The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained individuals. It provides simple and direct voice prompts and indications for a straightforward rescue operation. The i-PAD NF1200 needs the user to press its SHOCK button to deliver a defibrillating shock.

During a resoue operation, it continuously acquires the electrocardiogram (ECG) of the patient. It also conducts arrhythmia detection continuously except during cardiopulmonary resuscitation (CPR). The timing and duration of the CPR are in accordance with the recommendations of the American Heart Association (AHA) 2005 Guidelines for CPR and Emergency Cardiovascular Care (ECC).

The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.)

It delivers a 150-Joule biphasic truncated exponential shock waveform that it compensates for patient impedance by adjusting its timing parameter. If the user decides not to deliver a charge, the i-PAD NF1200 disarms itself by dumping the charge into an internal resistive load.

The i-PAD NF1200 is capable of saving data and transmitting them to an external device.

The i-PAD NF1200 conducts periodic (daily, weekly, and 28-day) self-tests, a battery insertion self-test, and self-tests during power-ON and run-time. It informs the user if an error is detected through audio and visual indicators.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the i-PAD NF1200 Semi-automated External Defibrillator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical trial to establish novel safety and effectiveness. Therefore, the information provided does not detail acceptance criteria and a study in the same way one might for a new drug or a de novo device. Instead, the study aims to show that the new device performs comparably to existing, approved devices.

Here's a breakdown of the available information regarding acceptance criteria and the "study" (which is more accurately described as a set of verification and validation tests):

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with specific numerical targets and corresponding device performance for the entire device. Instead, it describes compliance with recognized standards and a comparison to predicate devices.

Acceptance Criteria Category	Description of Acceptance / Test Method	Reported Device Performance
Shock Waveform Effectiveness and Safety	Substantial equivalence to predicate device demonstrated by bench testing. Statistical analysis to show mean values of i-PAD NF1200 shock waveform parameters are closer to Philips HeartStart FR2+ than Defibtech DDU-100A.	Bench testing performed. Statistical analysis concluded that the mean values of the i-PAD NF1200's shock waveform parameters are closer to the mean values of the Philips HeartStart FR2+ shock waveform parameters compared to the Defibtech DDU-100A. (Specific numerical values for parameters or statistical significance are not provided in this summary.)
Arrhythmia Detection Algorithm	Tested using recommendations of the American Heart Association (AHA) and the ANSI/AAMI DF80 Standard.	The algorithm was tested against AHA recommendations and ANSI/AAMI DF80 Standard. (Specific performance metrics like sensitivity, specificity, or false alarm rates for arrhythmia detection are not provided in this summary.)
Electrical Safety and Compliance	Tested using EN60601-1 and EN60601-2-4. (EN60601-2-4 has contents similar to ANSI/AAMI DF80, with some additional sections for DF80).	The device was tested and found compliant with EN60601-1 and EN60601-2-4. (Specific test results or deviations are not detailed.)
Overall Safety and Effectiveness	Device does not raise new issues of safety and effectiveness compared to predicate devices.	Testing shows that the submission device does not raise new issues of safety and effectiveness, supporting substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Shock Waveform Effectiveness and Safety: The summary mentions "bench testing" and "statistical analysis" but does not specify the number of shocks or test cycles performed to derive the mean values for comparison, nor does it detail the specific types of impedance loads used. Data provenance is implied to be laboratory-generated (bench testing).
Arrhythmia Detection Algorithm: The summary states the algorithm was tested using recommendations from the AHA and the ANSI/AAMI DF80 Standard. These standards typically involve databases of annotated ECG recordings. However, the exact sample size (number of ECG records or patient hours) of the test set, the specific ECG databases used, or their provenance (e.g., country of origin, retrospective/prospective) are not specified in this submission summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For the arrhythmia detection algorithm testing against AHA recommendations and ANSI/AAMI DF80, these standards usually rely on expertly annotated ECG databases. However, the number of experts, their qualifications, or their role in establishing the ground truth for the specific test set used for the i-PAD NF1200 are not mentioned in this document. It is assumed that the ground truth for the standard databases would have been established by qualified cardiologists or electrophysiologists.

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. This device is an automated external defibrillator, where the primary function is automated arrhythmia detection and shock delivery, not human interpretation of images or signals. The "human reader" in this context is largely a user who follows voice prompts.

6. Standalone Performance Study

Yes, a standalone (algorithm only) performance assessment was done for the Arrhythmia Detection Algorithm. The algorithm was tested "using the recommendations of the American Heart Association and the ANSI/AAMI DF80 Standard." This implies an evaluation of the algorithm's performance in detecting treatable arrhythmias (Ventricular Fibrillation and Ventricular Tachycardia) and correctly identifying non-shockable rhythms, without human intervention during the analysis phase.

7. Type of Ground Truth Used

For the Arrhythmia Detection Algorithm, the ground truth would be based on expert annotations of the ECG waveforms within the standardized databases recommended by the AHA and ANSI/AAMI DF80. This falls under expert consensus (or expertly annotated databases).

