The Models 861388 and 861389 are intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The Models 861389 are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:

Unresponsiveness .
. Absence of normal breathing

If in doubt, apply the pads.

The Models 861388 and 861389 are intended for adults and children over 55 pounds (25 kg) or 8 years old. The Models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator.

WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings for the CPR feature has not been established in patients under 55 lbs (25 kg) or 8 years old.

The Models 861388 and 861389 are intended for use by personnel who have been trained in its operation and qualified by training in basic life support (BLS), advanced life support (ALS) or other physician-authorized emergency medical response.

Device Description

These battery powered, automated external defibrillators are available in two models, one with ECG (model 861389) and the other in text only (model 861388). Both models include the Philipis SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithum for determining if the rhythm is shockable. The models 861389 and 861388 deliver a nominal 150J to adults and a nominal 50J to infants and children when the optional infant/child key mode is used. As with previous generations of Philips AEDs, the models 861389 and 861388 have several methods of testing themselves and alerting the user if there is a problem. In addition to the periodic self tests performed each time the device is turned on, both models perform power on self tests, runtime self tests, and runtime operation checks. Using voice prompts, text prompts, graphics, audible tones, light emitting diodes (LEDs) and buttons, the responder is guided through the event.

The models 861388 and 861389 are compatible with several accessories. These items including the Smart Pads III, the Infant/Child Key, a non-rechargeable training battery, an optional Bluetooth transceiver module, an optional data card, an optional language card and various carry cases.

AI/ML Overview

The provided text describes a 510(k) summary for Philips HeartStart AED models 861388 and 861389. However, it does not contain the specific acceptance criteria or details of a study proving the device meets acceptance criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on shared technology, specifications, and algorithms, rather than presenting a standalone performance study with detailed acceptance criteria and reported device performance metrics.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the given text. The document states that "Testing demonstrates that the models 861389 and 861388 perform in a manner substantially equivalent to the predicates and do not raise any new issues of safety or effectiveness," but it does not present a table of specific acceptance criteria (e.g., sensitivity, specificity for shockable rhythm detection) or the corresponding numerical performance results for the device.

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

This information is not provided. The summary mentions "testing," but details about the sample size of the test set, its composition (e.g., number of ECGs, patient demographics), or the provenance (country of origin, retrospective/prospective) are omitted.

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

This information is not provided. As no specific performance study with a test set and ground truth establishment is detailed, the number and qualifications of experts involved in such a process are not mentioned.

4. Adjudication method for the test set

This information is not provided. Without a detailed study description for a test set, the adjudication method for establishing ground truth is not discussed.

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

This information is not provided. The device is an Automated External Defibrillator (AED) with a "Patient Analysis System (PAS) algorithm for determining if the rhythm is shockable." This typically functions in a standalone capacity to advise the user to deliver a shock or not. The document does not describe a study involving human readers or their improvement with or without AI assistance, as it's not a diagnostic imaging AI tool.

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

Yes, implicitly. The document states "Both models include the Philipis SMART biphasic, impedance-compensating exponential waveform and a multi-parameter Patient Analysis System (PAS) algorithum for determining if the rhythm is shockable." The primary function of an AED's algorithm is to analyze the rhythm and make a shock recommendation independently. The statement "Testing demonstrates that the models 861389 and 861388 perform in a manner substantially equivalent to the predicates" suggests that the standalone performance of this algorithm was evaluated against the predicate devices' algorithms. However, the specific results and methodology of this standalone evaluation are not detailed.

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

This information is not explicitly stated. For AEDs, the ground truth for rhythm analysis (shockable vs. non-shockable) is typically established by expert cardiologists/electrophysiologists reviewing ECGs, often verified against clinical outcomes where available. However, the document does not specify how the ground truth was established for the "testing" performed.

8. The sample size for the training set

This information is not provided. The document focuses on demonstrating substantial equivalence and refers to the algorithm as existing (from predicate devices or similar technology), but it does not provide details about the training set used for the algorithm's development.

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

This information is not provided. Similar to the training set size, the method for establishing ground truth for the training data is not discussed in this 510(k) summary.

