(330 days)
Not Found
No
The document describes standard medical device functionality for a defibrillator/monitor, including ECG analysis for shock advisement in AED mode. There is no mention of AI, ML, or advanced algorithms beyond typical signal processing for vital signs and ECG analysis. The predicate devices are also standard medical devices.
Yes.
The device provides therapeutic functions such as defibrillation (in AED and Manual Defibrillation Modes) and non-invasive transcutaneous pacing therapy. These directly treat medical conditions.
Yes
The device performs several diagnostic functions, including ECG monitoring, pulse oximetry (SpO2), and non-invasive blood pressure (NBP) monitoring, all of which are used to assess a patient's condition.
No
The device description clearly outlines hardware components such as paddles, electrode pads, ECG cables, and the ability to deliver electrical shocks for defibrillation and pacing. It also mentions optional hardware for SpO2 and NBP monitoring. This is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device interacts directly with the patient: The HeartStart XL+ is a defibrillator/monitor that directly interacts with the patient's body through electrodes, paddles, and sensors to monitor physiological signals (ECG, SpO2, NBP) and deliver electrical therapy (defibrillation, pacing).
- The intended use and device description focus on patient monitoring and therapy: The documentation clearly describes the device's functions as monitoring vital signs, analyzing the patient's electrical activity, and delivering electrical shocks or pacing pulses. These are all direct patient care activities, not laboratory analysis of samples.
Therefore, the HeartStart XL+ falls under the category of a medical device used for patient monitoring and therapy, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The HeartStart XL + is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician.
When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED.
When operating in Monitor, Manual Defib or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.
The HeartStart XL+ is a defibrillator monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician.
AED Therapy: AED Mode is used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.
Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive.
Synchronous defibrillation (cardioversion) is indicated for termination of atrial fibrillation.
Non-Invasive External Pacing: The pacing option is indicated for treating patients with symptomatic bradycardia.
Pulse Oximetry: The SpO2 option is indicated for use when it is beneficial to assess the patient's oxygen saturation level.
Non-invasive Blood Pressure Monitoring: The NBP option is indicated for non-invasive measurement of a patient's arterial blood pressure.
ECG Monitoring: The ECG monitoring option is indicated to be used for monitoring, alarming, and recording of the patient's heart rate and morphology.
Product codes
MKJ, LDD, DRO, DQA, DXN, MHX
Device Description
The HeartStart XL+ is a lightweight, portable defibrillator/monitor. It provides four clinical modes of operation: Monitor, Manual Defibrillator, AED and Pacer (optional).
In Monitor Mode, depending on the ECG inputs being used (pads, paddles, ECG cable), you can monitor up to 3 different ECG waveforms at one time. Using a 3-lead ECG cable you can view Lead I, II or III. With a 5-Lead ECG cable, you can view two leads from Leads I, III, avR, avF or V. Optional monitoring of SpO2 or NBP is available using existing and previously cleared technology as references in the predicate device comparison of the summary. Measurements are presented on the display and alarms are available to alert you to a change in the patient's condition. You can also display the Vital Signs Trending Report to view all key parameters and their measurements at a glance.
Manual Defibrillation Mode provides simple 1-2-3 defibrillation. You analyze the patient's ECG and, if appropriate: 1) select an energy setting; 2) charge; and 3) deliver the shock. Defibrillation is performed using paddles (internal or external) or multifunction electrode pads. You can also perform synchronized cardioversion in Manual Defibrillation Mode. The HeartStart XL+ incorporates Philips' low energy SMART Biphasic waveform for defibrillation which has been in use for over a decade.
In AED Mode, the HeartStart XL+ analyzes the patient's ECG and determines whether a shock is advised. Voice prompts guide you through the 2-step defibrillation process, with easy-to-follow instruction and patient information. Voice prompts are reinforced by messages on the display.
