(87 days)
The 12-Lead option (#C90) adds 12-Lead ECG functionality to the CodeMaster 100 monitor/defibrillator, M2475B. This feature will be used by emergency medical personnel who have been trained and authorized for its use.
The primary patient population for which this feature is intended is defined as persons with symptoms associated with acute myocardial infarction or cardiac annythmias. The 12-Lead feature can also be applied to patients for routine.medical examinations or anytime a baseline ECG is ordered by a physician. Note that a physician must review the preliminary report. Like any computer assisted ECG interpretation program, the predictive instrument evaluation is not a substitute for the physician's decision process.
This product is not intended for home use.
The #C90 12 Lead ECG option to the M2475B provides 12-Lead acquisition and high fidelity printing for on-site manual interpretation. The preview display allows the user to scroll through all 12 leads and computerized ECG analysis for fast ECG interpretation. The integrated modem (U.S. version only) provides combined cellular / land line for ECG transmission to a physician to over-read and diagnose ECGs. It offers an industry standard RS232 port for hardwire connection with an external (not provided) modem. In addition, it features the ACI-TIPI, Acute Cardiac Ischemia - Time Insensitive Predictive Instrument that aids in patient diagnosis. The complete system is compatible with the Hewlett-Packard cardiology network, which includes the TraceMaster ECG Management System, M1730B and the EGC Manager, M1765A.
This 510(k) summary (K982025) describes the Hewlett-Packard 12-Lead Option (#C90) for the M2475B CodeMaster 100 defibrillator/monitor. The submission claims substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for the device's performance in terms of diagnostic accuracy (e.g., sensitivity, specificity for detecting AMI). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to existing legally marketed predicate devices through non-clinical testing.
Reported Device Performance: The document states that "The results summarized in Appendix D show that non-clinical tests were successfully used to determine the substantial equivalence of the 12-Lead (#C90) option to the M2475B." However, Appendix D is not provided in the input text, so specific performance metrics from those non-clinical tests cannot be extracted. The text emphasizes that the device employs "the same technologies" and "re-use of... hardware, hardware design, application software, and algorithm software" as predicate devices, implying that its performance is expected to be equivalent.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: Substantial Equivalence to Predicate Devices (LifePak 11/11R, M1770A) in terms of safety and effectiveness, and compliance with mandatory and voluntary standards, software baselines, and hardware functionality. | Summary: "Non-clinical tests were successfully used to determine the substantial equivalence of the 12-Lead (#C90) option to the M2475B." The device uses "the same technologies" and "identical" hardware and software components (including the ECG interpretation algorithm) as the predicate devices. Specific quantitative performance data is not provided in this summary, but referenced in Appendix D (not included). |
2. Sample Size for the Test Set and Data Provenance
The provided document does not describe a clinical study with a "test set" or patient data. The claim of substantial equivalence is based on non-clinical tests, as stated: "The use of non-clinical tests as defined in the 'Verification and Validation' section contained in Appendix D demonstrates that the 12-Lead option #C90 is substantially equivalent..."
Therefore, information on sample size for a test set, data provenance (e.g., country of origin, retrospective/prospective) related to patient data, is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or provided. The device's substantial equivalence was established through non-clinical testing, not a clinical study involving experts establishing ground truth for a diagnostic test set. The use of computerized ECG analysis by the device for interpretation is "not a substitute for the physician's decision process."
4. Adjudication Method for the Test Set
This information is not applicable or provided. As there was no clinical test set described in the provided text, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed or described in this 510(k) summary. The submission focuses on non-clinical substantial equivalence.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for the algorithm per se is not explicitly described as a separate study with specific metrics. However, the document states: "The M2475B CodeMaster 100 Defibrillator/Monitor option #C90 employs the same technologies as the predicate devices...Re-use of PageWriter 200i Cardiograph hardware, hardware design, application software, and algorithm software to make the #C90 option for CodeMaster 100 demonstrate the technology is not just similar, but identical."
