(511 days)
No
The device description and performance studies focus on mechanical aspects and consistent depth, with no mention of AI/ML terms or data-driven decision making.
Yes
The device is used to compress the chest to provide blood flow during cardiac arrest, directly treating a life-threatening condition.
No.
The device is used to provide blood flow during cardiac arrest by compressing the chest, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical device with a frame structure, compression mechanism, handle, connecting bar, plunger, and depth controlling scale. It is a manually powered external device for chest compressions, indicating a hardware-based function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest for adult patients." This is a direct therapeutic intervention on the patient's body.
- Device Description: The description details a mechanical device for external chest compression. It does not involve the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device performs a physical action on the patient's body.
N/A
Intended Use / Indications for Use
The device is an external device that is manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest for adult patients.
Product codes
DRM
Device Description
The ENERTRON CPR JACK is a portable cardiopulmonary resuscitation device with a patented feature of consistent and precision compression depth. It includes a frame structure and a compression mechanism. The compression mechanism has a handle connected with a connecting bar to drive a plunger. The compression mechanism keeps the plunging movements in a perpendicular direction. A depth controlling scale is included on the frame structure for presetting the compression depth of the plunger.
Thus, CPR JACK could provide an adjustable preset compression depth. The design of the ENERTRON CPR JACK adopts very few numbers of components. Therefore it is a light weight device and is made easy to carry. In addition, a rescuer can sit on the sitting bars of the frame with the weight of the rescuer offsetting the heavy platform reaction force while performing compression on a patient. This saves rescue time and efforts. The ENERTRON CPR JACK has an option to add a base board. The base board is for securing the frame structure in a moving environment such as an ambulance or a rescuing boat. Its purpose is to perform the cardiopulmonary resuscitation steadily in a moving environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest in the region of the heart
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)
Enertron had conducted two performance tests, one of 4000 strokes and another of 250,000 strokes. These tests demonstrated that consistent compression depth ranging from 1.5" to 2.0" could be consistently maintained.
- Performance tests demonstrated that user could reliably set the device and 1 provide compressions of consistent depth for different size patients.
- Static load and durability tests were performed to ensure the quality of the CPR JACK
These tests were a 4000-stroke test and a 250,000 stroke test. The new device passes the depth consistence tests, with an accuracy of 99.99%. Thus the compression depth of 1.5" through 2.0" can be consistently maintained for the new device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
THUMPER MODEL 1007, K972525, ELCARE GRIP, K010526
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K02425
MAY 1 4 2004
Enertron Engineering Co.
Suite 200, 1033 E. Main Street, Alhambra, CA 91801, U.S.A. Fax: 408-351-7772 Telephone: 408-253-3389
SUMMARY
| • Submitter: Jen, Ke-Min, Official Correspondent
ENERTRON ENGINEERING CO.
Suite 200, 1033 E. Main Street
Alhambra, CA 91801, U.S.A
TEL-408-253 3389
| FAX - 408-351 7772 | ||
|---|---|---|
| • | Classification name: | EXTERNAL CARDIAC COMPRESSOR |
| • | Classification number: | DRM, Class III |
| • | Regulation Number: | 870.5200 |
| • | Proprietary name: | ENERTRON Various Models of CPR JACK |
| • | Common name of device: | EXTERNAL CARDIAC COMPRESSOR |
| • | Predicate Device: | THUMPER MODEL 1007, K972525 |
| ELCARE GRIP, K010526 |
● Intended use
The device is an external device that is manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest for adult patients.
● Description of the Subject Device
The ENERTRON CPR JACK is a portable cardiopulmonary resuscitation device with a patented feature of consistent and precision compression depth. It includes a frame structure and a compression mechanism. The compression mechanism has a handle connected with a connecting bar to drive a plunger. The compression mechanism keeps the plunging movements in a perpendicular direction. A depth controlling scale is included on the frame structure for presetting the compression depth of the plunger.
