(27 days)
Intended Use:
- Defibrillation .
- Cardioversion ●
- Noninvasive Pacing
- . ECG Monitoring
- CPR Sensor .
For use with ZOLL @ Defibrillators:
- R Series ◆
- M Series ●
By Trained Personnel only, Including:
- Physicians .
- Nurses ◆
- Paramedics .
- Emergency Medical Technicians .
- Cardiovascular Laboratory Technicians .
The OneStep Adult Electrodes are not indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg).
The OneStep Electrode System is intended for use with ZOLL R Series and M Series for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Sensor of adult patients in either the hospital or pre-hospital environment.
Through part number selection you can choose the full featured Complete model down to the Basic version which offers fewer therapy options. The OneStep Adult Electrodes consist of 5 versions related to the combination of features included with the electrodes.
The system is comprised of a single use, disposable electrode made of solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment. By product selection it is determined whether all therapy providing options are available or a reduced choice is made as applicable to caregiver needs.
This submission describes a Special 510(k) for the OneStep Adult Multi-Function Electrode, primarily to address a change in the self-test continuity circuit. The device is determined to be substantially equivalent to previously cleared ZOLL electrodes. The provided document does not contain acceptance criteria or a study that directly proves the device meets specific performance acceptance criteria in the context of typical AI/software device evaluation.
Instead, the document focuses on:
- Demonstrating substantial equivalence to predicate devices (ZOLL ready-padz OneStep Electrodes K060559 and ZOLL stat: padz MWP K051076).
- Describing a change in the self-test continuity circuit to enhance its effectiveness and reliability.
- Stating that the device has undergone "extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards."
- Mentioning Validation Project Number (VPN) 0730 which "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."
Therefore, the following information cannot be extracted from the provided text for the reasons stated below:
-
A table of acceptance criteria and the reported device performance: The document does not explicitly state numerical acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) nor does it provide a table of reported device performance against such criteria. It generally states that the device 'meets/exceeds National and International Standards ANSI/AAMI DF80 and EN 60601-2-4' but doesn't list specific metrics or results.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No specific clinical test set, sample size, or data provenance (country, retrospective/prospective) is described. The document refers to "clinical service since the latter part of October, 2006" for a previous version of the device, implying historical clinical use, but not a specific study with a defined test set for this submission.
-
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): Since no specific clinical test set is detailed, information about experts for ground truth establishment is not available.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no specific clinical test set is described.
-
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 device is an electrode for defibrillators, ECG monitoring, pacing, and CPR sensing. It does not involve "human readers" or AI assistance in the way a diagnostic imaging AI would.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical electrode system, not a standalone algorithm. Its function is to facilitate medical procedures.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology for cancer detection) does not directly apply here. The performance is assessed against technical standards for electrical and mechanical properties, and compatibility with defibrillators.
-
The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set in the conventional sense.
-
How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information from the Provided Text (within the context of the device):
- Device Type: Electrocardiograph, Multi-Function Electrode with CPR Sensor.
- Purpose of current submission (Special 510(k)): To address the relocation of the self-test continuity circuit.
- Performance Assessment:
- The device 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."
- The electrodes use the same hydrogel, acrylic adhesive closed-cell foam, and have a conductive area of the same dimensional size as predicate devices.
- The device "meet/exceed National and International Standards ANSI/AAMI DF80 and EN 60601-2-4 respectively."
- Validation Project Number (VPN) 0730 ensures "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."
In essence, the "study" proving the device meets acceptance criteria referred to here is a set of engineering and compliance tests against established national and international standards for medical electrodes and defibrillation accessories, along with design validation comparing its performance to predicate devices, focusing on the changes made (self-test circuit). Specific quantitative data from these tests are not present in this summary.
{0}------------------------------------------------
K110742
NCORPORA
APR 1 3 2011
510(k) Summary: Rev. 5
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: February 23, 2011
Device Name: OneStep ™ Adult Multi-Function Electrode (MFE)
Classification Name:
Electrode, Electrocardiograph, Multi-Function with CPR Sensor; Accessory to an Automated External Defibrillator
Substantial Equivalence:
The OneStep Electrode Family is substantially equivalent to ZOLL ready-padz OneStep Electrodes that were FDA cleared on 510(k), K060559. In addition, the OneStep Electrode is substantially equivalent to the originally cleared ZOLL stat: padz MWP identified on 510(k), K051076. The intent is to show that the OneStep Electrodes will assist in providing therapy for Defibrillation, Cardioversion, External Noninvasive Pacing, ECG Monitoring and CPR Sensor 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 Electrode System is intended for use with ZOLL R Series and M Series for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Sensor of adult patients in either the hospital or pre-hospital environment.
