THUMPER, MODEL: 1008

K073079 · Michigan Instruments, Inc. · DRM · Feb 14, 2008 · Cardiovascular

Device Facts

• Record ID: K073079
• Device Name: THUMPER, MODEL: 1008
• Applicant: Michigan Instruments, Inc.
• Product Code: DRM · Cardiovascular
• Decision Date: Feb 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thumper® Model 1008 is intended to perform CPR on adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

Device Story

Pneumatically-powered, electronically controlled external cardiac compressor; performs mechanical CPR on adult patients in clinical death. System comprises gas-powered piston assembly, massager pad, and backboard. Integrated ventilator provides respiratory support via facemask or advanced airway. Operates in two modes: 30:2 compression-ventilation ratio or continuous compressions (100 compressions/min) with nine asynchronous breaths/min. Designed for use by healthcare professionals to replace manual chest compressions and mouth-to-mouth breathing. Output provides consistent, AHA-compliant mechanical CPR to support circulation and respiration, potentially improving patient outcomes during resuscitation efforts.

Clinical Evidence

Bench testing only. Performance data confirmed conformance to product specifications and substantial equivalence to predicate devices regarding compression rate, duration, and ventilation parameters.

Technological Characteristics

Pneumatically-powered, electronically controlled external cardiac compressor. Components: gas-powered piston, massager pad, backboard, integrated ventilator. Dimensions/form factor: portable mechanical unit. Connectivity: none. Sterilization: not specified. Software: electronic control for compression/ventilation timing.

Indications for Use

Indicated for adult patients in clinical death (lack of spontaneous breathing and pulse) requiring mechanical cardiopulmonary resuscitation.

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® Cardiopulmonary Resuscitator, Model 1007 (K972525)
• ZOLL® AutoPulse® (K063602)

Submission Summary (Full Text)

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K073079

# 510(k) SUMMARY

### Michigan Instruments Inc.'s Thumper® Model 1008

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

000 | 4 -

Michigan Instruments, Inc. 4717 Talon Court. SE Grand Rapids, MI 49512 Phone: [phone] Facsimile: [phone]

Contact Person: Bruce H. Barkalow, Ph.D.

Date Prepared: October 29, 2007

### Name of Device and Name/Address of Sponsor

Thumper® Model 1008 Michigan Instruments, Inc. 4717 Talon Court, SE Grand Rapids, MI 49512

### Common or Usual Name

Mechanical Cardiopulmonary Resuscitation Device

#### Classification Name

External Cardiac Compressor, Product Code DRM, Regulation Number 870.5200

### Predicate Devices

Thumper® Cardiopulmonary Resuscitator, Model 1007 (K972525) ZOLL® AutoPulse® (K063602)

# Purpose of the Special 510(k) Notice

The Thumper® Model 1008 is a modification to Thumper® Model 1007.

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# Intended Use

The Thumper® Model 1008 is intended to perform CPR on adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

# Technological Characteristics

The Thumper® Model 1008 is a pneumatically-powered, electronically controlled external cardiac compressor used on adult patients in a state of clinical death and in immediate need of respiratory and circulatory support. The Thumper® Model 1008 uses a gas-powered piston assembly with a massager pad and associated backboard to perform the function of a rescuer pressing on the patient's chest with his or her hands. A built-in ventilator that is compatible with a facemask or advanced airway replaces the rescuer's mouth-to-mouth breathing for the patient. The action of the piston and the action of the associated ventilator have been designed to perform mechanical Cardiopulmonary Resuscitation ("CPR") according to contemporary American Heart Association ("AHA") CPR guidelines for manual CPR. The Thumper® Model 1008 delivers standard AHA compliant CPR in two modes. The first is a 30:2 compression-ventilation ratio with a compression duration that is 50% of the cycle length at a rate of 100 compressions per minute. The second is a continuous compressions mode having a compression duration that is 50% of the cycle length at a rate of 100 compressions per minute with nine asynchronous breaths per minute.

# Performance Data

Appropriate testing was conducted to evaluate conformance to product specifications and substantial equivalence to the predicate devices.

# Substantial Equivalence

The Thumper® Model 1008 has the same intended use/indications, and similar principles of operation, and technological characteristics as the Thumper® Model 1007 and the AutoPulse. The minor technological differences in the Thumper® Model 1008 do not raise any new questions of safety or effectiveness. Performance data demonstrates that the Thumper® Model 1008 is as safe and effective as the predicate devices. Thus, the Thumper® Model 1008 is substantially equivalent to its predicate devices.

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FEB 1 4 2008

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michigan Instruments, Inc. c/o Bruce H. Barkalow, Ph. D. 4717 Talon Court, SE Grand Rapids, MI 49512

Re: K073079

Thumper® Model 1008 Regulation Number: 21 CFR 870.5200 Regulation Name: External cardiac compressor Regulatory Class: Class III (three) Product Code: DRM Dated: October 31, 2007 Received: November 05, 2007

Dear Dr. Barkalow:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Bruce H. Barkalow, Ph. D.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrth/industry/support/index.html.

Sincerely yours,

Brimmer 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): __KO73079

Device Name: Thumper® Model 1008

Indications for Use: (same as Predicate device Thumper® Model 1007)

# "This device is used 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 __X (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Hummelmo

liovascular Devices