Optional Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through multifunction electrode pads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults and Pediatrics
Intended User / Care Setting
Qualified medical personnel, medical personnel trained in basic life support, healthcare professionals trained in advanced life support. Hospital setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The HeartStart XL + has all of the major features of the HeartStart XL plus the additional feature of NBP monitoring. Testing for performance was done according to applicable FDA recognized consensus standards for electrical defibrillation, ECG monitoring, SPO2 monitoring, and NBP monitoring. Additional standards testing beyond the list of FDA recognized standards was also performed. Small feature changes have been made to align the design with the 2010 AHA Resuscitation Guidelines. The previous product had only been evaluated against the 2005 AHA guidelines.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001725, K031187, K003819, K954597, K955628, K010634, K992977, K003228, K0012218, K991871, K002806, K021453
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
pg 1 of 7
FEB 16 2012
FEB 1 6 2012
5.0 510(k) Summary
As required by 21 CFR 807.87(h), a 510(k) Summary for this Premarket Notification submission is provided below. A 510(k) statement is therefore not required.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Philips Defibrillator Monitor
Submitter's Name and Address
| Submitter's Name: | Philips Medical Systems |
|---|---|
| Division: | Emergency Care Solutions |
| Address: | 3000 Minuteman Road |
| City, State, and Zip: | Andover, MA 01810 |
| Contact Name: | Paul Schrader, Senior Regulatory Affairs Manager |
| Telephone / Fax: | (978) 659-2404 / 978-659-3610 |
| 510(k) Summary Date | October 28, 2011 |
Manufacturers' Information: Establishment Registration Number
| Establishment name: | Philips Medical Systems |
|---|---|
| Address: | 3000 Minuteman Road |
| Andover, MA 01810 | |
| Establishment Registration No. | 1218950 |
1
||||0825
Image /page/1/Picture/1 description: The image shows a handwritten note on a white background. The note says "pg 2 of 7". The handwriting is somewhat cursive, and the ink appears to be dark. The image is simple and focuses solely on the handwritten text.
Device Details:
| Proprietary or Trade Name: | HeartStart XL + |
|---|---|
| Common Name: | ALS Defibrillator Monitor |
| Device Class: | III for AED mode (MKJ), II for the |
| remaining applicable ProCodes / CFR | |
| classifications | |
| Device ProCodes: | MKJ, LDD, DRO, DQA, DXN |
| Device CFR: | Several see table below |
| Classification Panel: | Cardiovascular |
| 21 CFR Classification Name / | |
| Description | Several see table below |
| Classification | ProCode | Classification Description |
|---|---|---|
| 870.5310-III | MKJ | Defibrillators, Automatic, External |
| 870.5300-II | LDD | Low-energy defibrillator1 |
| 870.5550-II | DRO | External Transcutaneous Pacemaker |
| (Non-invasive) | ||
| 870.2700-II | DQA | Pulse Oximeter |
| 870.1130-II | DXN | Non-Invasive Blood Pressure |
| 870.1025-II | MHX | Arrhythmia detector and alarm |
2
Device Name: Philips XL+ Defibrillator Monitor
Intended Use: The HeartStart XL + is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician.
When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED.
When operating in Monitor, Manual Defib or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.
Indications for Use: The HeartStart XL+ is a defibrillator monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training n basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician.
AED Therapy: AED Mode is used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.
Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive.
Synchronous defibrillation (cardioversion) is indicated for termination of atrial fibrillation.
Non-Invasive External Pacing: The pacing option is indicated for treating patients with symptomatic bradycardia.
Pulse Oximetry: The SpO2 option is indicated for use when it is beneficial to assess the patient's oxygen saturation level.
Non-invasive Blood Pressure Monitoring: The NBP option is indicated for non-invasive measurement of a patient's arterial blood pressure.
ECG Monitoring: The ECG monitoring option is indicated to be used for monitoring, alarming, and recording of the patient's heart rate and morphology.
3
Device Description
The HeartStart XL+ is a lightweight, portable defibrillator/monitor. It provides four clinical modes of operation: Monitor, Manual Defibrillator, AED and Pacer (optional).
