(115 days)
Not Found
No
The summary describes a standard multi-function defibrillator with features like manual defibrillation, pacing, ECG display, and CPR feedback based on a metronome and optional sensor. There is no mention of AI, ML, or any advanced algorithms for interpretation or decision support beyond basic signal processing and timing.
Yes.
The device provides defibrillation therapy, non-invasive external pacing, and synchronized cardioversion, all of which are direct medical treatments for specific conditions.
Yes
Explanation: The device is indicated for "displaying ECG" and "monitoring of the patient's ECG signal," which are diagnostic functions. It also provides "CPR Feedback" to assess the effectiveness of resuscitation efforts, which is a form of monitoring and diagnostics.
No
The device description explicitly states it is a "compact, lightweight, portable electromedical device that contains a direct current (DC) defibrillator capable of delivering up to 200 joules of electrical energy to a patient through selfadhesive external electrode pads." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the TEMPUS LS - MANUAL is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- TEMPUS LS - MANUAL Function: The TEMPUS LS - MANUAL is an electromedical device that directly interacts with the patient's body through electrical energy (defibrillation, pacing) and monitors physiological signals (ECG). It also provides feedback for CPR.
- No Specimen Analysis: The device does not analyze any specimens taken from the patient's body. Its functions are applied to the patient's body or monitor signals from the patient's body.
Therefore, the TEMPUS LS - MANUAL falls under the category of a therapeutic and monitoring medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TEMPUS LS - MANUAL is a multi-function, portable of providing defibrillation therapy, noninvasive external pacing, displaying ECG, and CPR feedback in hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support.
Manual Defibrillation
In Manual Defibrillation mode, the TEMPUS LS - MANUAL is indicated for victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:
- · Unconsciousness
- · Absence of breathing, and
- · Absence of pulse.
This product should be used only by qualified medical personnel for terminating ventricular fibrillation and ventricular tachycardia.
Defibrillation is indicated for adult and pediatic patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS - MANUAL should be used with the Tempus Pediatric Electrodes or in the device's pediatic mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
Cardioversion
The TEMPUS LS - MANUAL may be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardia (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified user trained in the operation of the device must decide when synchronized cardioversion is appropriate. Cardioversion is indicated for adult and pediatric patients.
External Pacing
The TEMPUS LS - MANUAL is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include:
- · Resuscitation from standstill or bradycardia of any etiology.
- · As a standby when standstill or bradycardia might be expected.
External pacing is indicated for adult and pediatric patients.
ECG Display
The TEMPUS LS - MANUAL is intended to display a patient's ECG from a 3- or 4- lead wire ECG patient cable. It is indicated for use in adult or pediatric for attended monitoring of the patient's ECG signal (e.g., before starting demand pacing or after successful defibrillation).
CPR Feedback
The TEMPUS LS - MANUAL may be supplied with an optional CPR feedback sensor, which is intended to provide visual and audio feedback to encourage rescuers to perform CPR in accordance with AHA/ERC guidelines for chest compression rate and depth. It is indicated for use on adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs.
CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55 lbs.
Product codes
LDD, DRO, DPS, LIX
Device Description
The TEMPUS LS – MANUAL is a compact, lightweight, portable electromedical device that contains a direct current (DC) defibrillator capable of delivering up to 200 joules of electrical energy to a patient through selfadhesive external electrode pads. The device is intended for use by advanced cardiac life support (ACLS) trained health care professionals in hospital settings to provide defibrillation therapy, non-invasive external pacing, cardiopulmonary resuscitation (CPR) feedback, and non-alarming electrocardiograph (ECG) monitoring. The device is intended for prescription-use only. The unit is powered by a rechargeable lithium-ion battery which is recharged when connected to a mains power supply. The unit incorporates a color LCD display that displays information related to a clinical intervention. The trained user may select an energy level between 1 - 200 ioules and deliver a shock in either an asynchronous mode of delivery or through synchronized cardioversion using the patient's R-wave as a timing reference for the shock.
