CPR RSQ ASSIST

K123248 · Avantech, Inc. · LIX · Dec 10, 2013 · Cardiovascular

Device Facts

• Record ID: K123248
• Device Name: CPR RSQ ASSIST
• Applicant: Avantech, Inc.
• Product Code: LIX · Cardiovascular
• Decision Date: Dec 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5210
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The CPR RsQ Assist is intended to assist the rescuer in performing chest compressions at the recommended American Heart Association (AHA) rate of 100 compressions/minute on a victim 8 years or older.

Device Story

CPR RsQ Assist is a manual CPR aid used by rescuers to maintain proper chest compression rates. Device consists of a rigid plastic top, support collar, foam-filled flexible plastic bellows, and a removable silicone base. During manual compressions, device provides visual (LED) and audio cues to guide the user to the AHA-recommended rate of 100 compressions/minute. Used in emergency settings to assist in resuscitation efforts. Output cues help the rescuer standardize compression frequency, potentially improving the quality of CPR and patient outcomes.

Clinical Evidence

Bench testing only. Testing included mechanical failure testing, structural integrity drop testing, simulated use on CPR manikins (measuring chest displacement depth, rate, and compression force), low battery indicator testing, and electromagnetic compatibility (IEC 60601-1-2, IEC 61000-4-2, IEC 61000-4-3). Biocompatibility was established per ISO 10993-1.

Technological Characteristics

Rigid plastic top, plastic support collar, foam-filled flexible plastic bellows, removable silicone base. Provides visual (LED) and audio cues. Non-sterile. Biocompatibility per ISO 10993-1. EMC testing per IEC 60601-1-2, IEC 61000-4-2, and IEC 61000-4-3.

Indications for Use

Indicated for assisting rescuers in performing chest compressions at 100 compressions/minute on victims 8 years of age or older.

Regulatory Classification

Identification

CPR Aid device with feedback is a device that provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines (to include, but not be limited to, parameters such as compression rate, compression depth, ventilation, recoil, instruction for one or multiple rescuers, etc.). These devices may also perform a coaching function to aid rescuers in the sequence of steps necessary to perform effective CPR on a victim.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(i) Nonclinical performance testing under simulated physiological or use conditions must demonstrate the accuracy and reliability of the feedback to the user on specific compression rate, depth and/or respiration over the intended duration, and environment of use. (ii) Labeling must include the clinical training, if needed, for the safe use of this device and information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations, *e.g.,* adult, pediatric and/or infant).(iii) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment. (iv) For devices containing software, software verification, validation, and hazard analysis must be performed. (v) Components of the device that come into human contact must be demonstrated to be biocompatible. (vi) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user. (3) *Premarket notification.* The CPR Aid with feedback device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter if it does not contain software (*e.g.,* is mechanical or electro-mechanical) and is in compliance with the special controls under paragraph (b)(2) of this section, subject to the limitations of exemptions in § 870.9.

Predicate Devices

• Bio-Detek, Inc.'s PocketCPR (K071321)
• Elcare Innovations, Inc.'s The Grip (K010526)

Submission Summary (Full Text)

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### 510(k) SUMMARY

### AvanTech, Inc.'s CPR RsQ Assist

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

AvanTech, Inc. 559 Audubon Blvd., Apt. 301 Naples, Florida 34110 Phone: [phone] Facsimile: [phone]

Contact Person: Joseph J. Hanson, President

Date Prepared: December 3, 2013

## Name of Device and Name/Address of Sponsor

CPR RsQ Assist

P

Joseph J. Hanson 559 Audubon Blvd., Apt. 301 Naples, Florida 34110

#### Common or Usual Name

Cardiopulmonary Resuscitation Aid

### Classification Name

21 CFR 870.5200 Cardiopulmonary Resuscitation Aid

# Predicate Devices

Bio-Detek, Inc.'s PocketCPR (K071321)

Elcare Innovations, Inc.'s The Grip (K010526)

DEC 1 0 2013

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#### Intended Use / Indications for Use

The CPR RsQ Assist is intended to assist the rescuer in performing chest compressions at the recommended American Heart Association (AHA) rate of 100 compressions/minute on a victim 8 years or older.

#### Technological Characteristics

The CPR RsQ Assist consists of a rigid plastic top with an integrated plastic support collar, a flexible plastic bellows filled with foam, and a removable silicone base platform. LED lights and a speaker component provide visual and audio cues, respectively, to the user during manual CPR compressions.

The CPR RsQ Assist is provided non-sterile:

### Performance Data

In support of this 510(k) Premarket Notification, AvanTech, Inc. has conducted bench testing to demonstrate that the CPR RsQ Assist provides adequate mechanical strength and performs appropriately for its intended use. The company has conducted the following tests:

- Mechanical test to failure ı
- Structural integrity "drop" test ı
- Simulated use on conventional CPR manikin .
- o Chest displacement depth and rate
- o Chest compression force
- Low battery indicator
- Electromagnetic compatibility testing according to IEC 60601-1-2 ।
- Electromagnetic Compatibility immunity testing according to IEC 61000-4-2 r (Electrostatic Discharge Immunity Test) and IEC 61000-4-3 (Radiated, Radio-Frequency Electromagnetic Field Immunity Test)

Performance testing confirmed that the CPR RsQ Assist functions as intended and meets all of its performance specifications. In addition, the biocompatibility of the patientcontacting device material was established based on testing performed according to ISO 10993-1.

#### Substantial Equivalence

The CPR RsQ Assist is as safe and effective as Bio-Detek, Inc.'s PocketCPR (K071321) and Elcare Innovations, Inc.'s The Grip (K010526). The CPR RsO Assist has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the CPR RsQ Assist and its predicate devices raise no new types of safety or effectiveness questions. Performance data demonstrate that the CPR RsQ Assist is safe and effective

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to perform its intended use to assist the rescuer in performing chest compressions at the recommended AHA rate of 100 compressions per minute on a victim 8 years or older. Thus, the CPR RsQ Assist is substantially equivalent to its predicates.

.

A

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ﺗﻘ

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms.

#### Public Health Service

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

December 10, 2013

Avantech. Inc. c/o Hogan Lovells US LLP Attn: Steven B. Datlof, M.D., J.D. 1835 Market Street, 29th Floor Philadelphia, PA 19103

Re: K123248

Trade Name: CPR RsQ Assist Device Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: III (Three) Product Code: LIX Dated: October 1, 2013 Received: October 1, 2013

Dear Dr. Datlof:

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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Page 2 - Steven B. Datlof, M.D., J.D.

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 [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" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

M 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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Indications for Use Statement

510(k) Number (if known): K123248

Device Name: CPR RsQ Assist

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> Indications for Use: The CPR RsQ Assist is intended to assist the rescuer in performing chest compressions at the recommended American Heart Association (AHA) rate of 100 compressions/minute on a victim 8 years or older.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ਨ (21 CFR 801 Subpart C)

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i Concurrence of CDRH, Office of Device Evaluation (ODE)

MDA

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