(58 days)
A single use, non-sterile dispersive electrode with or without a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
The E Surgical Patient Return Electrode Dual Plate is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electrosurgery between the generator, the active electrode, and an adult patient.
Unfortunately, the provided text describes an Electrosurgical Patient Return Electrode, which is a medical device and not an AI/ML-driven device. As such, many of the requested categories related to AI/ML device evaluation (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of traditional medical hardware.
The document focuses on demonstrating substantial equivalence to a predicate device, which is a common regulatory pathway for non-AI devices. The performance data presented relates to compliance with established industry standards for thermal safety and biocompatibility.
Therefore, I cannot provide a table with acceptance criteria and reported device performance in the context of an AI/ML device, nor can I fill in the details for AI/ML-specific study design elements.
However, I can extract the relevant performance and compliance information for this traditional device as presented:
Acceptance Criteria and Device Performance (for a traditional medical device, not AI/ML):
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Thermal Safety | ANSI/AAMI HF-18 standard Electrosurgical Devices for Dispersive Electrode Thermal Safety and Contact Impedance | The E Surgical Pad complies with the ANSI/AAMI HF-18 standard. | Demonstrates safety in preventing thermal injury at the return electrode site. |
| Biocompatibility | ISO 10993 | The pad design is proven safe by compliance to biocompatibility standard ISO 10993. | Ensures the device materials are safe for contact with the human body and do not elicit adverse biological responses. |
| Technological Equivalence | Comparable to Valleylab, Inc.'s VL 7600 Dual Pad, REM compatible electrode | The E Surgical Patient Return Dual Electrode is comparable in design (hydrogel adhesive, acrylic border) and function (compatible with return electrode monitoring generator systems) to the predicate device. | Basis for regulatory clearance via substantial equivalence for non-AI devices. |
As this is not an AI/ML device, the following points are not applicable and cannot be extracted from the provided text:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
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MAR 3 1 2006
510(k) Summary
E Surgical, LLC 1990 N. California Blvd., Suite 1040 Walnut Creek, CA 94596 925-280-8388 Phone 925-280-1788 Fax Contact: Hans Richter, RA/QA Director
K 060255
I. Trade Name: E Surgical
Electrosurgical Patient Return Electrode, Dual Plate with Cord Electrosurgical Patient Return Electrode, Dual Plate Cordless
II. Common Name: Electrosurgical Patient Return Electrode
III. Classification: 21 CFR 878.4400, Electrosurgical Cutting and Coagulation Devices and Accessories
IV. Product Code: GEI
V. Indications for Use:
A single use, non-sterile dispersive electrode with or without a pre-attached cord to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
VI. Predicate Device: Valleylab, Inc., VL 7600 REM Patient Return Electrode
VII. Device Description: The E Surgical Patient Return Electrode Dual Plate is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electrosurgery between the generator, the active electrode, and an adult patient.
VIII. Summary of Technological Characteristics: The E Surgical Patient Return Dual Electrode is comparable to the Valleylab, Inc.'s VL 7600 Dual Pad, REM compatible electrode, a legally marketed device. The E Surgical pad is furnished with a 9' cord or without a cord attached for use with a clamp accessory. The pad has a hydrogel adhesive for conductivity with an acrylic border to prevent invasion of fluids. Both pad designs are compatible with return electrode monitoring generator systems.
IX. Performance Data: The E Surgical Pad complies with the ANSI/AAMI HF-18 standard Electrosurgical Devices for Dispersive Electrode Thermal Safety and Contact Impedance. The pad design is proven safe by compliance to biocompatibility standard ISO 10993.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (USA). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines curving upwards. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2006
E Surgical, LLC. c/o L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301
Re: K060255
Trade/Device Name: E Surgical Electrosurgical Patient Return Electrode, Dual Plate with Cord and Electrosurgical Patient Return Electrode, Dual Plate, Cordless
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, JOS Dated: January 25, 2006 Received: February 1, 2006
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (sce above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Mr. Lewis Ward
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer 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 vours
Sincerely yours,
Elmase
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: E Surgical Electrosurgical Patient Return Electrode, Dual Plate With Cord and Electrosurgical Patient Return Electrode, Dual Plate, Cordless
Indications for Use:
A single use, non-sterile dispersive electrode with or without a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KOGOSZ Z 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.