The device provides non-invasive transcutaneous pacing in either fixed or demand modes of operation through the same self-adhesive pads used in manual defibrillation. In addition, the device incorporates an audible metronome to quide a user as to the correct rate at which chest compressions should be administered in accordance with current American Heart Association (AHA) resuscitation guidelines. The device may be supplied with an optional cardiopulmonary resuscitation (CPR) feedback sensor which assists caregivers during CPR in delivering chest compressions at a rate and depth in compliance with current AHA guidelines. The device may also be paired to a compatible external device via a secure wireless communications protocol called Tempus Data Link (TDL) to export event data (without patient identifiers) at the convenience of the user.
TEMPUS LS - MANUAL features list:
- Manual mode defibrillation delivered in a Bi-phasic Truncated Exponential (BTE) waveform ●
- 1 200 joule user-configurable energy levels 0
- Synchronized cardioversion 0
- External pacer (fixed & demand modes) .
- CPR metronome & optional sensor providing feedback on CPR rate and CPR depth ●
- 3-lead wire and 4-lead wire ECG monitoring (non-alarming) ●
- Export of event data via Bluetooth and USB cable
The following accessories are provided with the TEMPUS LS – MANUAL:
- External electrode pads (adult/child, pediatric) ●
- . 10.8 V Lithium-ion battery
- Mains power supply unit with mains cable ●
- 3-lead or 4-lead wire ECG cable (optional)
- CPR feedback sensor & disposable adhesive securing pads (optional) 0
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
Defibrillation: adult and pediatric patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS - MANUAL should be used with the Tempus Pediatric Electrodes or in the device's pediatic mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
Cardioversion: adult and pediatric patients.
External Pacing: adult and pediatric patients.
ECG Display: adult or pediatric patients.
CPR Feedback: adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs. CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55 lbs.
Intended User / Care Setting
qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support, in hospital settings.
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 Tempus LS - MANUAL was evaluated via non-clinical safety and performance testing to demonstrate that the device met pre-established acceptance criteria and/or the requirements of FDA recognized consensus standards, and testing demonstrates substantially equivalence to the predicate devices.
Performance Testing
- Sterilization and shelf-life: Non-sterile device and accessories. 36-month shelf-life for defibrillator electrode pads, meeting requirements for electrical testing per 60601-2-4. 24-month shelf-life for CPR feedback sensor securing pads.
- Biocompatibility: IEC 10993 testing met requirements for defibrillator electrode pads and CPR feedback sensor securing pads.
- Electrical safety: IEC 60601-1 testing met requirements of the standard.
- Electromagnetic compatibility: IEC 60601-1-2, RTCA DO 160G and AIM 7351731 and wireless coexistence testing met requirements.
- Software: Appropriate documentation for Major level of concern SW, including verification and validation testing at the unit, integration and system.
- Bench: Bench testing was performed to evaluate the performance of the TEMPUS LS-MANUAL, inclusive of defibrillation, synchronized cardioversion, CPR metronome, pacing, and ECG display. The performance of the accessories including the CPR feedback sensor, electrode pads, ECG leads, power management was also evaluated. Furthermore, environmental performance, including vibration and shock, altitude, decompression and pressure, and climate, was evaluated. The tests showed passing results and the device is considered compliant with applicable standards (IEC 60601-2-4, IEC 60601-2-27; IEC 60601-1-8, AAMI EC53; IEC 60601-1-12; MIL-STD-810G; IEC 62133; UN 38.3; ASTM D4169-16).
- Human Factors: A human factors validation testing involving 15 participants representing intended users was performed to evaluate the usability of the TEMPUS – LS MANUAL in its intended use environment (pre-hospital; in-hospital). The study demonstrated that users were able to successfully and safely use the device.
Clinical evidence was not necessary to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ZOLL E-Series ALS (K140502), Philips HeartStart XL (K021453), Philips HeartStart XL+ (K133659)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2020
Remote Diagnostic Technologies Ltd., a Philips Company % Meaghan Bailey Executive Director NSF Health Sciences, LLC 2001 Pennsylvania Avenue NW, Suite 950 Washington, District of Columbia 20006
Re: K200849
Trade/Device Name: TEMPUS LS - MANUAL Regulation Number: 21 CFR 870.5300 Regulation Name: DC-Defibrillator (Including Paddles) Regulatory Class: Class II Product Code: LDD, DRO, DPS, LIX Dated: June 26, 2020 Received: June 26, 2020
Dear Meaghan Bailey:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200849
Device Name TEMPUS LS - MANUAL
Indications for Use (Describe)
The TEMPUS LS - MANUAL is a multi-function, portable of providing defibrillation therapy, noninvasive external pacing, displaying ECG, and CPR feedback in hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support.
