The Impulse 6000D/7000DP is used to determine that defibrillators and transcutancous pacemekers are performing within their performance specifications through the measurement of energy output.

Device Description

The Impulse 600013/7000DP is a portable, rechargeable, battery-operated defibrillator tester. The Impulse 7000DP also functions as a transcutaneous pacemaker tester. The device's defibrillator input is connected to the output of a defibrillator under test which provides a 50-Ohm test load, approximately the impedance of the human body. The Impulse 6000D/7000DP simulates patient electrocardiogram signals to trigger automated defibrillation when a ventricular fibrillation waveform is presented, and the device tests that the automated defibrillator does not advise shock when a normal sinus rhythm electrocardiogram is presented. The energy output delivered by the defibrillator under test is measured. The Impulse 7000DP also tests transcutaneous pacemaker outputs by presenting a low level electrocardiogram at various pulse rates and measures the response of the pacemaker under testing rate and amplitude. For pacemaker testing, the device incorporates inputs of 50 to 1500 Ohm impedance test loads. The Impulse 6000D is a defibrillator tester only without the pacemaker test option. Both models have 10 electrocardiogram outputs to simulate patient milli-volt level electrocardiogram signals to test combination patient monitors/defibrillators/pacemakers.

The Impulse 7000DP has a USB type "B" interface to a PC to allow data download to a PC. It is electrically isolated from the measurement circuitry and allows remote control of the test from a PC. A BNC type connector on the rear panel also allows an oscilloscope to record the waveform output from the defibrillator under test, attenuated to a lower voltage level, and also electrically isolated from the measurement circuitry. Another BNC connector outputs a higher level signal (greater amplitude) to view the electrocardiogram signal on a second oscilloscope channel.

The accessories for the Impulse 6000D/7000DP include an external power supply to operate and re-charge the internal battery. Optional adapters to connect defibrillators marketed by different manufacturers to the standard 4 mm banana style input jacks are available.

Waveform analysis determines the characteristics of a defibrillator discharge pulse. Peak voltage amplitude, current, timing, overall energy and the refractory period of a pacemaker are recorded. Measurement is done by attenuating the high voltage signal to a lower voltage level, which is then input into an analog to digital converter. A digital signal processor calculates the measurements and corrects hardware error sources with mathematical calibration constants for any offset and gain errors.

AI/ML Overview

The provided text describes a medical device, the Impulse 6000D/7000DP Defibrillator Tester, and its FDA 510(k) clearance (K072114). However, it does not contain the specific details required to fully address your request.

The document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with acceptance criteria.

Therefore, I cannot provide a complete answer to your request. Here's specifically what is missing or cannot be inferred from the provided text:

Acceptance Criteria Table: No explicit acceptance criteria are mentioned for the device's performance. The document only states the device "is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications." These "performance specifications" are not detailed.
Study That Proves the Device Meets Acceptance Criteria: While a 510(k) submission requires performance data, the provided summary does not include the actual study design, results, or comparison to specific acceptance criteria. It mentions "waveform analysis determines the characteristics of a defibrillator discharge pulse," and "digital signal processor calculates the measurements and corrects hardware error sources," but doesn't elaborate on the studies or their outcomes.

Here's what can be extracted/inferred from the provided text, acknowledging the significant gaps:

Analysis of Acceptance Criteria and Performance Study:

The provided document (a 510(k) summary and FDA clearance letter) does not detail specific acceptance criteria or a comprehensive study that proves the device meets those criteria. Instead, it focuses on establishing substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document. The device's purpose is to determine if defibrillators and pacemakers are performing "within their performance specifications." These specifications themselves are not provided.
Reported Device Performance: The document describes the device's functions (e.g., measuring energy output, simulating ECG signals, testing pacemaker outputs), but it does not provide quantitative performance metrics or results against any defined criteria.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no such expert-based ground truth establishment is described for a performance study in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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:

Not applicable. This device is a defibrillator and pacemaker tester, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The device itself is a standalone tester. The document describes its functional capabilities (e.g., "Measurement is done by attenuating the high voltage signal to a lower voltage level, which is then input into an analog to digital converter. A digital signal processor calculates the measurements and corrects hardware error sources..."). This implies the device provides objective measurements independently. However, no specific details on standalone performance studies (e.g., accuracy, precision tests) are provided in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For a device like this, the "ground truth" would likely be established through reference standards (e.g., highly accurate and calibrated physical measurement equipment, or known electrical signals) to which the device's measurements are compared. However, the document does not specify the ground truth methodology used for its internal validation or for its 510(k) submission package.

8. The sample size for the training set:

Not applicable. This device is a measurement instrument, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable (as above).

In summary, the provided 510(k) documents focus on device description, intended use, and substantial equivalence to a predicate device, rather than detailed performance study reports with acceptance criteria, sample sizes, or ground truth methodologies. To obtain such information, one would typically need to review the full 510(k) submission package, which is not provided here.

Summary

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K072114

JAN 2 8 2008

Image /page/0/Picture/1 description: The image shows a logo with the letters 'sds' in a stylized font. A curved line extends from the left, arching over the letters, adding a dynamic element to the design. The letters are bold and black, creating a strong visual impact against the white background. The logo appears to be for a company or organization with the initials 'SDS'.

SYBRON DENTAL SPECIALTIES Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: January 2008

Device Name:

Trade Name -Impulse 6000D/7000DP છ
. Common Name - Defibrillator Tester
Classification Name Defibrillator Tester, per 21 CFR § 870.5325 e

Devices for Which Substantial Equivalence is Claimed:

g Fluke Biomedical, Impulse 4000

Device Description:

1717 West Collins Avenne, Brange, CA 92867 880-537 7824 214 316 7400

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record the waveform output from the defibrillator under test, attenuated to a lower voltage level, and also electrically isolated from the measurement circuitry. Another BNC connector outputs a higher level signal (greater amplitude) to view the electrocardiogram signal on a second oscilloscope channel.

Indication for Use:

The Impulse 6000D/7000DP is used to determine that defibrillators and transcutaneous pacemakers are performing within their performance specifications though the measurement of energy output.

Substantial Equivalence:

The Impulse 6000D/7000DP is substantially equivalent to other legally marketed devices in the United States. The Impulse 6000D/7000DP functions in a manner similar to and is intended for the same use as the Impulse 4000 marketed by Fluke Biomedical.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

JAN 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fluke Biomedical c/o Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, CA 92867

Re: K072114

Trade/Device Name: IMPULSE 6000D/7000DP Regulation Number: 21 CFR 870.5325 Regulation Name: Defibrillator tester Regulatory Class: Class II (two) Product Code: DRL Dated: January 15, 2008 Received: January 16, 2008

Dear Ms. Boswell:

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 - Ms. Colleen Boswell

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,

Blymmimon 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: K072114

Device Name: Impulse 6000D/7000DP

Indications for Use:

The Impulse 6000D/7000DP is used to determine that defibrillators and transcutancous pacemekers are performing within their performance specifications through the measurement of energy output.

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)

Blumima

200-Of sion of Cardiovascu 510(k) Number

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Regulation Number and Section

§ 870.5325 Defibrillator tester.

(a)
Identification. A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.(b)
Classification. Class II (performance standards).