(469 days)
The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient's electrocardiogram. The recorder is intended to be used by either paediatric or adult patients suspected of cardiac arrhythmias in either a clinical setting or at home. The recorder does no cardiac analysis and is used with Spacelabs Ambulatory ECG Analysis Software.
The Eclipse MINI Model 98900 (Eclipse MINI) is an ambulatory electrocardiograph (ECG) recorder capable of providing a 3-lead recording. It is connected to the patient using a custom, disposable, single-patient only, 3-lead sensor patch that is adhesively attached to the patient's chest. The Eclipse MINI is powered by batteries that are integrated in the Eclipse Sensor Patch. These batteries are primary cells which cannot be recharged and power the recorder for up to 15 days. For an extended recording multiple Eclipse Sensor Patches may be required. The single patient event button allows the patient to indicate symptomatic episodes in the recording for correlation with the patient diary. The Eclipse MINI is fully sealed and waterproof. The Eclipse MINI is attached to the "holster" of the Eclipse MINI Sensor Patch by inserting the USB connector on the sensor patch into the USB receptacle on the bottom of Eclipse MINI housing. Patient data from the Eclipse MINI is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse MINI, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921). Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.
This is a 510(k) premarket notification for the Spacelabs Eclipse MINI Model 98900. A 510(k) submission generally aims to demonstrate substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study for a novel device. The document primarily focuses on demonstrating that the Eclipse MINI Model 98900 is substantially equivalent to the Reynolds Medical Ltd. Lifecard CF 7-Day Holter Recorder (K011837) based on technological characteristics and performance testing in accordance with regulatory standards.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial for a new device, is not fully applicable or explicitly detailed in this 510(k) summary. The "acceptance criteria" here largely refer to meeting recognized standards for safety and performance to demonstrate substantial equivalence.
Here's an attempt to extract and interpret the information based on the provided document within the context of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document does not present a single table of "acceptance criteria" and "reported device performance" in the way one might expect for a specific clinical endpoint. Instead, the device's performance is demonstrated through compliance with various national and international standards and internal requirements, and by performing comparably to the predicate device.
The "Technology Comparison" table (page 5) lists various characteristics and indicates that the Eclipse MINI's performance is consistent with these standards and the predicate. The "Summary of Performance Testing" sections (pages 6 and 7) state that the device "complies with internal requirements, applicable Standards, and the guidance document."
Here is a summary of the broad performance areas and the reported compliance:
| Acceptance Criteria Category (implied by standards) | Reported Device Performance (Summary of Testing) |
|---|---|
| Shelf-Life | The Eclipse MINI does not have a shelf life. The Eclipse MINI 3-lead Sensor Patch has a defined product life of 1 year from the date of manufacture. Test results indicated that the Eclipse MINI 3-lead Sensor Patch complies with its stated shelf-life. |
| Biocompatibility | Tested in accordance with ISO 10993-1: 2009. Test results indicated that the patient-contact materials in the Eclipse MINI comply with the applicable Standard and guidance document. |
| Software Verification & Validation | Designed and developed according to a robust software development process and rigorously verified and validated, adhering to FDA guidance (e.g., "Content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," "General principles of software validation," "Cybersecurity"). Test results indicate that the Eclipse MINI complies with its predetermined specifications, guidance documents and Standards. |
| Electrical Safety | Tested in accordance with IEC 60601-1: 2012 and IEC 60601-1-11: 2015. Test results indicated that the Eclipse MINI complies with the applicable Standards. |