Manual Defibrillation
In Manual Defibrillation mode, the TEMPUS LS - MANUAL is indicated for victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:
- · Unconsciousness
- · Absence of breathing, and
- · Absence of pulse.
This product should be used only by qualified medical personnel for terminating ventricular fibrillation and ventricular tachycardia.
Defibrillation is indicated for adult and pediatic patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS - MANUAL should be used with the Tempus Pediatric Electrodes or in the device's pediatic mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
Cardioversion
The TEMPUS LS - MANUAL may be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardia (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified user trained in the operation of the device must decide when synchronized cardioversion is appropriate. Cardioversion is indicated for adult and pediatric patients.
External Pacing
The TEMPUS LS - MANUAL is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include:
- · Resuscitation from standstill or bradycardia of any etiology.
- · As a standby when standstill or bradycardia might be expected.
External pacing is indicated for adult and pediatric patients.
ECG Display
The TEMPUS LS - MANUAL is intended to display a patient's ECG from a 3- or 4- lead wire ECG patient cable. It is indicated for use in adult or pediatric for attended monitoring of the patient's ECG signal (e.g., before starting demand pacing or after successful defibrillation).
CPR Feedback The TEMPUS LS - MANUAL may be supplied with an optional CPR feedback sensor, which is intended to provide
FORM FDA 3881 (7/17)
3
visual and audio feedback to encourage rescuers to perform CPR in accordance with AHA/ERC guidelines for chest compression rate and depth. It is indicated for use on adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs.
CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55 lbs.
Type of Use (Select one or both, as applicable) | |
---|---|
Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) SUMMARY
Submitter Information
- Applicant
Name: | Remote Diagnostic Technologies Ltd, a Philips company |
---|---|
Address: | Pavilion C2, Ashwood Park, Ashwood Way, Basingstoke, |
RG23 8BG, United Kingdom | |
Attn: Martin Newman, Director, Quality Assurance + | |
Regulatory Affairs | |
Phone No: | +44 (0) 1256 362 400 |
Submitter | |
Name: | NSF Health Sciences |
Address: | 2001 Pennsylvania Ave. NW, Suite 950, Washington DC |
20006 | |
Contact Person: | Meaghan Bailey, Executive Director |
Phone No: | 202-445-0577 |
Email: | mbailey@nsf.org |
Date Summary Prepared: | July 22, 2020 |
Device Identification | |
Device Name: | TEMPUS LS – MANUAL |
Common Name: | Low-Energy Defibrillator |
Classification: | II |
Product Code: | LDD |
Secondary Product Codes: | DRO, LIX, DPS |
Regulation Number: | 21 CFR 870. 5300 |
Predicate Device(s) | |
Primary Predicate: | ZOLL E-Series ALS (K140502) |
Secondary Predicate: | Philips HeartStart XL (K021453) |
Philips HeartStart XL+ (K133659) |
Device Description
The TEMPUS LS – MANUAL is a compact, lightweight, portable electromedical device that contains a direct current (DC) defibrillator capable of delivering up to 200 joules of electrical energy to a patient through selfadhesive external electrode pads. The device is intended for use by advanced cardiac life support (ACLS) trained health care professionals in hospital settings to provide defibrillation therapy, non-
Traditional 510(k) – TEMPUS LS – MANUAL Defibrillator |
---|
510(k) Summary |
5
invasive external pacing, cardiopulmonary resuscitation (CPR) feedback, and non-alarming electrocardiograph (ECG) monitoring. The device is intended for prescription-use only. The unit is powered by a rechargeable lithium-ion battery which is recharged when connected to a mains power supply. The unit incorporates a color LCD display that displays information related to a clinical intervention. The trained user may select an energy level between 1 - 200 ioules and deliver a shock in either an asynchronous mode of delivery or through synchronized cardioversion using the patient's R-wave as a timing reference for the shock.
