(176 days)
Not Found
No
The document mentions "auto analysis software" for measurement and interpretation, but does not use terms like AI, ML, deep learning, or neural networks, which are typically associated with AI/ML technologies in regulatory submissions. The description of the analysis process (amplified, filtered, analyzed) suggests traditional signal processing rather than AI/ML.
No
The device is used to acquire, analyze, display, and record ECG signals for diagnostic purposes, not to provide therapy or treatment.
Yes.
The "Intended Use / Indications for Use" section states, "The cardiogram recorded by CardioExpress can help users to analyze and diagnose heart disease." This directly indicates a diagnostic function.
No
The device description explicitly states that the CardioExpress consists of two basic components: (1) the signal acquisition module, and (2) the central processing unit, and also mentions a rechargeable battery, LCD display, and printer, indicating it is a hardware device with integrated software.
Based on the provided information, the Spacelabs Healthcare CardioExpress is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The CardioExpress acquires ECG signals directly from the patient's body using electrodes. It does not analyze blood, urine, tissue, or other biological samples.
- The intended use is to acquire and analyze electrical signals from the heart. This is a physiological measurement, not an in vitro test.
- The device description focuses on signal acquisition, processing, display, and recording. These are all related to capturing and presenting the electrical activity of the heart.
Therefore, the Spacelabs Healthcare CardioExpress is a medical device used for in vivo (within the living body) measurement and analysis of cardiac electrical activity.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
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.
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
Adult and pediatric patients. However, the interpreted ECG with measurements and interpretive statements are only intended to be used on adult patients.
Intended User / Care Setting
hospitals or healthcare facilities by doctors and trained healthcare professionals.
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)
Software Testing: Software was designed and developed according to a robust software development process, and was rigorously verified and validated. 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.
Performance Testing: CardioExpress was tested for performance in accordance with internal requirements and the following standards: IEC 60601-1-6: 2004, IEC 60601-1-8: 2003, Am1: 2006, IEC 60601-2-25: 1993, Am: 1999, and IEC 60601-2-51: 2003. Test results indicate that CardioExpress complies with its predetermined specifications and the applicable standards.
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.
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
Not Found
§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
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'
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