(36 days)
Intended Use:
- Defibrillation
- Cardioversion
- Noninvasive Pacing
- ECG Monitoring
For use with ZOLL® Defibrillators:
- ZOLL Defibrillators, such as;
- R Series
- M Series
- E Series
By Trained Personnel only, Including:
- Physicians
- Nurses
- Paramedics
- Emergency Medical Technicians
- Cardiovascular Laboratory Technicians
The OneStep Pediatric Electrodes are indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg).
The OneStep pediatricElectrode System is intended for use with ZOLL Defibrillators, such as, R Series M Series, and E Series for ECG monitoring, defibrillation, noninvasive pacing and cardioversion of pediatric patients in either the hospital environment. The system is comprised of a single use, disposable electrode made of conductive hydrogel with a metal conductor and adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.
This submission for the OneStep™ Pediatric Multi-function Electrode is a 510(k) premarket notification claiming substantial equivalence to previously cleared devices. It doesn't describe a study designed to establish acceptance criteria for a novel device, but rather uses nonclinical testing to demonstrate that the new device meets established functional requirements and performance specifications defined in applicable national/international standards, and performs comparably to predicate devices.
Therefore, many of the requested sections (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how training ground truth was established) are not explicitly detailed in the provided document, as they would typically be for a de novo device or a more complex AI/diagnostic system.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The device leverages existing, recognized national and international standards for multi-function electrodes used with defibrillators. The acceptance criterion is essentially compliance with these standards and demonstrating comparable performance to the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets/exceeds National Standard ANSI/AAMI DF80 | The submission states: "All four products use the same hydrogel, adhesive material and have a conductive area similar in size that meet/exceed National and International Standards ANSI/AAMI DF80..." This implies the OneStep Pediatric Electrode meets or exceeds this standard. |
| Meets/exceeds International Standard EN 60601-2-4 | The submission states: "...and EN 60601-2-4 respectively." This implies the OneStep Pediatric Electrode meets or exceeds this standard. |
| Performance comparable to predicate devices in: Defibrillation, Cardioversion, Noninvasive Pacing, ECG Monitoring | "VPN 0731 addresses design validation to ensure the safety and effectiveness considerations have been successful in integrating the OneStep electrode with previously stated ZOLL defibrillators and performs as well and/or better than the legally marketed predicate devices." This suggests comparable or superior performance across all intended uses when integrated with ZOLL defibrillators. |
| Functional requirements and performance specifications | "The OneStep Pediatric Electrode System has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards." |
| Indicated for use on patients less than 8 years of age or weighing less than 55 Lbs (25Kg) | The device is explicitly indicated for this patient population. Performance in this specific population is validated through the aforementioned testing and compliance with standards. |
Study Details
-
Sample size used for the test set and the data provenance:
The document does not specify a "test set" in the context of clinical data for performance evaluation in the typical sense (e.g., patient cases). The evaluation relies on "extensive performance testing" against standards. The data provenance is nonclinical (laboratory/engineering testing) rather than patient data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this was a nonclinical performance validation against engineering standards and comparison to predicate devices, not a diagnostic or AI-based study requiring expert ground truth in clinical cases. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. -
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:
Not applicable. This is a medical device (electrode) for therapy and monitoring, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an electrode, not an algorithm. Its performance is inherent in its design and material properties. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission are the established performance specifications and functional requirements outlined in the ANSI/AAMI DF80 and EN 60601-2-4 standards, as well as the demonstrated safe and effective operation of the predicate devices. -
The sample size for the training set:
Not applicable. No "training set" is mentioned as this is not an AI/machine learning device. -
How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for BIO-DETEK INCORPORATED. The words "BIO-DETEK" are in large, bold, sans-serif font. Below that, the word "INCORPORATED" is in a smaller, sans-serif font. The logo is black and white.
