The SmartPads III is intended for adults and children over 8 years of age or greater than 55 pounds (25kg) with all compatible defibrillators. The SmartPads III is also intended for children of all ages when used with a Philips Medical System model FRx equipped with an Infant/Child Key or with other compatible defibrillators which incorporate adjustable defibrillation energy functionality.

The device is non-sterile and single-use only.

Device Description

The Philips Medical Systems HeartStart SmartPads III is a disposable, selfadhesive, single use disposable defibrillator pad set, designed for external defibrillation, external pacing, cardioversion and monitoring with current and future Philips Medical Systems defibrillators. The SmartPads III are also compatible with other defibrillators through currently marketed Philips adapters.

The HeartStart SmartPad III consists of foam backing, laminated metallic substrate, conductive adhesive gel, cabling and molded connector. The SmartPad III are packaged in pairs within a water-vapor proof, heat sealed, non-transparent aluminized pouches.

AI/ML Overview

The provided text is a 510(k) summary for the Philips HeartStart SmartPads III Multifunction Defibrillation Pads. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets those criteria in the typical format of a clinical trial or performance study report that tests against numerical targets.

Instead, the document states: "Testing demonstrated the Philips HeartStart SmartPads III perform in a manner substantially equivalent to the predicate SmartPads II and is acceptable for its indicated use and meets the predefined criteria." This implies that the 'study' conducted was primarily a substantial equivalence comparison to an already cleared device (Philips HeartStart SmartPads II).

Given the information provided, it's not possible to populate all the requested fields as they pertain to a detailed performance study with explicit acceptance criteria, sample sizes, and ground truth establishment methods. The document primarily focuses on regulatory clearance through substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Performance substantially equivalent to Philips HeartStart SmartPads II	"Perform[s] in a manner substantially equivalent to the predicate SmartPads II"
Acceptable for its indicated use	"acceptable for its indicated use"
Meets predefined criteria	"meets the predefined criteria"

Note: The document does not specify what these "predefined criteria" are or present numerical performance metrics for them. The primary 'acceptance criterion' is substantial equivalence to the predicate device in terms of safety and performance.

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

Sample Size for Test Set: Not specified. The document states "Testing demonstrated...", but does not provide details on the sample size (e.g., number of pads tested, number of patients/simulations).
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the testing was retrospective or prospective. It refers to "testing," implying internal validation by Philips Medical Systems.

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

Number of Experts: Not applicable/Not specified. For a device like defibrillation pads, "ground truth" and expert consensus in the sense of image interpretation or diagnosis is not typically relevant. Performance would be assessed against engineering specifications, electrical characteristics, and functional testing to ensure proper signal transmission, current delivery, and adhesion, similar to the predicate device.
Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where different human readers disagree on an outcome. For a physical device like defibrillation pads, the "adjudication" would be based on meeting engineering and performance specifications, likely through laboratory or simulated testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Was an MRMC study done? No. This type of study (MRMC) is generally for diagnostic devices where human readers interpret images or data, and AI assistance is being evaluated for its impact on reader performance. This device is a physical medical accessory, not an AI diagnostic tool.
Effect Size of human readers improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Was a standalone study done? This question is generally for AI algorithms. For a physical device like defibrillation pads, its "standalone performance" refers to its ability to meet its technical specifications independently. The document implies this was done through "testing demonstrated the performance of the SmartPads III is acceptable for its indicated use and the meets predefined criteria," but no specifics are given. There isn't an "algorithm only" component in the traditional sense.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For a device of this nature, the "ground truth" would likely be established by engineering specifications, recognized electrical standards (e.g., for impedance, current delivery), and functional performance benchmarks derived from the predicate device and relevant industry standards for defibrillation pads. It would not typically be pathology, expert consensus in a diagnostic sense, or outcomes data from a clinical trial.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. This device is a physical electrode, not a machine learning model, so there is no "training set" in the context of AI or algorithms. Product development and design validation would involve various tests (e.g., biocompatibility engineering, electrical performance, adhesion), but these are not referred to as "training sets."

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

How Ground Truth for Training Set was Established: Not applicable. As there is no "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply.

Summary

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FES 26

510(k) Summary Philips HeartStart SmartPads III Multifunction Defibrillation Pads

1. 510(k) Submission Number: K072812

1. Date Summary Prepared: February 22, 2008

3. Submitter's Name and Address:

Philips Medical Systems 2301 Fifth Avenue, Suite 200 Seattle, WA 98121

4. Contact Person:

Larry Walker Philips Medical Systems 2301 Fifth Avenue, Suite 200 Seattle WA 98121 Telephone: (206) 664-5000 Fax: (206) 664-5001

5. Device Name:

Proprietary Name:	Philips HeartStart SmartPads III Multifunction Defibrillation Pads
Common Name:	Multifunction Defibrillation Pad
Classification Name:	(MKJ) Automated External Defibrillator (Class III) (MLN) Multifunction Electrocardiograph Electrode (Class II)

6. Predicate Device

The legally marketed device, to which Philips Medical Systems claims equivalence, is the Philips Medical Systems HeartStart SmartPads II Multifunction Defibrillation Pads, cleared as a part of the Philips Medical System HeartStart model FRx Automated External Defibrillator (K050004).

The design and the intended use of the HeartStart SmartPad III is substantially equivalent in safety and performance to the device named above.

CONFIDENTIAL

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7. Device Description Summary

8. Intended Use

The Philips HeartStart SmartPads III is indicated for external defibrillation, pacing, monitoring and cardioversion.

The SmartPads III is intended for adults and children over 8 years of age or greater than 55 pounds (25kg) with all compatible defibrillators. The SmartPads III is also indicated for children of all ages when used with a Philips Medical System model FRx equipped with an Infant/Child Key or with other compatible defibrillators which incorporate adjustable defibrillation energy functionality

9. Indications for use

The Philips HeartStart SmartPads III is indicated for external defibrillation, pacing, monitoring and cardioversion.

The device is non-sterile and single-use only.

10. Comparison of Technology Characteristics

The Phillips HeartStart SmartPads III employs the same fundamental scientific technology as the currently available Philips HeartStart SmartPad II.

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11. Data Used in Determination of Substantial Equivalence

Testing demonstrated the Philips HeartStart SmartPads III perform in a manner substantially equivalent to the predicate SmartPads II and is acceptable for its indicated use and meets the predefined criteria.

Testing demonstrated the performance of the SmartPads III is acceptable for its indicated use and the meets predefined criteria.

12. Conclusion

The proposed modifications do not present new issues of safety or effectiveness.

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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of the HHS symbol, which is a stylized human figure embracing the world, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The symbol is black, and the text is also black.

FEB 2 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Mr. Larry Walker Regulatory Affairs Specialist 2301 Fifth Avenue, Suite 200 Seattle, WA 98121

Re: K072812

Trade/Device Name: Philips Heartstart Smartpads III Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillators Regulatory Class: III (three) Product Code: MKJ, MLN Dated: January 18, 2008 Received: January 22, 2008

Dear Mr. Walker:

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. Larry Walker

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,

Bfimmimor 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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11. Indications for Use

510(k) Number (if known): K072812

Device Name: Philips HeartStart SmartPads III Multifunction Defibrillator Pads

Indications For Use:

The Philips HeartStart SmartPads III is indicated for external defibrillation, pacing, monitoring and cardioversion.

The device is non-sterile and single-use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

t D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Zimmerman

ovascur Devices

PREMARKET NOTIFICATION PHILIPS MEDICAL SYSTEMS, HEARTSTREAM SMARTPAD III 510(K) PAGE 22 OF 27 CONFIDENTIAL

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.