(168 days)
Not Found
No
The document describes a gas analysis module that measures respiratory and anesthetic gases using sensors (galvanic cell and paramagnetic sensor). There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The software update mentioned appears to be for compatibility and data reporting, not for implementing AI/ML algorithms.
No
The device is solely for measurement and monitoring of patient parameters, not for treating conditions or diseases.
Yes
The device measures physiological parameters (respiration rate, CO2, O2, and anesthetic gas concentrations) from the patient, which are then used by healthcare professionals to determine if these devices are required for patient care. This process of measuring and displaying patient data for healthcare professionals to assess health status aligns with the purpose of a diagnostic device.
No
The device description explicitly states that the devices are "free standing units" and describes hardware components like galvanic cells and paramagnetic sensors for gas measurement. While software is mentioned as being enhanced, the core functionality relies on physical hardware modules.
Based on the provided text, the Siemens SC9000/SC9015 MULTIGas and MULTIGas+ Modules are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is to measure respiratory and anesthetic gases directly from the patient's breathing circuit. This is a measurement of physiological parameters in vivo (within the living body), not in vitro (outside the living body using samples).
- Device Description: The description confirms that the modules perform "sidestream measurements of respiratory gases," which means they are sampling gas directly from the patient's airway.
- Lack of IVD Characteristics: The description does not mention the analysis of biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.
Therefore, these modules are considered patient monitoring devices, not IVD devices.
N/A
Intended Use / Indications for Use
The intended use of the Siemens SC9000/ SC9015 MULTIGas ™ Module is to measure inspiratory and expiratory carbon dioxide, inspiratory oxygen, inspiratory and expiratory Nitrous Oxide and anesthetic agents. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce recordings. This device will connect to either the Siemens SIRENET or Infinity (Olympus) network.
The Siemens SC9000/SC9015 MULTIGas "" and MULTIGas+"" Modules are indicated for adult and pediatric patient populations in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that these devices are required to measure any one or more of the following parameters:
- . Respiration rate
- inspired and expired Carbon Dioxide (CO3) .
- inspired and expired Oxygen (MULTIGas+ only) 9
- average inspired Oxygen (MULTIGas only)
- inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, . Sevoflurane, and Nitrous Oxide
Product codes (comma separated list FDA assigned to the subject device)
74DRT, 74DSI, 73BZQ, 74BWS, 74DXN, 80BWX, 74DQA, 74KFN, 73CCK, 74CAA, 74FLO, 73FLS, 74FLP, 73CBQ, 73CBS, 73CBR, 73CCL
Device Description
There are two multi gas modules being submitted as part of this 510(K) Notification: the MULTIGas™ (MGM) and the MULTIGas+ "" (MGM+). Both modules are free standing units that perform sidestream measurements of respiratory gases (CQ2, N3O, and O2) and anesthetic gases. Both modules automatically identify and report measurement data to the SC9000/SC9015 Bedside Monitor for display.
The MULTIGas™ and MULTIGas+ ™ modules differ only in the way they measure O2. The basic MULTIGas Module measures O2 using a galvanic cell, and calculates average inspiratory values for O2 (labeled iO2). The MULTIGas+ incorporates a faster-responding paramagnetic sensor that provides both inspired and expired O2 measurements (iO2 and etO2).
The enhanced software (version VB1.1) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions.
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 and Pediatric
Intended User / Care Setting
healthcare professionals (Physician, Nurse, Technician)
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)
Not Found
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.
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
§ 870.1025 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
K 96 50 60
JUN - 4 1997
510 (K) Notification 510 (K) Notification
Siemens SC9000/ SC9015 MULTIGas ™ and MULTIGas+ ™ Modules
510(k) SUMMARY
as required per 807.92(c)
2: Submitters Name, Address:
Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Fax. (306) 771-55376
Official Correspondent: David Simard, Director Quality Assurance and Regulatory Affairs Contact person for this submission: Jacqueline E. M. Emery Date submission was prepared: December 9, 1996
3: Trade Name, Common Name and Classification Name:
A. Trade Name: Siemens SC9000/ SC9015 Series MULTIGas ™ Module Siemens SC9000/SC9015 Series MULTIGas+ ™ Module
B. Common Name, Classification Number, Class and Regulation Number:
| Common Name | Classification Number | Class | Regulation Number |
|---|---|---|---|
| Cardiac monitor | 74DRT | II | 21 CFR 870.2300 |
| Arrhythmia detector | |||
| & Alarm System | 74DSI | III | 21 CFR 870.1025 |
| Breathing frequency | |||
| monitor | 73BZQ | II | 21 CFR 868.2375 |
| Pulse rate monitor | 74BWS | II | 21 CFR 870.2300 |
| Non-indwelling blood | |||
| pressure monitor | 74DXN | II | 21 CFR 870.1130 |
| Clinical electronic thermometer | 80BWX | II | 21 CFR 880.2910 |
| Pulse Oximeter | 74DQA | II | 21 CFR 870.2700 |
| Cardiac Output Monitor | 74KFN | II | 21 CFR 870.1435 |
| end-tidal Carbon-Dioxide Monitor | 73CCK | II | 21 CFR 868.1400 |
| Indwelling Blood Pressure Monitor | 74CAA | II | 21 CFR 870.1110 |
| Indwelling blood | |||
| pressure monitor | 74CAA | II | 21 CFR 870.1110 |
| Heart Rate Monitor, Neonatal | 74FLO | II | 21 CFR 870.2300 |
| Ventilatory Effort Monitor | |||
| (Apnea Detector) | 73FLS | II | 21 CFR 868.2375 |
| Monitor Blood Pressure, Neonatal, | |||
| Invasive | 74FLP | II | 21 CFR 870.1110 |
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)
1
510 (K) Notification Siemens SC9000/ SC9015 MULTIGas ™ and MULTIGas+ *™ Modules
| Multi Gas Monitor | |||
|---|---|---|---|
| Analyzer, Gas, Carbon Dioxide, | |||
| Gaseous | 73CCK | II | 21CFR868.1400 |
| Analyzer, Gas, Enflurane Gaseous | 73CBQ | II | 21CFR868.1500 |
| Analyzer, Gas, Halothane, Gaseous | 73CBS | II | 21CFR868.1620 |
| Analyzer, Gas, Nitrous Oxide, | |||
| Gaseous | 73CBR | II | 21CFR868.1700 |
| Analyzer, Gas, Oxygen, Gaseous | 73CCL | II | 21CFR868.1720 |
4: Predicate Device Identification:
The MULTIGas modules use the same hardware, provided by the same OEM manufacturer, as the Hewlett-Packard model M1026A Anesthesia Gas Module Gas Module, cleared under 510(K) number K951127.
