(86 days)
No
The document describes standard ECG analysis and reporting software and does not mention AI or ML capabilities.
No.
The devices are intended for analyzing, editing, reviewing, reporting, storing, and transferring ECG recordings, which are diagnostic functions, not therapeutic.
Yes.
The "Intended Use / Indications for Use" section states that the devices (SyneScope™, EasyScope™, SyneCom™, and HolterReader) are used for "evaluation of the following: - Patient symptoms such as syncope, dizziness or palpitations. . - Ischemia, especially in patients who cannot exercise or in patients with variant . angina. - Function of an implanted pacemaker or defibrillator." These evaluations are for the purpose of identifying or characterizing diseases or conditions, which aligns with the definition of a diagnostic device.
No
The device description explicitly states that the software applications are installed on "Microsoft Windows-based personal computers equipped with flash-card readers and/or tape cassette readers," indicating the inclusion of hardware components beyond just the software itself.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, a congenital abnormality, a mental impairment, injury or disability, or to determine the safety and compatibility with potential recipients.
- Device Function: The described devices (SyneScope™, EasyScope™, SyneCom™, and HolterReader) are software applications that analyze, edit, review, report, store, and transfer ECG recordings. These recordings are obtained from electrical signals generated by the heart, not from specimens derived from the human body.
- Intended Use: The intended use clearly states they are for analyzing and managing ECG recordings to evaluate patient symptoms, ischemia, and the function of implanted devices. This is a diagnostic process based on physiological signals, not on the analysis of biological specimens.
Therefore, these devices fall under the category of medical devices that process physiological signals, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:
- SpiderView™ Holter ECG recorder (K032466),
- SyneFlash™ Holter ECG (K990727), or
- other compatible cassette tape recorder.
In addition, any ISHNE compatible recording can be read by SyneScope™.
EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:
- SpiderView™ Holter ECG recorder (K032466),
- SyneFlash™ Holter ECG (K990727), or
- other compatible cassette tape recorder.
SyneCom™ is intended to download, transfer for analysis, print and store multi-channel ECG recordings on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:
HolterReader is intended to view and print Holter reports from SyneScope™, EasyScope™ and SyneCom™.
Product codes
DQK
Device Description
SyneScope™, EasyScope™, SyneCom™ and HolterReader are software applications that Syncocope - ; Lasy Seoper recordings obtained with an ELA Medical Holter ECG digital and & U [SuneFlash™( K990727) and SpiderView™(K032466)], a standard cassette tape recorder, or an ISHNE compatible recording (for SyneScope™ only).
SyneScope™, EasyScope™, SyneCom™ and HolterReader are Microsoft Windows-based Dynoodoop ; Lasy oopersonal computers equipped with flash-card readers and/or tape cassette readers.
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
SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting.
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 following functional testing was performed on the SyneScope™, EasyScope™ SyneCom™ and HolterReader:
- SyneScopeTM, EasyScopeTM, SyneComTM and HolterReader safety and performance testing: Safety and performance tests according to the AAMI/ANSI EC38:1998 & IEC 60601-2-47 standards. (Report of results: See Attachment 10.9.)
- SyneScopeTM, EasyScopeTM, SyneComTM and HolterReader software verification and validation testing: Module and functional testing for SyneScopeTM, EasyScopeTM, SyneComTM and HolterReader software applications (Report of results: See Attachment 10.6.)
- SyneScopeTM, EasyScopeTM, SyneComTM and HolterReader field testing: Field validation protocol and evaluation form completion. (Report of results: See Attachment 10.4.)
All test systems were representative of final production devices unless otherwise specified.
Compliance with European Medical Device Directive 93/42/CEE and European standards IEC-60601-2-47 was verified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K002817, K990727, K004017, K930564, K020213, K896396
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
042002
page 1 of 5
510 (k) Summary of Safety and Effectiveness
Submitter:
ELA Medical, Inc. 2950 Xenium Lane North, Suite 120 Plymouth, MN 55441 Phone: (763) 519-9400 Fax: (763) 519-9440
Contact Person:
Susan Olive, Regulatory Affairs Manager
Devices trade names / Common names:
- Trade Name: SyneScope™ 道
- Common name: Holter ECG analysis software (or Holter ECG analyzer, or Holter O ECG scanner).
- Trade Name: EasyScope™ 지
- Common name: Holter ECG analysis software (or Holter ECG analyzer, or Holter o ECG scanner).
- Trade Name: SyneCom™ 해
- o Common name: Holter ECG data transfer software or system.
