MINIATURIZE CHEST COMPRESSOR (MCC)

K102068 · Resuscitation International · DRM · Nov 16, 2010 · Cardiovascular

Device Facts

• Record ID: K102068
• Device Name: MINIATURIZE CHEST COMPRESSOR (MCC)
• Applicant: Resuscitation International
• Product Code: DRM · Cardiovascular
• Decision Date: Nov 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Device Story

Miniaturized Chest Compressor (MCC) is an automated, portable mechanical device providing continuous chest compressions as an adjunct to manual CPR. Powered by compressed oxygen or air; device delivers consistent compressions to cardiac arrest patients in settings where manual techniques are hindered. Operated by healthcare personnel; device functions as a mechanical support tool to maintain circulation. Benefits include consistent, uninterrupted chest compressions, potentially improving resuscitation efficacy compared to manual-only efforts.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench testing to evaluate performance and effectiveness during simulated CPR, and animal testing to compare CPR efficacy and outcomes. Biocompatibility testing was conducted per ISO 10993 standards.

Technological Characteristics

Automated, portable mechanical chest compressor. Powered by compressed oxygen or air. Patient-contact materials verified via ISO 10993 biocompatibility testing. Mechanical actuation principle.

Indications for Use

Indicated for adult patients in clinical death, defined by lack of spontaneous breathing and pulse, requiring cardiopulmonary resuscitation (CPR).

Regulatory Classification

Identification

An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use. (2) Labeling must include the following: (i) The clinical training necessary for the safe use of this device; (ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling; (iii) 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); and(iv) Information on the time necessary to deploy the device as demonstrated in the performance testing. (3) 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. (4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device. (5) For devices containing software, software verification, validation, and hazard analysis must be performed. (6) Components of the device that come into human contact must be demonstrated to be biocompatible.

Predicate Devices

• Thumper (K972525)

Submission Summary (Full Text)

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K102068

NOV 1 6 2010

Premarket Notification [510(k)], Resuscitation International, Miniaturize Chest Compressor

## 5. 510(k) Summary

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## SUMMARY

Resuscitation International, Inc. Submitter's name: 35100 Bob Hope Dr. Address: Rancho Mirage, CA 92270 760-778-3460 Phone: [phone] Fax number: Robyn Scopis Name of contact person: Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone]

Date the summary was prepared: November 9, 2010

Name of the device: Trade or proprietary name: Common or usual name: Classification name: Classification Product Code

Miniaturize Chest Compressor (MCC) Miniaturize Chest Compressor (MCC) Mechanical Cardiopulmonary Resuscitator compressor, cardiac, external Class III DRM

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

| 510(k)<br>Number | Trade or Proprietary or Model Name | Manufacturer |
|------------------|------------------------------------|------------------------------|
| 1 K972525 | Thumper | Michigan<br>Instruments, Inc |

Description of the device:

The miniaturized compressor (MCC) is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by compressed oxygen or air.

The MCC provides consistent CPR support for cardiac arrest patients under conditions, which might otherwise hinder the effectiveness of manual techniques.

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Indications:

To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Intended Use: .

To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Summary of the technological characteristics of our device compared to the predicate device:

The predicate and Resuscitation International Miniaturize Chest Compressor (MCC) were compared in the following areas and found to have similar technological characteristics and to be equivalent:

Physical Characteristics Material Characteristics Operating Characteristics Indications for Use

Nonclinical Tests Submitted:

Bench Testing - The purpose of these tests are to evaluate the performance of the Miniaturized Chest Compressor (MCC) and to measure its effectiveness during simulated cardiopulmonary resuscitation (CPR).

Animal Testing - To evaluate the effects of three different mechanical chest compressors devices on CPR efficacy and ultimately on outcomes after prolonged cardiac arrest.

Biocompatibility - Biocompatibility testing was completed to establish the safety of all patient contact materials. Testing was done to ISO 10993 standards.

Clinical Tests Submitted:

No clinical testing was performed.

Nonclinical and Clinical Conclusions:

Nonclinical testing shows results for the MCC are within the range recommended by the CPR guidelines. Animal testing results show the MCC as effective as the predicate. Biocompatibility was successfully completed.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Room -WO66-G609 Silver Spring, MD 20993-0002

Resuscitation International, Inc. c/o Ms. Robyn Scopis Regulatory Consultant 7322 Avenue Sausalito Irvine, CA 92606

NOV 1 6 2010

Re: K102068

Miniaturize Chest compressor (MCC) Regulation Number: 21 CFR 870.5200 Regulation Name: Compressor, Cardiac, External Regulatory Class: Class III (three) Product Code: " DRM Dated: October 19, 2010 Received: October 21, 2010

Dear Ms. Scopis:

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.

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Page 2 - Ms. Robyn Scopis

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

sina R. Kirchner

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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Premarket Notification [510(k)], Resuscitation International, Miniaturize Chest Compressor

## 4. Indications for Use Statement

## Indications for Use

510(k) Number (if known): K (o 2 06 S

NOV 1 6 2010

Device Name: Miniaturize Chest Compressor (MCC)

Indications for Use:

To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Prescription Use AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. V. Luna

(Division Sign-Off) (Division Sign-Om)
Division of Cardiovascular Devices

510(k) Number_K103068

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