This implies that the "computerized ECG analysis" algorithm is the same as that in the predicate Hewlett-Packard PageWriter 200i Cardiograph (M1770A). Therefore, the standalone performance of the algorithm would be based on prior evaluations of that predicate device's algorithm, rather than a new standalone study for this specific 12-Lead option. The provided text doesn't offer details of such prior evaluations.
7. Type of Ground Truth Used
For the non-clinical tests, the ground truth would typically be established based on engineering specifications, recognized standards, and functional requirements rather than clinical outcomes or pathology. The goal was to prove the device met these engineering and performance standards, showing it functions equivalently to predicate devices.
8. Sample Size for the Training Set
The document does not provide information on a training set sample size. The submission focuses on the new device's substantial equivalence to existing devices, relying on the 'identical' software and algorithms already proven in the predicate devices. Therefore, any training of the algorithm would have occurred prior to the predicate device's original submission, and is not detailed here.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As with the training set size, the method for establishing ground truth for the algorithm's training would have been part of the development process for the predicate device's ECG interpretation algorithm, not this specific 510(k) submission.
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A 1998 SEP
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits. The digits appear to be '4982025'. The numbers are written in a dark ink or marker on a white background. The handwriting is somewhat stylized, with some variability in the thickness and shape of the strokes.
510(k) Summary for 12-Lead Option (#C90), for CodeMaster (M2475B)
DATE SUMMARY PREPARED
May 29, 1998
SUBMITTER'S NAME AND ADDRESS
Hewlett-Packard Company
Medical Products Group
3000 Minuteman Road
Andover, MA 01810-1099
CONTACT PERSON
Richard J. Petersen .
Telephone: (978) 659-2213
Facsimile: (978) 687-2651
DEVICE NAME
Proprietary Name: 12-Lead option (#C90) to the M2475B
Common Name: 12 Lead option to the CodeMaster 100
Classification Name: Class II, Electrocardiograph / Defibrillator / Monitor
PREDICATE DEVICE(S)
The lecally marketed devices to which equivalencies are being claimed is the LifePak 11/11R, defibrillator / pacemaker / diagnostic cardiac monitor, manufactured by Physio-Control, (K951593) and (K912189). Also, the M1770A Electrocardiograph, manufactured by Hewlett-Packard, (K935772, K954980, K981265). The design of the #C90 option is substantially equivalent in safety and performance to the LifePak 11/11R and M1770A features.
DEVICE DESCRIPTION
The #C90 12 Lead ECG option to the M2475B provides 12-Lead acquisition and high fidelity printing for on-site manual interpretation. The preview display allows the user to scroll through all 12 leads and computerized ECG analysis for fast ECG interpretation. The integrated modem (U.S. version only) provides combined cellular / land line for ECG transmission to a physician to over-read and diagnose ECGs. It offers an industry standard RS232 port for hardwire connection with an external (not provided) modem. In addition, it features the ACI-TIPI, Acute Cardiac Ischemia - Time Insensitive Predictive Instrument that aids in patient diagnosis. The complete system is compatible with the Hewlett-Packard cardiology network, which includes the TraceMaster ECG Management System, M1730B and the EGC Manager, M1765A.
HEWLETT-PACKARD COMPANY M2475B 12-LEAD ECG OPTION
CONFIDENTIAL
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INTENDED USE
The 12-Lead Option (#C90) for the CodeMaster 100, Hewlett-Packard M2475B is intended for use by emergency medical personnel who are under physician-approved protocols to acquire electrocardiograms (ECGs) from patients. The resulting 12-Lead report, with or without computerized interpretation, is intended to be used by medical personnel as a tool to help diagnose a variety of cardiac disorders.
The application of 12-Lead electrocardiography in pre-hospital emergency medicine is proving to be a key factor for reducing the time needed to identify and treat patients suffering from Acute Myocardial Infarction (AMI). Once identified, this patient is more likely to be transported to a hospital with the appropriate facilities and the ED staff at that hospital is more likely to be prepared when the patient arrives. The addition of the 12-Lead option to the CodeMaster 100 will aid emergency medical personnel to move quickly and accurately identify and triage patients suffering from AMI.
