AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

K100129 · Ambu A/S · DRX · Jun 11, 2010 · Cardiovascular

Device Facts

Record IDK100129
Device NameAMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
ApplicantAmbu A/S
Product CodeDRX · Cardiovascular
Decision DateJun 11, 2010
DecisionSESE
Submission TypeAbbreviated
Regulation21 CFR 870.2360
Device ClassClass 2
AttributesPediatric

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.

Device Story

Ambu® Blue Sensor NEO/NEO X are disposable, self-adhesive ECG electrodes for neonatal and pediatric patients. Multi-layer construction includes sensor, hydrogel, medical adhesive, top film/disc, and pre-attached lead wire with connector. Used in clinical settings, including high-humidity incubator environments, to transmit body surface electrical signals to an external ECG processor. Physician-ordered use. Benefits include gentle adhesion for fragile neonatal skin and reliable signal transmission for cardiac monitoring.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ANSI/AAMI EC12:2000 for electrical/mechanical functionality and ISO 10993-1 for biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity) confirmed.

Technological Characteristics

Multi-layer construction: sensor, hydrogel, medical adhesive, top film/disc, pre-attached lead wire with connector. Complies with ANSI/AAMI EC12:2000. Biocompatibility per ISO 10993-1, ISO 10993-5, and ISO 10993-10. Single-patient use, disposable.

Indications for Use

Indicated for ECG monitoring of neonatal and pediatric patients. Applied to body surface to transmit electrical signals for ECG or vectorcardiogram production. Single patient use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ ## Abbreviated 510(k) Application – Ambu® Blue Sensor NEO/NEO X ## 510(k) Summary - 1. 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 Contact person: Anne Bielefeldt Regulatory Affairs Specialist **JUN** **11** **2010** - 2. Preparation date of the 510(k) summary: April 2010 | | 3. Name of device:<br>Device Common name: | Disposable ECG electrode | |--|-------------------------------------------|--------------------------------------------------| | | Device Trade name: | Ambu® Blue Sensor NEO<br>Ambu® Blue Sensor NEO X | | | Classification Name: | Electrode, Electrocardiograph<br>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<br>Sensor NF | K902407 | DRX | | Ambu A/S | Ambu® Blue<br>Sensor BRS | K921579 | DRX | | Neotech Prod-<br>ucts, Inc. | Micro NeoLead | K011564 | DRX | | Ambu A/S | Ambu® Blue<br>Sensor<br>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. - 6. 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. 7. 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), - 8. 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: Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous reactivity test (ISO 10993-10) Result: All tests were passed. {2}------------------------------------------------ - 9. 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
Innolitics
510(k) Summary
Decision Summary
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