(178 days)
The Spacelabs Model 98700 is a portable non-invasive Holter recorder intended to record the patient's ambulatory electrocardiogram. The device is intended to be used by either pediatric or adult patients in either or at home. The device does no cardiac analysis and is used with a Holter Analysis System.
The Eclipse PRO Model 98700 (Eclipse PRO) is an ambulatory electrocardiograph (ECG) recorder capable of providing a true 12-channel recording for up to 72 hours or a 3-lead recording for up to 14 days. It is connected to the patient using Eclipse PRO-specific 3, 4, or 10 lead wire cables with the recorder located in a pouch on a lanyard.
The Eclipse PRO has a large, color display which allows the user to view recorder status, configure the recorder and to view ECG lead application.
It has an internal, fast-charge, long-life, rechargeable lithium-ion battery, which is charged when connected by a cable between the USB port of a personal computer (PC) or a USB charger, and the recorder's USB-C connector.
Two (2) arrow keys on the front of the Eclipse PRO are used to navigate and select options in the recorder's menu or as a patient event button when the patient desires to indicate symptomatic episodes in the recording.
The Eclipse PRO is fully sealed and waterproof.
Patient cables are attached to the Eclipse PRO using the USB connector on the bottom of the housing and protective cable retention loop.
Patient data from the Eclipse PRO 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 PRO, 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.
The Spacelabs Eclipse PRO Model 98700 is an ambulatory electrocardiograph (ECG) recorder. The provided text outlines its characteristics and the performance testing conducted to demonstrate its substantial equivalence to the predicate device, Reynolds Medical Ltd. Lifecard CF 7 Day (K011837).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a quantitative, metrics-based format for the overall device performance in recording ECGs. Instead, it focuses on demonstrating compliance with various regulatory standards and guidance documents, and technological equivalence to the predicate device. The performance testing section primarily reports that the device "complies" with these standards.
However, based on the "Technology Comparison" table, we can infer some functional acceptance criteria by comparing the proposed device against the predicate.
| Feature/Criterion | Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (Eclipse PRO Model 98700) |
|---|---|---|
| Intended Use | Records patient's ambulatory electrocardiogram; for pediatric or adult patients in clinical or home settings; does no cardiac analysis; used with Holter Analysis System. | The Spacelabs Model 98700 is a portable non-invasive Holter recorder intended to record the patient's ambulatory electrocardiogram. The device is intended to be used by either pediatric or adult patients in either a clinical setting or at home. The device does no cardiac analysis and is used with a Holter Analysis System. (Matches criteria) |
| Channels | 1, 2, or 3 channels (Predicate) | 3 or 12 channels (Meets or exceeds predicate's capability) |
| Leads | 3, 4, and 6 leads (Predicate) | 3 leads, 4 leads, and 10 IEC or AHA leads (Meets or exceeds predicate's capability) |
| Recording Duration | Up to 24 hours recording x channels, up to 7 days recording x channels (Predicate) | Up to 3 days recording 12 channels, up to 14 days recording 3 channels (Exceeds predicate's capability in both duration and channel options) |
| Data Stored | Full disclosure ECG with pacing and patient event markers, recording date and time, patient name and record number, encrypted patient record file, 8-second voice recording, recorder serial number. (Predicate) | Full disclosure ECG, with pacing and patient event markers. Recording date and time. Patient name and record number (only if permitted by user). Recorder serial number. (Matches essential data points, with reasonable variations like voice recording not present but not critical for ECG recording, and encrypted record replaced by user-permitted name/record number and internal memory data transfer method). |
| Pacemaker Detection | Yes | Yes (Matches criteria) |
| Power Source | Battery, rechargeable or disposable | Battery, rechargeable (Meets criteria) |
| Biocompatibility | Compliance with ISO 10993-1: 2009 for patient-contact materials. | Test results indicated that the patient-contact materials in the Eclipse PRO and accessories comply with the applicable Standard and guidance document. |
| Software Robustness | Designed and developed according to a robust software development process, verified and validated, compliant with FDA guidance documents (e.g., "The content of premarket submissions for software contained in medical devices," "General principles of software validation"), IEC 62304: 2015. | Test results indicate that the Eclipse PRO complies with its predetermined specifications, guidance documents and Standards. |
| Electrical Safety | Compliance with IEC 60601-1: 2012 and IEC 60601-1-11: 2015. | Test results indicated that the Eclipse PRO complies with the applicable Standards. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: 2014. | Test results indicated that the Eclipse PRO complies with the applicable Standard. |
| Performance Testing – Bench | Compliance with internal requirements, IEC 60601-1-6: 2013, IEC 60601-2-47: 2012, IEC 62366-1: 2015, and inter-operability guidance. | Test results indicated that the Eclipse PRO complies with internal requirements, applicable Standards, and the guidance document. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document describes performance testing related to device functionality, electrical safety, EMC, software validation, and biocompatibility, but does not detail any clinical study or human subject trial for evaluating ECG recording performance. Therefore, there is no information on a "test set sample size" or "data provenance" related to patient data evaluation. The tests mentioned are primarily bench tests, engineering validations, and compliance checks against regulatory standards.
