(469 days)
No
The summary explicitly states that the recorder "does no cardiac analysis" and relies on separate, cleared software for analysis. There is no mention of AI or ML in the device description or performance studies.
No.
The "Intended Use / Indications for Use" states that the device is "intended to record the patient's electrocardiogram" and "does no cardiac analysis." This indicates it is a diagnostic tool, not a therapeutic one that treats or manages a condition.
Yes
Explanation: The device is intended to record the patient's electrocardiogram for suspected cardiac arrhythmias, and the recorded data is later analyzed by software to provide diagnostic information. Although the device itself does not perform analysis, it is an integral part of a system used for diagnosis.
No
The device description clearly outlines a physical hardware component, the "Eclipse MINI Model 98900," which is an ECG recorder that attaches to the patient via a sensor patch and is powered by batteries. While it interacts with software for data analysis, the core device is a piece of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient's electrocardiogram." It explicitly states that the "recorder does no cardiac analysis."
- Device Description: The description focuses on the hardware for recording ECG signals and the process of downloading this data for analysis by separate software.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device records electrical signals from the body in vivo (within the body).
The device is a medical device for recording physiological signals, but it does not perform any diagnostic testing on biological samples outside the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for 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.
Product codes
MWJ
Device Description
The Eclipse MINI Model 98900 (Eclipse MINI) is an ambulatory electrocardiograph (ECG) recorder capable of providing a 3-lead recording. It is connected to the patient using a custom, disposable, single-patient only, 3-lead sensor patch that is adhesively attached to the patient's chest.
The Eclipse MINI is powered by batteries that are integrated in the Eclipse Sensor Patch. These batteries are primary cells which cannot be recharged and power the recorder for up to 15 days. For an extended recording multiple Eclipse Sensor Patches may be required.
The single patient event button allows the patient to indicate symptomatic episodes in the recording for correlation with the patient diary.
The Eclipse MINI is fully sealed and waterproof.
The Eclipse MINI is attached to the "holster" of the Eclipse MINI Sensor Patch by inserting the USB connector on the sensor patch into the USB receptacle on the bottom of Eclipse MINI housing.
Patient data from the Eclipse MINI is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse MINI, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921).
Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's chest
Indicated Patient Age Range
paediatric or adult patients
Intended User / Care Setting
Used in either a clinical setting or at home; used by clinician for data download, viewing, analysis, and report creation.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Eclipse MINI was tested for performance in accordance with internal requirements, applicable Standards, and guidance document. ANSI/AAMI EC12:2000/ (R)2015, Disposable ECG electrodes IEC 60601-1-6: 2013, Medical electrical equipment: General requirements for basic safety and essential performance – collateral standard: Usability. IEC 60601-2-47: 2012, Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems IEC 62366-1: 2015, Medical devices – Application of usability engineering to medical devices. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17. Test results indicated that the Eclipse MINI complies with internal requirements, applicable Standards, and the guidance document.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 7, 2022
Spacelabs Healthcare Ltd. % Thomas Kroenke Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland, Colorado 80466
Re: K212317
Trade/Device Name: Eclipse MINI Model 98900 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II Product Code: MWJ Dated: November 2, 2022 Received: November 3, 2022
Dear Thomas Kroenke:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shruti N. Mistry -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212317
Device Name
Spacelabs Eclipse MINI Model 98900
Indications for Use (Describe)
The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient's electrocardiogram. The recorder is intended to be used by either paediatric or adult patients suspected of cardiac arrhythmias in either a clinical setting or at home. The recorder does no cardiac analysis and is used with Spacelabs Ambulatory ECG Analysis Software.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Submission Date: | 05 November 2022 | ||
|---|---|---|---|
| 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 MINI Model 98900 | ||
| Common and | |||
| Classification | |||
| Name: | Medical Magnetic Tape Recorder | ||
| Classification | |||
| Regulation: | 21 CFR §870.2800 | ||
| Product Code: | MWJ | ||
| Substantially | |||
| Equivalent Devices: | New Spacelabs | ||
| Model | Predicate | ||
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Eclipse MINI Model | |||
| 98900 | K011837 | Reynolds Medical Ltd. / | |
| Lifecard CF 7-Day Holter | |||
| Recorder |
4
| Device Description: | The Eclipse MINI Model 98900 (Eclipse MINI) is an ambulatory
electrocardiograph (ECG) recorder capable of providing a 3-lead
recording. It is connected to the patient using a custom, disposable,
single-patient only, 3-lead sensor patch that is adhesively attached to the
patient's chest.
The Eclipse MINI is powered by batteries that are integrated in the
Eclipse Sensor Patch. These batteries are primary cells which cannot be
recharged and power the recorder for up to 15 days. For an extended
recording multiple Eclipse Sensor Patches may be required.
The single patient event button allows the patient to indicate
symptomatic episodes in the recording for correlation with the patient
diary.
The Eclipse MINI is fully sealed and waterproof.
The Eclipse MINI is attached to the "holster" of the Eclipse MINI Sensor
Patch by inserting the USB connector on the sensor patch into the USB
receptacle on the bottom of Eclipse MINI housing.
