THUMPER

K972525 · Michigan Instruments, Inc. · DRM · Oct 2, 1997 · Cardiovascular

Device Facts

• Record ID: K972525
• Device Name: THUMPER
• Applicant: Michigan Instruments, Inc.
• Product Code: DRM · Cardiovascular
• Decision Date: Oct 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Thumper® Model 1007 is intended for use on persons in immediate need of manual cardiopulmonary resuscitation (CPR) as described in the American Heart Association, Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiac Care, 1992. The Thumper® Model 1007 type of medical device is referred to in the AHA CPR Guideline as an "automatic mechanical chest compressor." It is used as an adjunct to manual CPR for use by trained personnel to optimize compression and reduce rescuer fatigue in prolonged resuscitation efforts.

Device Story

Thumper Model 1007 is a pneumatically powered mechanical cardiopulmonary resuscitator; provides automated chest compressions and ventilation to patients in clinical death. Device consists of gas-powered piston assembly, massager pad, and backboard. Operates by delivering compressions at 90 cycles/minute with 50% duty cycle and 5:1 compression-to-ventilation ratio, mimicking manual CPR. Includes built-in constant-flow, time-cycled ventilator delivering 100% oxygen. Used by trained personnel as an adjunct to manual CPR to optimize compression consistency and reduce rescuer fatigue during prolonged resuscitation. Healthcare providers use the device to support circulatory and respiratory function; output directly replaces manual chest compressions and mouth-to-mouth breathing. Benefits include standardized CPR delivery and reduced physical strain on rescuers.

Clinical Evidence

Bench testing only. Comparative testing performed on Thumper Models 1004, 1005, and 1007 using a calibrated spring load (MII model T106) and a calibrated test lung (MII Pneu® View Model 2601i). Endpoints included piston compression rate (cycles/min), depth of compression (inches), and compression duration duty cycle (%). Results demonstrated compliance with AHA manual CPR standards and comparable performance to predicate devices.

Technological Characteristics

Pneumatically powered mechanical chest compressor. Components: gas-powered piston, massager pad, backboard, and integrated constant-flow, time-cycled ventilator. Delivers 100% oxygen. Dimensions: smaller and lighter than predicates. Operation: 90 compressions/minute, 50% duty cycle, 5:1 compression-to-ventilation ratio. No software or electronic algorithms; purely mechanical/pneumatic control system.

Indications for Use

Indicated for adult patients in clinical death (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® Model 1004
• Thumper® Model 1005 (K851139)

Submission Summary (Full Text)

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K972525

Image /page/0/Picture/1 description: The image shows the logo for Michigan Instruments INC. The logo consists of a stylized globe with three arrowheads pointing to the right. To the right of the globe is the text "Michigan Instruments" in a bold, sans-serif font, with "INC." in a smaller font below the word "Instruments".

OCT - 2 1997

4717 Talon Court. S.E. · Grand Rapids, MI 49512-5409 Phone [phone] · Fax [phone]

## July 2, 1997

## 510(k) Summary - Thumper® Model 1007

- James D. Maatman, President Submitter -Michigan Instruments. Inc. 4717 Talon Court, SE Grand Rapids, MI 49512-5409 Tel: [phone] Fax: [phone]
- Trade Name Thumper® Model 1007 .
- . Common name - Mechanical Cardiopulmonary Resuscitator
- . Classification name - External cardiac compressor, product code 870.5200
- Substantially equivalent devices -.

Thumper® Model 1004:

a "preamendment device."

Thumper® Model 1005:

510(k) Clearance dated May 15, 1985), reference number K851139.

### Description of Thumper® Model 1007

The Thumper® Model 1007 is a pneumatically powered external cardiac compressor used on a patient in a state of clinical death and in immediate need of respiratory and circulatory support. The Thumper® Model 1007 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 to 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 CPR according to contemporary American Heart Association (AHA) CPR guidelines for manual CPR. The Thumper® Model 1007 delivers standard CPR in a 5:1 compression-ventilation ratio with a compression duration that is 50% of the cycle length at a rate of 90 compressions per minute.