The device provides non-invasive transcutaneous pacing in either fixed or demand modes of operation through the same self-adhesive pads used in manual defibrillation. In addition, the device incorporates an audible metronome to quide a user as to the correct rate at which chest compressions should be administered in accordance with current American Heart Association (AHA) resuscitation guidelines. The device may be supplied with an optional cardiopulmonary resuscitation (CPR) feedback sensor which assists caregivers during CPR in delivering chest compressions at a rate and depth in compliance with current AHA guidelines. The device may also be paired to a compatible external device via a secure wireless communications protocol called Tempus Data Link (TDL) to export event data (without patient identifiers) at the convenience of the user.
TEMPUS LS - MANUAL features list:
- Manual mode defibrillation delivered in a Bi-phasic Truncated Exponential (BTE) waveform ●
- 1 200 joule user-configurable energy levels 0
- Synchronized cardioversion 0
- External pacer (fixed & demand modes) .
- CPR metronome & optional sensor providing feedback on CPR rate and CPR depth ●
- 3-lead wire and 4-lead wire ECG monitoring (non-alarming) ●
- Export of event data via Bluetooth and USB cable
The following accessories are provided with the TEMPUS LS – MANUAL:
- External electrode pads (adult/child, pediatric) ●
- . 10.8 V Lithium-ion battery
- Mains power supply unit with mains cable ●
- 3-lead or 4-lead wire ECG cable (optional)
- CPR feedback sensor & disposable adhesive securing pads (optional) 0
Indications for Use
The TEMPUS LS – MANUAL is a multi-function, portable device that is capable of providing defibrillation therapy, non-invasive external pacing, displaying ECG, and CPR feedback in hospital and pre-hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support.
Manual Defibrillation
In Manual Defibrillation mode, the TEMPUS LS - MANUAL is indicated for victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:
- Unconsciousness .
- . Absence of breathing, and
- o Absence of pulse.
This product should be used only by qualified medical personnel for terminating ventricular fibrillation and ventricular tachycardia.
Traditional 510(k) – TEMPUS LS – MANUAL Defibrillator |
---|
510(k) Summary |
6
Defibrillation is indicated for adult and pediatric patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS-MANUAL should be used with the Tempus Pediatric Electrodes or in the device's pediatric mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.
Cardioversion
The TEMPUS LS - MANUAL may be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardia (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified user trained in the operation of the device when synchronized cardioversion is appropriate. Cardioversion is indicated for adult and pediatric patients.
External Pacing
The TEMPUS LS - MANUAL is indicated for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include:
- Resuscitation from standstill or bradycardia of any etiology. .
- . As a standby when standstill or bradycardia might be expected.
External Pacing is indicated for adult and pediatric patients.
ECG Display
The TEMPUS LS-MANUAL is intended to display a patient's ECG from a 3- or 4- lead wire ECG patient cable. It is indicated for use in adult or pediatric patients for attended monitoring of the patient's ECG signal (e.g., before starting demand pacing or after successful defibrillation).
CPR Feedback
The TEMPUS LS - MANUAL may be supplied with an optional CPR feedback sensor, which is intended to provide visual and audio feedback to encourage rescuers to perform CPR in accordance with AHA/ERC quidelines for chest compression rate and depth. It is indicated for use on adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs.
CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55lbs.
Summary of Technological Characteristics
The TEMPUS LS - MANUAL utilizes features and technologies substantially equivalent to the primary (K140502) and secondary (K021453 and K133659) predicate devices.
The intended use, indications for use, and technological features provided by the TEMPUS LS -MANUAL (subject device) are substantially equivalent to those provided by the primary predicate, the ZOLL E-Series ALS (K140502). The fundamental technological characteristics of the TEMPUS LS -MANUAL and ZOLL E-Series ALS are also the same in that both devices use a biphasic waveform for defibrillation therapy.
The electrical waveform delivered in manual defibrillation is substantially equivalent to the biphasic truncated exponential (BTE) waveform utilized by the Philips HeartStart XL (K021453). The electrical waveform delivered in non-invasive pacing therapy is substantially equivalent to the monophasic rectilinear waveform utilized by the Philips HeartStart XL+ (K133659) device.