The SC900/9015 Bedside Monitor System (510 (K) number K946306) provides the display and user interface capabilities for the MULTIGas "" modules.
5. Device Description
There are two multi gas modules being submitted as part of this 510(K) Notification: the MULTIGas™ (MGM) and the MULTIGas+ "" (MGM+). Both modules are free standing units that perform sidestream measurements of respiratory gases (CQ2, N3O, and O2) and anesthetic gases. Both modules automatically identify and report measurement data to the SC9000/SC9015 Bedside Monitor for display.
The MULTIGas™ and MULTIGas+ ™ modules differ only in the way they measure O2. The basic MULTIGas Module measures O2 using a galvanic cell, and calculates average inspiratory values for O2 (labeled iO2). The MULTIGas+ incorporates a faster-responding paramagnetic sensor that provides both inspired and expired O2 measurements (iO2 and etO2).
The enhanced software (version VB1.1) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions.
6. Intended Use:
The intended use of the Siemens SC9000/ SC9015 MULTIGas ™ Module is to measure inspiratory and expiratory carbon dioxide, inspiratory oxygen, inspiratory and expiratory Nitrous Oxide and anesthetic agents. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce recordings. This device will connect to either the Siemens SIRENET or Infinity (Olympus) network.
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD) 大學 二十
2
- Table of device similarities and differences to predicate device
| | Substantial Equivalence
Hewlett Packard
Model M1026A Anesthesia Gas
Module | SC 9000/9015 Series MULTIGAS™
and MULTIGAS+™ Modules |
|----------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Manufacturer | Hewlett-Packard | Siemens Medical Systems -
Electromedical Group |
| 510K Number | K951127 | New |
| Intended Population | Not stated in literature | Adult and Pediatric |
| Module/Stand-Alone Monitor | Module: Communicates only
with HP Anesthesia Component
Monitoring System | Module: Communicates only
with Siemens SC9000/9015
Bedside Monitors |
| Displayed Parameters | CO2, N2O, Respiration Rate,
Anesthetic Agents | Same |
| Principle of Operation | Non-dispersive Infra Red | Same |
| Measuring Methods | sidestream | Same |
| Waveform Display | Inspired and expired
concentrations (in %) plus
waveform and trend data | Same |
| Dimensions HxWxD (mm/in) | 80x370x439 / 3.5x14.5x17.3 | 146x183x451 / 5.7x7.2/17.8 |
| Weight kg / lb | 8.2 / 18 | 7.3 / 16.0 |
-
Assesment of non-clinical performance data for equivalence: Both the Siemens MULTIGas™ Modules and the HP M1026A Anesthesia Gas module employ, internally, the Andros Inc Model 4700 MGM Multi Gas Module as the means for measuring the various gases.
-
Assesment of clinical performance data for equivalence: Not applicable
-
Biocompatability: Not applicable
-
Sterilization: Not applicable
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol with three branches, representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 1997
Ms. Jacqueline E. M. Emery Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923
Re: ¸ K965062 Siemens SC9000/SC9015 MULTIGas™ and MULTIGas+™ Modules Regulatory Class: III (three) Product Code: 74 DSI Dated: March 25, 1997 Received: March 27, 1997
Dear Ms. Emery:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Jacqueline E. M. Emery
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbrandinq by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
D. Thomas J. Callahon
Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
Indicated Use Statement
The Siemens SC9000/SC9015 MULTIGas "" and MULTIGas+"" Modules are indicated for adult and pediatric patient populations in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that these devices are required to measure any one or more of the following parameters:
- . Respiration rate
- inspired and expired Carbon Dioxide (CO3) .
- inspired and expired Oxygen (MULTIGas+ only) 9
- average inspired Oxygen (MULTIGas only) �
- inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, . Sevoflurane, and Nitrous Oxide
MRI Compatibility Statement:
The Siemens SC9000/9015 MULTIGas tm and MULTIGas+ tm modules are not intended for use in an MRI magnetic field
Picscription hie
für Z1 CFR 801.109
PCRND Sig
(Division Sign-Off)
Division of Cardiova
and Neurological De
510(k) Number
Zathey
PCRND Sign-off
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Over-the-Counter via
Company Confidential
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue Danvers, MA 01923 USA
Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)