(106 days)
Not Found
No
The document describes a monitor/defibrillator with standard physiological monitoring features and does not mention any AI or ML capabilities. The new features are temperature monitoring and auxiliary power, which are not AI/ML related.
Yes
The device performs therapeutic functions such as manual and automated external defibrillation, and noninvasive pacing to treat various cardiac conditions.
Yes
The device diagnoses various medical conditions through features like 12-lead Electrocardiography for cardiac disorders, Pulse Oximetry for hypoxemia, Noninvasive Blood Pressure Monitoring for hypertension/hypotension, End-Tidal CO2 monitoring for breathing efficacy, and Invasive Pressure Monitoring for physiological pressure changes.
No
The device description clearly outlines a physical monitor/defibrillator with various hardware components (defibrillation pads, ECG leads, pulse oximetry sensors, blood pressure cuff, CO2 sensor, temperature probes) and power options (batteries, AC/DC adapters). It is not solely software.
Based on the provided text, the LIFEPAK 15 monitor/defibrillator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- LIFEPAK 15 Functionality: The LIFEPAK 15 monitor/defibrillator is a device that directly interacts with the patient's body to monitor physiological signals (ECG, blood pressure, pulse oximetry, EtCO2, temperature, invasive pressure) and deliver therapy (defibrillation, pacing). It does not analyze samples taken from the body.
The device description and intended use clearly indicate that it is a patient-contacting device used for monitoring and treatment, not for analyzing biological specimens.
N/A
Intended Use / Indications for Use
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients.
Automated external defibrillation mode is intended for use on patients eight years of age and older.
Manual Defibrillation:
Indications
Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.
Noninvasive Pacing:
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST-elevation myocardial infarction (STEMI).
Pulse Oximetry:
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
Invasive Pressure Monitoring:
Indications
Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.
Temperature Monitoring:
Indications
Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.
Product codes (comma separated list FDA assigned to the subject device)
LDD, MKJ, DRT, DRO, DQA, DXN, CCK, DSK, FLL
Device Description
The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LIFEPAK 15 monitor/defibrillator was designed for use in a variety of hospital and pre-hospital settings including emergency rooms, catheterization laboratories, electrophysiology laboratories, crash carts, operating rooms, and ground ambulances.
Features of the LIFEPAK 15 monitor/defibrillator include manual and automated external defibrillation, noninyasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry (SpO2, SpCO. and SpMet), synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring and invasive pressure monitoring. The existing LIFEPAK 15 monitor/defibrillator is powered by rechargeable lithium-ion batteries.
The proposed LIFEPAK 15 monitor/defibrillator includes all of the same features and functions as the predicate device plus 2 new features: 1) temperature monitoring and 2) auxiliary power. The temperature monitoring feature allows continuous monitoring of body temperature with the use of temperature probes. The temperature reading can be trended and displayed on the LIFEPAK 15 monitor/defibrillator screen. The temperature trend graph can also be printed or saved and transmitted to the Physio-Control CODE-STAT" software for post event review.
The new auxiliary power feature gives users an additional option for powering the LIFEPAK 15 monitor/defibrillator. In addition to the existing rechargeable lithium-ion batteries, users will have the option to operate their device from AC power sources via an AC power adapter or from DC power sources via a DC power adapter. The LIFEPAK 15 monitor/defibrillator charges installed batteries when connected to auxiliary power.
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
Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients.
Automated external defibrillation mode is intended for use on patients eight years of age and older.
In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.
