(238 days)
Not Found
No
The description focuses on data collection, storage, display, and transfer, with no mention of AI/ML algorithms for analysis or interpretation. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as a software product for data collection, storage, and display related to cardiac arrest events, specifically for documenting care provided, not for delivering therapy.
No
The instructions explicitly state that the device 'should only be used by those whose responsibilities do not include direct delivery of therapy or diagnostic decision making.' This indicates it is not a diagnostic device. Its purpose is to collect, store, and display patient data, not to interpret or diagnose.
Yes
The device description explicitly states "The proposed ZQLL Code Writer is a software-only product." and describes two software components. While it runs on a Microsoft Windows Smart Phone, the device itself is the software, not the phone hardware.
Based on the provided information, the ZOLL Code Writer 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. They are used to provide information for diagnosis, monitoring, or screening.
- Code Writer's Function: The Code Writer's intended use is for the collection, storage, and display of patient data related to cardiac arrest events. This data is entered by a user (ACLS caregiver) or uploaded from a defibrillator/monitor. It is a tool for documentation and record-keeping of care provided during an event.
- No Analysis of Biological Samples: The description does not mention the Code Writer analyzing any biological samples from the patient. Its function is purely related to managing and displaying data about the event and the care given.
- Intended Use Focus: The intended use clearly states its purpose is for documenting care and generating a record of patient data, not for performing diagnostic tests on patient samples.
Therefore, the ZOLL Code Writer falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Code Writer is intended for the collection, storage and display of patient data that is entered by a user (ACLS caregiver) or uploaded from a ZOLL R Series defibrillator/ monitor. Code Writer is intended for use by qualified ACLS caregivers responding to cardiac arrest events in a hospital environment to document the care provided. Code Writer is indicated for use by health care providers whenever there is a need for generation of a record of patient data for cardiac arrest events in a hospital environment. Code Writer should only be used by those whose responsibilities do not include direct delivery of therapy or diagnostic decision making.
Product codes (comma separated list FDA assigned to the subject device)
DXJ, NSX
Device Description
The proposed ZQLL Code Writer is a software-only product. The primary goal of Code Writer is to provide a reliable and consistent method for Advanced Cardiac Life Support (ACLS) caregivers to electronically record observations and care interventions during cardiac resuscitation events and allow users to view, edit and integrate that data into their medical record systems. The Code Writer system is comprised of two components, Code Writer and Code Writer Service software. Code Writer is a software application that runs on a Microsoft Windows Smart Phone. Code Writer allows users to log code events in real time; code records can be saved to the mobile device for later viewing and modification. The code record can be transferred to a server computer using the wireless communication capabilities of the mobile device to communicate with the Code Writer Service software which is installed on the server computer. Code Writer Service software enables the uploading of defibrillator data to the code record that is stored in Code Writer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Code Writer is intended for use by qualified ACLS caregivers responding to cardiac arrest events in a hospital environment to document the care provided. Code Writer is indicated for use by health care providers whenever there is a need for generation of a record of patient data for cardiac arrest events in a hospital environment. Code Writer should only be used by those whose responsibilities do not include direct delivery of therapy or diagnostic decision making.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive performance testing ensures that ZOLL Code Writer performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ZOLL RescueNet ePCR (K103473)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
ZOLL Medical Corporation, Worldwide Headquarters Shannon Duhamel Regulatory Affairs Specialist 269 Mill Road Chelmsford, Massachusetts 01824-4105
September 1, 2023
Re: K132488
Trade/Device Name: ZOLL Code Writer Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-ray Tube Display Regulatory Class: Class II Product Code: DXJ
Dear Shannon Duhamel:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 3, 2014. Specifically, FDA is updating this SE Letter to remove the secondary product code NSX as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Aneesh Deoras, OHT2: Office of Cardiovascular Devices, 240-402-4363, Aneesh.Deoras@fda.hhs.gov.
Sincerely,
Aneesh S. Deoras -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
Zoll Medical Corporation c/o Ms. Shannon Duhamel Regulatory Affairs Specialist 269 Mill Road Chelmsford, MA 01824-4105
Re: K132488
Trade/Device Names: Zoll Code Writer Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-ray Tube Display Regulatory Class: Class II (two) Product Code: DXJ, NSX Dated: February 24, 2014 Received: February 25, 2014
Dear Ms. Duhamel:
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.