1
Suite 200, 1033 E. Main Street, Alhambra, CA 91801, U.S.A. Telephone: 408-253-3389 Fax: 408-351-7772
Thus, CPR JACK could provide an adjustable preset compression depth. Enertron had conducted two performance tests, one of 4000 strokes and another of 250,000 strokes. These tests demonstrated that consistent compression depth ranging from 1.5" to 2.0" could be consistently maintained. According to a CPR laboratory study of the American Heart Association 1996, it was stated that "Consistence of chest compression or blood flow is desirable to ensure returning of live."
The design of the ENERTRON CPR JACK adopts very few numbers of components. Therefore it is a light weight device and is made easy to carry. In addition, a rescuer can sit on the sitting bars of the frame with the weight of the rescuer offsetting the Therefore, a heavy platform reaction force while performing compression on a patient. is not necessary as it is not necessary to move the patient for more space under the CPR JACK frame structure. This saves rescue time and efforts.
The ENERTRON CPR JACK has an option to add a base board. The base board is for securing the frame structure in a moving environment such as an ambulance or a rescuing boat. Its purpose is to perform the cardiopulmonary resuscitation steadily in a moving environment.
2
Suite 200, 1033 E. Main Street, Alhambra, CA 91801, U.S.A. Telephone: 408-253-3389 Fax: 408-351-7772
| COMPARISON –
| ITEMS | NEW DEVICE | Predicate device 1 | Predicate device 2 |
|---|---|---|---|
| Model | ENERTRON | MICHIGAN | |
| INSTRUMENTS INC. | ELCARE | ||
| INNOVATION INC. | |||
| Name | CPR JACK | THUMPER 1007 | MODIFIED GRIP |
| Classification name | External cardiac | ||
| compressor | External cardiac | ||
| compressor | Cardiopulmonary | ||
| resuscitation aids | |||
| Product code | DRM | DRM | LIX |
| Panel | Cardiovascular | Cardiovascular | Cardiovascular |
| 510K NUMBER | K024215 | K972525 | K010526 |
| Intended use | The device is an | ||
| external device that is | |||
| manually powered | |||
| and is used to | |||
| compress the chest | |||
| periodically in the | |||
| region of the heart to | |||
| provide blood flow | |||
| during cardiac arrest | |||
| for adult patients. | The device is used to | ||
| perform CPR on adult | |||
| patients and only adult | |||
| patients in cases of | |||
| clinical death as defined | |||
| by a lack of spontaneous | |||
| breathing and pulse. | To assist a rescuer in | ||
| maintaining performance | |||
| during application of CPR | |||
| to a victim of cardiac | |||
| arrest. | |||
| Construction material | Stainless steel | ABS | ABS |
| Rubber | Rubber | Plastics | |
| Foam | plastics | Foam | |
| Depression source | Manual | Gas power | Manual |
| Oxygen input | Manual | Compressed oxygen | |
| with valve control | Manual | ||
| Restraining patient | |||
| with | Frame and / or belt | 2 retraining belts | none |
| Force Indicator | Depth indicator | YES | LED type |
| Breathing source | Manual | Compress oxygen | Manual |
| Sternal Depression | |||
| depth 3.8 – 5.1 cm | |||
| (1.5" – 2.0") | 0.0 – 2.0 inches | 0 – 3.15 inches | 40-100 lbs |
| Stroke count | Manual 100 / min | Automatic 100 / min | Manual 80 /min |
| Compress / breath | 15:2 | 15:2 | 15:2 |
| Force applied | 40-100 pounds | ||
| manual | 40 –100 pounds | ||
| indication | 40-100 lbs | ||
| manual | |||
| Weight | CPR JACK 5.1kgs | ||
| With Board 7kgs | 20 lbs | About 8.8 kgs | |
| Dimension ( L x H x W) | 20"x 20" x 7" | 19" x22"x 9" | About 4.7"x7.8"x1.2" |
COMPARISON .
3
Suite 200, 1033 E. Main Street, Alhambra, CA 91801, U.S.A. Fax: 408-351-7772 Telephone: 408-253-3389
- . Benchmark Tests
- Performance tests demonstrated that user could reliably set the device and 1 provide compressions of consistent depth for different size patients.