| Electromagnetic Compatibility (EMC) | Tested in accordance with IEC 60601-1-2: 2014. Test results indicated that the Eclipse MINI complies with the applicable Standard. |
| Performance Testing – Bench | Tested in accordance with internal requirements, ANSI/AAMI EC12:2000/(R)2015, IEC 60601-1-6: 2013, IEC 60601-2-47: 2012, IEC 62366-1: 2015, and relevant FDA guidance. This includes aspects like ECG recording accuracy, usability, and essential performance for ambulatory ECG systems. Test results indicated that the Eclipse MINI complies with internal requirements, applicable Standards, and the guidance document. Additionally, for Defibrillator Protection, it is stated that it is "Not defibrillator proof; however, Eclipse MINI is compliant with IEC 60601-1: 2005, Am1: 2012, Clause 8.5.5.2, Energy Reduction Test." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in a way that relates to a "test set" for a diagnostic study. The performance testing described (shelf-life, biocompatibility, software V&V, electrical safety, EMC, bench performance) are engineering and laboratory tests, not clinical studies with a patient test set in the traditional sense. Therefore, details like "sample size used for the test set" and "data provenance" (country/retrospective/prospective) are not applicable or detailed for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device, the Eclipse MINI Model 98900, is an ECG recorder and "does no cardiac analysis" itself. It is used with "Spacelabs Ambulatory ECG Analysis Software" (which would have its own clearances, e.g., K152881, K110001, K201921). As such, it is not a diagnostic algorithm that provides an output requiring ground truth established by experts. Its function is to accurately record ECG data, and its performance is assessed against technical standards for signal acquisition and safety, not diagnostic accuracy. Therefore, this information is not applicable to the device described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no diagnostic "test set" and no "ground truth" adjudicated by experts for this recording device as described in the submission.
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
Not applicable. This device is an ECG recorder and not an AI/CADe/CADx system. No MRMC study or AI assistance improvement is mentioned or relevant to the device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ECG recorder, not an algorithm, and performs "no cardiac analysis."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As described in points 3, 4, 5, and 6, this device does not perform analysis that would require a ground truth for diagnostic accuracy. Its "ground truth" for performance is compliance with engineering and safety standards, and reliable recording of ECG data.
8. The sample size for the training set
Not applicable. This device is primarily hardware an embedded software for recording. It is not an AI/machine learning model that requires a training set. The software mentioned is developed through robust software development processes (as noted in the "Software" testing section) and validated against specifications, not "trained" on a data set in the ML sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
{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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 7, 2022
Spacelabs Healthcare Ltd. % Thomas Kroenke Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland, Colorado 80466
Re: K212317
Trade/Device Name: Eclipse MINI Model 98900 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: MWJ Dated: November 2, 2022 Received: November 3, 2022
Dear Thomas Kroenke:
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,
Shruti N. Mistry -S
for
Jennifer Shih Kozen 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) K212317
Device Name
Spacelabs Eclipse MINI Model 98900
Indications for Use (Describe)
The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient's electrocardiogram. The recorder is intended to be used by either paediatric or adult patients suspected of cardiac arrhythmias in either a clinical setting or at home. The recorder does no cardiac analysis and is used with Spacelabs Ambulatory ECG Analysis Software.
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."
