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.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the "Rapid Hair Removal Pads" (RHRP) and its substantial equivalence determination to a predicate device. The document details performance testing conducted to support this claim, which includes Human Factors/Usability testing, Impedance testing, and Biocompatibility studies.

Here's an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with numerical targets, but rather describes the successful outcomes of the tests. Based on the reported findings, we can infer the implicit acceptance criteria met by the device.

Test Category	Implicit Acceptance Criteria	Reported Device Performance
Human Factors/Usability	- ALS personnel can be effectively trained to properly apply and remove RHRP. - RHRP labeling effectively directs users. - Application and removal of RHRP can be completed within a reasonable timeframe (implied performance goal). - No user confusion or error identified.	- Training of ALS personnel and RHRP labeling effectively directed users on proper application and removal. - Proposed labeling changes will further enhance the user interface. - Timed simulation: ALS personnel were able to properly place and remove RHRP in under 15 seconds. - No user confusion or user error identified based on simulation and questionnaire responses.
Impedance Testing	- RHRP application should substantially decrease impedance at electrode placement sites. - This decrease in impedance should optimize electrode-to-skin contact and aid defibrillation therapy.	- The hair removal accomplished by the RHRP adhesive substantially decreases impedance, thereby optimizing the electrode pad-to-skin contact and aiding defibrillation therapy. - Impedance readings were taken before and after RHRP application to demonstrate this effect.
Biocompatibility	- No detectable interaction with human cells (cytotoxicity). - Minimal or temporary skin irritation (human use testing). - No chemical irritation of the skin. - The adhesive materials coming into contact with the skin are non-toxic, do not contain color additives, and have no adverse environmental effects (based on manufacturer records).	- Cytotoxicity test results show no detectable interaction between RHRP and human cells, with a reactivity grade of "O". - Human Use Testing showed only minor and temporary mechanical irritation of the skin. - No chemical irritation of the skin was experienced after application and removal. - Analysis of the RHRP adhesive material (based on manufacturer records) deemed them non-toxic, free of color additives, and with no adverse environmental effects.

2. Sample Size Used for the Test Set and Data Provenance

Human Factors/Usability Testing:
- Sample Size: 15 Advanced Life Safety (ALS) trained professionals.
- Data Provenance: Prospective, conducted in a simulated emergency setting with live human subjects. The country of origin is not specified but is implied to be within the jurisdiction of the FDA submission (USA).
Impedance Testing:
- Sample Size: 26 total chest pulls (implying the RHRP was used 26 times, likely on different subjects or areas).
- Data Provenance: Prospective, as impedance readings were taken before and after RHRP application. Country of origin not specified (implied USA).
Biocompatibility Studies:
- Cytotoxicity Test: Sample size not explicitly stated for the test itself, but performed on the device material.
- Human Use Testing: Sample size not explicitly stated, but implies observation on human subjects.
- Adhesive Material Analysis: Based on manufacturer records (no specific sample size for a test set provided here).
- Data Provenance: Assumed prospective for cytotoxicity and human use testing, retrospective/document review for adhesive material analysis. Country of origin for tests not specified (implied USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Human Factors/Usability Testing: The "ground truth" here is the ability of ALS personnel to correctly and efficiently use the device without confusion or error. This was established through observation and questionnaire responses from 15 ALS trained professionals. Their specific qualifications are stated as "Advanced Life Safety trained professionals (ALS personnel)".
Impedance Testing: The "ground truth" is the change in impedance. This was measured objectively using a "CheckTrode Ohm meter" by presumably study personnel, not through expert consensus on images or outcomes.
Biocompatibility Studies:
- Cytotoxicity: Measured objectively in a lab setting by trained personnel following established protocols.
- Human Use Testing: Based on observation of skin reactions, likely by trained medical observers.
- Adhesive Material Analysis: Based on manufacturer records, implying expert analysis of material composition and safety data by the manufacturer's qualified personnel.

The document does not detail a process of using a specific number of "experts" to establish ground truth in the sense of image interpretation or medical diagnosis for these types of tests.

4. Adjudication Method for the Test Set

Human Factors/Usability Testing: No explicit adjudication method (like 2+1 or 3+1) is mentioned. User performance was assessed through direct observation during a simulated environment and through post-testing questionnaire responses from the 15 ALS personnel. "No user confusion or user error was identified" suggests a consensus or clear determination from the observed data.
Impedance Testing: No adjudication method. It relies on objective meter readings.
Biocompatibility Studies: No adjudication method. Based on laboratory test results and observations.

5. 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

No MRMC comparative effectiveness study was done or reported. The device is a physical hair removal pad, not an AI or digital diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. As the device is a physical hair removal pad, there is no "algorithm only" performance separate from its interaction with a human user applying it.

7. The Type of Ground Truth Used

Human Factors/Usability Testing: Observational data (user performance, task completion time) and self-reported feedback (questionnaire responses) from trained professionals.
Impedance Testing: Objective quantitative measurements (impedance readings in ohms) from a testing device (CheckTrode Ohm meter).
Biocompatibility Studies: Laboratory assay results (cytotoxicity grade), clinical observation of skin reactions (human use testing), and material composition analysis (manufacturer records).

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI/machine learning algorithms that require a "training set" in the context of data. The "training" mentioned in the Human Factors study refers to training the ALS personnel on how to use the device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See point 8).

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines representing movement or connection.

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.

{1}------------------------------------------------

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 (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 Industry and Consumer Education 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.

FDA

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

Enclosure

{2}------------------------------------------------

Attachment 12—Revised Page 36

Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

{4}------------------------------------------------

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.
1. 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.
1. 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

{5}------------------------------------------------

(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.

Regulation Number and Section

§ 870.5300 DC-defibrillator (including paddles).

(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is 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.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is 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.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.