(68 days)
The Ambu® Blue Sensor MRX electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram. The electrode is designed for use in MR environment, therefore the electrode is MR safe, and for X-ray purposes, therefore the electrode is x-ray translucent. The electrode is for single patient use only.
Each electrode consists of a foam material with an adhesive to be mounted on the patient. The sensor element consists of a foil furnished with a conductive carbon filled polymer snap and a Ag/AgCl sensor point. On top of the sensor point a sponge is positioned filled with a wet gel that conducts the signal from the patient further on to the electrode. The choise of materials ensures a non-ferromagnetic electrode which makes it x-ray translucent and MR safe. The electrodes are delivered on a foil sheet with 8 electrodes and 32 electrodes are packed in a laminated foil pouch. The electrode is non sterile and intended for single use.
This 510(k) summary does not contain the detailed study information needed to fully address all parts of your request. It mainly describes the device and claims substantial equivalence to a predicate device. However, I can extract the available information and highlight what is missing.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not explicitly state specific acceptance criteria in a quantitative manner (e.g., Sensitivity > X%, Specificity > Y%). Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to a general standard.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K983689) | The MRX electrode is "almost identical with the SUPAtab electrode." The main change is the metal snap on the SUPAtab has been changed to a carbon-filled polymer snap on the MRX. Both electrodes have the same Ag/AgCl sensor material and the same materials except for the snap. The FDA reviewed the 510(k) and "determined the device...is substantially equivalent." This implies the performance is considered comparable enough for its intended use. |
| MR Safety | The choise of materials ensures a non-ferromagnetic electrode which makes it...MR safe. |
| X-ray Translucency | The choise of materials ensures a non-ferromagnetic electrode which makes it x-ray translucent. |
| Adherence to AAMI EC12 2000 standard | Both electrode types meet the AAMI EC12 2000 standard. (This standard likely outlines performance requirements for ECG electrodes, such as impedance, DC offset, amplitude response, etc., but the specific values are not detailed in this document.) |
| Intended Use: Transmit electrical signal for ECG/vectorcardiogram in MR environment (new for MRX) | "The Ambu® Blue Sensor MRX electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram." The device is "designed for use in MR environment, therefore the electrode is MR safe, and for X-ray purposes, therefore the electrode is x-ray translucent." The FDA's substantial equivalence determination implies that it performs this function acceptably in the specified environment. |
| Single Patient Use | The electrode is for single patient use only. (This is a design characteristic, not a performance metric per se, but it's part of the product specification.) |
| Shelf Life of 2 years | Both electrode types… have a shelf life of 2 years. (This would typically be confirmed through stability testing, but the details are not provided here.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance evaluation with a numerical sample size. The substantial equivalence argument primarily relies on material changes and adherence to a standard, rather than a clinical trial with a defined test set.
- Sample Size: Not specified for a performance test set.
- Data Provenance: Not applicable in the context of a "test set" for clinical evaluation. The comparison is primarily in vitro based on materials and design, and in silico regarding MR safety and X-ray translucency.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission concerns a medical device accessory (ECG electrode) and relies on technical specifications and substantial equivalence, not a ground truth established by medical experts for a diagnostic performance study.
4. Adjudication Method for the Test Set
Not applicable, as a test set for clinical performance requiring adjudication is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is more common for diagnostic imaging algorithms where human readers' performance with and without AI assistance is evaluated.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study in the context of an algorithm is not discussed. This device is an electrode, not a standalone diagnostic algorithm. Its performance is tied to its physical properties and ability to reliably transmit an electrical signal according to industry standards.
7. Type of Ground Truth Used
The "ground truth" for this device, implicitly, is:
- Physical and material properties: Ensuring non-ferromagnetic characteristics for MR safety and X-ray translucency.
- Adherence to AAMI EC12 2000 standard: This standard sets performance benchmarks for ECG electrodes (e.g., impedance, offset voltage, noise) which are considered "ground truth" for electrical signal transmission quality.
- Substantial equivalence to the predicate device: The predicate device (SUPAtab) has an established history of safe and effective use, so matching its performance in critical aspects serves as a form of "ground truth."
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this device is not a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.
{0}------------------------------------------------
JUN 2 8 2004
510(k) Summary
Summery prepared: 31 of March 2004
Name and address of Device Manufacturer Submitting 510(k) Notification:
Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark
Regulatory Correspondent of Device Manufacturer:
US Agent:
Sanjay Parikh Technical & Regulatory Affairs Manager
Ambu Inc. 611 N. Hammonds Ferry Road Linthicum, Maryland 21090-1356
Phone: 800-262-8462 x 1136 Cell Phone: 443 831 9844
Name of device:
Ambu® Blue Sensor MRX, ECG electrode Catalogue number: MRX-00-S
Classification:
Class II 21 CFR 870.2360 Electrocardiograph electrode.
