(28 days)
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No
The document describes a device for monitoring EtCO2 and respiration rate using infrared absorption technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a patient monitor that measures EtCO2 and respiration rate; it does not directly treat a condition or restore function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate." Monitoring patient physiological parameters for clinical assessment and decision-making is a diagnostic function.
No
The device description explicitly states it includes a "module is contained in a small plastic enclosure with a short cable" and uses "infrared absorption technology," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device 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.
- Device Function: The ZOLL M Series EtCO2 LoFlo™ Option is described as a device for continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate. It uses sampling cannulas and on-airway adapter kits to measure gases exhaled by the patient.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient's body. The measurement is of the gas being exhaled.
Therefore, the device falls under the category of a patient monitoring device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ZOLL M Series EtCO2 LoFlo™ Option is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in intubated and non-intubated adult, pediatric and infant patients requiring ventilator support, procedural sedation, transport, anesthesia and other clinical vonditions where EtCO, monitoring is deemed appropriate by the attending care giver. The M Series EtCO2 LoFlo™ Option uses nasal and nasal/oral sampling cannulas and sidestream on-airway adapter kits .
Product codes
MKJ, CCK
Device Description
The ZOLL M Series EtCO2 Option with LoFlo™ Sidestream CO2 is a sidestream sampling system using a 50ml/minute low sampling rate to measure the EtCO2 of non-intubated and intubated infant, pediatric and adult patients using specially designed sampling cannulas and on-airway adapter kits.
The LoFlo™ Sidestream CO2 module includes Respironics Novametrix CAPNOII infrared absorption technology. The module is contained in a small plastic enclosure with a short cable that connects to the same M Series connector used by the existing EtCO2 Capnostat 3 sensor. The module uses the same hardware communications interface to the M Series as the existing Capnostat 3 sensor and a slightly expanded software communications protocol.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adult, pediatric and infant
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Extensive performance testing ensures that the ZOLL M Series EtCO2 LoFlo™ Option meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards.
Conclusion
Performance and safety testing of the ZOLL M Series EtCO2 LoFlo™ Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the word "ZOLL" in bold, sans-serif font. The letters are large and blocky, with a slightly rough or textured appearance. The word is horizontally oriented and centered in the image.
OCT 5 - 2004
ZOLL Medical Corporation
Worldwide Headquarters Chelmsford, Massachusetts 01824-4105 USA 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:
Sean Reynolds (978) 421-9655, Ext. 9386
Date Summary Prepared:
August 24, 2004
Device:
ZOLL. M Series EtCO2 LoFlo™ Option
Classification:
The previously approved EtCO2 Option (K993036) was established as a Class III device due to its combination with the ZOLL Defibrillator/Pacer/Monitor, which was classified as being Class III under 510(k) application number K972241. The proposed update to the EtCO2 Option would maintain a Class III status due to the same configuration.
Description:
The ZOLL M Series EtCO2 Option with LoFlo™ Sidestream CO2 is a sidestream sampling system using a 50ml/minute low sampling rate to measure the EtCO2 of non-intubated and intubated infant, pediatric and adult patients using specially designed sampling cannulas and on-airway adapter kits.
The LoFlo™ Sidestream CO2 module includes Respironics Novametrix CAPNOII infrared absorption technology. The module is contained in a small plastic enclosure with a short cable that connects to the same M Series connector used by the existing EtCO2 Capnostat 3 sensor. The module uses the same hardware communications interface to the M Series as the existing Capnostat 3 sensor and a slightly expanded software communications protocol.
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Substantial Equivalence:
The features and functions of the proposed update to the M Series EtCO2 Option are substantially equivalent to the current features and functions of the EtCO2 Option (K993036), cleared for use on 2/28/2000 and the GE Medical Systems Dash 3000/4000 Patient Monitor (K030431), cleared for use on 2/26/2003.
Intended Use:
The ZOLL M Series EtCO2 LoFlo™ Option is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in intubated and non-intubated adult, pediatric and infant patients requiring ventilator support, procedural sedation, transport, anesthesia and other clinical vonditions where EtCO, monitoring is deemed appropriate by the attending care giver. The M Series EtCO2 LoFlo™ Option uses nasal and nasal/oral sampling cannulas and sidestream on-airway adapter kits .
Comparison of Technological Characteristics
The features and functions of the ZOLL M Series EtCO2 LoFlo™ Option are similar to those of the currently marketed ZOLL M Series EtCO2 Option. The LoFlo™ Sidestream feature utilizes the existing CO2 measurement technology adapted to include a gas sampling system for monitoring the end tidal carbon dioxide and respiration rate in resting adult, pediatric and infant patients using specially designed sampling cannulas and on-airway adapter kits. These sampling cannulas and on-airway adapter kits are the same as those used on the GE Medical Systems Dash 3000/4000 Patient Monitor.
The existing mainstream EtCO, features, functions and technology will continue to be provided in the M Series in addition to the sidestream option.
Performance Testing:
Extensive performance testing ensures that the ZOLL M Series EtCO2 LoFlo™ Option meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards.
Conclusion
Performance and safety testing of the ZOLL M Series EtCO2 LoFlo™ Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like extensions, suggesting movement or flight.
Public Health Service
OCT 5 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zoll Medical Corporation C/O Mr. Sean Reynolds Regulatory Affairs Engineer Worldwide Headquarters 269 Mill Road Chelmsford, Massachusetts 01824-4105
Re: K042417
Trade/Device Name: Zoll M Series EtCO2 LoFloTM Option Regulation Number: 870.5310, 868.1400 Regulation Name: Automated External Defibrillator, Carbon Dioxide Gas Analyzer Regulatory Class: III Product Code: MKJ, CCK Dated: September 3, 2004 Received: September 8, 2004
Dear Mr. Reynolds:
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 such 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. Reynolds
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chih-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
ZOLL M Series EtCO2 LoFlo™ Option Device Name:
Indications for Use:
The ZOLL M Series EtCO2 Option with Respironics Novametrix technology and Capnostat® sensor is indicated for the continuous noninvasive monitoring of end tidal carbon dioxide (EtCO2) and respiration rate in patients requiring ventilator support, transport, and anesthesia. The M Series EtCO2 Option is designed to monitor adult, pediatric, and neonatal patients.
Amy Jackson
(Division Sign-Qff) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
K042417 510(k) Number: _
X Prescription Use (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)