COMPARISON OF TECHNOLOGY CHARACTERISTICS
The M2475B CodeMaster 100 Defibrillator/Monitor option #C90 employs the same technologies as the predicate devices used for comparison; the Hewlett-Packard PageWriter 200i Cardiograph, Model HP M1770A (510th) no. K954980) with option #A05 ECG Storage and Transmission, and the Physio Control LifePak 11 diagnostic cardiac monitor (510(k) no. K912189), and the LifePak 11R defibrillator-pacer (510(k) no. K951593) .
These devices acquire an ECG signal through a 10-wire cable and patient electrodes placed in standard 12-Lead positions. Common analog-to-digital signal acquisition techniques are used to produce a digitized ECG signal that can be displayed, analyzed heart rate, and processed for computerized interpretation. The resulting information is presented on displays, and formatted into a diagnostic report that can be printed or transmitted to remote sites using landlines and standard modem protocols. Re-use of PageWriter 200i Cardiograph hardware, hardware design, application software, and algorithm software to make the #C90 option for CodeMaster 100 demonstrate the technology is not just similar, but identical.
NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The "Device Comparison Tables" in Section I of this document contains comparison information of the 12-Lead option #C90 for the M2475B to legally marketed devices of similar functionality. The tabular comparison establishes the substantial equivalence of the 12-Lead option to those devices currently marketed with regard to the overall performance of the device to safety and effectiveness criteria. The use of non-clinical tests as defined in the "Verification and Validation" section contained in Appendix D demonstrates that the 12-Lead option #C90 is substantially equivalent to other legally marketed devices that meet the same or similar test performance criteria. The selection of tests in Appendix D were chosen in order to establish clear conformance to mandatory and voluntary standards, software baselines, and hardware functionality. The results summarized in Appendix D show that non-clinical tests were successfully used to determine the substantial equivalence of the 12-Lead (#C90) option to the M2475B.
CONCLUSION FROM NONCLINICAL TESTING
HEWLETT-PACKARD COMPANY M2475B 12-LEAD ECG OPTION
CONFIDENTIAL
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The results of the "Device Comparison Tables" and the Appendix D test data confirm that the verification strategy using non-clinical testing to establish substantial equivalence was a successful process for testing the 12-Lead option #C90 to the M2475B.
·
HEWLETT-PACKARD COMPANY M2475B 12-LEAD ECG OPTION
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Image /page/3/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 a stylized symbol consisting of three curved lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SED 1 1998
Mr. Richard J. Petersen Hewlett-Packard Company Medical Products Group Cardiology Products Division 3000 Minuteman Road Andover, MA 01810
K982025 Re: 12-Lead Option (#C90) for the M2475B Monitor/Defibrillator Requlatory Class: III (three) Product Code: 74 MKJ Dated: June 8, 1998 Received: June 9, 1998
Dear Mr. Petersen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2 - Mr. Richard J. Petersen
On August 16, 1993, the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please not the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http:77/www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Auth A. Ciarkowski.
Kor Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Indications for Use
510(k) 982025.
Device Name: Hewlett-Packard 12-Lead Option (#C90) for the M2475B CodeMaster 100
Indications For Use: The 12-Lead option (#C90) adds 12-Lead ECG functionality to the CodeMaster 100 monitor/defibrillator, M2475B. This feature will be used by emergency medical personnel who have been trained and authorized for its use.
The primary patient population for which this feature is intended is defined as persons with symptoms associated with acute myocardial infarction or cardiac annythmias. The 12-Lead feature can also be applied to patients for routine.medical examinations or anytime a baseline ECG is ordered by a physician. Note that a physician must review the preliminary report. Like any computer assisted ECG interpretation program, the predictive instrument evaluation is not a substitute for the physician's decision process.
This product is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-The-Counter Use _
(Per 21 CFR 801.109)
Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.