- . Static load and durability tests were performed to ensure the quality of the CPR JACK
- Discussion
The intended uses for the CPR JACK and the two predicate devices are almost the same. The CPR JACK imposes no safety and effectiveness hazards and it serves the intended purposes more effectively.
Two of the predicate devices have knob force indication and the new device (CPR JACK) has a DEPTH indication. According to the AHA recommendation an effective CPR depends mainly on the compression depth, not on compression force. So the new device imposes no safety hazards but effectiveness.
The maximum compression depth for the new device is 2.00 inches and for the Thumper 3.15 inches. The maximum compression for Elcare Grip is 100 lbs. According to the AHA guideline, 2.00 inches should be the maximum compression depth. The CPR JACK has a limiting mechanism for restricting the depth to a maximum of 2.00 inches. Enertron had conducted two performance tests to demonstrate that the consistent compression depth ranging 1.5" to 2.0" could be maintained. These tests were a 4000-stroke test and a 250,000 stroke test. Thus the new device imposes no safety hazards and its effectiveness had been tested.
There is no force indicator for the new device. This is different from its two predicate devices. There is a knob indicator for the Thumper device and a LED force indicator for the Elcare device. It is known that an effective CPR is related to the consistency of compression depth, not to the compression force indicator is not a major contributing factor for a successful CPR. Force indication may be proportional to the actual compression depth but the effectiveness of such correlation may vary from patient to patient. The new device is at least as the predicate devices and is conceivably more effective than its predicates.
4
Suite 200, 1033 E. Main Street, Alhambra, CA 91801, U.S.A. Fax: 408-351-7772 Telephone: 408-253-3389
The compression of the new device and Eleare Grip are performed manually. The Thumper is air powered. These differences are relevant to the compression depth consistence. The new device has depth setting mechanism and passes the depth consistence tests, with an accuracy of 99.99%. Thus the compression depth of 1.5" through 2.0" can be consistently maintained for the new device. A rescuer needs to have strength to compress for a long period of time. Assume the rescuer has enough strength to exccute the CPR manually with the basic requirements for a basic CPR, the three devices are considered to be substantially equivalent.
The stroke count by Thumper is automatically performed. The Grip does that manually with an indicator. The new device does it totally manually. Since the rescuer has to pass the basic CPR training, the stroke control should be a known knowledge to CPR rescuers. Differences in stroke count by the three devices are not important as the rescuers are certified to perform the CPR.
Although the new device and the predicate devices use different constructing materials, they all passed the biological compatibility tests. They all will not cause any contacting biocompatibility hazard to patients. In this regard, they are substantially equivalent.
To restrain a patient, the new device uses the stainless frame and a restraining belt. The Thumper device uses two restraining belts, and the Grip device uses none. During the CPR process using the new device, there is has no moving hazard to the patient since there is a stainless frame and a restraining belt to restrain the patient in position. In this regard, the three devices are substantially equivalent.
Based on the above information and discussion, we certify that the subject device of Class III is to be substantially equivalent to the predicate devices in the US.
KeMin Jer
Ke-Min Jen, Official Correspondent Enertron Engineering Company
5
Image /page/5/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
MAY 1 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Enerton Engineering Co. C/O Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society 1033 E. Main Street Alhamba, CA 91801
Re: K024215 Trade Name: CPR Jack Dated: March 10, 2004 Received: March 12, 2004 Regulation Number: 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: III Product Code: DRM
Dear Dr. Ke-Min Jon:
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 mendments, 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 controls providents of 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 (1 writ), it may of subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roughtsh further announcements concerning your device in the Federal Register.
6
Page 2 –Dr. Ke-Min Jen
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 (301) 594-5613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE STATEMENT 4.
ENERTRON ENGINEERING CO. Applicant : 510(k) Number : ______________________________________________________________________________________________________________________________________________________________
Device Name : ENERTRON Various Models of CPR JACK
Indications for Use :
The device is an external device that is manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest for adult patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQUEIER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
ાર
Over-The-Counter (Optional Format 1-2-96)
Cun Sakhom
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K024215