(273 days)
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Not Found
No
The summary describes a passive attenuator/splitter and a cutting/coagulating electrode, which are electrosurgical tools. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is described as being indicated for "cutting and coagulation of the tissue," which signifies a direct medical intervention for therapeutic purposes.
No
Explanation: The device is described as an RF Passive Attenuator/Splitter and a Cutting/Coagulating Electrode, indicated for "cutting and coagulation of the tissue." This function is therapeutic, not diagnostic. There is no mention of it being used to identify or analyze medical conditions.
No
The device description explicitly mentions "RF Passive Attenuator/Splitter Model I 100, I 200 and Cutting/Coagulating Electrode Model R 10," which are hardware components used in electrosurgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and coagulation of the tissue" using electrosurgery. This is a direct surgical intervention on living tissue, not an in vitro test performed on samples taken from the body.
- Device Description: The device components (attenuator/splitter and electrode) are consistent with electrosurgical equipment used for tissue manipulation.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically alter tissue during surgery.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
qualified medical personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
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
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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.