(115 days)
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.
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.
This is a 510(k) summary for the TEMPUS LS - MANUAL, a multi-function defibrillator. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological comparisons and non-clinical performance testing. It does not contain information about a clinical study with acceptance criteria in the typical sense of metrics like sensitivity or specificity for an AI algorithm.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document describes "pre-established acceptance criteria" but does not explicitly list them or quantify performance metrics in a table. Instead, it states that various tests "met requirements" or "met the requirements of the standard," implying that the acceptance criteria were compliance with specific industry standards and successful operation in bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-2-4 | Met requirements for defibrillator electrode pads |
| Compliance with IEC 60601-1 | Met requirements of the standard |
| Compliance with IEC 60601-1-2, RTCA DO 160G, AIM 7351731, and wireless coexistence testing | Met requirements |
| Appropriate documentation for Major level of concern SW, including verification and validation testing | Successful verification and validation testing at the unit, integration, and system levels |
| Performance of defibrillation, synchronized cardioversion, CPR metronome, pacing, and ECG display | Bench testing 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) |
| Usability in intended use environment | Human factors validation testing involving 15 participants showed users were able to successfully and safely use the device. |
2. Sample size used for the test set and the data provenance
The document does not detail a "test set" in the context of an AI algorithm's performance. The closest analogous information is for the Human Factors validation testing:
- Sample size: 15 participants
- Data provenance: Not specified, but given the manufacturer is UK-based and the test was for usability, it's likely the participants were located in a similar context. It was a prospective study to evaluate usability.
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 the document describes non-clinical testing and human factors usability, not a clinical study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as the document does not describe a process that would involve expert adjudication of a test set for diagnostic performance.
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
No, a MRMC comparative effectiveness study was not done with human readers and AI assistance. This document describes a medical device (defibrillator) primarily relying on hardware and embedded software functionality, not an AI-powered diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the device described. The "algorithm" here refers to the device's operational functions (defibrillation waveform generation, pacing parameters, CPR metronome, etc.) rather than a diagnostic algorithm generating an output for review. Bench testing was performed for these functionalities, which could be considered "standalone" in the sense that the device's technical specifications were verified against standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" was the pre-established acceptance criteria derived from recognized consensus standards (e.g., IEC 60601-1, IEC 60601-2-4). For the human factors study, the ground truth was the successful and safe use of the device by participants, evaluated against predefined usability metrics.
8. The sample size for the training set
The document does not mention a "training set" as it is not for an AI/ML algorithm that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
{0}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 DC20006 |
| 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 |
|---|
| 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, portableelectronic device – lowenergy 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 |
| OperatingTemperature | 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 SafetyStandard | IEC 60601-1 | Identical |
| EMC Standard | IEC 60601-1-2RTCA DO-160 | IEC 60601-1-2RTCA DO-160GCat. M and R |
| Defibrillator Standard | IEC/EN 60601-2-4 | Identical |
| ECG Standard | IEC 60601-2-27 | Identical |
| TECHNOLOGICAL CHARACTERISTICS - DEFIBRILLATION AND CARDIOVERSION | ||
| Manual DefibrillationModes | Asynchronous manualSynchronous 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 | FixedDemand | Identical |
| Fixed-mode principle | Use configurable; pre-set intervals;independent of intrinsic cardiacactivity | Identical |
| Demand-modeprinciple | Use configurable; triggers whenheart rate falls below target | Identical |
| Pacing delivery | Multifunction electrode pads | Identical |
| Pacing waveform | Monophasic Rectilinear, constantcurrent, 40 milliseconds | Monophasic Rectilinear, constantcurrent, 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 EquivalentFor attended monitoring only, onlytechnical 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 padsFully isolated, defibrillation-protected | Identical |
| Heart Rate Display | Digital readout on display | Identical |
| Heart Rate Range | 0 to 300 bpm with accuracy ± 5% bpm | Substantially Equivalent15 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 EquivalentAverages the interval between the last 4-16 detected beats (user configurable) |
| Bandwidth | 0.05 Hz – 150 Hz (-3 dB) | Identical |
| Tall T-wave rejection | < 1.0 mV | Substantially Equivalent< 0.8 mV |
| Pacemaker detection | ± 2 mV to ± 700 mV0.1 ms to 2 ms width | Identical |
| Reaction to irregular rhythm | A1: 40 bpmA2: 60 bpmA3: 120 bpmA4: 90 bpm | Substantially Equivalent per 60601-2-27A1: 80 bpmA2: 60 bpmA3: 120 bpmA4: 90 bpm |
| Alarms | Yes | Yes, for technical alerts |
Table 2: Comparison of waveform characteristics with Philips HeartStart XL (K021453) and Philips HeartStart XL+ (K133659)
| Philips HeartStart XL | HeartStart XL+ | TEMPUS LS - MANUAL | |
|---|---|---|---|
| DefibrillationWaveform | Biphasic truncatedexponential | N/A | Biphasic truncatedexponential |
| PacingWaveform | N/A | Monophasic Rectilinear, constant current, 20 milliseconds duration | Monophasic Rectilinear, constant current, 20 milliseconds duration |
Safety and Performance Data
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.
| Table 3: Summary of Performance Testing | |||
|---|---|---|---|
| ----------------------------------------- | -- | -- | -- |
| Performance Testing | Summary |
|---|---|
| Sterilization and shelf-life | Non-sterile device and accessories |
| 36-month shelf-life for defibrillator electrode pads, meetingrequirements 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 padsand 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 wirelesscoexistence testing met requirements |
| Software | Appropriate documentation for Major level of concern SW, includingverification and validation testing at the unit, integration and system |
| Traditional 510(k) – TEMPUS LS – MANUAL Defibrillator |
|---|
| 510(k) Summary |
{9}------------------------------------------------
| Performance Testing – Bench | Bench testing was performed to evaluate the performance of theTEMPUS LS-MANUAL, inclusive of defibrillation, synchronizedcardioversion, CPR metronome, pacing, and ECG display. Theperformance of the accessories including the CPR feedback sensor,electrode pads, ECG leads, power management was also evaluated.Furthermore, environmental performance, including vibration andshock, altitude, decompression and pressure, and climate, wasevaluated. The tests showed passing results and the device isconsidered compliant with applicable standards (IEC 60601-2-4, IEC60601-2-27; IEC 60601-1-8, AAMI EC53; IEC 60601-1-12; MIL-STD-810G; IEC 62133; UN 38.3; ASTM D4169-16) |
|---|---|
| Performance Testing –Human Factors | A human factors validation testing involving 15 participantsrepresenting intended users was performed to evaluate the usabilityof the TEMPUS – LS MANUAL in its intended use environment (pre-hospital; in-hospital). The study demonstrated that users were ableto successfully and safely use the device. |
Clinical evidence was not necessary to demonstrate substantial equivalence.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Remote Diagnostic Technologies Limited conclude that the TEMPUS LS - MANUAL defibrillator described in this pre-market notification is substantially equivalent to the predicate devices.
§ 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.