(55 days)
The KSEA Monopolar Coagulating and Needle Electrodes are designed to be used by qualified surgeons and physicians to cut, coagulate, and/or fulgurate tissue via high-frequency electrical current wave forms, during endoscopic general and plastic surgical procedures.
The Monopolar Coagulating Electrodes are indicated for use in cutting, coagulating, and/or fulgurating tissue during endoscopic general and plastic electrosurgical procedures.
The KSEA Monopolar Coagulating and Needle Electrodes are reusable surgical devices. The body-contact portions of the electrodes are composed of AISI series 420 surgical-grade stainless steel. The shafts are composed of AISI series 303 and 304 surgical-grade stainless steel, and are insulated with polytetrafluoroethylene (PTFE).
The provided document is a 510(k) summary for the Karl Storz Endoscopy-America, Inc. Monopolar Coagulating and Needle Electrodes. This type of regulatory submission is for medical devices that are substantially equivalent to a predicate device and generally does not include detailed clinical study data or acceptance criteria for device performance. It focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and does not raise new safety or effectiveness concerns.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment for either test or training sets.
The core of this submission is to establish "substantial equivalence," not to prove specific performance metrics against pre-defined acceptance criteria through a clinical study. The safety and effectiveness are inferred from the predicate device.
What the document does state regarding substantial equivalence:
- Claim: "The KSEA Monopolar Coagulating and Needle Electrodes are substantially equivalent to the predicate devices since the basic designs and intended uses are the same. The minor difference between the K.SEA Monopolar Coagulating and Needle Electrodes and the predicate devices raise no new issues of safety and effectiveness, as the design differences have no effect on the performance, function, or intended uses of the devices."
- Basis for Equivalence: The document highlights the similarity in basic designs, intended uses, and material composition of the body-contact portions and shafts (surgical-grade stainless steel) and insulation (PTFE) with the predicate devices.
In summary, none of the requested information regarding acceptance criteria and performance study details is present in the provided 510(k) summary.
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Karl Storz Endoscopy-America, Inc
Culver City, California 90230-760 Phone 110 568 11.75
上できる(800) 4.21 13
Image /page/0/Picture/3 description: The image shows a logo for "TORZ Endoscopy". The logo features the word "TORZ" in a stylized font, with the "O" represented by a circle with a smaller circle inside. Below the word "TORZ" is the word "Endoscopy" in a smaller, simpler font. The image is black and white and has a grainy texture.
K972+97
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy-America, Inc.600 Corporate PointeCulver City, California 90230(310) 558-1500 |
|---|---|
| Contact: | Marlena Allen Piercy, Ph.D.Senior Clinical Affairs Specialist |
| Device Identification: | Common Name:Electrosurgical Coagulating ElectrodesElectrosurgical Needle Electrodes |
| Trade Name (optional): |
KSEA Monopolar Coagulating Electrodes KSEA Monopolar Coagulating Needle Electrode
Indication: The KSEA Monopolar Coagulating and Needle Electrodes are designed to be used by qualified surgeons and physicians to cut, coagulate, and/or fulgurate tissue via high-frequency electrical current wave forms, during endoscopic general and plastic surgical procedures.
Device Description: The KSEA Monopolar Coagulating and Needle Electrodes are reusable surgical devices. The body-contact portions of the electrodes are composed of AISI series 420 surgical-grade stainless steel. The shafts are composed of AISI series 303 and 304 surgical-grade stainless steel, and are insulated with polytetrafluoroethylene (PTFE).
Substantial Equivalence: The KSEA Monopolar Coagulating and Needle Electrodes are substantially equivalent to the predicate devices since the basic designs and intended uses are the same. The minor difference between the K.SEA Monopolar Coagulating and Needle Electrodes and the predicate devices raise no new issues of safety and effectiveness, as the design differences have no effect on the performance, function, or intended uses of the devices.
Signed: Marlena Allen Piercy, Ph.D.
Senior Clinical Affairs Specialist
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1997
Marlena Allen Piercy, Ph.D. Senior Clinical Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 92030-7600
K972497 Re:
Trade Name: Karl Storz Monopolar Coagulating Electrodes and Karl Storz Monopolar Coagulating Needle Electrodes Regulatory Class: II Product Code: GEI Dated: July 2, 1997 Received: July 3, 1997
Dear Dr. Piercy:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 300 to 895. A substanially 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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
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Page 2 - Marlena Allen Piercy, Ph.D.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. " " w
If you desire specific advice for your devices 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 devices, 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,
[signature]
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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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "Karl Storz Endoscopy" in a smaller font. The logo is simple and modern, and it is likely used to represent the company's brand.
Karl Storz Endoscopy-America, Inc.
500 Corporate Porne Culver City, California 90230-7600 Phone 310 558 1500
01 Free 800 421 08.13 Fax 340 410 5521
K9124997
510(k) Number (if known): Not yet assigned
Device Name: Monopolar Coagulating Electrodes for General and Plastic Surgery
Indications for Use:
The Monopolar Coagulating Electrodes are indicated for use in cutting, coagulating, and/or fulgurating tissue during endoscopic general and plastic electrosurgical procedures.
CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: (Per 21 CFR 801.109) | (Division Sign-Off) | (Division Sign-Off) | OR Over-the-Counter Use: | (Optional Format 1-2-96) |
|---|---|---|---|---|
| (Division Sign-Off) | ||||
| Division of General Restorative Devices | ||||
| 510(k) Number K972497 |
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00003
§ 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.