MAY 1 3 2011
510(k) Summary: Rev. 2
Submitter's Name and Address: Bio-Detek, Inc. A Division of ZOLL®Medical Corporation 525 Narragansett Park Drive Pawtucket. RI 02861 Tel. (401) 729-1400
Contact Person: Robert Morse Director, Regulatory Affairs Tel. (866) 639-0060 x. 224
Date Summary Prepared: March 29, 2011
Device Name: OneStep™ Pediatric Multi-function Electrode
Classification Name: Electrode, Electrocardiograph, Multi-Function; Accessory to an External Defibrillator
Substantial Equivalence:
The OneStep Pediatric Electrode System is substantially equivalent to ZOLL ready-padz OneStep Pediatric Electrodes that were FDA cleared on 510(k), K06559. In addition, the OneStep Pediatric Electrode is substantially equivalent to the originally cleared ZOLL pedipadz solid gel identified on 510(k), K931787 and pedi-padz II cleared on K033474. The intent is to show that the OneStep Pediatric Electrodes will assist in providing therapy for defibrillation. cardioversion, Noninvasive pacing and ECG monitoring comparable to the previously cleared devices, for use with ZOLL Defibrillators. All of the cleared devices are in the Regulatory Class III category.
Description of Device:
The OneStep pediatricElectrode System is intended for use with ZOLL Defibrillators, such as, R Series M Series, and E Series for ECG monitoring, defibrillation, noninvasive pacing and cardioversion of pediatric patients in either the hospital environment.
525 Narragansell Park Drive, Pawtucket, Rhode Island 02861-4323, Tel. (401) 729-1400 or (800) 729-1408
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The system is comprised of a single use, disposable electrode made of conductive hydrogel with a metal conductor and adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment.
Indications for Use:
Intended Use:
- o Defibrillation
- o Cardioversion
- o Noninvasive Pacing
- o ECG Monitoring
For use with ZOLL® Defibrillators:
- ZOLL Defibrillators, such as; o
- R Series o
- M Series o
- E Series 0
By Trained Personnel only, Including:
- Physicians 0
- Nurses 0
- Paramedics �
- Emergency Medical Technicians o
- Cardiovascular Laboratory Technicians o
The OneStep Pediatric Electrodes are indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg).
Comparison of Technological Characteristics:
The intended use of the OneStep Pediatric Multi-Function Electrodes as described in the indications for use, and labeling, has not changed as a result of this submission. For the ZOLL R Series, M Series and E Series, the connection to the defibrillator cable is identical to the predicate devices. All four products use the same hydrogel, adhesive material and have a conductive area similar in size that meet/exceed National and International Standards ANSI/AAMI DF80 and EN 60601-2-4 respectively.
Nonclinical Testing:
The OneStep Pediatric Electrode System has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards.
Validation Project Number (VPN) 0731 addresses design validation to ensure the safety and effectiveness considerations have been successful in integrating the OneStep electrode with previously stated ZOLL defibrillators and performs as well and/or better than the legally marketed predicate devices. Applicable standards are defined in Form FDA 3514, VPN 0731 and Section 2, Device Description, within this premarket submission.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zoll Medical Corporation c/o Mr. Robert Morse Director, Regulatory Affairs Bio-Detek, Inc. 525 Narragansett Park Drive Pawtucket, RI 02861
MAY 1 3 2011
Re: K110978
Trade/Device Name: OneStep Pediatric Multi-function Electrode Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ, DRO, DQA, LDD, LIX Dated: April 6, 2011 Received: April 7, 2011
Dear Mr. Morse:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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. Robert Morse
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
fu-
Bram D. 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
K110978 510(k) number (if known): __
Device Name: OneStep™ Pediatric Multi-Function Electrode
Intended Use:
- Defibrillation �
- . Cardioversion
- Noninvasive Pacing ◆
- ECG Monitoring .
For use with ZOLL® Defibrillators:
- ZOLL Defibrillators, such as; .
- R Series �
- M Series .
- E Series .
By Trained Personnel only, Including:
- Physicians �
- Nurses ●
- Paramedics .
- Emergency Medical Technicians �
- Cardiovascular Laboratory Technicians
The OneStep Pediatric Electrodes are indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg).
(Please do not write below this line - Continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off Division of Cardiovascular Devices
510(k) Number k//0178
Prescription Use న OR
Over the Counter Use
Rev. 1
OneStep™ Pediatric
(Per 21 CFR 801.109)
Section 4, pg. 1
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.