(148 days)
No
The summary describes a software modification to an existing algorithm (EASI) that improves correlation coefficients. There is no mention of AI, ML, or related concepts, and the performance evaluation focuses on comparing correlation coefficients and physician over-reads, not typical AI/ML validation metrics.
No
The device is used for assessment and analysis of ST segment in adult patients, which is a diagnostic function, not a therapeutic one. It provides information for diagnosis but does not directly treat a condition.
Yes
The device is described as assessing "real time ST segment analysis" and performing "reconstruction to simulate a Mason Likar lead placement," which are activities related to identifying or characterizing medical conditions, thus making it a diagnostic device.
Yes
The device description explicitly states the modification is "software-based" and focuses on algorithmic changes (EASI algorithm, correlation coefficients, Mason Likar simulation). There is no mention of new or modified hardware components. The testing described also focuses on the performance of the software modification in analyzing existing ECG data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The device is described as a software modification to an existing system that performs real-time ST segment analysis based on the EASI algorithm. It also allows for reconstruction to simulate a Mason Likar lead placement. This indicates it's analyzing electrical signals from the body (ECG data), not samples taken from the body.
- Intended Use: The intended use is "Assessment of real time ST segment analysis in adult patients." This is a direct assessment of physiological signals from the patient.
- Lack of Mention of Samples: There is no mention of analyzing any biological samples.
Therefore, this device falls under the category of a medical device that analyzes physiological signals directly from the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the hospital environment.
Note to Users on Patient Population:
Based on the FDA review of K992595 the following labeling must be disclosed within user documentation for EASI 12 LEAD ST Analysis:
Assessment of EASI 12 LEAD derived 12-lead ST measurements is recommended for adult patients that meet the following parameters:
Ages 33 to 82 years
Heights: 147 to 185 cm (58 to 73 in) .
Weights: 53 to 118 kg (117 to 261 lbs.) .
Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb.) .
Product codes
74DRW
Device Description
The new device is a modification to previously reviewed submittals containing the EASI algorithm. The modification is a software-based change that slightly improves existing correlation coefficients. The modification also allows reconstruction to simulate a Mason Likar lead placement. The new device has the same technological characteristics as the legally marketed predicate device.
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
Ages 33 to 82 years
Intended User / Care Setting
hospital environment
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)
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved 2 physician over-reads comparing the modified coefficients to traditional 12 Lead ECG and Mason Likar 12 Lead ECG on the same patients. A comparison of the correlation coefficients from earlier studies on the same patients was done. The modified coefficients did not show a decreased correlation in any of the leads. Several of the leads showed improvements with the improvement in the correlation coefficient varying from 0 to 0.10 in one case.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient varying from 0 to 0.10
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2350 Electrocardiograph lead switching adaptor.
(a)
Identification. An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III.(b)
Classification. Class II (performance standards).
0
K020456
page 1 of 1
9 2002 JUL
SMDA/510(k) Summary:
510(k) Summary 30 January 2002
This 510(k) summary for safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 8807.92.
-
- The submitter of this premarket notification is:
Paul Schrader Quality and Regulatory Manager Philips Medical Systems 3000 Minuteman Road, Andover, MA 01810-1085 978 659 2404 Fax: 978 659 7360 Tel:
- The submitter of this premarket notification is:
-
Unique Identifier for Submittal: EASI 12 Lead Algorithm / Coefficients 2.
| 14/11/2017 | ||
|---|---|---|
| 000 00000 | ||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | The Trans | electrocardiograph |
| ead switching. |
-
- The new device is a modification to previously reviewed submittals containing the EASI algorithm.
- The modification is a software-based change that slightly improves existing 4. correlation coefficients. The modification also allows reconstruction to simulate a Mason Likar lead placement.
- The new device has the same technological characteristics as the legally marketed న. predicate device.
- Verification, validation, and testing activities establish the performance, 6. functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved 2 physician over-reads comparing the modified coefficients to traditional 12 Lead ECG and Mason Likar 12 Lead ECG on the same patients. A comparison of the correlation coefficients from earlier studies on the same patients was done. The modified coefficients did not show a decreased correlation in any of the leads. Several of the leads showed improvements with the improvement in the correlation coefficient varying from 0 to 0.10 in one case. It was therefore concluded that the modification does not increase patient risk relative to what is on the market today. It does improve effectiveness in some of the leads based on the data gathered.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2002 புரட
Phillins Medical System c/o Mr. Paul M. Schrader Q&R Manger Cardiology Division 3000 Minuteman Road Andover, MA 01810-1085
- Re: K020456
Device Name: EASI 12 LEAD TM 12 Lead Coefficients Regulation Number: 21 CFR 870.2350 Regulation Name: Adapter, Lead Switching, ECG Regulatory Class: Class II (two) Product Code: 74DRW Dated: February 7, 2002 Received: February 11, 2002
Dear Mr. Schrader:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
2
Page 2 - Mr. Paul M. Schrader
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.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Roark Till
D nna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number: K020456 EASI 12 LEAD™ 12 Lead Coefficients Device Name:
Indications for Use:
,
Assessment of real time ST segment analysis in adult patients. Assessment is indicated for the hospital environment.
Note to Users on Patient Population:
- Based on the FDA review of K992595 the following labeling must be disclosed within user documentation for EASI 12 LEAD ST Analysis:
- Assessment of EASI 12 LEAD derived 12-lead ST measurements is recommended for adult patients that meet the following parameters:
- . Ages 33 to 82 years
- Heights: 147 to 185 cm (58 to 73 in) .
- Weights: 53 to 118 kg (117 to 261 lbs.) .
- Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb.) .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHI R PAGE 11 NI (1 SS (R) 1
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | ----------------------------------------- |
OR over-the-counter Use
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular | |
| and Respiratory Devices |
| 510(k) Number | K020456 |
|---|---|
| --------------- | --------- |