(106 days)
Not Found
No
The description details a mechanical, pneumatically-powered device with electronic control for performing CPR according to pre-defined guidelines. There is no mention of learning, adaptation, or data-driven decision-making characteristic of AI/ML.
Yes.
The device is used to perform Cardiopulmonary Resuscitation (CPR) to provide respiratory and circulatory support for patients in clinical death, which is a therapeutic intervention.
No
The device is described as an external cardiac compressor used to perform mechanical Cardiopulmonary Resuscitation (CPR). Its function is to provide respiratory and circulatory support, not to diagnose a medical condition.
No
The device description clearly states it is a pneumatically-powered, electronically controlled external cardiac compressor with a gas-powered piston assembly, massager pad, backboard, and built-in ventilator, indicating it is a hardware device with software control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Thumper® Model 1008 is an external mechanical device that performs physical actions on the patient's body (chest compressions and ventilation) to provide life support. It does not analyze any biological samples.
- Intended Use: The intended use is to perform CPR on adult patients in cases of clinical death, which is a direct intervention on the patient, not an analysis of a specimen.
Therefore, the Thumper® Model 1008 falls under the category of a therapeutic or life-support device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
"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."
Product codes (comma separated list FDA assigned to the subject device)
DRM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Appropriate testing was conducted to evaluate conformance to product specifications and substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5200 External cardiac compressor.
(a)
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).(b)
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.
0
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: (616) 554-9696 Facsimile: (616) 554-3067
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.
1
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.
FEB 1 4 2008
__, and so on.
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
4
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