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)
As no clinical test set using patient data is described, this information is not applicable and not provided in the document. The performance evaluation focuses on technical compliance, not diagnostic accuracy requiring expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no clinical test set involving human interpretation of data is described, an adjudication method is not applicable and not provided.
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
The device described, Spacelabs Eclipse PRO, is a Holter recorder that "does no cardiac analysis" and is "used with a Holter Analysis System." The document explicitly states it's a recorder, not an analytical or AI-assisted diagnostic tool. Therefore, no MRMC comparative effectiveness study with AI assistance was performed or is relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
As the device itself "does no cardiac analysis" and is a pure recorder, there is no algorithm for standalone performance to be evaluated. This question is not applicable to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the technical performance testing (biocompatibility, software, electrical safety, EMC, bench performance), the "ground truth" used is compliance with established international standards and FDA guidance documents (e.g., ISO 10993-1, IEC 62304, IEC 60601 series). For the functional comparison, the "ground truth" for substantial equivalence is the predicate device's characteristics and specifications. There is no clinical data 'ground truth' in the context of expert diagnosis or patient outcomes.
8. The sample size for the training set
Since this is a medical device (Holter recorder) and not an AI/ML-based diagnostic algorithm, there is no concept of a "training set" as would be applicable to machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set 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 22, 2021
Spacelabs Healthcare Ltd. % Thomas Kroenke Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland, Colorado 80466
Re: K211651
Trade/Device Name: Eclipse PRO Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: May 27, 2021 Received: May 28, 2021
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.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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.
for
Jennifer Shih Kozen External Heart Rhythm and Rate Team Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211651
Device Name Spacelabs Eclipse PRO Model 98700
Indications for Use (Describe)
The Spacelabs Model 98700 is a portable non-invasive Holter recorder intended to record the patient's ambulatory electrocardiogram. The device is intended to be used by either pediatric or adult patients in either or at home. The device does no cardiac analysis and is used with a Holter Analysis System.
| 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: | 20 October 2021 | |||
|---|---|---|---|---|
| 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 PRO Model 98700 | |||
| Common andClassificationName: | Electrocardiograph, Ambulatory (Without Analysis) | |||
| ClassificationRegulation: | 21 CFR §870.2800 | |||
| Product Code: | MWJ | |||
| SubstantiallyEquivalent Devices: | New SpacelabsModel | Predicate510(k) Number | PredicateManufacturer / Model | |
| Eclipse PRO Model98700 | K011837 | Reynolds Medical Ltd.Lifecard CF 7 Day |
{4}------------------------------------------------
| Device Description: | The Eclipse PRO Model 98700 (Eclipse PRO) is an ambulatoryelectrocardiograph (ECG) recorder capable of providing a true 12-channel recording for up to 72 hours or a 3-lead recording for up to 14days. It is connected to the patient using Eclipse PRO-specific 3, 4, or 10lead wire cables with the recorder located in a pouch on a lanyard.The Eclipse PRO has a large, color display which allows the user to viewrecorder status, configure the recorder and to view ECG lead application.It has an internal, fast-charge, long-life, rechargeable lithium-ion battery,which is charged when connected by a cable between the USB port of apersonal computer (PC) or a USB charger, and the recorder's USB-Cconnector.Two (2) arrow keys on the front of the Eclipse PRO are used to navigateand select options in the recorder's menu or as a patient event buttonwhen the patient desires to indicate symptomatic episodes in therecording.The Eclipse PRO is fully sealed and waterproof.Patient cables are attached to the Eclipse PRO using the USB connectoron the bottom of the housing and protective cable retention loop.Patient data from the Eclipse PRO 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 PRO, 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. |
|---|---|
| Intended Use: | The Spacelabs Model 98700 is a portable non-invasive Holter recorderintended to record the patient's ambulatory electrocardiogram. Thedevice is intended to be used by either pediatric or adult patients in eithera clinical setting or at home. The device does no cardiac analysis and isused with a Holter Analysis System. |
{5}------------------------------------------------
Technology Comparison:
The Spacelabs Healthcare (Spacelabs) Eclipse PRO Model 98700 (Eclipse PRO) employs the same technological characteristics as the predicate device.
