(77 days)
No
The summary describes a standard patient monitor with gas analysis capabilities and alarm functions based on preset limits. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a patient monitor, capable of measuring vital signs and displaying gas monitoring data. Its primary function is to monitor, not to provide therapy.
Yes
Explanation: The device monitors various physiological parameters such as heart rate, respiration rate, blood pressure, temperature, arterial oxygen saturation, and analyzes arrhythmia and ST segments, all of which are used to assess a patient's medical condition and identify potential issues, characteristic of a diagnostic device. It also monitors end-tidal CO2 and anesthetic agents, which are diagnostic indicators in specific medical contexts.
No
The device description explicitly mentions hardware components like the "INFINITY GammaXL and SC 6802XL" monitors and a "Scio gas module" which are connected via a cable. The software runs on these hardware components.
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 description clearly states that this device monitors physiological parameters directly from the patient (Heart Rate, Respiration Rate, Pressure, Temperature, Oxygen Saturation, etc.) and analyzes breathing gases. It does not perform tests on samples taken from the body.
- Intended Use: The intended use is for monitoring patient vital signs and gas levels in a healthcare setting, not for analyzing biological samples.
Therefore, this device falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea is accomplished through impedance plethysmography and apnea through capnography, end-tidal carbon dioxide, and ST Segment Analysis. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.
This device is capable of monitoring:
- . Heart Rate
- Respiration Rate ●
- Invasive Pressure .
- . Non-Invasive Pressure
- Arrhythmia .
- . Temperature
- Arterial oxygen saturation .
- . Pulse rate
- central apnea accomplished through impedance plethysmography ●
- apnea accomplished through capnograpy .
- end-tidal CO2
- ST Segment Analysis ◆
This Infinity GammaXL and SC 6802XL will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.
When connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
Product codes
MHX, 74DSI, MSX, NHP
Device Description
The INFINITY GammaXL and SC 6802XL with software version VF3 and above are capable of displaying gas-monitoring data received from a Scio gas module (K031340). Anesthetic gas monitoring is available when a GammaXL or SC 6802XL is attacted via a specific cable to a Scio gas module. This is a password protected locked optical. The GammaXL and SC 6802XL with Scio are similar to the Infinity Modular Monitors with Scio (K031340) in that they display gas-monitoring parameters received from the Scio gas module. Testing of the INFINITY GammaXL and SC 6802XL with Scioindic bero new issues of safety and efficacy.
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 Arrhythmia and ST Segment Analysis which are not intended for the neonalal population.
Intended User / Care Setting
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
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)
Assessment of non-clinical performance data for equivalence: Verification and validation testing of the Infinity GammaXL and SC 6802XL with SCIO, indicates no new issues relative to safety and efficacy.
Assessment of clinical performance data for equivalence: The review of clinical data indicates that the GammaXL/SC 6802XL with Scio operates as intended with no adverse affects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1500 Enflurane gas analyzer.
(a)
Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.(b)
Classification. Class II (performance standards).
0
INFINITY GAMMAXL / SC 6802XL WITH SCIO
510(k) SUMMARY
as required per 807.92(c)
Submitters Name. Address:
(k) Notification
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 Regulatory Submissions Manager Date submission was prepared: January 23, 2004
Trade Name, Common Name and Classification Name: Trade Name: INFINITY GammaXL and SC 6802XL with Scio
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 | 870.1025 |
| Arrhythmia Detector & Alarm | 74DSI | II | 870.1025 |
| System, Network and Communication, | |||
| Physiological Monitors | MSX | II | 870.2300 |
Legally Marketed Device:
INFINITY GammaXL / SC 6802XL INFINITY Modular Monitors with Scio
K033600 / K030313 / K993974 K031340
Description of Device Modifications:
The INFINITY GammaXL and SC 6802XL with software version VF3 and above are capable of displaying gas-monitoring data received from a Scio gas module (K031340). Anesthetic gas monitoring is available when a GammaXL or SC 6802XL is attacted via a specific cable to a Scio gas module. This is a password protected locked optical. The GammaXL and SC 6802XL with Scio are similar to the Infinity Modular Monitors with Scio (K031340) in that they display gas-monitoring parameters received from the Scio gas module. Testing of the INFINITY GammaXL and SC 6802XL with Scioindic bero new issues of safety and efficacy.
Page 1 of 2
COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA . 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
Intended Use:
The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea is accomplished through impedance plethysmography and apnea through capnography, end-tidal carbon dioxide, and ST Segment Analysis. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.
Assessment of non-clinical performance data for equivalence: Verification and validation testing of the Infinity GammaXL and SC 6802XL with SCIO, indicates no new issues relative to safety and efficacy.
Assessment of clinical performance data for equivalence: The review of clinical data indicates that the GammaXL/SC 6802XL with Scio operates as intended with no adverse affects.
Biocompatability: Not applicable
Sterilization: Not applicable
- Draft Reviewer Guidance for Premarket Notification 510(k) Standards: Submissions, November 1993 IEC 601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
Page 2 of 2
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 features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written in a circle around the eagle. The eagle is black, and the text is also black. The background of the seal is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Penelope H. Greco Regulatory Submissions Manager Draeger Medical Systems, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923
Re: K040188
Trade/Device Name: Infinity Gammaxl and SC 6802XL with the Scio Gas Module Regulation Number: 868.1500 Regulation Name: Enflurane gas analyzer Regulatory Class: II Product Code: NHP. MHX Dated: April 8, 2004 Received: April 9, 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 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.
APR 1 4 2004
3
Page 2 - Ms. Greco
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 (OS) 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 (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 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.
Qur
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
510(k) Number (if known):_ KO40 188
Device Name: INFINITY GammaXL / SC 6802XL with Scio
Indications for Use:
This device is capable of monitoring:
- . Heart Rate
- Respiration Rate ●
- Invasive Pressure .
- . Non-Invasive Pressure
- Arrhythmia .
- . Temperature
- Arterial oxygen saturation .
- . Pulse rate
SAwhlm
logy. General Hospital
510(k) Number: KO 40188
- central apnea accomplished through impedance plethysmography ●
- apnea accomplished through capnograpy .
- � end-tidal CO2
- ST Segment Analysis ◆
This Infinity GammaXL and SC 6802XL will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.
When connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the device, 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 for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonalal population.
MRI Compatibility Statement:
The INFINITY GammaXL and SC 6802XL are not compatible for use in a MRI magnetic field.
Prescription Use _ ) OR Over-The-Counter Use_ (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)