(12 days)
This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.
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).
The provided document is a 510(k) summary for the Defibrillator Cable Tester Model DT2200. It details the device's function, comparison to a predicate device, and the FDA's substantial equivalence determination. However, it does not contain a full study report with detailed acceptance criteria, device performance data, sample sizes, ground truth establishment, or multi-reader multi-case studies as typically expected for complex AI/ML medical devices.
The information primarily focuses on a comparison to a predicate device to demonstrate substantial equivalence, rather than a detailed performance study against defined acceptance criteria.
Here's an attempt to structure the information based on your request, highlighting what is available and what is missing:
Acceptance Criteria and Device Performance Study for Defibrillator Cable Tester Model DT2200
The Defibrillator Cable Tester Model DT2200 is a device designed to serve as a 50-ohm cable test load for low-energy DC defibrillators. The 510(k) submission primarily establishes substantial equivalence to a legally marketed predicate device (Physio-control Defibrillator Test Load, K790394) rather than a formal performance study with pre-defined acceptance criteria against a clinical ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (DT2200) | Notes |
|---|---|---|---|
| Indications for Use | "This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators." (Predicate) | SAME | Substantially equivalent |
| Test Load (Resistance) | 50 ohms nominal, 50 watt (Predicate) | SAME | Substantially equivalent |
| Basic Features | Dummy load and green LED (Predicate) | SAME (built-in load resistance of 50 ohms with a test lamp) | Substantially equivalent |
| LED Turn-on Threshold | Not specified for predicate ("Set defibrillator energy at 360 joules") | 200 joules or more | This is a specific performance characteristic of the DT2200, which differs from the predicate's description but is stated as acceptable for its intended use. |
| Connector Type | Physio-control Post Connector (Predicate) | PadPro System: Anderson touch-proof connector | This is a difference, but not considered to affect substantial equivalence for the core function by the FDA. |
| Power Source | From defibrillator (Predicate) | SAME | Substantially equivalent |
| Construction | A printed circuit board mounted inside an ABS plastic enclosure with a green indicator LED (Predicate) | SAME | Substantially equivalent |
| Where Used | Hospitals and Paramedic situations (Predicate) | SAME | Substantially equivalent |
| Size | 6.25" x 3.625" x 1.75" (Predicate) | 5" x 2.5" x 2.125' | Different dimensions, but within design variations for test loads. |
| Enclosure | ABS Plastic, Beige (Predicate) | ABS Plastic, Gray | Different color, no functional impact. |
Summary of Device Performance:
The document states that the Defibrillator Cable Tester Model DT2200 is "substantially equivalent to other test loads that are legally marketed for this purpose" in "all material respects." The device's primary function is to provide a 50-ohm test load and indicate if a defibrillator energy of greater than 200 joules is detected, which it is designed to do.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission does not describe a traditional "test set" in the context of clinical or AI/ML performance evaluation. The evaluation is based on technical specifications and comparison to a predicate device.
- Data Provenance: Not applicable. No patient data or clinical study data is presented. The evaluation is based on engineering specifications and direct comparison to a predicate device's design and function.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. No clinical "ground truth" was established in this context. The determination of "substantial equivalence" was made by the FDA based on the provided technical comparison.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a hardware test device, not an AI/ML algorithm or imaging diagnostic tool. Therefore, an MRMC study is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a way. The device itself operates in a standalone manner as a test load. Its performance is inherent to its design and functional specification (providing a 50-ohm load and illuminating an LED at 200+ joules). It does not involve an algorithm separate from its hardware function.
7. The Type of Ground Truth Used
- Ground Truth: For this type of device, the "ground truth" is intrinsically tied to established engineering standards for resistive loads and electrical safety/performance in medical devices. The predicate device's established safety and effectiveness implicitly serve as the benchmark for "substantial equivalence." The device's function is purely technical: to provide a specific electrical load and indicate a threshold energy.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model.
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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 TestLoad, K790394 | Defibrillator Cable TesterModel DT2200 |
| Indications for use | This device is designed to serve as a50 ohm cable test load for lowenergy 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 mountedinside an ABS plastic enclosure witha green indicator LED | SAME |
| LED turn onthreshold | Not specified, "Set defibrillatorenergy at 360 joules" | 200 joules or more |
| Connector | Physio-control Post Connector | PadPro System: Andersontouch 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
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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.
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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
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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
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§ 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).