PHILIPS HEARTSTART SMARTPADS III

K072812 · Philips Medical Systems · MKJ · Feb 26, 2008 · Cardiovascular

Device Facts

• Record ID: K072812
• Device Name: PHILIPS HEARTSTART SMARTPADS III
• Applicant: Philips Medical Systems
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

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 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 Story

Disposable, self-adhesive, single-use multifunction defibrillation pads; used for external defibrillation, pacing, cardioversion, and monitoring. Inputs: electrical signals from patient body; outputs: electrical therapy delivery and ECG monitoring signals to compatible defibrillators. Components: foam backing, laminated metallic substrate, conductive adhesive gel, cabling, molded connector. Used in clinical or emergency settings by healthcare providers or trained responders. Pads interface with defibrillator units to deliver energy or monitor cardiac rhythm; facilitates life-saving intervention for cardiac arrest or arrhythmia management.

Clinical Evidence

Bench testing only; no clinical data presented. Performance demonstrated to meet predefined criteria and equivalence to predicate.

Technological Characteristics

Disposable, self-adhesive, single-use pads. Construction: foam backing, laminated metallic substrate, conductive adhesive gel, cabling, molded connector. Non-sterile. Compatible with Philips defibrillators and adapters for other systems.

Indications for Use

Indicated for external defibrillation, pacing, monitoring, and cardioversion. Intended for adults and children >8 years or >55 lbs (25kg) with compatible defibrillators; indicated for children of all ages when used with Philips FRx with Infant/Child Key or other compatible defibrillators with adjustable energy functionality.

Regulatory Classification

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.

Predicate Devices

• Philips Medical Systems HeartStart SmartPads II Multifunction Defibrillation Pads (K050004)

Submission Summary (Full Text)

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#### FES 26

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

### 1. 510(k) Submission Number: K072812

- 2. 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: [phone] Fax: [phone]

### 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

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.

## 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 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.

# 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 [phone]. 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 [phone] or [phone] 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 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

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t D)

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

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

Or

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