(143 days)
I'm sorry, I cannot fulfill that request. The provided input "Not Found" does not contain any information about Predicate Device(s) or K/DEN numbers. Therefore, I cannot identify or list them.
Not Found
No
The document describes a passive electrode for transmitting electrical signals and does not mention any processing or analysis of the signal using AI/ML.
No
The device is used for monitoring ECG signals, not for treating a disease or condition. Its purpose is diagnostic, to transmit electrical signals for an electrocardiogram.
Yes
The device is described as electrodes used for ECG monitoring, which involves transmitting electrical signals to a processor to produce an electrocardiogram or vectorcardiogram. This process of generating an electrocardiogram is a diagnostic function, as it provides information about the heart's electrical activity that can be used to identify medical conditions.
No
The device description clearly outlines a physical, multi-layer electrode with a pre-attached lead wire and connector, hydrogel, and adhesive. This is a hardware device, not software only.
Based on the provided text, 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 Function: The description clearly states that the Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are applied to the surface of the body to transmit electrical signals for ECG monitoring. This is an external application, not an analysis of a sample taken from the body.
- Intended Use: The intended use is for ECG monitoring, which is a physiological measurement taken from the body's surface.
Therefore, the device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Not Found
§ 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.
0
Abbreviated 510(k) Application – Ambu® Blue Sensor NEO/NEO X
510(k) Summary
-
- 510(k) owner: Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark Tel.: +45 72252000 Fax.: +45 72252050
ﻟﻬﻢ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ
- 510(k) owner: Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark Tel.: +45 72252000 Fax.: +45 72252050
Contact person: Anne Bielefeldt Regulatory Affairs Specialist
JUN
11 2010
-
- Preparation date of the 510(k) summary: April 2010
| | 3. Name of device:
Device Common name: | Disposable ECG electrode |
|--|-------------------------------------------|--------------------------------------------------|
| | Device Trade name: | Ambu® Blue Sensor NEO
Ambu® Blue Sensor NEO X |
| | Classification Name: | Electrode, Electrocardiograph
21 CFR 870.2360 |
| | Product Code: | DRX |
4. Identifies the legally marketed device to which equivalence is claimed
| Manufacturer | Trade Name | 510k number | Product code |
|---|---|---|---|
| Ambu A/S | Ambu® Blue | ||
| Sensor NF | K902407 | DRX | |
| Ambu A/S | Ambu® Blue | ||
| Sensor BRS | K921579 | DRX | |
| Neotech Prod- | |||
| ucts, Inc. | Micro NeoLead | K011564 | DRX |
| Ambu A/S | Ambu® Blue | ||
| Sensor | |||
| NEO/NEO X | K053550 | DRX |
1
5. Description of device
Ambu® Blue Sensor NEO/NEO X is non-sterile, self-adhesive ECG electrodes. Ambu® Blue Sensor NEO/NEO X should only be used by or on the order of a physician.
Ambu® Blue Sensor NEO/NEO X is single patient use disposable devices.
Ambu® Blue Sensor NEO/NEO X is a multi-layer construction containing a pre-attached lead wire with an attached connector, a top disc, a top film, a sensor, a hydrogel, and a medical adhesive.
The NEO/NEO X electrodes can be used for all pediatric populations (including neonates)
The adhesive on the NEO/NEO X electrodes is suitable in the high humidity environment in the incubators and still gentle to the fragile neonatal skin.
-
- The intended use
The Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are made for ECG monitoring of neonatal and paediatric patients. The ECG electrodes are 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. The electrodes are for single patient use only.
- The intended use
- Summary of the technological characteristics in comparison to the predicate devices
Ambu® Blue Sensor NEO/NEO X is a multi-layer construction containing a pre-attached lead wire with an attached connector, a top disc, a top film, a sensor, a hydrogel and a medical adhesive.
The technological characteristics of Ambu® Blue Sensor NEO/NEO X are identical to the predicate devices: (See section 4 of this summary),
-
- Brief discussion of the nonclinical tests submitted The non-clinical tests performed are laboratory tests to ensure the electrical and mechanical functionality of the electrode meets the standard ANSI/AAMI EC12:2000 - Disposable ECG Electrodes. All test are passed
The biological safety of the Ambu® Blue Sensor NEO/NEO X has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. Tests were selected on the basis of ISO 10993-1 - Biological evaluation of Medical Devices:
- Brief discussion of the nonclinical tests submitted The non-clinical tests performed are laboratory tests to ensure the electrical and mechanical functionality of the electrode meets the standard ANSI/AAMI EC12:2000 - Disposable ECG Electrodes. All test are passed
Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous reactivity test (ISO 10993-10) Result: All tests were passed.
2
-
- Clinical test Not Applicable
- 10.Conclusions drawn from the nonclinical, clinical and biocompatibility tests The Ambu® Blue Sensor NEO/NEO X meet the mandatory performance standard requirements under ANSI/AAMI EC12:2000 - Disposable ECG electrodes.
The biocompatibility of the Ambu® Blue Sensor NEO/NEO X has been established.
It is concluded that Ambu® Blue Sensor NEO/NEO X is as safe, as effective and performs as well as or better than the legally marketed devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 1 2010
Ambu Inc. c/o Mr. Sanjay Parikh Vice President Operations 6740 Baymeadow Dr. Glen Burnie, MD 21060
Re: K100129
Trade/Device Name: Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrodes Regulatory Class: Class II (Two) Product Code: DRX Dated: June 7, 2010 Received: June 8, 2010
Dear Mr. Parikh:
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 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.
4
Page 2 - Mr. Sanjay Parikh
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram Dl Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K100129
Device Name: Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X
Indications For Use:
The Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are made for ECG monitoring of neonatal and paediatric patients. The ECG electrodes are 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. The electrodes are for single patient use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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
Division of Cardloyascular Devices 00 510(k) Numbe
Page 1 of