Intended User / Care Setting
trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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SECTION E - 510(K) SUMMARY
Submitter:
Physio-Control, Inc. 11811 Willows Road Northeast P.O. Box 97006 Redmond, Washington 98073-9706
MAR 2 2 20i1
Contact Person:
Michelle Ackermann Principal Regulatory Affairs Specialist Phone: 425-867-4744, Fax: (425) 867-4154
Date Summary Prepared:
December 3, 2010
Device Trade Name:
LIFEPAK®15 monitor/defibrillator
Device Common Name:
External monitor/defibrillator
Device Classification:
| Classification Name | Class |
|---|---|
| Low Energy DC-Defibrillator (Including Paddles), (21CFR | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 870.5300, Product Code LDD) | |
| Automatic External Defibrillators (Non-Wearable) (21CFR | |
| 870.5310, Product Code MKJ) | |
| Cardiac Monitor (Including Cardiotachometer & Rate Alarm) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| (21CFR870.2300, Product Code DRT) | |
| External Cardiac Transcutaneous (Non-Invasive) | - |
| Pacemaker (21CFR870.5550, Product Code DRO) | |
| Oximeter (21CFR870.2700, Product Code DQA) | ============================================================================================================================================================================== |
| Noninvasive Blood Pressure Measurement System | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| (21CFR870.1130, Product Code DXN) | |
| Carbon-Dioxide Gas Analyzer Gaseous-Phase | ll |
| (21CFR868.1400 Product Code CCK) | |
| Blood Pressure Computer (21CFR870.1110, Product Code | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| DSK) |
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=
SECTION E - 510(K) SUMMARY
K103567
p 2/6
Clinical Electronic Thermometer. (21CFR880,2910, Product Code FLL)
Predicate Device:
The features and functions of the proposed LIFEPAK 15 monitor/defibrillator are substantially equivalent to the previously cleared LIFEPAK 15 monitor/defibrillator. The LIFEPAK 15 monitor/defibrillator was cleared under 510(k) number K082937 on 03/11/09.
Description:
The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LIFEPAK 15 monitor/defibrillator was designed for use in a variety of hospital and pre-hospital settings including emergency rooms, catheterization laboratories, electrophysiology laboratories, crash carts, operating rooms, and ground ambulances.
Features of the LIFEPAK 15 monitor/defibrillator include manual and automated external defibrillation, noninyasive pacing, ECG monitoring (3-lead, 7-lead and interpretive 12-Lead), pulse oximetry (SpO2, SpCO. and SpMet), synchronized cardioversion, noninvasive blood pressure monitoring, end-tidal CO2 monitoring and invasive pressure monitoring. The existing LIFEPAK 15 monitor/defibrillator is powered by rechargeable lithium-ion batteries.
The proposed LIFEPAK 15 monitor/defibrillator includes all of the same features and functions as the predicate device plus 2 new features: 1) temperature monitoring and 2) auxiliary power. The temperature monitoring feature allows continuous monitoring of body temperature with the use of temperature probes. The temperature reading can be trended and displayed on the LIFEPAK 15 monitor/defibrillator screen. The temperature trend graph can also be printed or saved and transmitted to the Physio-Control CODE-STAT" software for post event review.
The new auxiliary power feature gives users an additional option for powering the LIFEPAK 15 monitor/defibrillator. In addition to the existing rechargeable lithium-ion batteries, users will have the option to operate their device from AC power sources via an AC power adapter
2
Image /page/2/Picture/0 description: The image shows the logo for Physio-Control. The logo is a black rectangle with the word "PHYSIO" in white, block letters on top. Below that is the word "CONTROL" in smaller, white, block letters. The logo is simple and easy to read.
Image /page/2/Picture/3 description: The image shows handwritten text on a white background. The text includes the alphanumeric string "K1035B7" on the first line. The second line contains the letter "p" followed by the fraction "3/6", indicating a page number or a similar reference.
or from DC power sources via a DC power adapter. The LIFEPAK 15 monitor/defibrillator charges installed batteries when connected to auxiliary power.
Intended Use:
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients.
Automated external defibrillation mode is intended for use on patients eight years of age and older.
Indications for Use:
Manual Defibrillation:
Indications
Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.
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K103567
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Noninvasive Pacing
Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST-elevation myocardial infarction (STEMI).
Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoglobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate
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K103567 p 5/6
compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
Invasive Pressure Monitoring:
Indications
Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.
