Eclipse MINI Model 98900

K212317 · Spacelabs Healthcare, Ltd. · MWJ · Nov 7, 2022 · Cardiovascular

Device Facts

• Record ID: K212317
• Device Name: Eclipse MINI Model 98900
• Applicant: Spacelabs Healthcare, Ltd.
• Product Code: MWJ · Cardiovascular
• Decision Date: Nov 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Portable, non-invasive, continuous ambulatory ECG patch recorder; captures 2-channel ECG signals via disposable 3-lead sensor patch adhesively attached to patient chest. Device powered by integrated primary cell batteries (up to 15 days duration). Patient uses event button to mark symptomatic episodes. Used in clinical or home settings; operated by patient. Data downloaded via USB to PC running Spacelabs Sentinel Cardiology Information Management System for clinician review, analysis, and reporting. Further analysis supported by Spacelabs Pathfinder SL Holter Analyzer or Lifescreen PRO Analyzer. Optional non-medical mobile app available for electronic patient diary. Device provides full disclosure ECG data to assist clinicians in diagnosing cardiac arrhythmias.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified against standards including IEC 60601-2-47 (ambulatory ECG systems), ANSI/AAMI EC12 (disposable electrodes), and usability standards (IEC 62366-1). Biocompatibility, electrical safety, and EMC testing confirmed compliance with applicable standards.

Technological Characteristics

Ambulatory 2-channel ECG recorder; disposable 3-lead sensor patch; internal memory; USB connectivity; battery-powered (primary cells). Compliant with IEC 60601-1 (safety), IEC 60601-1-11 (home healthcare), IEC 60601-1-2 (EMC), and IEC 60601-2-47 (ambulatory ECG). Biocompatibility per ISO 10993-1. Waterproof, sealed housing.

Indications for Use

Indicated for pediatric and adult patients suspected of cardiac arrhythmias for continuous ambulatory ECG recording in clinical or home settings.

Regulatory Classification

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.

Predicate Devices

• Lifecard CF 7-Day Holter Recorder (K011837)

Reference Devices

• Spacelabs Sentinel Cardiology Information Management System (K152881)
• Spacelabs Pathfinder SL Holter Analyzer (K110001)
• Spacelabs Lifescreen PRO Analyzer (K201921)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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### 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)

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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| Submission Date: | 05 November 2022 | | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------|
| Submitter: | Spacelabs Healthcare Ltd.<br>Unit B, Foxholes Centre<br>John Tate Road<br>Hertford<br>Hertfordshire<br>SG13 7DT<br>United Kingdom | | |
| Submitter<br>Correspondent | Mr. Roger Moldon<br>Phone: [phone]<br>Email: [e-mail]) | | |
| Application<br>Correspondent: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>[phone] | | |
| Manufacturing Site: | Spacelabs Healthcare, Inc.<br>35301 SE Center Street<br>Snoqualmie, WA 98065 USA | | |
| Trade Name: | Eclipse MINI Model 98900 | | |
| Common and<br>Classification<br>Name: | Medical Magnetic Tape Recorder | | |
| Classification<br>Regulation: | 21 CFR §870.2800 | | |
| Product Code: | MWJ | | |
| Substantially<br>Equivalent Devices: | New Spacelabs<br>Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
| | Eclipse MINI Model<br>98900 | K011837 | Reynolds Medical Ltd. /<br>Lifecard CF 7-Day Holter<br>Recorder |

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| <b>Device Description:</b> | The Eclipse MINI Model 98900 (Eclipse MINI) is an ambulatory<br>electrocardiograph (ECG) recorder capable of providing a 3-lead<br>recording. It is connected to the patient using a custom, disposable,<br>single-patient only, 3-lead sensor patch that is adhesively attached to the<br>patient's chest.<br><br>The Eclipse MINI is powered by batteries that are integrated in the<br>Eclipse Sensor Patch. These batteries are primary cells which cannot be<br>recharged and power the recorder for up to 15 days. For an extended<br>recording multiple Eclipse Sensor Patches may be required.<br><br>The single patient event button allows the patient to indicate<br>symptomatic episodes in the recording for correlation with the patient<br>diary.<br><br>The Eclipse MINI is fully sealed and waterproof.<br><br>The Eclipse MINI is attached to the "holster" of the Eclipse MINI Sensor<br>Patch by inserting the USB connector on the sensor patch into the USB<br>receptacle on the bottom of Eclipse MINI housing.<br><br>Patient data from the Eclipse MINI is downloaded to a PC upon which<br>the Spacelabs Sentinel Cardiology Information Management System<br>(Sentinel), cleared in 510(k) submission K152881, has been installed.<br>This allows the clinician to download, view, and analyze patient data<br>from the Eclipse MINI, and create reports. Further analysis of these<br>patient data can be performed by using Spacelabs Pathfinder SL Holter<br>Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs<br>Lifescreen PRO Analyzer (cleared in 510(k) submission K201921).<br><br>Finally, a non-medical device mobile phone app is available for patient<br>use as an electronic note taking option in lieu of a manual, written patient<br>diary. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Indications for Use:</b> | The Eclipse MINI Model 98900 is a portable non-invasive continuous<br>ambulatory ECG patch recorder intended to record the patient's<br>electrocardiogram. The recorder is intended to be used by either<br>paediatric or adult patients suspected of cardiac arrhythmias in either a<br>clinical setting or at home. The recorder does no cardiac analysis and is<br>used with Spacelabs Ambulatory ECG Analysis Software. |