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## 510(k) Summary - Thumper® Model 1007

- Intended use The Thumper® Model 1007 is intended for use on persons in immediate need of manual cardiopulmonary resuscitation (CPR) as described in the American Heart Association, Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiac Care, 1992. The Thumper® Model 1007 type of medical device is referred to in the AHA CPR Guideline as an "automatic mechanical chest compressor." It is used as an adjunct to manual CPR for use by trained personnel to optimize compression and reduce rescuer fatigue in prolonged resuscitation efforts.
- Technical characteristics The Thumper® Model 1007 is very similar and performs the same clinical function as the predicate devices. Thumper® Model 1004 and Thumper® Model 1005. The main distinguishing characteristics of the Thumper® Model 1007 are in response to Thumper® Model 1004 and Thumper® Model 1005 clinical user input and requests for product changes:
- The Model 1007 is smaller and lighter than the predicate devices. .
- The complexity and number of the Model 1007 controls has been reduced .
- . The Model 1007 controls have improved ergonomics and ease of use.
- . The built-in ventilator of the Model 1007 is of the constant flow, timecycled operation as opposed to the previous pressure limited time-cycled operation.
- . The Model 1007 built-in ventilator delivers 100% oxygen as compared to approximately 80% delivered oxygen of the Model 1004 and Model 1005
- Bench Test The Thumper® Model 1004. Thumper® Model 1005. and Thumper® Model 1007 were comparatively tested. An exemplar model of each unit was first qualified by passing its respective quality assurance test. Then, in turn, each exemplar was tested using a MII calibrated spring load. This unit (MII model T106) was designed and built based on a clinical study of human chest elastic properties during CPR. The T106 was instrumented to produce piston deflection waveforms for comparison. Simultaneously with the operation of the Thumper® piston, the associated built-in ventilators for each exemplar were used to ventilate a calibrated test lung, MII Pneu® View Model 2601i, set to lung compliance and resistance values typical of an adult CPR situation. The resultant piston compression rate (cycles/min), depth of compression (inches), compression duration duty cycle (%) demonstrate compliance with AHA standards for manual CPR. The ventilators for each exemplar demonstrated comparable ventilation of the test lung.

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# 510(k) Summary - Thumper® Model 1007

- Conclusions from Bench Tests The Thumper Model 1007 provides compressive piston action similar to the Thumper Model 1004 and Thumper Model 1005. The compression action of the Thumper Model 1007 at 90 compressive cycles per minute with a compression duty cycle of 50% against the T 106 spring test load complies with present AHA manual CPR standards. The Thumper® Model 1007 built-in ventilator ventilated the test lung in the same manner as the Thumper® Model 1004 and Thumper® Model 1005. All three models of the Thumper® comply with 2-rescuer manual CPR ventilation by providing ventilation on a 5:1 compression to ventilation ratio. The bench tests indicate the Thumper® Model 1007 is substantially equivalent in design and performance to both the predicate devices, Thumper® Model 1004 and Thumper® Model 1005.
James D. Moatman

James D. Maatman, President Michigan Instruments, Inc.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a single snake winding around a staff, and it is positioned within a circular frame. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

OCT - 2 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. James D. Maatman President Michigan Instruments, Inc. 4717 Talon Court, S.E. Grand Rapids, Michigan 49512-5409

Re: K972525 Thumper® Model 1007 Requlatory Class: III (Three) Product Code: DRM September 25, 1997 Dated: Received: September 26, 1997

Dear Mr. James D. Maatman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. James D. Maatman

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(K) Number: K972525

Device Name: Thumper® Cardiopulmonary Resuscitator

Indications for Use:

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.

## PLEASE DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Seon G. Lemkelee

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_k 97

Prescription Use
(Per 21 C.F.R. § 801.109)

Over-the-Counter Use ___________

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