- Trade Name: HolterReader 특
- Common name: Holter ECG report viewer and printing software or tool.
Note: SyneCom™ and HolterReader are considered accessories of Holter ECG analyzers (they can be distributed separately to analyzers but they are intended to be used in conjunction with them).
Classification name:
Computer, diagnostic, programmable DQK (21CFR 870.1425)
Predicate devices:
The legally marketed devices to which ELA Medical is claiming equivalence are:
- SyneTec (ELA Medical): ELA Medical "SyneTec™" (510(1) K002817, ELA -Medical Inc.).
- SyneView (ELA Medical): ELA Medical "SyneView™" (510(k) K990727, ELA ﺖ Medical Inc.) including SyneView2™
- H-Scribe (Mortara): Mortara Instrument, Inc. "H-Scribe" (510(k) K004017, Mortara -Instrument, Inc.).
1
K042002
page 2 of 5
- Holter For Windows + (Rozinn): Rozinn Electronics, Inc. "Holter For Windows +" (based on 510(k) K930564, Northeast Monitoring, Inc.) including also Rozinn Electronics, Inc. "Netlink/NetScan" (510(k) K020213, Rozinn Electronics, Inc.).
- Mida (Ortivus sold by Philips Medical Systems): based on "Mida System Models -1000/1100" (510(k) K896396, Medical Graphics Corp.)
Device description:
SyneScope™, EasyScope™, SyneCom™ and HolterReader are software applications that Syncocope - ; Lasy Seoper recordings obtained with an ELA Medical Holter ECG digital and & U [SuneFlash™( K990727) and SpiderView™(K032466)], a standard cassette tape recorder, or an ISHNE compatible recording (for SyneScope™ only).
SyneScope™, EasyScope™, SyneCom™ and HolterReader are Microsoft Windows-based Dynoodoop ; Lasy oopersonal computers equipped with flash-card readers and/or tape cassette readers.
Intended use:
SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:
- SpiderView™ Holter ECG recorder (K032466), -
- SyneFlash™ Holter ECG (K990727), or -
- other compatible cassette tape recorder. -
In addition, any ISHNE compatible recording can be read by SyneScope™
EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel ECG recording on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:
- SpiderView™ Holter ECG recorder (K032466), -
- SyneFlash™ Holter ECG (K990727), or -
- other compatible cassette tape recorder. ﺳ
SyneCom™ is intended to download, transfer for analysis, print and store multi-channel ECG recordings on pediatric or adult patients (for periods up to 96 hours). These recordings are provided by:
2
042002
page 3 of 5
HolterReader is intended to view and print Holter report from SyneScope™, EasyScope™ and SyneCom™.
SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. all superville for Holter monitoring include, but are not limited to, evaluation of the following:
- Patient symptoms such as syncope, dizziness or palpitations. .
- Ischemia, especially in patients who cannot exercise or in patients with variant . angina.
- Function of an implanted pacemaker or defibrillator. .
| Model | SyneScope | EasyScope | SyneTec | SyneView/
SyneView 2 | H-Scribe | Holter for
Windows |
|-----------------------------------------------------------|-----------------------------------------------------|------------------------|----------------------|--------------------------|----------------------|-------------------------------|
| Company | ELA Medical | ELA Medical | ELA Medical | ELA Medical | Mortara | Rozinn |
| 510(k) Number | | | K002817 | K990727 | K004017 | K930564 |
| CE / MDD
certification | Yes | Yes | Yes | Yes | Yes | Yes |
| Type | Holter Analyzer | Holter Analyzer | Holter Analyzer | Holter Analyzer | Holter Analyzer | Holter Analyzer |
| PC based | Yes | Yes | Yes | Yes | Yes | Yes |
| Operating
System | Microsoft
Windows | Microsoft
Windows | Microsoft
Windows | Microsoft
Windows | Microsoft
Windows | Microsoft
Windows |
| Network
