(58 days)
The ERBE APC Applicators' intended use is for the delivery of argon gas plasma energy for coagulation of tissue.
The APC Applicators are used with the ERBOTOM ICC Series Electrosurgery Units and ERBE's APC 300 (K963189) Argon Plasma Coagulator.
The APC Applicators are provided in various shaft lengths, shaft diameters, and bend angles to accommodate the variations in anatomical configuration of the target population and surgeon preference. The shaft lengths vary from 110 mm to 500 mm. The shaft diameters vary from 1.5 mm to 2.3 mm.
The APC Applicators work by using argon gas with a monopolar power source. The electrode in the argon channel of the applicator is connected to an electrosurgical generator. When high frequency voltage is high enough, and the proximity to tissue is close enough, electrically conductive argon plasma forms in the gas stream. This allows the current to flow between the applicator and the tissue. Current density upon arrival at the tissue surface causes coagulation. The application of the energy to the tissue is uniform and contact free. A silicon sleeve is available for APC Applicators with lateral openings at the distal end that are used in small lumen.
The APC Applicators' tips are either straight, curved, angled, or needle. The APC Applicators are made of PTFE shafts, ceramic tips, and Zytel and steel connector assemblies.
Both the flexible and rigid APC Applicators are provided non-sterile and are reusable using steam sterilization, whereas the other devices are provided sterile and are disposable. ERBE USA has conducted a sterilization validation per EN45001 to define and support the resterilization.
This 510(k) summary describes a device, ERBE APC Applicators, which is a reusable accessory for electrosurgery systems. The submission asserts substantial equivalence to predicate devices. However, the provided document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth, or adjudication methods.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is absent from the provided text.
The document primarily focuses on:
- Device Identification: Trade name, proprietary name, common name, classification, and product code.
- Predicate Devices: Listing of substantially equivalent legally marketed devices.
- Device Description: Explanation of how the APC Applicators work, their physical characteristics (shaft lengths, diameters, tips), materials, and reusability/sterilization.
- Intended Use: For the delivery of argon gas plasma energy for coagulation of tissue, specifically with ERBOTOM ICC Series Electrosurgery Units and ERBE's APC 300.
- Regulatory Correspondence: An FDA letter confirming the substantial equivalence determination and allowing the device to be marketed.
To answer your questions, details of performance testing or clinical studies would need to be present in the submission. For a device like this (an accessory to an electrosurgical unit), the focus of a 510(k) submission is typically on substantial equivalence to existing devices based on technological characteristics and intended use, rather than extensive clinical performance studies. Performance data, if any, would likely relate to safety aspects (e.g., electrical safety, biocompatibility, sterilization validation) and functional performance to demonstrate it performs as intended and is equivalent to predicates, usually through bench testing or limited animal/cadaver studies, not necessarily large-scale clinical trials with acceptance criteria for diagnostic accuracy or treatment efficacy as might be seen for AI/diagnostic devices.
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OCT 1 4 1999
K992769
510(k) SUMMARY
Christian Erbe Submitted By: ERBE-USA 2225 Northwest Parkway Suite 105 Marietta, GA 30067
Tel: 770-955-4400 Fax: 770-955-2577
Common Name:
Contact Person: Scott Cundy
August 12, 1999 Date Prepared:
Device Name:
Argon Plasma Coagulation (APC) Applicators for use with HF current ERBOTOM ICC Series Electrosurgery Systems.
Trade Name: ERBE APC Applicators
ERBE APC Applicators Proprietary Name:
Classification Name: Electrosurgical cutting and coagulation device and accessories (21CFR878.4400)
Product Code: 79GEI
Substantially Equivalent Devices:
The ERBE APC Applicators are substantially equivalent to the following legally marketed devices: Beacon's Argon Beam Laparoscopic Electrode (K902996), Everest Medical's Bipolar Laparoscopic Cutting Electrosurgical Needle (K945975), and ERBE USA's APC Probes (K963189).
Device Description:
The APC Applicators are provided in various shaft lengths, shaft diameters, and bend angles to accommodate the variations in anatomical configuration of the target population and surgeon preference. The shaft lengths vary from 110 mm to 500 mm. The shaft diameters vary from 1.5 mm to 2.3 mm.
Image /page/0/Picture/18 description: The image shows the logo for ERBE USA Incorporated. The word "ERBE" is in large, bold, black letters at the top. Below that, the words "USA INCORPORATED" are in smaller, black letters. The words "Electrosurgical Equipment" are at the bottom in smaller, black letters.
2225 Northwest Parkway Suite 105 Marietta, GA 30067 Tel. (770) 955-4400 Tel. (800) 778-3723 Fax (770) 955-2577
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510(K) SUMMARY
Device Description:
The APC Applicators work by using argon gas with a monopolar power source. The electrode in the argon channel of the applicator is connected to an electrosurgical generator. When high frequency voltage is high enough, and the proximity to tissue is close enough, electrically conductive argon plasma forms in the gas stream. This allows the current to flow between the applicator and the tissue. Current density upon arrival at the tissue surface causes coagulation. The application of the energy to the tissue is uniform and contact free. A silicon sleeve is available for APC Applicators with lateral openings at the distal end that are used in small lumen.
The APC Applicators' tips are either straight, curved, angled, or needle. The target population is both for laparoscopic and open electrosurgical procedures. The anatomical sites are for various general surgical procedures. The APC Applicators are made of PTFE shafts, ceramic tips, and Zytel and steel connector assemblies.
Both the flexible and rigid APC Applicators are provided non-sterile and are reusable using steam sterilization, whereas the other devices are provided sterile and are disposable. ERBE USA has conducted a sterilization validation per EN45001 to define and support the resterilization.
Intended Uses:
The ERBE APC Applicators' intended use is for the delivery of argon gas plasma energy for coagulation of tissue.
The APC Applicators are used with the ERBOTOM ICC Series Electrosurgery Units and ERBE's APC 300 (K963189) Argon Plasma Coagulator.
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Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, bold font. The words are stacked on top of each other, with "Public" and "Health" on the top line and "Service" on the bottom line.
Image /page/2/Picture/2 description: The image is a black and white 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" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.
OCT 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Cundy Regulatory Affairs/Quality Assurance Manager ERBE USA Incorporated 2225 Northwest Parkway, Suite 105 Marietta, Georgia 30067
K992769 Re: Trade Name: ERBE APC Applicators Regulatory Class: II Product Code: GEI Dated: August 16, 1999 Received: August 17, 1999
Dear Mr. Cundy:
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 enclosures) 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. Scott Cundy
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,
Colin M. Witt, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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INDICATIONS FOR USE
K 992769
APC Coagulation .
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Prescription Use J Prescription 801.109)
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(Division Sign-Off)
Division of General Restorative Devices Kgg2769 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.