Eclipse PRO

K211651 · Spacelabs Healthcare, Ltd. · MWJ · Nov 22, 2021 · Cardiovascular

Device Facts

• Record ID: K211651
• Device Name: Eclipse PRO
• Applicant: Spacelabs Healthcare, Ltd.
• Product Code: MWJ · Cardiovascular
• Decision Date: Nov 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Portable non-invasive Holter recorder; captures ambulatory ECG signals; supports 12-channel recording (up to 72 hours) or 3-lead recording (up to 14 days). Device features color display for status, configuration, and lead application viewing; internal rechargeable lithium-ion battery; USB-C connectivity for charging and data download. Operated by clinicians or patients in clinical/home settings; patient event button allows marking symptomatic episodes. Data downloaded to PC-based Spacelabs Sentinel Cardiology Information Management System for clinician review, analysis, and reporting. Compatible with Spacelabs Pathfinder SL and Lifescreen PRO analyzers. Benefits include extended ambulatory monitoring for cardiac rhythm assessment.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified against IEC 60601-2-47 (ambulatory ECG systems), IEC 60601-1 (general safety), IEC 60601-1-11 (home healthcare), and IEC 60601-1-2 (EMC). Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Portable ambulatory ECG recorder; 3 or 12-channel input; internal rechargeable lithium-ion battery; USB-C interface. Fully sealed, waterproof housing. Patient-contact materials compliant with ISO 10993-1. Connectivity via USB to PC-based analysis software. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-2-47, IEC 62304, IEC 62366-1.

Indications for Use

Indicated for pediatric and adult patients requiring ambulatory electrocardiogram recording in clinical or home settings. No specific contraindications listed.

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

• Reynolds Medical Ltd. Lifecard CF 7 Day (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 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.

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

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### 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) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <span style="text-decoration: underline;"></span> | |
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| Submission Date: | 20 October 2021 | | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------|--|
| 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 PRO Model 98700 | | | |
| Common and<br>Classification<br>Name: | Electrocardiograph, Ambulatory (Without Analysis) | | | |
| 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 PRO Model<br>98700 | K011837 | Reynolds Medical Ltd.<br>Lifecard CF 7 Day | |

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| Device Description: | The Eclipse PRO Model 98700 (Eclipse PRO) is an ambulatory<br>electrocardiograph (ECG) recorder capable of providing a true 12-<br>channel recording for up to 72 hours or a 3-lead recording for up to 14<br>days. It is connected to the patient using Eclipse PRO-specific 3, 4, or 10<br>lead wire cables with the recorder located in a pouch on a lanyard.<br><br>The Eclipse PRO has a large, color display which allows the user to view<br>recorder status, configure the recorder and to view ECG lead application.<br><br>It has an internal, fast-charge, long-life, rechargeable lithium-ion battery,<br>which is charged when connected by a cable between the USB port of a<br>personal computer (PC) or a USB charger, and the recorder's USB-C<br>connector.<br><br>Two (2) arrow keys on the front of the Eclipse PRO are used to navigate<br>and select options in the recorder's menu or as a patient event button<br>when the patient desires to indicate symptomatic episodes in the<br>recording.<br><br>The Eclipse PRO is fully sealed and waterproof.<br><br>Patient cables are attached to the Eclipse PRO using the USB connector<br>on the bottom of the housing and protective cable retention loop.<br><br>Patient data from the Eclipse PRO 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 PRO, 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. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Spacelabs Model 98700 is a portable non-invasive Holter recorder<br>intended to record the patient's ambulatory electrocardiogram. The<br>device is intended to be used by either pediatric or adult patients in either<br>a clinical setting or at home. The device does no cardiac analysis and is<br>used with a Holter Analysis System. |

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### 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.<br>Lifecard CF 7 Day<br>(K011837) | Spacelabs Healthcare Ltd.<br>Eclipse PRO Model 98700<br>(Proposed Device) |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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 Spacelabs Model 98700 is a<br>portable non-invasive Holter recorder<br>intended to record the patient's<br>ambulatory electrocardiogram. The<br>device is intended to be used by either<br>pediatric or adult patients in either a<br>clinical setting or at home. The device<br>does no cardiac analysis and is used<br>with a Holter Analysis System. |
| Software<br>Information<br>Management<br>and Analyzer<br>Compatibility | The Eclipse PRO is compatible<br>with:<br>• Spacelabs Sentinel Cardiology<br>Information Management System<br>(cleared in K152881).<br>• Spacelabs Pathfinder SL Holter<br>Analyzer (cleared in K110001)<br>• Spacelabs Lifescreen PRO<br>Analyzer (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 AHA<br>leads |
| Recording<br>Duration | Up to 24 hours recording x channels<br>Up to 7 days recording x channels | Up to 3 days recording 12 channels<br>Up to 14 days recording 3 channels |
| Data Transfer<br>Method<br>between<br>Recorder and<br>Analysis<br>Software | Removable CompactFlash<br>Association (Type 1) card | USB cable |
| Media Type | Removable CompactFlash<br>Association (Type 1) card | Internal memory |

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| Technology<br>Comparison<br>(continued): | Characteristic | Reynolds Medical Ltd.<br>Lifecard CF 7 Day<br>(K011837) | Spacelabs Healthcare Ltd.<br>Eclipse PRO Model 98700<br>(Proposed Device) |
|------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Data Stored | Full disclosure ECG, with pacing<br>and 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 pacing and<br>patient event markers.<br>Recording date and time<br>Patient name and record number<br>(only if permitted by user)<br>Recorder serial number. |
| | Pacemaker<br>Detection | 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:<br>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.

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### 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.

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### Summary of Performance Testing (continued):

| Electromagnetic<br>Compatibility | The Eclipse PRO was tested for EMC in accordance with the following<br>Standard:<br>IEC 60601-1-2: 2014, Medical Electrical Equipment, Part 1: Part<br>1-2: General Requirements for Safety – Collateral Standard:<br>Electromagnetic Compatibility-Requirements and Tests. Test results indicated that the Eclipse PRO complies with the applicable<br>Standard. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing<br>– Bench | The Eclipse PRO was tested for performance in accordance with<br>internal requirements, applicable Standards, and guidance document.<br>IEC 60601-1-6: 2013, Medical electrical equipment: General<br>requirements for basic safety and essential performance – collateral<br>standard: Usability. IEC 60601-2-47: 2012, Medical electrical equipment – Part 2-47:<br>Particular requirements for the basic safety and essential<br>performance of ambulatory electrocardiographic systems IEC 62366-1: 2015, Medical devices – Application of usability<br>engineering to medical devices. Design Considerations and Premarket Submission<br>Recommendations for Interoperable Medical Devices, 06 Sep 17. Test results indicated that the Eclipse PRO complies with internal<br>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 PRO. The results of these activities demonstrate that the<br>Eclipse PRO is safe and effective when used in accordance with its<br>intended use and labeling.<br>Therefore, the Eclipse PRO is considered substantially equivalent to the<br>predicate device |