Rapid Hair Removal Pads

K150349 · Full Power Aed · LDD · Jul 14, 2015 · Cardiovascular

Device Facts

• Record ID: K150349
• Device Name: Rapid Hair Removal Pads
• Applicant: Full Power Aed
• Product Code: LDD · Cardiovascular
• Decision Date: Jul 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5300
• Device Class: Class 2

Indications for Use

To remove excessive hair prior to placement of defibrillator electrodes.

Device Story

Rapid Hair Removal Pads (RHRP) are single-use, high-tack adhesive pads designed for emergency use by medical professionals. Device removes hair from chest and side torso sites where defibrillator electrodes are to be placed. User peels pad from PET liner, presses firmly onto skin/hair, and pulls quickly against hair growth direction. Mechanical hair removal reduces skin impedance; improves electrode-to-skin contact; facilitates accurate heart rhythm analysis and shock delivery by defibrillators. Used in emergency settings; operated by ALS-trained personnel. Benefits patient by ensuring optimal defibrillation therapy performance.

Clinical Evidence

Bench and human factors testing: 1) Usability study with 15 ALS personnel demonstrated proper use in <15 seconds with no user error. 2) Impedance testing (26 chest pulls) showed significant reduction in impedance post-application. 3) Biocompatibility: Cytotoxicity testing (reactivity grade 0) and human use testing showed no chemical irritation, only minor/temporary mechanical irritation.

Technological Characteristics

Disposable, single-use adhesive pads. High-tack adhesive on PET liner backing. Mechanical hair removal principle. No energy source. Non-electronic, non-software device.

Indications for Use

Indicated for removal of excessive chest and side torso hair in victims of sudden cardiac arrest prior to placement of defibrillator electrodes.

Regulatory Classification

Identification

Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

Predicate Devices

• 700-F Series Disposable Cardiac Stimulation Monitoring Electrodes (K964469)

Submission Summary (Full Text)

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

July 14, 2015

Full Power AED Mr. Jahn Power, President 707 East Hudson Ave. Durham, NC 27704

K150349 Re:

Trade/Device Name: Rapid Hair Removal Pads Regulation Number: 21 CFR 870.5300 Regulation Name: DC-Defibrillator (Including Paddles) Regulatory Class: Class II (two) Product Code: LDD Dated: June 1, 2015 Received: June 5, 2015

Dear Mr. Jahn Power,

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 of medical devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

FDA

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Attachment 12—Revised Page 36

Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K150349 | | |
| Device Name | Rapid Hair Removal Pads | | |
| Indications for Use (Describe) | To remove excessive hair prior to placement of defibrillator electrodes. | | |
| Type of Use (Select one or both, as applicable) | <div> <table><tr><td><div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div></td><td><div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div></td></tr></table> </div> | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> | <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |
| <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> | <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> | | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | |
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| <b>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*</b> | | | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | | | |
| Department of Health and Human Services | | | |
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| [e-mail] | | | |
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K150349

Image /page/3/Picture/1 description: The image shows the logo for Full Power AED. The logo consists of a black diamond shape with the letters F and P on either side of a heart symbol. Above the heart is a lightning bolt symbol. Below the diamond shape is the text "FULL POWER" in large, bold letters, followed by "- AED -" in smaller letters.

# 510(k) Summary

Summary of Information Contained in the 510(k) Premarket Notification

Date: February 2, 2015

- Submitter: Full Power AED, LLC 707 East Hudson Avenue Durham, NC 27704
Contact Person: Jahn Power President 919-475-6088

Rapid Hair Removal Pads or "RHRP" Trade name:

Common name: Chest Hair Removal Pads

Classification: The Rapid Hair Removal Pads are disposable accessories to the DC-Defibrillator, Low Energy, Product Code LDD, Class II, CFR Section 870.5300.

The Rapid Hair Removal Pads are substantially equivalent to the 700-F Series Disposable Cardiac Stimulation Monitoring Electrodes, 510(k) # K964469, manufactured by Cardiotronics.

#### Device Description

The Rapid Hair Removal Pads ("RHRP") are intended to be used by medical professionals prior to the placement of DC-Defibrillator, Low Energy electrodes to remove excessive chest and side torso hair from a victim of sudden cardiac arrest. This hair can significantly impede the defibrillator's performance in analyzing the heart's rhythm and delivering an appropriate shock. The primary mechanism of the RHRP is a high-tack adhesive that removes hair from the sites on the chest and side torso on which these electrodes are to be placed, prepping the site for optimal electrode-to-skin contact. RHRP is a single-use product and can be disposed of with other emergency single-use equipment.

To use the RHRP, the user removes the pads from the outer packaging, peels the pads sequentially off the non-stick PET liner backing, and places the adhesive side of the pad at two sites—on the chest and side torso-where the defibrillator electrodes will be placed. The user presses the pads on firmly to adhere them to the hair and skin at those sites. The user then pulls the pads quickly away from the skin in the opposite direction of hair growth. The resulting area is left substantially cleared of hair, decreasing impedance and increasing electrode-to-skin contact.

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### Intended Use

To remove excessive hair prior to placement of defibrillator electrodes.

## Substantial Equivalence Determination

The RHRP is equivalent to the 700-F Series Disposable Cardiac Stimulation Monitoring Electrodes ("DCSME") in its intended use, conditions of use and anatomical sites of use. Substantial equivalence has been determined on the basis of comparisons to the DCSME's intended use, user and target populations, anatomical sites of use, limited contact duration, use environment, post-use disposal, and design. The RHRP and the DCSME are different in their mechanism of use and in their sequence of use in defibrillation therapy, but these differences are minor and do not adversely affect safety and effectiveness of the RHRP.

Substantial equivalence has also been determined by the following performance testing:

- 1. Human Factors/Usability testing, in which 15 Advanced Life Safety trained professionals (ALS personnel) were trained on how to use the RHRP, put into a simulated emergency setting, and timed as they used a set of the RHRP pads on a live human subject. This testing demonstrated that:
- a) Training of ALS personnel and the RHRP labeling effectively directed the users how to properly apply and remove the RHRP pads from a live subject and proposed labeling changes will further enhance the user interface;
- b) In a timed simulation, these ALS personnel were able to properly place and remove the RHRP in under 15 seconds; and
- No user confusion or user error was identified based on the simulation and the c) questionnaire responses of the ALS personnel taken after the testing.
- 2. Impedance testing, in which the RHRP pads were used in 26 total chest pulls; impedance readings of the site were taken with a CheckTrode Ohm meter before and after RHRP application. This testing demonstrated that:
- a) The hair removal accomplished by the RHRP adhesive substantially decreases impedance, thereby optimizing the electrode pad-to-skin contact and aiding defibrillation therapy.
- 3. Biocompatibility studies:
- a) Cytotoxicity test results show no detectable interaction between the RHRP and human cells, and a reactivity grade of "O;"
- (b) Human Use Testing showed that the RHRP caused only minor and temporary mechanical irritation of the skin; no chemical irritation of the skin was experienced after application and removal of the RHRP; and

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- (c) Analysis of the RHRP adhesive material that comes into contact with the skin (based on manufacturer records) shows that they are not toxic, do not contain color additives, and have no adverse environmental effects.
The comparisons of the RHRP to the DCSME and the results of the above testing demonstrate that: (1) the RHRP is as safe, as effective, and performs as well as the DCSME for the intended use; and (2) that the RHRP is substantially equivalent to the DCSME and is suitable for the specified intended uses in the environment for use indicated.