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set of the arrhythmia detection algorithm. It only mentions the testing against standards.

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established, as the training set itself is not explicitly mentioned. For algorithms compliant with standards like ANSI/AAMI DF80, it's generally assumed that any training data would also be derived from expertly annotated ECG datasets.

Summary

{0}------------------------------------------------

JAN 222 2008

167970

510(k) Summary

Submitted on behalf of:

Company Name: CU Medical Systems, Inc Address: Medical Industry Complex, Bldg. No. 2, 1720-26 Taejang-dong, Wonju-si, Gangwon-do, 220-120 Republic of Korea Telephone: 8233 747 7657 8233 747 7659 Fax:

by:

Telephone: Fax:

CONTACT PERSON: DATE PREPARED:

Elaine Duncan January 15, 2008

Stillwater, MN 55082

PO Box 560

715-549-6035

715-549-5380

Elaine Duncan, MS.ME., RAC President, Paladin Medical, Inc.

DEVICE TRADE NAME: i-PAD NF1200 Semi-automated External Defibrillator COMMON NAME: Semi-automated External Defibrillator CLASSIFICATION NAMES: Low Energy Defibrillator PRODUCT CODE and REGULATION NUMBER: MKJ, 21 CFR 870.5310 -Automated External Defibrillator

PREDICATE DEVICES:

The i-PAD NF1200 is substantially equivalent to other marketed AEDs in the United States, specifically the following:

Device Name	Manufacturer	510(K) Number
Philips HeartStart OnSite	Philips Medical Systems	K020715
Philips HeartStart FR2+	Philips Medical Systems	K013425
Defibtech Sentry DDU-100A	Defibtech, LLC	K013896

The shock delivered by the device is in the form of a Biphasic Truncated Exponential which has characteristics and results that are substantially equivalent to the cited predicate devices (K013425 and K013896). The operation of this device and its minor differences with the predicate device does not raise new issues regarding safety and efficacy.

{1}------------------------------------------------

DESCRIPTION of the DEVICE:

The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.)

The i-PAD NF1200 is capable of saving data and transmitting them to an external device.

Indications for Use

The i-PAD NF1200 is used to treat a person suffering from sudden cardiac arrest (SCA) and who exhibits symptoms of

No movement and no response when shaken .
No normal breathing .

Contraindication for Use

The device must not be used on a person who:

Is moving or is responsive when shaken .
. Is breathing normally
Target Patients
. Adults
Children over 55 lbs or 8 years old .
The device is not to be used on children below 8 years old or under 55 lbs .

Intended User

The device is intended for use by persons:

who have been specifically trained in its operation. .
who have training in cardiopulmonary resuscitation (CPR) or other physician-authorized . emergency medical response program in accordance with local and state requirements

{2}------------------------------------------------

COMPARISON OF TECHNOLOGY CHARACTERISTICS

The i-PAD NF1200 employs the same fundamental technological characteristics as the predicate devices. Differences in implementation are verified and validated using relevant test protocols.

SUMMARY of TESTING:

Shock Waveform Effectiveness and Safety

Substantial equivalence with the predicate device is shown by bench testing. The submission device and the predicate device are discharged and the shock waveform parameters are captured using an oscilloscope with energy measurement capability.

Statistical analysis is used to show that the mean values of the shock waveform parameters of the i-PAD NF1200 are closer to the mean values of the shock waveform parameters of the Philips HeartStart FR2+ than the mean values of the Defibtech DDU-100A shock waveform parameters.

Arrhythmia Detection Algorithm

The arrhythmia detection algorithm is tested using the recommendations of the American Heart Association and the ANSI/AAMI DF80 Standard.

Electrical Safety and Compliance to Defibrillator Standard

The i-PAD NF1200 was tested using EN60601-1 and EN60601-2-4. The EN60601-2-4 has the same contents as the ANSI/AAMI DF80 Standard except for some additional sections in the ANSI/AAMI DF80 regarding Defibrillator Electrodes and External Pacing.

CONCLUSION

The i-PAD NF1200 is substantially equivalent to its predicate devices. Testing shows that the submission device does not raise new issues of safety and effectiveness.

{3}------------------------------------------------

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

JAN 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CU Medical Systems, Inc c/o Ms. Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082

Re: K062970

Trade/Device Name: I-Pad NF1200 Semi-Automated External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III Product Code: MKJ Dated: November 28, 2007 Received: November 29, 2007

Dear Ms Duncan:

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.

{4}------------------------------------------------

Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: i-PAD NF1200

Indications For Use:

The i-PAD NF1200 is used to treat a person suffering from sudden cardiac arrest (SCA) and who exhibits symptoms of

No movement and no response when shaken .
No normal breathing .

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)(Division Sign/Off)

Division of Cardiovascular Devices
510(k) number K062970

Page 1 of

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.