(178 days)
No
The description focuses on the hardware and basic software functionalities of the Holter recorder. It explicitly states the device does no cardiac analysis and relies on separate analysis systems (cleared in other 510(k)s) for data processing. There is no mention of AI or ML in the device description or performance studies.
No
The device is a diagnostic tool that records electrocardiograms for later analysis and does not provide any therapeutic intervention.
Yes
Explanation: The device is a Holter recorder intended to record the patient's ambulatory electrocardiogram for later analysis, which is a diagnostic purpose. While it does not perform the analysis itself, it provides the data necessary for diagnosis. The "Intended Use" explicitly states it records the patient's ambulatory electrocardiogram, which is a diagnostic procedure.
No
The device description clearly outlines physical hardware components including a recorder, display, battery, USB ports, buttons, and patient cables, in addition to the software.
Based on the provided information, the Spacelabs Model 98700 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Spacelabs Model 98700 is a Holter recorder. Its primary function is to record the patient's ambulatory electrocardiogram (ECG). It does not perform any analysis on the biological specimen (the electrical signals from the heart).
- Analysis is Separate: The description explicitly states that the device "does no cardiac analysis" and is used with a "Holter Analysis System" (like the Spacelabs Sentinel, Pathfinder SL, and Lifescreen PRO Analyzers). These separate systems are responsible for analyzing the recorded ECG data.
Therefore, the Spacelabs Model 98700 is a non-invasive medical device that collects physiological data, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
MWJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric or adult patients
Intended User / Care Setting
clinical setting or at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Eclipse PRO and its 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 ISO 10993-1: 2009. Test results indicated compliance.
Software: The Eclipse PRO software was designed and developed according to a robust software development process and was rigorously verified and validated, adhering to FDA guidance documents and IEC 62304: 2015. Test results indicate compliance with predetermined specifications, guidance documents, and Standards.
Electrical Safety: The Eclipse PRO was tested for patient safety in accordance with IEC 60601-1: 2012 and IEC 60601-1-11: 2015. Test results indicated compliance.
Electromagnetic Compatibility: The Eclipse PRO was tested for EMC in accordance with IEC 60601-1-2: 2014. Test results indicated compliance.
Performance Testing – Bench: The Eclipse PRO was tested for performance in accordance with internal requirements, applicable Standards (IEC 60601-1-6: 2013, IEC 60601-2-47: 2012, IEC 62366-1: 2015), and guidance documents. Test results indicated compliance.
Conclusion: Verification and validation activities demonstrate that the device modifications made to the Eclipse PRO are safe and effective when used in accordance with its intended use and labeling, and it is considered substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) |
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3
| Submission Date: | 20 October 2021 | |||
|---|---|---|---|---|
| Submitter: | Spacelabs Healthcare Ltd. | |||
| Unit B, Foxholes Centre | ||||
| John Tate Road | ||||
| Hertford | ||||
| Hertfordshire | ||||
| SG13 7DT | ||||
| United Kingdom | ||||
| Submitter | ||||
| Correspondent | Mr. Roger Moldon | |||
| Phone: +011 44-1992-507730 | ||||
| Email: roger.moldon@spacelabs.com | ||||
| Application | ||||
| Correspondent: | Thomas Kroenke | |||
| Principal Consultant | ||||
| Speed To Market, Inc. | ||||
| PO Box 3018 | ||||
| Nederland, CO 80466 USA | ||||
| tkroenke@speedtomarket.net | ||||
| +1 (303) 956 4232 | ||||
| Manufacturing Site: | Spacelabs Healthcare, Inc. | |||
| 35301 SE Center Street | ||||
| Snoqualmie, WA 98065 USA | ||||
| Trade Name: | Eclipse PRO Model 98700 | |||
| Common and | ||||
| Classification | ||||
| Name: | Electrocardiograph, Ambulatory (Without Analysis) | |||
| Classification | ||||
| Regulation: | 21 CFR §870.2800 | |||
| Product Code: | MWJ | |||
| Substantially | ||||
| Equivalent Devices: | New Spacelabs | |||
| Model | Predicate | |||
| 510(k) Number | Predicate | |||
| Manufacturer / Model | ||||
| Eclipse PRO Model | ||||
| 98700 | K011837 | Reynolds Medical Ltd. | ||
| Lifecard CF 7 Day |
4
| Device Description: | 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. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
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-Day
Holter recorder (Lifecard CF) is a
modification of the Reynolds
Lifecard CF Holter Recorder,
K001025. It is indicated when it is
desired to record the patient's
ambulatory electrocardiogram.
It is a portable Holter recorder
designed to record the patient's
ambulatory electrocardiogram for up
to seven 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 a
clinical setting or at home. The device
does no cardiac analysis and is used
with a Holter Analysis System. |
| Software
Information
Management
and Analyzer
Compatibility | The Eclipse PRO is compatible
with:
• Spacelabs Sentinel Cardiology
Information Management System
(cleared in K152881).
• Spacelabs Pathfinder SL Holter
Analyzer (cleared in K110001)
• Spacelabs Lifescreen PRO
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
leads |
| Recording
Duration | Up to 24 hours recording x channels
Up to 7 days recording x channels | Up to 3 days recording 12 channels
Up to 14 days recording 3 channels |
| Data Transfer
Method
between
Recorder and
Analysis
Software | Removable CompactFlash
Association (Type 1) card | USB cable |
| Media Type | Removable CompactFlash
Association (Type 1) card | Internal memory |
6
| Technology
Comparison
(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 pacing
and patient event markers
Recording date and time
Patient name and record number
(Pathfinder systems)
Encrypted patient record file
(CardioNavigator)
8 second voice recording
Recorder serial number | 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. |
| | Pacemaker
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: |
| 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):
| Electromagnetic
Compatibility | The Eclipse PRO 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 PRO complies with the applicable
Standard. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing
– Bench | The Eclipse PRO was tested for performance in accordance with
internal requirements, applicable Standards, and guidance document.
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 PRO complies with internal
requirements, applicable Standards, and the guidance document. |
| Conclusion | Verification and validation activities were conducted to establish the
performance and safety characteristics of the device modifications made
to the Eclipse PRO. The results of these activities demonstrate that the
Eclipse PRO is safe and effective when used in accordance with its
intended use and labeling.
Therefore, the Eclipse PRO is considered substantially equivalent to the
predicate device |