(144 days)
No
The document describes a standard multi-parameter patient monitor and gas analysis system. There is no mention of AI, ML, or any advanced analytical techniques beyond basic physiological parameter monitoring and alarm generation. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a "multi-parameter patient monitoring" system that produces alarms and recordings. Its function is to monitor physiological parameters and breathing gases, not to treat or provide therapy to a patient.
No
The device is intended for multi-parameter patient monitoring, producing real-time physiological data and alarms, but the text does not state that it provides a specific diagnosis based on this data. It provides information for healthcare professionals to assess the patient's medical condition.
No
The device description explicitly mentions "hardware modifications" and the intended use describes a "monitor" which is a hardware device. The software release is a modification to an existing hardware system.
Based on the provided information, 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 INFINITY Modular Monitors are described as monitoring physiological parameters directly from the patient (heart rate, respiration, pressure, temperature, etc.). While some modules sample breathing gases, this is still a direct measurement of gases being inhaled and exhaled by the patient, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states "multi-parameter patient monitoring" and describes the device's function in monitoring real-time physiological data and producing alarms based on these measurements.
The device is a patient monitoring system, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to an R50 Bedside recorder, either directly or via the INFINITY Network.
The INFINITY Modular monitors are capable of monitoring:
- Heart rate .
- Respiration rate .
- Invasive pressure .
- Non-invasive pressure .
- Arrhythmia .
- Temperature .
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- Apnea .
- ST Segment Analysis •
- 12-Lead ST Segment Analysis •
- tcn02/tcp(02 .
- EEG signals .
- FiQ2 .
The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas I he octo and ivalitious mancedo internet of CO2, NO, O2 and one of the anesthetic agents, halothane, inoduces continuously mousal rane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration with etCO2 and instream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.
The monitors can interface with specific third party devices via an MIB protocol converter.
The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the The devices are intended to ot Segment Analysis, and arrhythmia which are intended for use in the adult purameter Cardial Galph, and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
Product codes
MHX, 74DSI
Device Description
The INFINITY Modular monitor VF4 software release includes a modification in support of the Scio gas module for dual-anesthetic agent display.
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
Adult, Pediatric and Neonatal populations, with the exception of the ST Segment Analysis, and arrhythmia which are intended for use in the adult parameter Cardial Galph, and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
Intended User / Care Setting
Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, in the environment where patient care is provided.
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)
Verification and validation testing of VF4 software, as well as testing applicable to the hardware modifications for the new Draeger look indicate no new issues relative to safety and efficacy.
Testing in accordance with internal design control procedures has verified that the INFINITY Modular Monitors VF4 modifications with Scio are as safe and effective as the previous released versions of the monitors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K983632, K990563, K003243, K982730, K980882
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Special 510(k) Notification INFINITY Modular Monitors VF4 Modifications with Scio
MAY 1 4 2004
510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: May 13, 2004
Trade Name, Common Name and Classification Name:
-
A. Trade Name:
INFINITY Modular Monitors -
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Monitor, Physiological, Patient | |||
| (with arrhythmia detection or | |||
| alarms) | MHX | II | 21 CFR 870.1025 |
| Arrhythmia detector & Alarm | 74DSI | II | 21 CFR 870.1025 |
Legally Marketed Device Identification:
INFINITY Modular Monitors with Scio K031340 INFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K031340, K003243/K982730/ K980882
Description of Modification:
The INFINITY Modular monitor VF4 software release includes a modification in support of the Scio gas module for dual-anesthetic agent display.
Testing in accordance with internal design control procedures has verified that the INFINITY Modular Monitors VF4 modifications with Scio are as safe and effective as the previous released versions of the monitors.
1 of 2
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
Special 510(k) Notification INFINITY Modular Monitors VF4 Modifications with Scio
Intended Use:
The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to an R50 Bedside recorder, either directly or via the INFINITY Network.
Assessment of non-clinical performance data for equivalence:
Verification and validation testing of VF4 software, as well as testing applicable to the hardware modifications for the new Draeger look indicate no new issues relative to safety and efficacy.
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
IEEE 802.11 Standards and Guidances: Reviewer Guidance for Premarket Notification 510(k) Submissions, November 1993
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three stylized human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2004
Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, MA 01923
Re: K033957
Trade Name: INFINITY Modular Monitors VF4 Modifications with Scio Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor, (W/ Arrhythmia Detection or Alarms) Regulatory Class: II Product Code: MHX Dated: April 14, 2004 Received: April 15, 2004
Dear Ms. Greco:
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 adultcration.
If your device is classified (sec 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.
3
Page 2 -- Ms. Penelope H. Greco
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DT 5 issualled on that your device complies with other requirements mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and regirements, including, but not limited to: registration You must comply with an the Fee o required (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 007), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ison 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) This letter will anow you to begal mading of substantial equivalence of your device to a premarket notification. - The PD Printers 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), If you desire specific advice for your as at (301) 594-4646. 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 Inay obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driston 01 01 01638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
4
Indications for Use
510(k) Number (if known): Device Name:____ INFINITY Modular Monitors
Indications for Use:
The INFINITY Modular monitors are capable of monitoring:
- Heart rate .
- Respiration rate .
- Invasive pressure .
- Non-invasive pressure .
- Arrhythmia .
- Temperature .
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- Apnea .
- ST Segment Analysis ●
- 12-Lead ST Segment Analysis �
- tcn02/tcp(02 .
- EEG signals .
- FiQ2 .
The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas I he octo and ivalitious mancedo internet of CO2, NO, O2 and one of the anesthetic agents, halothane, inoduces continuously mousal rane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration with etCO2 and instream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.
The monitors can interface with specific third party devices via an MIB protocol converter.
The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the The devices are intended to ot Segment Analysis, and arrhythmia which are intended for use in the adult purameter Cardial Galph, and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
MRI Compatibility Statement:
The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.
Prescription Use_Y (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
(
(SDL)
Division Sign-Off)