Compatible | Yes | Yes | Yes | Yes | Yes | Yes |
| Read digital | Yes | Yes | Yes | Yes | Yes | Yes |
| Cassette Tape | Yes | Yes | Yes | Yes | Yes | Yes |
| ECG Channels | Basic: 2/3 | Basic: 2/3 | Basic: 2/3 | Basic: 2/3 | Basic: 2/3 | Basic: 2/3 |
| | Max: 12 | Max: 3 | Max: 3 | Max: 3 | Max: 12 | Max: 12 |
| Multi-Channel
Arrhythmia
Analysis | Yes | Yes | Yes | Yes | Yes | Yes |
| 24H Full
Disclosure | Yes | Yes | Yes | Yes | Yes | Yes |
| ST deviation
analysis | Yes | Yes | Yes | Yes | Yes | Yes |
| Pacemaker
Activity | Yes | Yes | Yes | Yes | Yes | Yes |
| Trend Review | Yes | Yes | Yes | Yes | Yes | Yes |
| Templates
editing | Yes | Yes | Yes | Yes | Yes | Yes |
| Beat to Beat
editing | Yes | Yes | Yes | Yes | Yes | Yes |
| Strip editing | Yes | Yes | Yes | Yes | Yes | Yes |
| ECG
Superimposition | Yes | Yes | Yes | Yes | Yes | Yes |
| Page Mode | Yes | Yes | Yes | Yes | Yes | Yes |
| Editing report | Yes | Yes | Yes | Yes | Yes | Yes |
| Model | SyneScope | EasyScope | SyneTec | Syne View/
SyneView 2 | H-Scribe | Holter for
Windows+ |
| Company | ELA Medical | ELA Medical | ELA Medical | ELA Medical | Mortara | Rozinn |
| 510(k) Number | | | K002817 | K990727 | K004017 | K930564 |
| Customized
report | Yes | Yes | Yes | Yes | Yes | Yes |
| Archiving | Yes | Yes | Yes | Yes | Yes | Yes |
| Printing ECG
strip | Yes | Yes | Yes | Yes | Yes | Yes |
| Printing Full
Disclosure | Yes | Yes | Yes | Yes | Yes | Yes |
| Import/Export
capabilities | Yes | No | Yes | No | Yes | Yes |
| Import ASCII
RR Files | Yes | No | Yes | No | | |
| Export Results in
ASCII format | Yes | No | Yes | No | | |
| Export RR or
HR files in ASCII
format | Yes | No | Yes | No | | |
| Export ECG files
in ISHNE format | Yes | No | Yes | No | | |
| Read High
Resolution ECG
file | Yes | No | Yes | No | | |
| Export High
Resolution ECG
files in ISHNE
format | Yes | No | Yes | No | | |
| Heart Rate
Variability
(HRV) | Yes | Partial | Yes | Partial | Yes | Yes |
| Time Domain
(TD) | Yes | No | Yes | No | Yes | Yes |
| Frequency
Domain (FD) | Yes | No | Yes | No | No | Yes |
| Multiday | Yes (96H) | Yes (96H) | No | No | Yes (48H) | Yes (48H) |
| True 12-Lead
ECG | Yes | No | No | No | Yes | Yes |
| 12-Lead ECG
Derived | Yes (Dower
method - from
XYZ-Lead
system)* | No | No | No | No | No |
| 12-Lead ST
segment analysis | Yes | No | No | No | Yes | Yes |
| Holter Data
Transfer | Yes
(like SYNECOM) | Yes
(like SYNECOM) | No | No | Yes | Yes |
| Holter ECG
Report
Viewer/Editor | Yes (Holter
Reader) | Yes (Holter
Reader) | No | No | Yes | Yes |
| Import ISHNE
ECG file | Yes | No | No | No | No | No |
| Internet | Yes | Yes | No | No | Yes | Yes (with
Netlink/Netscan) |
Comparison of technology characteristics to predicate devices:
3
042002
page 4 of 5
- see Attachment 10.8 for details.
·
4
y2002
page 5 of 5
Summary of Studies:
The following functional testing was performed on the SyneScope™, EasyScope™ SyneCom™ and HolterReader:
| Test group | Tests | Report of results |
|---|---|---|
| SyneScopeTM, EasyScopeTM, | ||
| SyneComTM and HolterReader | ||
| safety and performance | ||
| testing. | Safety and performance tests | |
| according to the AAMI/ANSI | ||
| EC38:1998 & IEC 60601-2-47 | ||
| standards. | See Attachment 10.9. | |
| SyneScopeTM, EasyScopeTM, | ||
| SyneComTM and HolterReader | ||
| software verification and | ||
| validation testing. | Module and functional testing | |
| for SyneScopeTM, | ||
| EasyScopeTM, SyneComTM | ||
| and HolterReader software | ||
| applications | See Attachment 10.6. | |
| SyneScopeTM, EasyScopeTM, | ||
| SyneComTM and HolterReader | ||
| field testing | Field validation protocol and | |
| evaluation form completion. | See Attachment 10.4. |
All test systems were representative of final production devices unless otherwise specified.