Temperature Monitoring:
Indications
Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.
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Technological characteristics of the proposed and predicate device:
The main difference between the predicate LIFEPAK 15 monitor/defibrillator and the proposed LIFEPAK 15 monitor/defibrillator is the addition of 2 new features; temperature monitoring and auxiliary power. Device characteristics such as the defibrillation waveform and ECG analysis system are unchanged from the predicate device.
Conclusion of Testing
The information in this 510(k) notification demonstrates that the LIFEPAK 15 monitor/defibrillator is substantially equivalent to the predicate LIFEPAK 15 device with respect to safety, effectiveness, and performance.
E-6
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Physio-Control, Inc. c/o Ms. Michelle Ackermann Principal Regulatory Affairs Specialist 11811 Willows Road Northeast P.O. Box 97006 Redmond, WA 98073-9706
MAR 2 2 2011
Re: K103567
Trade/Device Name: LIFEPAK 15 monitor/defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: March 10, 2011 Received: March 14, 2011
Dear Ms. Ackermann:
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.
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.
7
Page 2 - Ms. Michelle Ackermann
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/CDRH0ffices/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.
F.S. Gind
Dr. Bram D. Zuckerman, M.D.
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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510(k) Number (if known): not yet assigned
Device Name: LIFEPAK 15 monitor/defibrillator
Indications For Use:
Manual Defibrillation:
Indications
Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and, in relatively stable patients, ventricular tachycardia.
Contraindications
Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as indioventricular or ventricular escape rhythms, and in the treatment of asystole.
Automated External Defibrillation:
Indications
AED mode is to be used only on patients in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient's ECG rhythm. In AED mode, the LIFEPAK 15 monitor/defibrillator is not intended for use on pediatric patients less than 8 years old.
| 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 CBBH: Office/of Device Evaluation(ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| Page 1 of 4 | D-1 |
|---|---|
| ------------- | ----- |
| 510(k) Number | K103567 |
|---|---|
| --------------- | --------- |
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510(k) Number (if known): not vet assigned
Device Name: LIFEPAK 15 monitor/defibrillator
Indications For Use:
Noninvasive Pacing
- Indications
Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse. ·
Contraindications: Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.
12-lead Electrocardiography:
Indications
The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST-elevation myocardial infarction (STEMI).
Pulse Oximetry
Indications
Pulse Oximetry is indicated for use in any patient who is at risk of developing hypoxemia, carboxyhemoglobinemia, or methemoqlobinemia. SpO2 monitoring may be used during no motion and motion conditions, and in patients who are well or poorly perfused. SpCO and SpMet accuracies have not been validated under motion or low perfusion conditions.
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) | BDC |
|---|---|
| Page 2 of 4 | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K102567 |
| D-2 |
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510(k) Number (if known): not yet assigned
Device Name: LIFEPAK 15 monitor/defibrillator
Indications For Use:
Noninvasive Blood Pressure Monitoring:
Indications
Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.
End-Tidal CO2 monitoring:
Indications
EtCO2 monitoring is used to detect trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care, for example, to determine if adequate compressions are being performed during CPR or to rapidly detect whether an endotracheal tube has been placed successfully.
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)
Page 3 of 4
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number 1103567
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510(k) Number (if known): not yet assigned
Device Name: LIFEPAK 15 monitor/defibrillator
Indications For Use:
Invasive Pressure Monitoring:
Indications
Invasive pressure monitoring is indicated for use in patients who require continuous monitoring of physiological pressures in order to rapidly assess changes in the patient's condition or response to therapy. It may also be used to aid in medical diagnosis.
Temperature Monitoring:
Indications
Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.
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) 5
| Concurrence of CDRH, Office of Device Evaluation (ODE) | signature BOZ |
|---|---|
| Page 4 of 4 | (Division Sign-Off) |
| Division of Cardiovascular Devices | |
| 510(k) Number K103567 D-4 |