Traditional 510(k) – TEMPUS LS – MANUAL Defibrillator |
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510(k) Summary |
7
Based on the information provided in this premarket notification, Remote Diagnostic Technologies Limited concludes that the TEMPUS LS – MANUAL defibrillator is substantially equivalent to the predicate devices. See Tables 1 and 2 below for a more detailed summary of substantial equivalence between the TEMPUS LS – MANUAL subject device and the predicate devices.
Table 1: Comparison of Technological Characteristics with ZOLL E-Series ALS (K140502) | |
---|---|
ZOLL E-Series ALS (K140502) | TEMPUS LS - MANUAL |
ZOLL E-Series ALS (K140502) | TEMPUS LS - MANUAL | |
---|---|---|
TECHNOLOGICAL CHARACTERISTICS - GENERAL | ||
Indications for Use | Multifunctional, portable | |
electronic device – low | ||
energy defibrillator | Identical | |
Size | 13.1" (W) | |
10.5" (D) | ||
5.75" (H) | 6.4" (W) | |
3.7" (D) | ||
7.8" (H) | ||
Weight | 13.2 lbs | 4.5 lbs |
Ingress Protection | IP34 | IP65 |
Operating | ||
Temperature | 0° C to 55° C | 0°C to 50°C |
Operating Pressure | 594 to 1060 mBar | 540 to 1060 mBar |
Shock & Vibration | MIL-STD-810 | Identical |
Display Type | Color Liquid Crystal Display (LCD) | Identical |
Screen Size | 5.6 inches diagonally | 5.7 inches diagonally |
Electrical Safety | ||
Standard | IEC 60601-1 | Identical |
EMC Standard | IEC 60601-1-2 | |
RTCA DO-160 | IEC 60601-1-2 | |
RTCA DO-160G | ||
Cat. M and R | ||
Defibrillator Standard | IEC/EN 60601-2-4 | Identical |
ECG Standard | IEC 60601-2-27 | Identical |
TECHNOLOGICAL CHARACTERISTICS - DEFIBRILLATION AND CARDIOVERSION | ||
Manual Defibrillation | ||
Modes | Asynchronous manual | |
Synchronous manual | ||
(cardioversion) | Identical | |
Output Energy | 1 - 200 Joules into a 50 Ohm load | Identical |
Defibrillation Waveform | Biphasic Rectilinear | Biphasic Truncated Exponential |
TECHNOLOGICAL CHARACTERISTICS - PACING | ||
Modes | Fixed | |
Demand | Identical | |
Fixed-mode principle | Use configurable; pre-set intervals; | |
independent of intrinsic cardiac | ||
activity | Identical | |
Demand-mode | ||
principle | Use configurable; triggers when | |
heart rate falls below target | Identical | |
Pacing delivery | Multifunction electrode pads | Identical |
Pacing waveform | Monophasic Rectilinear, constant | |
current, 40 milliseconds | Monophasic Rectilinear, constant | |
current, 20 milliseconds | ||
Pulse Amplitude | 5 mA to 140 mA ±5% or 5 mA, | |
whichever is greater | 10 mA to 200 mA ± 10% or 5 mA, | |
whichever is greatest | ||
Pacing Rate | 30 ppm to 180 ppm ± 1.5% | 40 ppm to 180 ppm ± 1.5% |
TECHNOLOGICAL CHARACTERISTICS – ECG MONITORING | ||
Standard | IEC 60601-2-27:2011 | Substantially Equivalent |
For attended monitoring only, only | ||
technical alerts | ||
Patient Connection | ECG cable | Identical |
Traditional 510(k) – TEMPUS LS – MANUAL Defibrillator |
---|
510(k) Summary |
8
ZOLL E-Series ALS (K140502) | TEMPUS LS – MANUAL | |
---|---|---|
Protection | Multifunction electrode pads | |
Fully isolated, defibrillation-protected | Identical | |
Heart Rate Display | Digital readout on display | Identical |
Heart Rate Range | 0 to 300 bpm with accuracy ± 5% bpm | Substantially Equivalent |
15 to 350 bpm with accuracy ± 10% bpm or 5 bpm, whichever is greater | ||
Heart rate averaging | Averages the interval between the last 5 detected beats | Substantially Equivalent |
Averages the interval between the last 4-16 detected beats (user configurable) | ||
Bandwidth | 0.05 Hz – 150 Hz (-3 dB) | Identical |
Tall T-wave rejection |