{3}------------------------------------------------
| Submission Date: | 05 November 2022 | ||
|---|---|---|---|
| Submitter: | Spacelabs Healthcare Ltd.Unit B, Foxholes CentreJohn Tate RoadHertfordHertfordshireSG13 7DTUnited Kingdom | ||
| SubmitterCorrespondent | Mr. Roger MoldonPhone: +011 44-1992-507730Email: roger.moldon@spacelabs.com) | ||
| ApplicationCorrespondent: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net+1 (303) 956 4232 | ||
| Manufacturing Site: | Spacelabs Healthcare, Inc.35301 SE Center StreetSnoqualmie, WA 98065 USA | ||
| Trade Name: | Eclipse MINI Model 98900 | ||
| Common andClassificationName: | Medical Magnetic Tape Recorder | ||
| ClassificationRegulation: | 21 CFR §870.2800 | ||
| Product Code: | MWJ | ||
| SubstantiallyEquivalent Devices: | New SpacelabsModel | Predicate510(k) Number | PredicateManufacturer / Model |
| Eclipse MINI Model98900 | K011837 | Reynolds Medical Ltd. /Lifecard CF 7-Day HolterRecorder |
{4}------------------------------------------------
| Device Description: | The Eclipse MINI Model 98900 (Eclipse MINI) is an ambulatoryelectrocardiograph (ECG) recorder capable of providing a 3-leadrecording. It is connected to the patient using a custom, disposable,single-patient only, 3-lead sensor patch that is adhesively attached to thepatient's chest.The Eclipse MINI is powered by batteries that are integrated in theEclipse Sensor Patch. These batteries are primary cells which cannot berecharged and power the recorder for up to 15 days. For an extendedrecording multiple Eclipse Sensor Patches may be required.The single patient event button allows the patient to indicatesymptomatic episodes in the recording for correlation with the patientdiary.The Eclipse MINI is fully sealed and waterproof.The Eclipse MINI is attached to the "holster" of the Eclipse MINI SensorPatch by inserting the USB connector on the sensor patch into the USBreceptacle on the bottom of Eclipse MINI housing.Patient data from the Eclipse MINI is downloaded to a PC upon whichthe Spacelabs Sentinel Cardiology Information Management System(Sentinel), cleared in 510(k) submission K152881, has been installed.This allows the clinician to download, view, and analyze patient datafrom the Eclipse MINI, and create reports. Further analysis of thesepatient data can be performed by using Spacelabs Pathfinder SL HolterAnalyzer (cleared in 510(k) submission K110001) and/or SpacelabsLifescreen PRO Analyzer (cleared in 510(k) submission K201921).Finally, a non-medical device mobile phone app is available for patientuse as an electronic note taking option in lieu of a manual, written patientdiary. |
|---|---|
| Indications for Use: | The Eclipse MINI Model 98900 is a portable non-invasive continuousambulatory ECG patch recorder intended to record the patient'selectrocardiogram. The recorder is intended to be used by eitherpaediatric or adult patients suspected of cardiac arrhythmias in either aclinical setting or at home. The recorder does no cardiac analysis and isused with Spacelabs Ambulatory ECG Analysis Software. |
{5}------------------------------------------------
Technology Comparison:
The Eclipse MINI Model 98900 (Eclipse MINI) employs the same technological characteristics as the predicate device.
| Characteristic | Reynolds Medical Ltd. | Spacelabs Healthcare Ltd. |
|---|---|---|
| Lifecard CF 7-Day Holter Recorder | Eclipse MINI | |
| (K011837) | (K212317) | |
| Indications forUse | The Reynolds Lifecard CF 7-DayHolter recorder (Lifecard CF) is amodification of the ReynoldsLifecard CF Holter Recorder,K001025. It is indicated when it isdesired to record the patient'sambulatory electrocardiogram.It is a portable Holter recorderdesigned to record the patient'sambulatory electrocardiogram for upto seven days. | The Eclipse MINI Model 98900 is aportable non-invasive continuousambulatory ECG patch recorderintended to record the patient'selectrocardiogram. The recorder isintended to be used by eitherpaediatric or adult patients suspectedof cardiac arrhythmias in either aclinical setting or at home. Therecorder does no cardiac analysis andis used with a Ambulatory ECGAnalysis System or Rapid AnalysisSoftware module. |
| Software | The Eclipse PRO is compatible with: | The Eclipse PRO is compatible with: |
| InformationManagementand AnalyzerCompatibility | Spacelabs Sentinel CardiologyInformation ManagementSystem (cleared in K152881). Spacelabs Pathfinder SL HolterAnalyzer (cleared in K110001) Spacelabs Lifescreen PROAnalyzer (cleared in K201921). | Spacelabs Sentinel CardiologyInformation ManagementSystem (cleared in 152881). Spacelabs Pathfinder SL HolterAnalyzer (cleared in K110001) Spacelabs Lifescreen PROAnalyzer (cleared in K201921). |
| Channels | 1, 2, or 3 channels | 2 channels |