In Monitor Mode, depending on the ECG inputs being used (pads, paddles, ECG cable), you can monitor up to 3 different ECG waveforms at one time. Using a 3-lead ECG cable you can view Lead I, II or III. With a 5-Lead ECG cable, you can view two leads from Leads I, III, avR, avF or V. Optional monitoring of SpO2 or NBP is available using existing and previously cleared technology as references in the predicate device comparison of the summary. Measurements are presented on the display and alarms are available to alert you to a change in the patient's condition. You can also display the Vital Signs Trending Report to view all key parameters and their measurements at a glance.
Manual Defibrillation Mode provides simple 1-2-3 defibrillation. You analyze the patient's ECG and, if appropriate: 1) select an energy setting; 2) charge; and 3) deliver the shock. Defibrillation is performed using paddles (internal or external) or multifunction electrode pads. You can also perform synchronized cardioversion in Manual Defibrillation Mode. The HeartStart XL+ incorporates Philips' low energy SMART Biphasic waveform for defibrillation which has been in use for over a decade.
In AED Mode, the HeartStart XL+ analyzes the patient's ECG and determines whether a shock is advised. Voice prompts guide you through the 2-step defibrillation process, with easy-to-follow instruction and patient information. Voice prompts are reinforced by messages on the display.
Optional Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through multifunction electrode pads.
4
redicate Device Comparison: Previous Philips Defibrillator Monitors
| Specification / Clinical Function | HeartStart XL
HeartStart MRx | Philips HeartStart XL+
Complies w/
IEC 60601-2-4:2005 &
monitoring standards
listed below | Comparison | Predicate 510(k) #s |
|-----------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Defibrillation Waveform | Bi-phasic 1 – 200 Joules | Bi-phasic 1 – 200 Joules | Same design as
HeartStart XL and
HeartStart MRx | K001725 HeartStart XL
K031187 HeartStart MRx
K001725 HeartStart XL K031187
HeartStart MRx |
| Defibrillation Modes | Manual and AED | Manual and AED | Pediatrics has been added
by using previously
reviewed algorithm and
pads | K001725 HeartStart XL (Adult)
K031187 HeartStart MRx (Adult)
K003819 FR2 (Pediatrics) |
| AED Modes | Adults | Adults and Pediatrics | Philips has standardized
on use of the PAS
algorithm. | K954597 HP Shock Advisory (Adult)
K955628 PAS Algorithm (Adult)
K003819 PAS Algorithm (Pediatrics) |
| Shock Advisory Algorithm | Hewlett-Packard Shock Advisory | HeartStream Patient Analysis System (PAS) Algorithm | Same waveform as MRx | K010634 Cardioversion added to XL
K031187 HeartStart MRx |
| Cardioversion | Available | Available | Same waveform as MRx | K001725 HeartStart XL
K031187 HeartStart MRx |
| External Pacing | Yes w/ Pads | Yes w/ Pads | | |
| Specification / Clinical Function | HeartStart XL HeartStart MRx | Philips HeartStart XL+ Complies w/ IEC 60601-2-4:2005 & monitoring standards listed below | Comparison | Predicate 510(k) #s |
| Pads and Paddles | | | | |
| Pads | Several different pads as listed in predicate list in the last column | No change in pad construction from pads currently used with HeartStart XL/MRx | Same pads as currently being used with HeartStart MRX and HeartStart XL. Labeling changed to standardize format and content for whole family. One IFU created for three different groupings: infant pads (previously called pediatric pads), adult pads and adult preconnect pads. | Infant Pads:
M3504A:K992977
M3717A:K003228
M3719A (Radiotransparent): K0012218
Adult / Child Pads:
M3501A: K991871
M3713A: K002806
M3716A (Radiolucent): K002806
M3718A (Radiotransparent): K002806
989803166021(Preconnect): K002806 |
| Paddles | Internal and External | Complies w/ IEC 60601-2-4:2005 | No change to internal paddles. External paddles were modified to allow use of inter-changeable electrode selected on patient size. Customer no longer needs two separate external paddles. | K021453 Internal Paddles
K001725 External Paddles |
| MONITORING | | | | |
| ECG monitoring | Tested to 60601-2-27 | Complies w/ IEC 60601-2-27: 2005 | Available on both XL and MRx, design is leveraged from MRx | K031187 HeartStart MRx |
