DEFIBRILLATOR CABLE TESTER, MODEL DT2200

K061606 · Medical Devices/Padpro, Inc. · DRG · Jun 21, 2006 · Cardiovascular

Device Facts

• Record ID: K061606
• Device Name: DEFIBRILLATOR CABLE TESTER, MODEL DT2200
• Applicant: Medical Devices/Padpro, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jun 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.

Device Story

The Defibrillator Cable Tester Model DT2200 is a diagnostic tool used in hospitals and paramedic settings to verify the functionality of defibrillator cables. It acts as a 50-ohm dummy load that connects to the defibrillator via a PadPro System-compatible connector. When the defibrillator delivers an energy pulse, the device dissipates the energy; if the detected energy exceeds 200 joules, a test lamp (LED) illuminates to provide visual confirmation of cable integrity. The device is powered by the defibrillator itself, requiring no external power source. It allows healthcare providers to perform routine maintenance checks on defibrillator equipment to ensure readiness for patient use, thereby reducing the risk of device failure during critical cardiac resuscitation events.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

The device consists of a 50-ohm load resistor mounted on a printed circuit board within an ABS plastic enclosure. It features a green LED indicator for energy detection. The device is passive, powered by the defibrillator energy pulse, and utilizes an Anderson touch-proof connector compatible with PadPro System disposable pads. Dimensions are 5" x 2.5" x 2.125".

Indications for Use

Indicated for use as a 50 ohm cable test load for low energy DC defibrillators in hospital and paramedic settings.

Regulatory Classification

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.

Predicate Devices

• Physio-control Defibrillator Test Load (K790394)

Submission Summary (Full Text)

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## JUN 21 2 EXHIB 510(k) Summary Medical Devices/Padpro, Inc. 5643 Plymouth Rd. Ann Arbor, MI 48105 Phone: [phone] Fax: [phone] 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

- 2. Equivalent legally marketed device: This device identical in function and similar in design to the Physio-control Defibrillator Test Load, K790394.
- 3. Indications for Use: This device is designed to serve as a 50 ohm cable test load for low energy DC defibrillators.
- 4. 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<br>Load, K790394 | Defibrillator Cable Tester<br>Model DT2200 |
| Indications for use | This device is designed to serve as a<br>50 ohm cable test load for low<br>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<br>inside an ABS plastic enclosure with<br>a green indicator LED | SAME |
| LED turn on<br>threshold | Not specified, "Set defibrillator<br>energy at 360 joules" | 200 joules or more |
| Connector | Physio-control Post Connector | PadPro System: Anderson<br>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
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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 [phone] or [phone] 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

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