| RecordingDuration | Up to 48 hours recording 2 - 3channelsUp to 7 days recording 2 - 3 channelsin extended mode | Recorder supports up to 30 daysrecording 2 channels.Patch sensors used with the recorderhave an 8-day wear duration. |
| Data TransferMethodbetweenRecorder andAnalysisSoftware | Removable CompactFlashAssociation (Type 1) card | Standard USB cable. |
| Media Type | Removable CompactFlashAssociation (Type 1) card | Internal memory |
| Data Stored | Full disclosure ECG, with pacing andpatient event markersRecording date and timePatient name and record number(Pathfinder systems)Encrypted patient record file(CardioNavigator)8 second voice recordingRecorder serial number | Full disclosure ECG with patientevent markers.Recording date and time.Recording ID.Recorder serial number. |
| DefibrillatorProtection | Not defibrillator proof. | Not defibrillator proof; however,Eclipse MINI is compliant with IEC60601-1: 2005, Am1: 2012, Clause8.5.5.2, Energy Reduction Test. |
| Power Source | Battery, rechargeable or disposable | Battery, disposable |
| Shelf-Life | The Eclipse MINI does not have a shelf life.The Eclipse MINI 3-lead Sensor Patch has a defined product life of 1year from the date of manufacture. Test results indicated that theEclipse MINI 3-lead Sensor Patch complies with its stated shelf-life. | |
| Biocompatibility | The patient-contact materials in the Eclipse MINI were tested forbiocompatibility compliance in accordance with the following Standardand guidance document: ISO 10993-1: 2009, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. Use of International Standard ISO 10993-1, "Biological evaluationof medical devices - Part 1: Evaluation and testing within a riskmanagement process," 04 Sep 20 Test results indicated that the patient-contact materials in the EclipseMINI comply with the applicable Standard and guidance document. | |
| Software | The Eclipse MINI software was designed and developed according to arobust software development process and was rigorously verified andvalidated.Software information is provided in accordance with internalrequirements and the following guidance documents and Standards: FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05. FDA guidance: Off-the-shelf software use in medical devices, 27Sep 19. FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02. Content of Premarket Submissions for Management ofCybersecurity in Medical Devices, 02 Oct 14. Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) software, 14 Jan 05. Design Considerations and Premarket SubmissionRecommendations for Interoperable Medical Devices, 06 Sep 17. IEC 62304: 2006, Am1:2015, Medical device software – Softwarelife-cycle processes. Test results indicate that the Eclipse MINI complies with itspredetermined specifications, guidance documents and Standards. | |
| Electrical Safety | The Eclipse MINI was tested for patient safety in accordance with the following Standards:IEC 60601-1: 2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. IEC 60601-1-11: 2015, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Test results indicated that the Eclipse MINI complies with the applicable Standards. | |
| Electromagnetic Compatibility | The Eclipse MINI was tested for EMC in accordance with the following Standard:IEC 60601-1-2: 2014, Medical Electrical Equipment, Part 1: Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests. Test results indicated that the Eclipse MINI complies with the applicable Standard. | |
| Performance Testing – Bench | The Eclipse MINI was tested for performance in accordance with internal requirements, applicable Standards, and guidance document.ANSI/AAMI EC12:2000/ (R)2015, Disposable ECG electrodes IEC 60601-1-6: 2013, Medical electrical equipment: General requirements for basic safety and essential performance – collateral standard: Usability. IEC 60601-2-47: 2012, Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems IEC 62366-1: 2015, Medical devices – Application of usability engineering to medical devices. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17. Test results indicated that the Eclipse MINI complies with internal requirements, applicable Standards, and the guidance document. | |
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of the device modifications madeto the Eclipse MINI. The results of these activities demonstrate that the | |
| Eclipse MINI is considered substantially equivalent to the predicatedevice. |
{6}------------------------------------------------
Summary of Performance Testing:
{7}------------------------------------------------
Summary of Performance Testing (continued):
{8}------------------------------------------------
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).