(12 days)
No
The device description and intended use are purely hardware-based, focusing on electrical resistance and a simple energy detection mechanism. There is no mention of any software, algorithms, or data processing that would indicate AI/ML.
No
This device is a test load used to ensure defibrillators are functioning correctly, not to directly treat a patient.
No
The device is described as a "cable test load" for defibrillators, designed to test the output of the defibrillator and indicate if a certain energy level is detected, not to diagnose a patient's condition.
No
The device description clearly states it has a "built-in load resistance" and a "test lamp," indicating physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "serve as a 50 ohm cable test load for low energy DC defibrillators." This describes a device used to test the functionality of another medical device (a defibrillator), not to perform tests on biological samples (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description: The description focuses on the electrical properties (50 ohm resistance) and a visual indicator (test lamp) related to detecting energy from a defibrillator. There is no mention of analyzing biological samples or providing diagnostic information about a patient.
- Lack of IVD Characteristics: The information provided does not include any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Providing diagnostic, monitoring, or screening information about a patient's health.
- Reagents or assays.
This device falls under the category of a medical device accessory used for testing and maintenance of another medical device (a defibrillator).
N/A
Intended Use / Indications for Use
This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.
Product codes (comma separated list FDA assigned to the subject device)
DRG
Device Description
The device has a built-in load resistance of 50 ohms with a test lamp which briefly illuminates if defibrillator energy of greater than 200 joules is detected. The device has a connector which is compatible with the PadPro System disposable defibrillator pads (K003548, K014209, K020288, K020203, and K020743).
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
Not Found
Intended User / Care Setting
Hospitals and Paramedic situations
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)
Not Found
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.
K003548, K014209, K020288, K020203, K020743
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
JUN 21 2 EXHIB 510(k) Summary Medical Devices/Padpro, Inc. 5643 Plymouth Rd. Ann Arbor, MI 48105 Phone: 734-663-0132 Fax: 734 213 5640 Contact: Stuart Schulman, President Prepared: May 23, 2006
Identification of the Device: l . Proprietary-Trade Name: Defibrillator Cable Tester Model DT2200 Classification Name: Tester, Defibrillator Common/Usual Name: Defibrillator Test Load
-
- Equivalent legally marketed device: This device identical in function and similar in design to the Physio-control Defibrillator Test Load, K790394.
-
- Indications for Use: This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.
-
- Description: The device has a built-in load resistance of 50 ohms with a test lamp which briefly illuminates if defibrillator energy of greater than 200 joules is detected. The device has a connector which is compatible with the PadPro System disposable defibrillator pads (K003548, K014209, K020288, K020203, and K020743).
| 5. Safety and Effectiveness, comparison to predicate device. | ||
|---|---|---|
| Comparison Areas | Physio-control Defibrillator Test | |
| Load, K790394 | Defibrillator Cable Tester | |
| Model DT2200 | ||
| Indications for use | This device is designed to serve as a | |
| 50 ohm cable test load for low | ||
| energy DC defibrillators. | SAME | |
| Where used | Hospitals and Paramedic situations | SAME |
| Basic features | Dummy load and green LED | SAME |
| Test load | 50 ohms nominal, 50 watt | SAME |
| Construction | A printed circuit board mounted | |
| inside an ABS plastic enclosure with | ||
| a green indicator LED | SAME | |
| LED turn on | ||
| threshold | Not specified, "Set defibrillator | |
| energy at 360 joules" | 200 joules or more | |
| Connector | Physio-control Post Connector | PadPro System: Anderson |
| touch proof connector | ||
| Power Source | From defibrillator | SAME |
| Size | 6.25" x 3.625" x 1.75" | 5" x 2.5" x 2.125' |
| Enclosure | ABS Plastic, Beige | ABS Plastic, Gray |
- Safety and Effectiveness, comparison to predicate device: ハ
- Conclusion In all material respects, the Defibrillator Cable Tester Model DT2200 is 6. substantially equivalent to other test loads that are legally marketed for this purpose.
.EXHIBIT 3
Page 7 of 33
page 1 of 1
1
Image /page/1/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 AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2006
Medical Devices/Padpro Inc. c/o Mr. Mark Job Responsible Third Party Offical Regulatory Technology Services LLC. 1394 2501 Street NW Buffalo, MN 55313
Re: K061606
Trade Name: Defibrillator Cable Tester Model DT2200 Regulation Number: 21 CFR 870.5325 Regulation Name: Defibrillator Tester Regulatory Class: II (two) Product Code: DRG Dated: June 6, 2006 Received: June 9, 2006
Dear Mr. Job
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.
2
Page 2 - Mr. Mark Job
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 (see bottom for #s). 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/cdrh/industry/support/index.html.
Sincerely yours,
Blymmumar for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Defibrillator Cable Tester Model DT2200
Indications For Use: This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhumima
1 3:00-01 Division of Cardio 510(k) Numbe
Page 1 of 1
Page 6 of 33