Patient data from the Eclipse MINI is downloaded to a PC upon which
the Spacelabs Sentinel Cardiology Information Management System
(Sentinel), cleared in 510(k) submission K152881, has been installed.
This allows the clinician to download, view, and analyze patient data
from the Eclipse MINI, and create reports. Further analysis of these
patient data can be performed by using Spacelabs Pathfinder SL Holter
Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs
Lifescreen PRO Analyzer (cleared in 510(k) submission K201921).
Finally, a non-medical device mobile phone app is available for patient
use as an electronic note taking option in lieu of a manual, written patient
diary. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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. |
5
Technology Comparison:
The Eclipse MINI Model 98900 (Eclipse MINI) employs the same technological characteristics as the predicate device.
| Characteristic | Reynolds Medical Ltd. | Spacelabs Healthcare Ltd. |
|---|---|---|
| Lifecard CF 7-Day Holter Recorder | Eclipse MINI | |
| (K011837) | (K212317) | |
| Indications for | ||
| 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 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 a Ambulatory ECG | ||
| Analysis System or Rapid Analysis | ||
| Software module. | ||
| Software | The Eclipse PRO is compatible with: | The Eclipse PRO is compatible with: |
| Information | ||
| Management | ||
| and Analyzer | ||
| Compatibility | Spacelabs Sentinel Cardiology | |
| Information Management | ||
| System (cleared in K152881). Spacelabs Pathfinder SL Holter | ||
| Analyzer (cleared in K110001) Spacelabs Lifescreen PRO | ||
| Analyzer (cleared in K201921). | Spacelabs Sentinel Cardiology | |
| Information Management | ||
| System (cleared in 152881). Spacelabs Pathfinder SL Holter | ||
| Analyzer (cleared in K110001) Spacelabs Lifescreen PRO | ||
| Analyzer (cleared in K201921). | ||
| Channels | 1, 2, or 3 channels | 2 channels |
| Recording | ||
| Duration | Up to 48 hours recording 2 - 3 | |
| channels | ||
| Up to 7 days recording 2 - 3 channels | ||
| in extended mode | Recorder supports up to 30 days | |
| recording 2 channels. | ||
| Patch sensors used with the recorder | ||
| have an 8-day wear duration. | ||
| Data Transfer | ||
| Method | ||
| between | ||
| Recorder and | ||
| Analysis | ||
| Software | Removable CompactFlash | |
| Association (Type 1) card | Standard USB cable. | |
| Media Type | Removable CompactFlash | |
| Association (Type 1) card | Internal memory | |
| 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 patient | |
| event markers. | ||
| Recording date and time. | ||
| Recording ID. | ||
| Recorder serial number. | ||
| Defibrillator | ||
| Protection | Not defibrillator proof. | Not defibrillator proof; however, |
| Eclipse MINI is compliant with IEC | ||
| 60601-1: 2005, Am1: 2012, Clause | ||
| 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. | |
| The Eclipse MINI 3-lead Sensor Patch has a defined product life of 1 | ||
| year from the date of manufacture. Test results indicated that the | ||
| Eclipse MINI 3-lead Sensor Patch complies with its stated shelf-life. | ||
| Biocompatibility | The patient-contact materials in the Eclipse MINI 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 | ||
| MINI comply with the applicable Standard and guidance document. | ||
| Software | The Eclipse MINI software was designed and developed according to a | |
| 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: 2006, Am1:2015, Medical device software – Software | ||
| life-cycle processes. Test results indicate that the Eclipse MINI complies with its | ||
| predetermined specifications, guidance documents and Standards. | ||
| Electrical Safety | The Eclipse MINI was tested for patient safety in accordance with the following Standards: | |
| IEC 60601-1: 2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. IEC 60601-1-11: 2015, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Test results indicated that the Eclipse MINI complies with the applicable Standards. | ||
| Electromagnetic Compatibility | The Eclipse MINI was tested for EMC in accordance with the following Standard: | |
| IEC 60601-1-2: 2014, Medical Electrical Equipment, Part 1: Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests. Test results indicated that the Eclipse MINI complies with the applicable Standard. | ||
| Performance Testing – Bench | The Eclipse MINI was tested for performance in accordance with internal requirements, applicable Standards, and guidance document. | |
| ANSI/AAMI EC12:2000/ (R)2015, Disposable ECG electrodes IEC 60601-1-6: 2013, Medical electrical equipment: General requirements for basic safety and essential performance – collateral standard: Usability. IEC 60601-2-47: 2012, Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems IEC 62366-1: 2015, Medical devices – Application of usability engineering to medical devices. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17. Test results indicated that the Eclipse MINI complies with internal requirements, applicable Standards, and the guidance document. | ||
| Conclusion | Verification and validation activities were conducted to establish the | |
| performance and safety characteristics of the device modifications made | ||
| to the Eclipse MINI. The results of these activities demonstrate that the | ||
| Eclipse MINI is considered substantially equivalent to the predicate | ||
| device. |
6
Summary of Performance Testing:
7
Summary of Performance Testing (continued):
8