Who is the manufacturer of SPACELABS HEALTHCARE CARDIOEXPRESS?

Spacelabs Healthcare, Ltd. filed the 510(k) submission for SPACELABS HEALTHCARE CARDIOEXPRESS (K130207).

What is the FDA product code for SPACELABS HEALTHCARE CARDIOEXPRESS?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SPACELABS HEALTHCARE CARDIOEXPRESS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SPACELABS HEALTHCARE CARDIOEXPRESS?

Edan Instruments, Inc. / SE-601 Series Electrocardiograph (K090367); Edan Instruments, Inc. / SE-3, SE-300A, SE-300B, SE-6, SE-600, SE-12, SE-12 Express, SE-1200 AND SE-1200 Express (K091513).

Who can help prepare an FDA 510(k) submission like SPACELABS HEALTHCARE CARDIOEXPRESS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPACELABS HEALTHCARE CARDIOEXPRESS

K130207 · Spacelabs Healthcare, Ltd. · DPS · Jul 23, 2013 · Cardiovascular

Device Facts

Record ID	K130207
Device Name	SPACELABS HEALTHCARE CARDIOEXPRESS
Applicant	Spacelabs Healthcare, Ltd.
Product Code	DPS · Cardiovascular
Decision Date	Jul 23, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2
Attributes	Pediatric

Intended Use

The intended use of the Spacelabs Healthcare CardioExpress (CardioExpress) is to acquire ECG signals from adult and pediatric patients using ECG electrodes. CardioExpress is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by CardioExpress can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements are only intended to be used on adult patients, and is offered to clinicians on an advisory basis only.

Device Story

CardioExpress (models SL3, SL6, SL12) is an electrocardiograph for acquiring, analyzing, displaying, and recording ECG signals. Device consists of a signal acquisition module and a central processing unit with a rechargeable battery. Inputs are ECG signals from patient electrodes; device amplifies, filters, and analyzes signals using peak-to-peak detection. Outputs include ECG waveforms and analysis results presented on an LCD display, recorded via thermal or USB printer, or stored in memory. Data can be transmitted to a PC via UART or Ethernet. Used in hospitals/healthcare facilities by doctors and trained professionals. Auto-analysis software provides measurements and interpretive statements for adult patients on an advisory basis to assist clinical diagnosis.

Clinical Evidence

No clinical data. Performance established via bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6), alarm systems (IEC 60601-1-8), and specific electrocardiograph performance standards (IEC 60601-2-25, IEC 60601-2-51).

Technological Characteristics

Electrocardiograph with 3, 6, or 12-channel configurations. Features 12-lead simultaneous acquisition, thermal dot-matrix recorder, LCD display, and rechargeable battery. Connectivity via UART or Ethernet. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-2-25, and 60601-2-51. Software-based auto-analysis for measurements and interpretation.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition for heart disease analysis and diagnosis. Auto-interpretation and measurement features are indicated for adult patients only. Intended for use in hospitals or healthcare facilities by trained professionals.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

Edan Instruments, Inc. / SE-601 Series Electrocardiograph (K090367)
Edan Instruments, Inc. / SE-3, SE-300A, SE-300B, SE-6, SE-600, SE-12, SE-12 Express, SE-1200 AND SE-1200 Express (K091513)

