The REM Polyhesive Infant Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord. The electrode adheres to the patient over its entire surface. Its complete the electrosurgical circuit between the generator, the active electrode, and the patient.

The product is used for general monopoloar electrosurgery on newborns, infants, and children weighing between approximately 6 and 30 lb.

Device Description

The Valleylab™ REM Polyhesive™ Infant Patient Return Electrodes are part of a family of patient return electrodes. They are non-sterile, single-use devices used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The infant return electrodes are designed to be compatible with the return electrode monitoring function of compatible Covidien generators.

There are two separate catalog numbers for the infant Polyhesive™ return electrodes. The two models differ only with regard to the length of the cord connecting the return electrode to the generator. One has a 9-foot cord and the other has a 15-foot cord.

AI/ML Overview

The provided FDA 510(k) document for the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing related to safety and effectiveness, rather than a diagnostic accuracy study for an AI-powered device. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and data provenance) are not directly applicable or available in this type of submission.

However, I can extract information regarding the acceptance criteria and studies mentioned for the device's performance related to its intended use and safety.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode are primarily based on meeting the requirements of recognized international electrical safety and performance standards. The document states that the device demonstrated appropriate performance by meeting applicable clauses within these standards.

Acceptance Criteria Category	Source/Standard	Reported Device Performance
Thermal Performance	The impact of differences (higher patient weight range, larger surface area compared to predicate) was evaluated through testing. The device is expected to carry more current due to the higher weight range. The standard IEC 60601-2-2: 2009 (Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) contains clauses related to thermal performance of patient return electrodes. Specific acceptance criteria (e.g., maximum temperature rise) are implied by adherence to this standard.	The infant return electrode has a larger surface area than the neonatal return electrode to accommodate the higher patient weight range. Testing was performed "to show that the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode meets thermal performance requirements for return electrodes indicated for use on patients weighing between 5 and 15 kg." The specific thermal performance results (e.g., actual temperature readings) are not explicitly stated but are implied to have met the necessary criteria for regulatory clearance. The phrase "meets thermal performance requirements" suggests compliance.
Shelf Life Performance	Verification in accordance with sub-clause 201.15.101.8 of IEC 60601-2-2: 2009, which requires products to be aged to within 30 days of their expiration date prior to thermal performance and contact impedance testing. Additionally, primary packaging integrity is assessed.	The packaged devices have a shelf life of two years. "Suitability of this shelf life has been verified" according to the specified IEC standard. The "primary packaging remains intact with no tears, holes, or other degradation and the seal remains intact (seal width maintained and no visual evidence of seal degradation)."
Biocompatibility	Evaluation in accordance with ISO 10993-1:2009 and the FDA Blue Book Memorandum G95-1. Acceptance criteria for cytotoxicity, sensitization, and primary skin irritation tests.	Production-representative devices were subjected to cytotoxicity, sensitization, and primary skin irritation tests. "The devices met all of the acceptance criteria for these tests." This confirms the materials in contact with the patient are safe for their intended use duration.
Electrical Safety and Essential Performance	IEC 60601-1: 2005 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) and IEC 60601-2-2: 2009 (Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). Specific clauses within these standards define acceptable levels of electrical safety, performance of the REM system, and current distribution.	"Appropriate performance...was demonstrated by showing that the device meets applicable clauses" in these standards. This indicates that all relevant safety and essential performance parameters, including those related to the REM system (preventing unintended RF burns by ensuring a low-impedance path and contact quality monitoring), were tested and found to be compliant.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2: 2007 and 2014 (Medical Electrical Equipment – Part 1-2: General requirements for safety – Collateral Standard: Electromagnetic compatibility – Requirements and Tests). These standards define limits for electromagnetic emissions and immunity to ensure the device operates correctly in its environment without causing interference or being affected by it.	"Appropriate performance...was demonstrated by showing that the device meets applicable clauses" in these standards. This implies that the device passed all required EMC tests, ensuring it functions safely and effectively without electromagnetic interference.

Since this is a submission for a medical device (patient return electrode) and not an AI/diagnostic software, the following sections from your request are not applicable or not provided in the document:

Sample sizes used for the test set and the data provenance: Not applicable. These are not diagnostic accuracy studies. Performance testing is usually conducted on a set number of samples required by the standards, not a "test set" in the context of an AI model. Data provenance (country, retrospective/prospective) is also not relevant here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI models (e.g., expert labels on images) is not relevant for this type of device testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is compliance with established international safety and performance standards (e.g., IEC, ISO).
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable.