Intended Use:
The Ambu® Blue Sensor MRX electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram.
{1}------------------------------------------------
The electrode is designed for use in MR environment, therefore the electrode is MR safe, and for X-ray purposes, therefore the electrode is x-ray translucent.
The electrode is for single patient use only.
Predicate Device:
The predicate device used for the purpose of substantial equivalence under this submission was the Blue Sensor SUPAtab ECG Electrode (K983689).
The MRX electrode under this submission is almost identical with the SUPAtab electrode. The most important change is that the metal snap on the SUPAtab electrode has been changed to a snap made from a carbon filled polymer on the MRX electrode.
Both electrodes have an Ag/AgCl sensor material and they consist of the same materials except from the snap.
The SUPAtab electrode is not X-ray translucent and MR safe, however, the MRX electrode is X-ray translucent and MR safe. Both electrode types meet the AAMI EC12 2000 standard and have a shelf life of 2 years. They are both designed for single patient use only.
Description:
Each electrode consists of a foam material with an adhesive to be mounted on the patient.
The sensor element consists of a foil furnished with a conductive carbon filled polymer snap and a Ag/AgCl sensor point.
On top of the sensor point a sponge is positioned filled with a wet gel that conducts the signal from the patient further on to the electrode. The choise of materials ensures a non-ferromagnetic electrode which makes it x-ray translucent and MR safe.
The electrodes are delivered on a foil sheet with 8 electrodes and 32 electrodes are packed in a laminated foil pouch.
The electrode is non sterile and intended for single use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, graphic style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2004
Ambu, Inc. c/o Mr. Sanjay Parikh Technical and Regulatory Affairs Manager 611 North Hammonds Ferry Road Linthicum, MD 21090
Re: K041026
Trade Name: Ambu® Blue Sensor MRX, ECG Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: April 20, 2004 Received: April 21, 2004
Dear Mr. Parikh:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematic is substantially equivalent (for the indications for referenced above and have delemined the devices marketed in interstate commerce
use stated in the enclosure) to legally market in the institute in to devices that use stated in the enclosure) to icgaily hiarkets preasure Amendments, or to devices that prior to May 28, 1976, the enactivent date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features (PMA). You may have been reclassified in accordance with the provisions of the Act. The Act. The general Act (Act) that do not require approval of a premaincomponsisions of the Act. The general therefore, market the device, subject to the general securements for annual registration, listing of devices, good
controls provisions of the Act include requirements for and controls provisions of the Act mende requirements of the misbranding and adulteration.
manufacturing practice, labeling, and prohibitions against 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 (See above) more in the energing in the may be vice can be
may be subject to such additional controls. may be subject to such additional controls. Έλλοιή του 89%. In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to Analy found in the Code of I ederal Regarming your device in the Federal Register
{3}------------------------------------------------
Page 2 – Mr. Sanjay Parikh
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's issuance of a substantial order requirements of the Act or
that FDA has made a determination that your device complies with arener. that FDA has made a determination that your device with benevies. You must comply with
any Federal statutes and regulations administical by other for and listing (2) CFR Par any Federal statutes and regulations administered by toner resuation and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: reguirements as all the Act's requirements, including, but not institutions as es forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as es forth in the labeling (21 CFR Part 801); good mandations (21 cm if applicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni systems (QS) regulation (21 CF CF te act); 21 CFR 1000-1050.
control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. control provisions (Sections 331-542 of the Act, 21-21-21 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your active of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your device premarket notification. The FDA finding of substannal equivation of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rst the regulation of the 1901) 504 1648 - Algo, mlease note the regulati If you desire specific advice for your uevice on our a sening segments the regulation entitled,
contact the Office of Compliance at (301) 594-4648. Also, please not of the re contact the Office of Compliance at (301) 53+440. " (212) 17). You may obtain other
"Misbranding by reference to premarket notification of Sun Pixision of Small "Misbranding by reference to premaince homreation Act from the Division of Small
general information on your responsibilities under the Act from the (800) 6 general information on your responsibilities that its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free addremamain htm Manufacturers, International and Consumer Assistantes and coloridation and smamain.html
Sincerely yours,
Neil R.P. Ogden
Bram D. Zuckerman, M.I. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
of 1 Page l
510 (k) Number (if known):
K04/020
Device Name: Ambu® Blue Sensor MRX , ECG electrode
Indications For Use:
The MRX disposable ECG electrode is applied to the surface of the body to transmit the electrical signal at The MICA disposation DOS creen or app
the body surface to a processor in order to produce an electrocardiogram.
the oody surface to a processor in arest to promment and made for X-ray purposes, therefore is MR safe and X-ray translucent.
The electrode is made for single patient use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K041026 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.