Compliance with European Medical Device Directive 93/42/CEE and European standards IEC-60601-2-47 was verified.
See Attachment 10.7 for copies of the SyneScope™, EasyScope™, SyneCom™ and HolterReader declarations of conformity and CE certificates.
Conclusion:
The information presented in this submission provides reasonable assurance that the SyneScope™, EasyScope™, SyneCom™ and HolterReader will perform in a safe and effective manner.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2004
ELA Medical, Inc. c/o Ms. Susan Olive Regulatory Affairs Manager 2950 Xenium Lane North, Suite 120 Plymouth, MN 55441
Re: K042002
K042002
Trade Name: SyneScope™, EasyScope™, SyneCom™, and HolterReader Holter Analyzers
11:11 PM EasyScope™, EasyScope 1125 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: July 23, 2004 Received: July 26, 2004
Dear Ms. Olive:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) premainer is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Amendments. for use stated in the enclosure) to regary manced produce aredical Device Ameralments, or to
commerce prior to May 28, 1976, the enactment of the wassision of the Federal Foo commerce prior to May 28, 1976, the enaculient and of the Federal Food. Drug, devices that have been reclassified in accordance who are approval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approvisions of the Act. T and Cosmetic Act (Act) that do not require approval or a pal controls provisions of the Act. The
You may, therefore, market the device, subject to the general conversior at You may, therefore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mende requirements as a seasonst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (secaded) in clicier case in personations affecting your device can
may be subject to such additional controls. Existing major regulations allec may be subject to such additional controlist Extrong may on to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Federal Regaralier, our device in the Federal Register.
6
Page 2 - Ms. Susan Olive
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substance oquires with other requirements of the Act
that FDA has made a determination that your device adders Reguirements of the that FDA has made a determination in a your develop other Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listing or any Federal statutes and regulations and limited to registration and listing (21
comply with all the Act's requirements, including, but not limited to registration as set comply with all the Act s requirements, including practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); god manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing nd if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000-1050. forth in the quality systems (QS) regulanton (2 - CF (CFR) 0f the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 -542 of the Act); 21 CFR 1000-1050 product radiation control provisions (Sections 351-37), and recorp), as in the stock of S (VC)
This letter will allow you to TB (Secures restants againstical nyour device to This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales on thus premarket notification. The PDA inding of subsamial equively .
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rstiled. If you desire specific advice for your device of bar noomig the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please not of the regulation contact the Office of Compliatics at (301) 57 1 107.07) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtained from the "Misbranding by reference to premarket nothlivanom (210) Act may be obtained from the Other general information on your responsionial and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its Division of Simall Mail Mail 2011 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B. Hummer for
MD
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number: K042002
Device Name:
Boves Hames
SyneScope™ (Holter ECG analysis software or Holter ECG analyzer, or Holter ECG scanner).
ecanner)
EasyScope™ (Holter ECG analysis software or Holter ECG analyzer, or Holter ECG scanner)
SyneCom™ (Holter ECG data transfer software or system)
HolterReader (Holter ECG report viewer and printing software or tool)
Indications For Use:
SyneScope™ is intended to analyze, edit, review, report, store and transfer multi-Synescope - Is Intended to anialyze, radult patients (for periods up to 96 hours). These recordings are provided by:
- SpiderView™ Holter ECG recorder (K032466), -
- SyneFlash™ Holter ECG (K990727), or ﺴ
- other compatible cassette tape recorder. -
In addition, any ISHNE compatible recording can be read by SyneScope™
EasyScope™ is intended to analyze, edit, review, report, store and transfer 2-3 channel Easyocope - 13 intended to analyal etients (for periods up to 96 hours). These recordings are provided by:
- SpiderView™ Holter ECG recorder (K032466), -
- SyneFlash™ Holter ECG (K990727), or -
- other compatible cassette tape recorder. -
SyneCom™ is intended to download, transfer for analysis, print and store multi-channel Synecom "Is Intended to download intinuts (for periods up to 96 hours). These recordings are provided by:
HolterReader is intended to view and print Holter reports from SyneScope™ p
orts of TM and Comment The TW EasyScope™ and SyneCom™ .
page 1 of 2
8
SyneScope™, EasyScope™, SyneCom™ and HolterReader are intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following:
- Patient symptoms such as syncope, dizziness or palpitations. .
- Ischemia, especially in patients who cannot exercise or in patients with variant . angina.
- Function of an implanted pacemaker or defibrillator. .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.B. Simmons
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number
Page 2
1 of 2