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### 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 for<br>Use | The Reynolds Lifecard CF 7-Day<br>Holter recorder (Lifecard CF) is a<br>modification of the Reynolds<br>Lifecard CF Holter Recorder,<br>K001025. It is indicated when it is<br>desired to record the patient's<br>ambulatory electrocardiogram.<br>It is a portable Holter recorder<br>designed to record the patient's<br>ambulatory electrocardiogram for up<br>to seven days. | The Eclipse MINI Model 98900 is a<br>portable non-invasive continuous<br>ambulatory ECG patch recorder<br>intended to record the patient's<br>electrocardiogram. The recorder is<br>intended to be used by either<br>paediatric or adult patients suspected<br>of cardiac arrhythmias in either a<br>clinical setting or at home. The<br>recorder does no cardiac analysis and<br>is used with a Ambulatory ECG<br>Analysis System or Rapid Analysis<br>Software module. |
| Software | The Eclipse PRO is compatible with: | The Eclipse PRO is compatible with: |
| Information<br>Management<br>and Analyzer<br>Compatibility | Spacelabs Sentinel Cardiology<br>Information Management<br>System (cleared in K152881). Spacelabs Pathfinder SL Holter<br>Analyzer (cleared in K110001) Spacelabs Lifescreen PRO<br>Analyzer (cleared in K201921). | Spacelabs Sentinel Cardiology<br>Information Management<br>System (cleared in 152881). Spacelabs Pathfinder SL Holter<br>Analyzer (cleared in K110001) Spacelabs Lifescreen PRO<br>Analyzer (cleared in K201921). |
| Channels | 1, 2, or 3 channels | 2 channels |
| Recording<br>Duration | Up to 48 hours recording 2 - 3<br>channels<br>Up to 7 days recording 2 - 3 channels<br>in extended mode | Recorder supports up to 30 days<br>recording 2 channels.<br>Patch sensors used with the recorder<br>have an 8-day wear duration. |
| Data Transfer<br>Method<br>between<br>Recorder and<br>Analysis<br>Software | Removable CompactFlash<br>Association (Type 1) card | Standard USB cable. |
| Media Type | Removable CompactFlash<br>Association (Type 1) card | Internal memory |
| Data Stored | Full disclosure ECG, with pacing and<br>patient event markers<br>Recording date and time<br>Patient name and record number<br>(Pathfinder systems)<br>Encrypted patient record file<br>(CardioNavigator)<br>8 second voice recording<br>Recorder serial number | Full disclosure ECG with patient<br>event markers.<br>Recording date and time.<br>Recording ID.<br>Recorder serial number. |
| Defibrillator<br>Protection | Not defibrillator proof. | Not defibrillator proof; however,<br>Eclipse MINI is compliant with IEC<br>60601-1: 2005, Am1: 2012, Clause<br>8.5.5.2, Energy Reduction Test. |
| Power Source | Battery, rechargeable or disposable | Battery, disposable |
| Shelf-Life | The Eclipse MINI does not have a shelf life.<br>The Eclipse MINI 3-lead Sensor Patch has a defined product life of 1<br>year from the date of manufacture. Test results indicated that the<br>Eclipse MINI 3-lead Sensor Patch complies with its stated shelf-life. | |
| Biocompatibility | The patient-contact materials in the Eclipse MINI were tested for<br>biocompatibility compliance in accordance with the following Standard<br>and guidance document: ISO 10993-1: 2009, Biological evaluation of medical devices —<br>Part 1: Evaluation and testing within a risk management process. Use of International Standard ISO 10993-1, "Biological evaluation<br>of medical devices - Part 1: Evaluation and testing within a risk<br>management process," 04 Sep 20 Test results indicated that the patient-contact materials in the Eclipse<br>MINI comply with the applicable Standard and guidance document. | |
| Software | The Eclipse MINI software was designed and developed according to a<br>robust software development process and was rigorously verified and<br>validated.<br>Software information is provided in accordance with internal<br>requirements and the following guidance documents and Standards: FDA guidance: The content of premarket submissions for software<br>contained in medical devices, 11 May 05. FDA guidance: Off-the-shelf software use in medical devices, 27<br>Sep 19. FDA guidance: General principles of software validation; Final<br>guidance for industry and FDA staff, 11 Jan 02. Content of Premarket Submissions for Management of<br>Cybersecurity in Medical Devices, 02 Oct 14. Cybersecurity for Networked Medical Devices Containing Off-The-<br>Shelf (OTS) software, 14 Jan 05. Design Considerations and Premarket Submission<br>Recommendations for Interoperable Medical Devices, 06 Sep 17. IEC 62304: 2006, Am1:2015, Medical device software – Software<br>life-cycle processes. Test results indicate that the Eclipse MINI complies with its<br>predetermined specifications, guidance documents and Standards. | |
| Electrical Safety | The Eclipse MINI was tested for patient safety in accordance with the following Standards:<br>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:<br>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.<br>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 the<br>performance and safety characteristics of the device modifications made<br>to the Eclipse MINI. The results of these activities demonstrate that the | |
| | Eclipse MINI is considered substantially equivalent to the predicate<br>device. | |

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### Summary of Performance Testing:

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### Summary of Performance Testing (continued):

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