525 Narragansell Park Drive, Pawtucket, Rhode Island 02861-4323, Tel. (401) 729-1400 or (800) 729-1408
{1}------------------------------------------------
Through part number selection you can choose the full featured Complete model down to the Basic version which offers fewer therapy options. The OneStep Adult Electrodes consist of 5 versions related to the combination of features included with the electrodes. The chart below contains the versions and their features:
| Version | MFE | CPR | MWP | Self Test | ZOLL Part Number |
|---|---|---|---|---|---|
| OneStep Complete | x | x | x | x | 8900-0214-01 |
| OneStep CPR AA | x | x | x | 8900-0217-01 | |
| OneStep CPR AP | x | x | x | 8900-0213-01 | |
| OneStep Pacing (MWP) | x | x | x | 8900-0212-01 | |
| OneStep Basic | x | x | 8900-0211-01 |
OneStep Electrode Versions:
MFE - Multi-Function Electrode
CPR - CPR Sensor
(Cardiopulmonary Resuscitation Aid)
MWP - Imbedded ECG Electrodes in front pad for pacing (MWP = Monitor While Pace)
AA - Optimized for Anterior / Anterior Placement
AP - Anterior / Posterior Placement
The system is comprised of a single use, disposable electrode made of solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment. By product selection it is determined whether all therapy providing options are available or a reduced choice is made as applicable to caregiver needs.
Indications for Use
Device Name: OneStep™ Adult Multi-Function Electrode
Intended Use:
- Defibrillation .
- Cardioversion ●
- Noninvasive Pacing �
- . ECG Monitoring
- CPR Sensor .
For use with ZOLL @ Defibrillators:
- R Series ◆
- M Series ●
{2}------------------------------------------------
By Trained Personnel only, Including:
- Physicians .
- Nurses ◆
- Paramedics .
- Emergency Medical Technicians .
- Cardiovascular Laboratory Technicians .
The OneStep Adult Electrodes are not 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 Multi-Function Electrodes as described in the indications for use, and labeling has not changed as a result of this submission. For the connection of the OneStep Family of Electrodes in this submission to the ZOLL defibrillator cables are similar to the predicate devices with the addition of the M Series utilizing an adaptor for CPR Monitoring functionality which can be procured under ZOLL part number 8000-0599. The OneStep MFE's within this submission as compared to the two ZOLL predicate electrode devices using the same hydrogel, acrylic adhesive closed cell foam and have a conductive area of the same dimensional size that meet/exceed National and International Standards ANSI/AAMI DF80 and EN 60601-2-4 respectively.
Nonclinical Testing & Clinical Service:
The OneStop 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. The ZOLL OneStep Electrode Family has been in clinical service since the latter part of October, 2006 through a substantial equivalence determination by FDA for clearance to distribute through a Traditional 510(k) process. This Special 510(k) has been compiled to address the relocation of the self test continuity circuit from the opening process of the pouch to two disconnect points on each electrode. Upon electrode removal from the release liner material, exposed when the pouch is opened, the self test circuit will disengage allowing therapy to be carried-out. It is our intent to present a safer and more reliable circuit disconnects to enhance the effectiveness of the self test process.
Validation Project Number (VPN) 0730 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 0730 and Section 2. Device Description, within this premarket submission.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract, curved shapes that resemble a bird in flight or flowing ribbons.
Public Health Service
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 Bio-Detek, Inc. 525 Narragansett Park Drive Pawtucket, RI 02861
APR 1 3 2011
Re: K110742
Trade/Device Name: Onestep Adult 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: March 1.7, 2011 Received: March 18, 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. Iisting 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
{4}------------------------------------------------
Page 2 - Mr. Robert Morse
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.
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?
signature
Bram D. Zuckerman, M.D. for 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): _ 长 ١١٥٦٧ 2
Device Name: OneStep™ Adult Multi-Function Electrode
Intended Use:
- Defibrillation .
- Cardioversion .
- Noninvasive Pacing �
- ECG Monitoring .
- CPR Sensor, (Optional) �
For use with ZOLL وه Defibrillators:
- R Series .
- M Series .
By Trained Personnel only, Including:
- Physicians ●
- Nurses ●
- Paramedics .
- Emergency Medical Technicians .
- Cardiovascular Laboratory Technicians ●
The OneStep Adult Electrodes are not 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) | ||||
| for Division of Cardiovascular Devices | ||||
| 510(k) Number | K110 792 | |||
| Prescription Use | OR | Over the Counter Use | ||
| (Per 21 CFR 801.109) | Rev. 4 |
§ 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.