| SPO2 monitoring | Tested to ISO 9919 | Complies w/ ISO 9919:2005 | Available on both XL and MRx, acquisition and processing of SPO2 data has not changed from MRx | K031187 HeartStart MRx |
| NBP monitoring | Tested to 60601-2-30 on MRx, Not available w/ XL | Complies w/ IEC 60601-2-30: 1999 | acquisition and processing of SPO2 data has not changed from MRx | K031187 HeartStart MRx |
5
K110825 pg 6 of 7
6
Performance Data
The HeartStart XL + has all of the major features of the HeartStart XL plus the additional feature of NBP monitoring. Testing for performance was done according to applicable FDA recognized consensus standards for electrical defibrillation, ECG monitoring, SPO2 monitoring, and NBP monitoring. Additional standards testing beyond the list of FDA recognized standards was also performed. Small feature changes have been made to align the design with the 2010 AHA Resuscitation Guidelines. The previous product had only been evaluated against the 2005 AHA guidelines.
Conclusions
The HeartStart XL + is substantially equivalent to previous Philips defibrillator monitor products and accessories. The predicates HeartStart FR2, HeartStart MRx have been commercially distributed and successfully used for several years.
Product design and testing was done in conformance with FDA-recognized standards. Conformance with recognized standards ensures product design and function will address known issues related to safety and effectiveness.
Based on similarity in technology, characteristics and indications for use as the predicate, the Philips defibrillator monitors (new and predicate) described in this summary are substantially equivalent.
7
Image /page/7/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
FEB 1 6 2012
Philips Healthcare c/o Mr. Paul Schrader Senior Regulatory Affairs Manager 3000 Minuteman Road Andover, MA 01810
Re: K110825
Trade/Device Name: Philips Heartstart XL+, Philips External Paddles, Philips Multifunction Electrodes Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External defibrillator Regulatory Class: Class III Product Code: MKJ, LDD, DRO, DQA, DXN, MHX Dated: February 3, 2012 Received: February 6, 2012
Dear Mr. Schrader:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
8
Page 2 - Mr. Paul Schrader
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.
- 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 (2) 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 (OS) 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/CDRH/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,
A-Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
9
K110825 pg lofl
4.0 Indications for Use Statement .
510(k) Number:
Device Name: Philips XL+ Defibrillator Monitor Indications for Use:
Intended Use:
The HeartStart XL + is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician.
When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED.
When operating in Monitor, Manual Defib or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.
Indications for Use:
The HeartStart XL+ is a defibrillator monitor. The device is for use by qualified medical personnel trained in the operation of the device and certified by training in basic life support, advanced life support or defibrillation. It must be used by or on the order of a physician.
AED Therapy
AED Mode is used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.
Manual Defibrillation
Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive.
Synchronous defibrillation (cardioversion) is indicated for termination of atrial fibrillation. Non-Invasive External Pacing
The pacing option is indicated for treating patients with symptomatic bradycardia. Pulse Oximetry
The SpO2 option is indicated for use when it is beneficial to assess the patient's oxygen saturation level.
Non-invasive Blood Pressure Monitoring
The NBP option is indicated for non-invasive measurement of a patient's arterial blood pressure. ECG Monitoring
The ECG monitoring option is indicated to be used for monitoring, alarming, and recording of the patient's heart rate and morphology.
| Prescription Use
| (21 CFR 801 Subpart D) | X | AND/OR |
|---|---|---|
| -------------------------------------------- | --- | -------- |
Over-The-Counter Use (21 CFR 801 Subpart C)
unter Use
Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K1108