(39 days)
Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
Model SB 313 PB and SB 313 PBH Disposable Hand Switching Pencil, Push Button, One Piece Body. With and Without Holster
This document is a 510(k) clearance letter from the FDA for a disposable hand switching pencil for electrosurgery. It is not a study and, therefore, does not contain information about acceptance criteria, device performance, ground truth, or study methodologies.
Here's why the requested information cannot be extracted from this document:
- Nature of the Document: This is a regulatory approval letter based on "substantial equivalence" to a predicate device. It confirms the device can be legally marketed but does not provide the underlying performance data or study details that led to that determination.
- Lack of Study Details: The letter explicitly states, "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...". This means the FDA compared the new device's characteristics (design, materials, indications for use) to a previously approved predicate device, not necessarily by conducting a new clinical study with specific acceptance criteria and performance metrics.
- Focus on Equivalence: The primary purpose of a 510(k) submission is to demonstrate substantial equivalence, not to prove meeting specific performance criteria through a detailed clinical trial or rigorous AI validation study.
Therefore, I cannot provide any of the requested information (acceptance criteria table, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) because this document does not contain that type of technical performance and study data.
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Food and Drug Administration 9200 Corporate Roulevard Rockville MD 20850
SEP 1 4 1998
New Deantronics Taiwan, Limited c/o L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301
Rc: K982743
Trade Name: Model SB 313 PB and SB 313 PBH Disposable Hand Switching Pencil, Push Button, One Piece Body. With and Without Holster Regulatory Class: II Product Code: GEI Dated: July 31, 1998 Received: August 6, 1998
Dear Mr. Ward:
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 legally marketed predicate 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 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 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. Lewis Ward
This letter will allow you to hegin 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/dsma/dsmamain.html".
Sincerely yours,
poate de
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Initial 510(k) K982743
Device Name: New Deantronics, Inc. Model SB 313 Disposable Hand Switching Pencil, Push Button, one piece.
Indications for Use:
Electrosurgical accessory. Hand switching, disposable pencil intended to remove tissue and control bleeding by use of high-frequency electrical current.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of DCRH, Office of Device Evaluation (ODE)
Prescription Use ✓ ✗ OR Over-the-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices 9/17/98
510(k) Number___
§ 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.