(77 days)
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No
The document describes a passive electrosurgical pad and its physical properties, with no mention of AI or ML technologies.
No
The device is described as an electrosurgical pad, which provides a safe return path for electrosurgical current and works with electrosurgical units. It is a component used during electrosurgery but does not directly provide therapy itself.
No
The device is an electrosurgical pad, which provides a return path for electrosurgical current during surgical applications. It does not diagnose or detect specific conditions, but rather facilitates a surgical procedure.
No
The device description clearly details physical components like pads, coatings, hydro-gel adhesive, and a pre-attached cord, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is designed to provide a safe return path for electrosurgical current during surgical procedures. This is an in-vivo application (used on a living patient), not an in-vitro application (used on samples outside the body).
- Device Description: The description details a pad with conductive surfaces and adhesive for placement on a patient's skin. This aligns with an in-vivo device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the 3M™ Universal Electrosurgical Pads are medical devices used during surgery on a patient, not for in-vitro diagnostic purposes.
N/A
Intended Use / 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.
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.
Product codes
GEI
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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".
1
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.
2
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
4
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)