SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

{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: - SpiderView™ Holter ECG recorder (K032466) or - - SyneFlash™ Holter ECG (K990727). - {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/<br>SyneView 2 | H-Scribe | Holter for<br>Windows | |-----------------------------------------------------------|-----------------------------------------------------|------------------------|----------------------|--------------------------|----------------------|-------------------------------| | Company | ELA Medical | ELA Medical | ELA Medical | ELA Medical | Mortara | Rozinn | | 510(k) Number | | | K002817 | K990727 | K004017 | K930564 | | CE / MDD<br>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<br>System | Microsoft<br>Windows | Microsoft<br>Windows | Microsoft<br>Windows | Microsoft<br>Windows | Microsoft<br>Windows | Microsoft<br>Windows | | Network<br>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<br>Arrhythmia<br>Analysis | Yes | Yes | Yes | Yes | Yes | Yes | | 24H Full<br>Disclosure | Yes | Yes | Yes | Yes | Yes | Yes | | ST deviation<br>analysis | Yes | Yes | Yes | Yes | Yes | Yes | | Pacemaker<br>Activity | Yes | Yes | Yes | Yes | Yes | Yes | | Trend Review | Yes | Yes | Yes | Yes | Yes | Yes | | Templates<br>editing | Yes | Yes | Yes | Yes | Yes | Yes | | Beat to Beat<br>editing | Yes | Yes | Yes | Yes | Yes | Yes | | Strip editing | Yes | Yes | Yes | Yes | Yes | Yes | | ECG<br>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/<br>SyneView 2 | H-Scribe | Holter for<br>Windows+ | | Company | ELA Medical | ELA Medical | ELA Medical | ELA Medical | Mortara | Rozinn | | 510(k) Number | | | K002817 | K990727 | K004017 | K930564 | | Customized<br>report | Yes | Yes | Yes | Yes | Yes | Yes | | Archiving | Yes | Yes | Yes | Yes | Yes | Yes | | Printing ECG<br>strip | Yes | Yes | Yes | Yes | Yes | Yes | | Printing Full<br>Disclosure | Yes | Yes | Yes | Yes | Yes | Yes | | Import/Export<br>capabilities | Yes | No | Yes | No | Yes | Yes | | Import ASCII<br>RR Files | Yes | No | Yes | No | | | | Export Results in<br>ASCII format | Yes | No | Yes | No | | | | Export RR or<br>HR files in ASCII<br>format | Yes | No | Yes | No | | | | Export ECG files<br>in ISHNE format | Yes | No | Yes | No | | | | Read High<br>Resolution ECG<br>file | Yes | No | Yes | No | | | | Export High<br>Resolution ECG<br>files in ISHNE<br>format | Yes | No | Yes | No | | | | Heart Rate<br>Variability<br>(HRV) | Yes | Partial | Yes | Partial | Yes | Yes | | Time Domain<br>(TD) | Yes | No | Yes | No | Yes | Yes | | Frequency<br>Domain (FD) | Yes | No | Yes | No | No | Yes | | Multiday | Yes (96H) | Yes (96H) | No | No | Yes (48H) | Yes (48H) | | True 12-Lead<br>ECG | Yes | No | No | No | Yes | Yes | | 12-Lead ECG<br>Derived | Yes (Dower<br>method - from<br>XYZ-Lead<br>system)* | No | No | No | No | No | | 12-Lead ST<br>segment analysis | Yes | No | No | No | Yes | Yes | | Holter Data<br>Transfer | Yes<br>(like SYNECOM) | Yes<br>(like SYNECOM) | No | No | Yes | Yes | | Holter ECG<br>Report<br>Viewer/Editor | Yes (Holter<br>Reader) | Yes (Holter<br>Reader) | No | No | Yes | Yes | | Import ISHNE<br>ECG file | Yes | No | No | No | No | No | | Internet | Yes | Yes | No | No | Yes | Yes (with<br>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,<br>SyneComTM and HolterReader<br>safety and performance<br>testing. | Safety and performance tests<br>according to the AAMI/ANSI<br>EC38:1998 & IEC 60601-2-47<br>standards. | See Attachment 10.9. | | SyneScopeTM, EasyScopeTM,<br>SyneComTM and HolterReader<br>software verification and<br>validation testing. | Module and functional testing<br>for SyneScopeTM,<br>EasyScopeTM, SyneComTM<br>and HolterReader software<br>applications | See Attachment 10.6. | | SyneScopeTM, EasyScopeTM,<br>SyneComTM and HolterReader<br>field testing | Field validation protocol and<br>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: - SpiderView™ Holter ECG recorder (K032466), - - SyneFlash™ Holter ECG (K990727) - 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