Related Devices

K111805 — ECG SERIES ELECTROCARDIOGRAPH · Advanced Instrumentations, Inc. · Aug 24, 2011
K091513 — SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 · Edan Instruments, Inc. · Jul 24, 2009
K113485 — ELECTROCARDIOGRAPH · Shenzhen Carewell Electronics Co., Ltd. · Apr 25, 2012
K131858 — DIGITAL ELECTROCARDIOGRAPH · Guangdong Biolight Meditech Co., Ltd. · Jun 11, 2014
K172068 — Kenz Cardico1211 · Suzuken Co., Ltd. · Jun 1, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ | Submission Date: | 25 January 2013 | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Spacelabs Healthcare 1 Harforde Court John Tate Road Hertford SG13 7NW United Kingdom | | Submitter Contact: | Mr. Al Van Houdt Spacelabs Healthcare Phone: +1 (425) 657-7200, ext 5970 Fax: +1 (425) 657-7210 Email: al.vanhoudt@spacelabs.com | | Application Correspondent: | Thomas Kroenke Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland, CO 80466 USA tkroenke@speedtomarket.net 303 956 4232 | | Manufacturing Site: | Edan Instruments, Inc. 2/F And 5/F, Block A/B, Unit 8, Xing Hua Building, Nanhai Rd, Nanshan Shenzhen CHINA 518067 | | Trade Name: | Spacelabs Healthcare CardioExpress, Models 98400-SL3-IEC, 98400-SL3-AHA, 98400-SL6-IEC, 98400-SL6-AHA, 98400-SL12- IEC, and 98400-SL12-AHA | | Common Name: | Electrocardiograph | | Classification Name: | Electrocardiograph | | Classification Regulation: | 21 CFR §870.2340 | | Product Code: | DPS | - {1}------------------------------------------------ · : . | Substantially Equivalent Devices: | New Spacelabs Models | Predicate 510(k) Number | Predicate Manufacturer / Model | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------| | | Spacelabs Healthcare CardioExpress, Models 98400-SL3-IEC, 98400-SL3-AHA, | K090367 | Edan Instruments, Inc. / SE-601 Series Electrocardiograph | | | 98400-SL6-IEC, 98400-SL6-AHA, 98400-SL12-IEC, and 98400-SL12-AHA | K091513 | Edan Instruments, Inc. / SE-3, SE-300A, SE-300B, SE-6, SE-600, SE-12, SE- 12 Express, SE-1200 AND SE-1200 Express | | Device Description: | The Spacelabs Healthcare (Spacelabs) CardioExpress, Models 98400- SL3-IEC, 98400-SL3-AHA, 98400-SL6-IEC, 98400-SL6-AHA, 98400-SL12-IEC, and 98400-SL12-AHA, are a series of electrocardiographs (ECGs) designed to acquire, analyze, display, and record ECG signals from ECG electrodes connected to a patient. After been amplified, filtered and analyzed, the ECG signal waveforms and analysis results are presented on a liquid crystal diode (LCD) display, and recorded on the paper through either a thermal or USB printer. ECG data, result and patient information may be stored in the memory file. The file can be transmitted to a personal computer (PC) through either an UART or Ethernet connection. The CardioExpress can optionally contain auto analysis software which assists in performing auto measurement and auto interpretation of data. The CardioExpress consists of two (2) basic components: (1) the signal acquisition module, and (2) the central processing unit. All models contain a rechargeable battery. The CardioExpress series of ECG monitors are provided in three (3) primary models: CardioExpress SL-3; CardioExpress SL-6; and CardioExpress SL-12. | | | | Intended Use: | The intended use of the Spacelabs Healthcare CardioExpress (CardioExpress) is to acquire ECG signals from adult and pediatric patients using ECG electrodes. CardioExpress is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by CardioExpress can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements are only intended to be used on adult patients, and is offered to clinicians on an advisory basis only. | | | {2}------------------------------------------------ | Technology Comparison: | Characteristic | Predicate Devices | Proposed Devices | |---------------------------|-------------------------------------|------------------------------------|------------------| | CardioExpress SL-3 | Channels | 3 | Same | | | Lead Color Coded Option | AHA and IEC | Same | | | Leads | 12 standard | Same | | | Acquisition Mode | 12 simultaneous leads | Same | | | Heart Rate Recognition Technique | Peak-to-peak detection | Same | | | Heart Rate Range | 30 - 300 beats per minute (BPM) | Same | | | Recorder | Thermal dot-matrix recorder | Same | | CardioExpress SL-6 | Channels | 6 | Same | | | Lead Color Coded Option | AHA and IEC | Same | | | Leads | 12 standard | Same | | | Acquisition Mode | 12 simultaneous leads | Same | | | Heart Rate Recognition Technique | Peak-to-peak detection | Same | | | Heart Rate Range | 30 - 300 beats per minute (BPM) | Same | | | Recorder | Thermal dot-matrix recorder | Same | | CardioExpress SL-12 | Channels | 12 | Same | | | Lead Color Coded Option | AHA and IEC | Same | | | Leads | 12 standard | Same | | | Acquisition Mode | 12 simultaneous leads | Same | | | Heart Rate Recognition Technique | Peak-to-peak detection | Same | | | Heart Rate Range | 30 - 300 beats per minute (BPM) | Same | | | Recorder | Thermal dot-matrix recorder | Same | p {3}------------------------------------------------ #### Summary of Performance Testing: | Software Testing | 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 standards and guidance documents: 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. 09 Sep 99; FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; and FDA guidance: Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 January 2005. Test results indicate that the CardioExpress complies with its predetermined specifications and the applicable standards and guidance documents. | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Electrical Safety Testing | CardioExpress was tested for performance in accordance with the following Standard: IEC 60601-1: 1988, Am1: 1991, and Am2: 1995. Medical electrical equipment. Part 1: Particular requirements for safety. Test results indicated that CardioExpress complies with the Standard. | | Electromagnetic Compatibility Testing | CardioExpress was tested for performance in accordance with the following Standard: IEC 60601-1-2: 2001, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests. | Test results indicated that CardioExpress complies with the Standards. . {4}------------------------------------------------ Performance Testing CardioExpress was tested for performance in accordance with internal requirements and the following standards: - IEC 60601-1-6: 2004, Medical electrical equipment -- Part 1-6: . General requirements for safety - Colluteral standard: Usabilitv: - IEC 60601-1-8: 2003, Am1: 2006, Medical electrical equipment -. Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical svstems; - IEC 60601-2-25: 1993. Am: 1999. Medical electrical equipment -. Part 2-25: Particular requirements for the safety of electrocardiographs; and - IEC 60601-2-51: 2003, Medical electrical equipment Part 2-51: . Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs. Test results indicate that CardioExpress complies with its predetermined specifications and the applicable standards. Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of CardioExpress. The results of these activities demonstrate that CardioExpress is safe and effective when used in accordance with its intended use and labeling. Therefore, CardioExpress is considered substantially equivalent to the predicate device. {5}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 23, 2013 Spacelabs Healthcare Ltd. c/o Mr. Thomas Kroenke PO Box 3018 Nederland, CO 80466 Re: K130207 Trade/Device Name: CardioExpress Electrocardiographs (SL3. SL6. and SL12) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 24, 2013 Received: June 24, 2013 Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 statutes and regulations administered by other Federal agencies. You must {6}------------------------------------------------ Page 2 - Mr. Thomas Kroenke 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Owen P. Faris -S for 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 (if known): | K130207 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Spacelabs Healthcare CardioExpress, Models 98400-SL3-IEC, 98400-SL3-AHA, 98400-SL6-IEC, 98400-SL6-AHA, 98400-SL12-IEC, and 98400-SL12-AHA | | Indications for Use: | The intended use of the Spacelabs Healthcare CardioExpress (CardioExpress) is to acquire ECG signals from adult and pediatric patients using ECG electrodes. CardioExpress is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by CardioExpress can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements are only intended to be used on adult patients, and is offered to clinicians on an advisory basis only. | X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Digitally signed by Owen P. Faris -S Date: 2013.07.23 09:17:50-04'00' Page 1 of 1