In summary, the provided content is a high-level 510(k) summary focusing on substantial equivalence to predicate devices, rather than a detailed report of a specific study that outlines acceptance criteria and performance metrics. It confirms that "testing" was done to show equivalence, but it omits the granular details of those tests, including specific performance data, sample sizes, and ground truth methodologies.

Summary

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Section 15 - 510(k) Summary

K 111693

1. Date Summary Prepared

June 8, 201 1

2. Submitter's Name and Address

Philips Medical Systems, Heartstream 2301 Fifth Avenue, Suite 200 Seattle, WA 98121-1825

3. Contact Person

Tamara Yount Senior Regulatory Affairs Specialist Telephone: 206.664.5000 Facsimile: 206.664.5001

4. Device Name and Classification Panel Information

Proprietary Name:	Philips HeartStart Model 861388 (text and graphics only) and Model 861389 (ECG) AEDs
Common Name:	Automated External Defibrillator
Classification Name:	Automated External Defibrillator

Device Classification: Class III prc-amendment (primary) Class II (secondary)

Automated External Defibrillator, 21 § 870.5310 (primary) Regulations: Low energy DC Defibrillator, 21 § 870.5300 (secondary)

Product Code: MKJ (primary) LDD (secondary)

5. Predicate Devices

The design technology and intended use of the models 861388 and 861389 arc substantially equivalent in safety and performance to the previously cleared Philips

Philips Medical Systems, Heartstream Traditional 5 10(k) PreMarket Notification 861388 and 861389

Section 15, page 1 of 3

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

HeartStart FRx AED (#K05004), Philips HeartStart FR2/ FR2+ AED (#K003565, #K003819, #K014157 and #K051632) and Philips SMART Pads III (#K072812).

6. Device Description

7. Intended Use

The models 861389 and 861388 are compact, lightweight, battery powered automated external defibrillators designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The models 861388 and 861388 are used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms:

Unresponsiveness .
t Absence of normal breathing

If in doubt, apply the pads.

The models 861389 and 861388 are intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment.

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

8. Comparison of Technology Characteristics

The waveform used in the models 861389 and 861388 are similar to the FRx and FR2+ in terms of specifications, nominal energy and peak current. Like the FRx and PR2+, models 861389 and 861388 use a similar algorithm to determine shock recommendations. Like the FR2+, the models 861389 and 861388 have a SMART CPR algorithm that supports the CPR First function.

9. Data Used in Determination of Substantial Equivalence

The models 861389 and 861388 employ many of the same technologies as those used in the predicate devices. Testing demonstrates that the models 861389 and 861388 perform in a manner substantially equivalent to the predicates and do not raise any new issues of safety or effectiveness.

10. Conclusion

The introduction of the models 861389 and 861388 does not present any new issues of safety or effectiveness.

Philips Medical Systems, Heartstream Traditional 510(k) PreMarket Notification 861388 and 861389

Section 15, page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 12 2011

Philips Medical Systems c/o Ms. Tamara Yount Senior Regulatory Affairs Specialist 2301 5th Avenue, Suite 200 Seattle, WA 98121

Re: K111693

Trade/Device Name: HeartStart FR3 Automated External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ and LDD Dated: October 18, 2011 Received: October 19, 2011

Dear Ms. Yount:

This letter corrects our substantially equivalent letter of October 28, 2011.

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 (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 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. Tamara Yount

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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

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

Section 12 - Indications for Use

510(k) Number (if known)

K 11693

Device Name

Philips HeartStart Automated External Defibrillator (AED), Models 861388 and 861389

Indications for Use

Unresponsiveness .
. Absence of normal breathing

If in doubt, apply the pads.

WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings for the CPR feature has not been established in patients under 55 lbs (25 kg) or 8 years old.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (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)

(Division Sign-Off)
Division of Cardiovascular Devices
for B Zuckerman
12/12/2011
510(k) Number K111693

Philips Medical Systems, Heartstream

Traditional 510(k) PreMarket Notification 861388 and 861389

Section 12, page 1 of 1

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.