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 Description

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.

AI/ML Overview

The primary document provided is a 510(k) summary for the Ambu® Blue Sensor NEO/NEO X disposable ECG electrodes. The study described focuses on demonstrating the substantial equivalence of the new device to previously marketed predicate devices, rather than a clinical efficacy study with human subjects.

Here's an analysis based on the provided text, addressing your specific questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance
Electrical and Mechanical Functionality: Meets ANSI/AAMI EC12:2000 - Disposable ECG Electrodes	All non-clinical tests passed.
Biocompatibility: Meets ISO 10993-1 - Biological evaluation of Medical Devices (including ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization, Intracutaneous reactivity))	All biocompatibility tests passed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document describes non-clinical laboratory tests. It does not specify the sample size of electrodes used for these tests.
Data Provenance: The tests are stated as "laboratory tests," implying they were conducted in a controlled environment. The country of origin of the data is not specified, but the manufacturer (Ambu A/S) is based in Denmark. The tests are prospective in the sense that they were conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This was a non-clinical study evaluating physical and biological properties against established standards, not a study requiring expert interpretation of diagnostic output to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no expert review or adjudication of diagnostic performance. The tests were objective measurements against predefined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a disposable ECG electrode, which is a hardware component for acquiring physiological signals. It does not involve AI or human readers for interpretation in the context of this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. This document pertains to electrodes, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance was established by recognized industry standards:

ANSI/AAMI EC12:2000 for electrical and mechanical functionality.
ISO 10993-1, ISO 10993-5, and ISO 10993-10 for biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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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

1. 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 NEOAmbu® Blue Sensor NEO X
	Classification Name:	Electrode, Electrocardiograph21 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® BlueSensor NF	K902407	DRX
Ambu A/S	Ambu® BlueSensor BRS	K921579	DRX
Neotech Prod-ucts, Inc.	Micro NeoLead	K011564	DRX
Ambu A/S	Ambu® BlueSensorNEO/NEO X	K053550	DRX

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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.

1. 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.

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),

1. 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.

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1. 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.

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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.

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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

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Indications for Use

510(k) Number (if known): K100129

Device Name: Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X

Indications For Use:

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

Regulation Number and Section

§ 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.