| Characteristic | Reynolds Medical Ltd.Lifecard CF 7 Day(K011837) | Spacelabs Healthcare Ltd.Eclipse PRO Model 98700(Proposed Device) |
|---|---|---|
| Intended Use | 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 Spacelabs Model 98700 is aportable non-invasive Holter recorderintended to record the patient'sambulatory electrocardiogram. Thedevice is intended to be used by eitherpediatric or adult patients in either aclinical setting or at home. The devicedoes no cardiac analysis and is usedwith a Holter Analysis System. |
| SoftwareInformationManagementand AnalyzerCompatibility | The Eclipse PRO is compatiblewith:• Spacelabs Sentinel CardiologyInformation Management System(cleared in K152881).• Spacelabs Pathfinder SL HolterAnalyzer (cleared in K110001)• Spacelabs Lifescreen PROAnalyzer (cleared in K201921). | Same. |
| Channels | 1, 2, or 3 channels | 3 or 12 channels |
| Leads | 3, 4, and 6 leads | 3 leads, 4 leads, and 10 IEC or AHAleads |
| RecordingDuration | Up to 24 hours recording x channelsUp to 7 days recording x channels | Up to 3 days recording 12 channelsUp to 14 days recording 3 channels |
| Data TransferMethodbetweenRecorder andAnalysisSoftware | Removable CompactFlashAssociation (Type 1) card | USB cable |
| Media Type | Removable CompactFlashAssociation (Type 1) card | Internal memory |
{6}------------------------------------------------
| TechnologyComparison(continued): | Characteristic | Reynolds Medical Ltd.Lifecard CF 7 Day(K011837) | Spacelabs Healthcare Ltd.Eclipse PRO Model 98700(Proposed Device) |
|---|---|---|---|
| Data Stored | Full disclosure ECG, with pacingand patient 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 pacing andpatient event markers.Recording date and timePatient name and record number(only if permitted by user)Recorder serial number. | |
| PacemakerDetection | Yes | Same. | |
| Power Source | Battery, rechargeable or disposable | Battery, rechargeable |
Summary of Performance Testing:
| Shelf-Life | The Eclipse PRO and it's accessories do not have a shelf life. |
|---|---|
| Biocompatibility | The patient-contact materials in the Eclipse PRO and accessories were tested for biocompatibility compliance in accordance with the following Standard and 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 evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." 04 Sep 20. |
Test results indicated that the patient-contact materials in the Eclipse PRO and accessories comply with the applicable Standard and guidance document.
{7}------------------------------------------------
Summary of Performance Testing (continued):
The Eclipse PRO software was designed and developed according to a Software robust software development process and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents and Standards: . FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05. FDA guidance: Off-the-shelf software use in medical devices, 27 . Sep 19. FDA guidance: General principles of software validation; Final . guidance for industry and FDA staff, 11 Jan 02. . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 02 Oct 14. Cybersecurity for Networked Medical Devices Containing Off-The-● Shelf (OTS) software, 14 Jan 05. Design Considerations and Premarket Submission . Recommendations for Interoperable Medical Devices, 06 Sep 17. IEC 62304: 2015, Medical device software – Software life-cycle . processes. Test results indicate that the Eclipse PRO complies with its predetermined specifications, guidance documents and Standards. Electrical Safety The Eclipse PRO 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 PRO complies with the applicable Standards.
{8}------------------------------------------------
Summary of Performance Testing (continued):
| ElectromagneticCompatibility | The Eclipse PRO was tested for EMC in accordance with the followingStandard:IEC 60601-1-2: 2014, Medical Electrical Equipment, Part 1: Part1-2: General Requirements for Safety – Collateral Standard:Electromagnetic Compatibility-Requirements and Tests. Test results indicated that the Eclipse PRO complies with the applicableStandard. |
|---|---|
| Performance Testing– Bench | The Eclipse PRO was tested for performance in accordance withinternal requirements, applicable Standards, and guidance document.IEC 60601-1-6: 2013, Medical electrical equipment: Generalrequirements for basic safety and essential performance – collateralstandard: Usability. IEC 60601-2-47: 2012, Medical electrical equipment – Part 2-47:Particular requirements for the basic safety and essentialperformance of ambulatory electrocardiographic systems IEC 62366-1: 2015, Medical devices – Application of usabilityengineering to medical devices. Design Considerations and Premarket SubmissionRecommendations for Interoperable Medical Devices, 06 Sep 17. Test results indicated that the Eclipse PRO complies with internalrequirements, 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 PRO. The results of these activities demonstrate that theEclipse PRO is safe and effective when used in accordance with itsintended use and labeling.Therefore, the Eclipse PRO is considered substantially equivalent to thepredicate device |
§ 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).