(77 days)
3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESUs) 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.). 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, 9135 & 9165 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 rechnology 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 33% 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 surface area to isolate the conductive area from surgical fluids. These pads include a disposable pre-attached cord.
The 3M™ Universal Electrosurgical Pads (9135 & 9165) demonstrate compliance with relevant performance standards through safety and efficacy testing, specifically focusing on biocompatibility and adherence to ANSI/AAMI HF18-1993 Voluntary Standard for Electrosurgical Devices.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI HF18-1993) | Device Performance |
|---|---|
| For 9165 (Split with cord): | Meets criteria. |
| 5.2.3.1 Maximum Safe Temperature Rise | Meets criteria. |
| 5.2.3.2 Electrode Contact Impedance | Meets criteria. |
| 5.2.8.2.2 Contact Quality Monitor | Meets criteria. |
| For 9135 (Solid with cord): | Meets criteria. |
| 5.2.3.1 Maximum Safe Temperature Rise | Meets criteria. |
| 5.2.3.2 Electrode Contact Impedance | Meets criteria. |
| 5.2.3.3 Electrode Adherence Test | Meets criteria. |
| For 9135 (Solid with cord): | |
| 5.2.5.1 Dielectric Withstand 60 Hz | Meets criteria. |
| 5.2.5.2 High Frequency Leakage Current | The biological safety of selected components has been assured through material selection demonstrating appropriate biocompatibility levels, based on ISO 10993-1, "Biological Evaluation of Medical Devices," Part 1 tests. Additionally, the device meets specific performance standards as listed above. |
| Biocompatibility |
2. Sample Size and Data Provenance for Test Set:
- The document does not specify the exact sample sizes used for each individual test conducted under the ANSI/AAMI standard.
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the tests were conducted by the device manufacturer, 3M, to demonstrate compliance with a US national standard (ANSI/AAMI).
3. Number of Experts and Qualifications for Ground Truth:
- This information is not applicable. The testing described involves objective physical and electrical measurements against a predefined standard (ANSI/AAMI HF18-1993), not a subjective assessment requiring expert consensus for ground truth.
4. Adjudication Method:
- This is not applicable as the testing involves objective measurements against a standard, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- This is not applicable to the evaluation of an electrosurgical pad, which does not involve human readers interpreting cases or AI assistance in a diagnostic context.
6. Standalone (Algorithm Only) Performance:
- This is not applicable as the device is a physical electrosurgical pad, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for the performance evaluation is the established technical specifications and thresholds outlined in the ANSI/AAMI HF18-1993 Voluntary Standard for Electrosurgical Devices. For biocompatibility, it's compliance with ISO 10993-1, "Biological Evaluation of Medical Devices" Part 1 tests.
8. Sample Size for Training Set:
- This is not applicable as the device is a physical electrosurgical pad and does not involve AI/machine learning requiring a training set.
9. How Ground Truth for Training Set was Established:
- This is not applicable for the reasons stated above.
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JAN 30 1998
510(k) Premarket Notification Submission 3MTM Universal Electrosurgical Pad 9135 & 9165 Page 62 of 63
K 97427 9
510(k) Summary 3M™ Universal Electrosurgical Pad 9135 & 9165
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 Regulatory 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:
3MTM Universal Electrosurgical Pad, with cord (Catalog 9135) 3MTM Universal Electrosurgical Pad, Split with cord (Catalog 9165)
Classification: Electrosurgical Cutting and Coagulation Device and Accessories, Class II per 21 CFR 878.4400
Indications for Use:
3M™ Universal Electrosurgical Pads 9135 & 9165 are designed to work with most electrosurgical units (ESUs) 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.). 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.
Description of the Devices: 3M™ Universal Electrosurgical Pads, 9135 & 9165 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 rechnology 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 33% 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 surface area to isolate the conductive area from surgical fluids. These pads include a disposable pre-attached cord.
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".
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Page 63 of 63
510(k) Premarket Notification Submission 3MTM Universal Electrosurgical Pad 9135 & 9165
ANSI/AAMI Performance Testing.
The 3M™ Universal Electrosurgical Pad, Split with cord (9165) 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 of the ANSI/AAMI HF18-1993 Voluntary Standard for Electrosurgical Devices.
The 3M™ Universal Electrosurgical Pad, with cord (9135) meets 5.2.3.1 Maximum Safe Temperature Rise, 5.2.3.2 Electrode Contact Impediance and 5.2.3.3 Electrode Adherence Test, of the ANSI/AAMI HF 18-1993 Voluntary Standard for Electrosurgical Devices.
The 3M™ Universal Electrosurgical Pad, with cord meets 5.2.5.1 Dielectric Withstand 60 Hz and 5.2.5.2 High Frequency Leakage Current of the ANSI/AAMI HF18-1993 Voluntary Standard for Electrosurgical Devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Ms. Linda Johnsen Regulatory Affairs Specialist 3M Health Care 3M Center, Building 275-3E-08 St. Paul. Minnesota 55144-1000
Re: K974279
Trade Name: 3M™ Universal Electosurgical Pad, with cord (Catalog 9135) 3MTM Universal Electrosurgical Pad, Split with cord (Catalog 9165) Regulatory Class: II Product Code: GEI Dated: November 12, 1997 Received: November 14, 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 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 800 to 895. A substantially 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 (OS) 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
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510(k) Premarket Notification Submission 3MTM Universal Electrosurgical Pad 9135 & 9165 Page 56 of 63
510(k) Number (If Known): _ K 97 4279
Device Name: 3M™ Universal Electrosurgical Pad, with cord (Catalog Number 9135) and 3M™ Universal Electrosurgical Pad, Split with cord (Catalog Number 9165)
Indications For Use:
3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESUs) 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.). 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: Federal (U.S.A.) 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)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K974279 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
§ 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.