In summary, the substantial equivalence assertion for the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode is based on demonstrating that its design and materials, despite minor differences in patient weight range and surface area from the predicate, meet required performance and safety standards for medical electrosurgery devices.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 19, 2016

Covidien LLC Ms. Nancy Sauer Principal Regulatory Affairs Specialist 5920 Longbow Drive Boulder, CO 80301

Re: K160290

Trade/Device Name: Valleylab™ REM Polyhesive™ Infant Patient Return Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device & accessories Regulatory Class: Class II Product Code: GEI Dated: April 19, 2016 Received: April 21, 2016

Dear Ms. Sauer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160290

Device Name

Valleylab REM Polyhesive Infant Patient Return Electrode

Indications for Use (Describe)

The product is used for general monopoloar electrosurgery on newborns, infants, and children weighing between approximately 6 and 30 1b.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Number: K160290

Date summary prepared: 5/18/2016

510(k) Submitter/Holder

Covidien 5920 Longbow Drive Boulder, CO 80301

Contact

Nancy Sauer Principal Regulatory Affairs Specialist Telephone: 303-581-6791 Fax: 303-530-6313 Email: nancy.k.sauer@medtronic.com

Name of Device

Trade Name:	Valleylab™™ REM Polyhesive™™ Infant Patient Return Electrode
Catalog Numbers:	E7510-25, E5710-25DB
Common Name:	Patient Return Electrode
Classification Name:	Electrosurgical device, cutting, coagulation, and accessories
Regulation Number:	21CFR 878.4400
Product Code:	GEI

Predicate Device

The primary predicate device for this submission is the Valleylab™ REM Polyhesive™ Neonatal Patient Return Electrode. This device was cleared for marketing under 510(k) K994428.

Device Description

Indications for Use

The REM Polyhesive Infant Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord. The electrode adheres to the patient over its entire surface. Its purpose is to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

The product is used for general monopoloar electrosurgery on newborns, infants, and children weighing between approximately 6 and 30 lb.

Technological Characteristics

This is a non-sterile single-use device that includes the following features:

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. Conductive resin that adheres to the patient's skin and conducts electrical current away from the patient's body.
. Non-conductive adhesive border that provides a stronger adhesive bond and helps to prevent fluid ingress.
. Two separate pieces of conductive metal foil. The presence of two separate foil sheets is necessary for the Covidien Return Electrode Monitoring (REM) system in the Covidien generators.
. An integral cord that conducts the current from the conductive metal foil back to the generator.

Comparison to the Predicate Device

Similarities

. Same general intended use
Both are indicated for use in pediatric populations, primarily newborns and infants .
Same materials and design
Both use the Covidien REM technology for contact quality monitoring.

Differences

The indicated patient weight range is higher for the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode. It is indicated for use in patients weighing between 6 and 30 pounds (2.7 - 13.6 kg), whereas the predicate device is indicated for use in patients weighing between 1 and 6 pounds. Because return electrodes intended for larger pediatric patients are expected to carry more current, the infant return electrode has a larger surface area than the neonatal return electrode.

The impact of these differences was evaluated through testing to show that the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode meets thermal performance requirements for return electrodes indicated for use on patients weighing between 5 and 15 kg.

Sterilization

The Valleylab™ REM Polyhesive™ Infant Patient Return Electrodes are not sterile. Because the products are not delivered in sterile form, the primary packaging is not intended to act as a sterile barrier.

Shelf Life

The packaged Valleylab™ REM Polyhesive™ Infant Return Electrodes have a shelf life of two years. The suitability of this shelf life has been verified in accordance with sub-clause 201.15.101.8 of IEC 60601-2-2: 2009, which requires that the products be aged to within 30 days of their expiration date prior to conducting thermal performance and contact impedance testing.

The primary packaging has also been evaluated to verify the suitability of the two year shelf life. The primary packaging remains intact with no tears, holes, or other degradation and the seal remains intact (seal width maintained and no visual evidence of seal degradation).

Biocompatibility

The products have been evaluated for biocompatibility in accordance with ISO 10993-1: 2009 and the FDA Blue Book Memorandum G95-1. Per the standard, patient return electrodes are classified as intact skin contacting devices with limited duration (< 24 hours) of contact.

The direct patient contact materials are:

. Conductive gel (adhesive polymer matrix, water, electrolytes, blue colorant, and preservative)
. Pressure-sensitive adhesive border
Silicone-coated paper (can be used to cover adhesive border at the surgeon's discretion) ●

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Two non-patient contacting materials were included in testing because of their potential for affecting the direct patient contact materials.

Conductive foil-polymer laminate .
Cross-linked foam backing

Production-representative devices made of these materials were subjected to cytotoxicity, sensitization, and primary skin irritation tests. The devices met all of the acceptance criteria for these tests.

Performance

Appropriate performance of the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode was demonstrated by showing that the device meets applicable clauses in the following standards:

IEC 60601-1: 2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-2-2: 2009. Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-1-2: 2007 and 2014, Medical Electrical Equipment – Part 1-2: General requirements for safety – Collateral Standard: Electromagnetic compatibility – Requirements and Tests.

Conclusion

The comparison of device characteristics and the review of the performance data support the conclusion that the Valleylab™ REM Polyhesive™ Infant Patient Return Electrode is substantially equivalent to the Valleylab™ REM Polyhesive™ Neonatal Patient Return Electrode.

Regulation Number and Section

§ 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.