(78 days)
3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESU'S) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY etc.). The 3M™ Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended applications could lead to an unsafe condition.
3M™ Universal Electrosurgical Pads, 9130 & 9160 have a green shaded coating technology that more uniformly distributes electrosurgical RF current over the whole conductive surface of the pad. The more uniform distribution technology and square shape permits universal orientation of the pad at a suitable placement site. The pad has a maximum temperature rise that is similar to pads up to 25% larger in conductor surface area. The entire surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolate the conductive area from surgical fluids.
The provided text describes the 3M™ Universal Electrosurgical Pads 9130 & 9160. Here's a breakdown of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI HF18-1993 Voluntary Standards for Electrosurgical Devices) | Reported Device Performance |
|---|---|
| For 3M™ Universal Electrosurgical Pad (9130 - Solid): | |
| 5.2.3.1 Maximum Safe Temperature Rise | Meets standard |
| 5.2.3.2 Electrode Contact Impedance | Meets standard |
| 5.2.3.3 Electrode Adherence c) Fluid Tolerance | Meets standard |
| For 3M™ Universal Electrosurgical Pad, Split (9160 - Split): | |
| 5.2.3.1 Maximum Safe Temperature Rise | Meets standard |
| 5.2.3.2 Electrode Contact Impedance | Meets standard |
| 5.2.8.2.2 Contact Quality Monitor/Maximum Safe Temperature Rise | Meets standard |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the devices meet the specified ANSI/AAMI standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The performance testing appears to be based on engineering and material standards rather than expert medical interpretation of images or patient data.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the tests (engineering performance standards), an adjudication method as typically described for clinical studies is unlikely to be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically for diagnostic imaging devices involving interpretation by multiple human readers, which is not relevant for an electrosurgical pad.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to an electrosurgical pad. The device's performance is standalone in the sense that its physical and electrical properties are tested, but it's not an "algorithm" or software that would normally be evaluated in a standalone manner for human interpretation. The testing described focuses on the device's inherent performance characteristics.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing was the requirements outlined in the ANSI/AAMI HF18-1993 Voluntary Standards for Electrosurgical Devices. These standards define measurable physical and electrical parameters that electrosurgical pads must meet for safety and efficacy.
Additionally, for biocompatibility, the ground truth was "appropriate levels of Biocompatibility" as defined by tests selected on the basis of Part-1 of ISO 10993-1, "Biological Evaluation of Medical Devices."
8. The Sample Size for the Training Set
This information is not provided in the document. "Training set" is a concept typically associated with machine learning or AI models, which is not relevant for this device. The testing described is performance validation against established standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" in the context of an electrosurgical pad. The "ground truth" for evaluation was established by industry-wide voluntary standards (ANSI/AAMI HF18-1993) and international biocompatibility standards (ISO 10993-1), developed by expert committees in those fields over time.
{0}------------------------------------------------
510(K) Premarket Notification Submission 3M™ Universal Electrosurgical Pad 9130 & 9160
Page 24 of 26
FEB - 3 1988
510(k) Summarv 3M™ Universal Electrosurgical Pad 9130 & 9160
Name and address of Device Manufacturer submitting 510(k) Notification:
3M Medical Products Group 3M Health Care 3M Center St. Paul. MN 55144-1000
Regulatory Correspondent of Device Manufacturer:
Linda Johnsen Requlatory Affairs Specialist 3M Health Care Building 275-3E-08 St. Paul, MN 55144-1000 612 737-4376
Date Summary was prepared:
November 12,1997
Name of Devices:
3M™ Universal Electrosurgical Pad, (Catalog 9130) 3M™ Universal Electrosurgical Pad, Split (Catalog 9160)
Classification:
Electrosurgical Cutting and Coagulation Device and Accessories, Class II per 21 CFR 878.4400
Indications for Use:
3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESU'S) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY etc.). The 3M™ Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended applications could lead to an unsafe condition.
{1}------------------------------------------------
Description of the Devices:
3M™ Universal Electrosurgical Pads, 9130 & 9160 have a green shaded coating technology that more uniformly distributes electrosurgical RF current over the whole conductive surface of the pad. The more uniform distribution technology and square shape permits universal orientation of the pad at a suitable placement site. The pad has a maximum temperature rise that is similar to pads up to 25% larger in conductor surface area. The entire surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolate the conductive area from surgical fluids.
Safety and Efficacy:
Biocompatibility:
The biological Safety of selected components of the 3M™ Universal Electrosurgical Pads has been assured through the selection of materials which demonstrate appropriate levels of Biocompatibility. Tests were selected on the basis of Part-1 of ISO 10993-1, "Biological Evaluation of Medical Devices".
AAMI Performance Testing:
The 3M™ Universal Electrosurgical Pad, (9130) meets the ANSI/AAMI 5.2.3.1 Maximum Safe Temperature Rise, 5.2.3.2 Electrode Contact Impedance and 5.2.3.3 Electrode Adherence c) Fluid Tolerance of the ANSI/AAMI HF18-1993 Voluntary Standards for Electrosurgical Devices.
The 3M™ Universal Electrosurgical Pad, Spilt (9160) meets 5.2.3.1 Maximum Safe Temperature Rise, 5.2.3.2 Electrode Contact Impedance and 5.2.8.2.2 Contact Quality Monitor/Maximum Safe Temperature Rise of the ANSI/AAMI HF18-1993 Voluntary Standards for Electrosurgical Devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 3 1998
Ms. Linda Johnsen Regulatory Affairs Specialist 3M Health Care 3M Center, Building 275-3E-08 St. Paul, Minnesota 55144-1000
Re: K974553
Trade Name: 3M™ Universal Electrosurgical Pad, (Catalog 9130) 3MTM Universal Electrosurgical Pad, Split (Catalog 9160) Regulatory Class: II Product Code: GEI Dated: November 12, 1997 ----Received: November 17, 1997
Dear Ms. Johnsen:
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 forannual 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 Gode 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 (OS) 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification
{3}------------------------------------------------
Page 2 - Ms. Johnsen
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 regulations.
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.
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,
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
{4}------------------------------------------------
510(K) Premarket Notification Submission 3M™ Universal Electrosurgical Pad 9130 & 9160
510(K) Number (If Known): ____________________________________________________________________________________________________________________________________________________
Device Name: 3M™ Universal Electrosurgical Pad, (Catalog Number 9130) 3M™ Universal Electrosurgical Pad, Split (Catalog Number 9160)
Indications For Use:
3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESU'S) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY etc.). The 3M™ Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended applications could lead to an unsafe condition.
These electrodes will include the precaution statement: USA Federal Law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over-the Counter Use
(Optional Format 1-2-96)
ral Restorative Devices
§ 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.