined herein may not be reproduced, used or disclosed without prior written consent of Advanced Closure Systems, Inc.
§ 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.