2
Page 2 - Ms. Shannon Duhamel
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); fabeling (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 4 - INDICATIONS FOR USE
510(k) Number (if known): K132488 Device Name: ZOLL Code Writer
Intended Use:
Code Writer is intended for the collection, storage and display of patient data that is entered by a user (ACLS caregiver) or uploaded from a ZOLL R Series defibrillator/ monitor. Code Writer is intended for use by qualified ACLS caregivers responding to cardiac arrest events in a hospital environment to document the care provided. Code Writer is indicated for use by health care providers whenever there is a need for generation of a record of patient data for cardiac arrest events in a hospital environment. Code Writer should only be used by those whose responsibilities do not include direct delivery of therapy or diagnostic decision making.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bram D. Zuckerman -S
2014.04.03 13:37:27 -04'00'
Page 1 of 1
4
Image /page/4/Picture/1 description: The image shows the word "ZOLL" in a bold, sans-serif font. The letters are all capitalized and black. A small registered trademark symbol is located to the right of the second "L" in the word. The background is plain white.
ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A.
APR 0 3 2014
978-421-9655 978-421-0025 Main Fax
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Shannon Duhamel
(978) 421-9574
Date Summary Prepared:
August 6, 2013
Device:
ZOLL Code Writer
Classification:
Classification Product Code:
21 CFR 870.2450. Display. Cathode Ray Tube, Medical. Product code: DXJ. Device Class: 2.
Secondary Product Code:
Software, Transmission and Storage, Patient Data. Product code: NSX. Device Class: Not Classified.
Description:
The proposed ZQLL Code Writer is a software-only product. The primary goal of Code Writer is to provide a reliable and consistent method for Advanced Cardiac Life Support (ACLS) caregivers to electronically record observations and care interventions during cardiac resuscitation events and allow users to view, edit and integrate that data into their medical record systems. The Code Writer system is comprised of two components, Code Writer and Code Writer Service software. Code Writer is a software application that runs on a Microsoft Windows Smart Phone. Code Writer allows users to log code events in real time; code records can be saved to the mobile device for later viewing and modification. The code record can be transferred to a server computer using the wireless
ર-I
5
K132488
communication capabilities of the mobile device to communicate with the Code Writer Service software which is installed on the server computer. Code Writer Service software enables the uploading of defibrillator data to the code record that is stored in Code Writer.
The minor differences between the Indications For Use for the proposed device and the predicate device merely reflect the more limited application of the proposed device as compared with the predicate device, specifically that the proposed Code Writer device is intended to be used by a very specific type of caregiver (ACLS) responding to very specific types of medical situations (cardiac arrest events) within a hospital environment.
Intended Use:
Code Writer is intended for the collection, storage and display of patient data that is entered by a user (ACLS caregiver) or uploaded from a ZOLL R Series defibrillator/ monitor. Code Writer is intended for use by qualified ACLS caregivers responding to cardiac arrest events in a hospital environment to document the care provided. Code Writer is indicated for use by health care providers whenever there is a need for generation of a record of patient data for cardiac arrest events in a hospital environment. Code Writer should only be used by those whose responsibilities do not include direct delivery of therapy or diagnostic decision making.
Substantial Equivalence:
The features and functions of the proposed ZOLL Code Writer are substantially equivalent to the predicate device, ZOLL RescueNet ePCR (K103473), cleared for use on 05/13/2011.
Comparison of Technological Characteristics:
ZOLL Code Writer System shares similar features and functions as the predicate device, ZOLL RescueNet ePCR. Both products are software applications designed to function on mobile devices that utilize Microsoft Windows. Both ZOLL Code Writer and the indicated predicate device are non-alarming softwareonly products intended for the collection and storage of patient data that is entered by a user (caregiver). Both software products upload patient data wirelessly from ZOLL defibrillators. After the information is collected on the mobile device, both software products allow the user to transmit the patient data wirelessly to a server computer where the information can be securely accessed by medical personnel for the further review, annotation and retrieval of patient data.
Code Writer is indicated for use by Advanced Cardiac Life Support (ACLS) caregivers in a hospital environment, whereas the indicated predicated for use by Emergency Medical Services (EMS) personnel engaged in acute or routine pre-hospital care or transport.
No new issues of safety or effectiveness are raised by this premarket notification.
6
Performance Testing:
Extensive performance testing ensures that ZOLL Code Writer performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications.
Conclusion:
.『
The information provided in this 510(k) submission demonstrates that the features and functions of the proposed ZOLL Code Writer software product are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.