(22 days)
ERBE Disposable Patient Return Electrodes are Indicated for Use only in conjunction with Electrosurgical Generators for cutting and coagulation of human tissue. The Electrodes are for use with Generators with Return Electrode Safety Systems (divided contact surface) and Generators without Return Electrode Safety Systems (single contact surface).
The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used orimarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers. The Erbe electrodes and are to be sold with and without a pre-attached cable.
The provided text is a 510(k) summary for the ERBE Disposable Patient Return Electrode. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance studies with specific acceptance criteria and detailed methodology for a new, complex AI/CAD device.
Based on the provided text, the following information can be extracted, and significant limitations exist due to the nature of a 510(k) for a relatively straightforward medical device like a disposable patient return electrode in 1997.
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or detailed performance metrics are provided in the document. The general acceptance criterion is "Safe and Effective for their intended purpose when used in accordance with the Instructions for Use," and achieving "substantial equivalence" to predicate devices. The performance is summarized qualitatively.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safe and Effective for intended purpose (cutting and coagulation of human tissue with electrosurgical generators) | "The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used primarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers." "Disposable return electrodes have been manufactured and distributed worldwide by Leonhard Lang GmbH and the ERBE Disposable Return Electrodes utilize the same materials and technology. There are no known adverse reactions or field problems with electrodes utilizing this technology or materials." |
| Substantial Equivalence to predicate devices | Found by FDA to be "substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." |
| Compatibility with Electrosurgical Generators | "The Erbe electrodes and are to be sold with and without a pre-attached cable...compatible with generators from other manufacturers." "The Electrodes are for use with Generators with Return Electrode Safety Systems (divided contact surface) and Generators without Return Electrode Safety Systems (single contact surface)." |
| No known adverse reactions or field problems | "There are no known adverse reactions or field problems with electrodes utilizing this technology or materials." (Referring to the materials and technology used in predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of this 510(k). This document does not describe a clinical performance study with a test set of data. The claim of safety and effectiveness is based on the use of "the same materials and technology" as predicate devices with "no known adverse reactions or field problems" from those predicate devices. This indicates reliance on historical data and material equivalence rather than a new clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There is no mention of experts establishing ground truth for a test set, as this is not a study involving diagnostic interpretation or complex algorithms.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI or CAD system, so an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a passive accessory and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth," in a broad sense for this type of device, is established by historical clinical performance and safety records of analogous predicate devices and the physical/electrical properties of the materials used. The statement "There are no known adverse reactions or field problems with electrodes utilizing this technology or materials" serves as the primary basis for safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning, so there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set for machine learning.
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June 13, 1997
510(k) Notification ERBE Disposable.Patient Return Electrode
JUL - 9 1997 Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
For more than 50 years, high-frequency (HF) surgery has been used to cut and/or coagulate biological tissue using the intrinsic thermal effect of electric current. ERBE has been working intensively during this entire period in the production and distribution of state-of-theart HF surgical instruments and accessories. The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used orimarily with Erbe's range of Electrosurgical Generators but they are also compatible with generators from other manufacturers.
The Erbe electrodes and are to be sold with and without a pre-attached cable. Erbe will offer the Return Electrodes without the pre-attached cable as these provide the user the option of purchasing a less expensive item and utilizing a re-usable cable.
Disposable return electrodes have been manufactured and distributed worldwide by Leonhard Lang GmbH and the ERBE Disposable Return Electrodes utilize the same materials and technology. There are no known adverse reactions or field problems with electrodes utilizing this technology or materials
It is Erbe's intention to apply for ISO Registration and market this product under the CE mark. It is Erbe policy that all product marketed under the Erbe name are so registered.
Based upon the documents enclosed in this Notification, we believe the ERBE Disposable Patient Return Electrodes are Safe and Effective for their intended purpose when used in accordance with the Instructions for Use.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Erbe USA, Inc. c/o Mr. Michael A. Clark South East Regulatory Associates; Inc. · 1070 Thornwood Lane Dacula, Georgia 30211-3007
Re : K972269 ERBE Disposable Patient Return Electrode Requlatory Class: II Product Code: GEI Dated: June 13, 1997 Received: June 17, 1997
JUL - 9 1997
Dear Mr. Clark:
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 qeneral 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 Requlation (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
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Page 2 - Mr. Michael A. Clark
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 obliqation 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 requlations.
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,
[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
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June 13, 1997
510(k) Notification ERBE Disposable Patient Return Electrode
INDICATIONS FOR USE
ERBE Disposable Patient Return Electrodes are Indicated for Use only in conjunction with Electrosurgical Generators for cutting and coagulation of human tissue.... ... ............
The Electrodes are for use with Generators with Return Electrode Safety Systems (divided contact surface) and Generators without Return Electrode Safety Systems (single contact surface).
The Electrodes must be applied as close as possible to the operative site, preferably on the thigh or upper arm of the patient, and must not be applied to scars, infected skin, bony protrusions, or over metal implarits.
Concurrence of CDRH; Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K972269 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ------------------------------------------ | ---------------------- |
§ 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.