(66 days)
No
The summary describes standard physiological parameter monitoring and data processing, with no mention of AI or ML technologies. The "advanced data processing" and "arrhythmia analysis" are typical functions of patient monitors and do not inherently indicate AI/ML.
Yes
The device is described as a "multiparameter patient monitor" intended to measure and display physiological parameters such as hemodynamic, respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status. It also aids in monitoring the effects of certain anesthetic agents. These functions are used for monitoring a patient's health status, which constitutes a therapeutic device as defined by the provided prompt.
Yes
Justification: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients." Monitoring these physiological parameters to assess a patient's condition falls under the definition of a diagnostic device. Additionally, it states that "when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents," further supporting its diagnostic nature.
No
The device description explicitly states it is a "patient monitor" that "displays the measurement of patient physiological parameters" and uses "specialized measurement modules" which are hardware components. While the software is a key part of the system, it is not a standalone software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "multiparameter patient monitoring" and monitoring of various physiological parameters (hemodynamic, respiratory, ventilatory, etc.) of patients. This involves directly monitoring the patient's body.
- Device Description: The description details how the device measures "patient physiological parameters" using modules connected to the patient via cables. This is in vivo measurement, not in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing samples of human origin (blood, urine, tissue, etc.) or providing information about a physiological state, health, or disease based on such analysis.
The device is a patient monitor that measures physiological signals directly from the patient's body. This falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A is intended for multiparameter patient monitoring with optional patient care documentation.
The S/57M Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients.
The S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents*.(*Gan TJ, Glass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index Monitoring Allows Faster Emergence and Improved Recovery from Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:808-15.) The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is also indicated for documenting patient care related information.The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for use by qualified medical personnel only.
Product codes
MHX
Device Description
The intended use and indications for use for the modified device, Datex-Olumeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software, is similar to the predicate Datex-Ohmeda S/5TM Compact Anesthesia Monitor with S-00A05, S-00A06, L-00A07, L-00A08 software (K002478). There has been no change to the fundamental scientific technology from the predicate. The S/5™ Compact Anesthesia Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The caregiver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care, Modules perform the functions of parameter measurement and minor data processing. The S/5TM Compact Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5TM Compact Anesthesia Monitor: L-CANE02 and L-CANE02A. L-CANE02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities. this software option is identical to L-CANE02.
The modifications to the device are:
- Technical alarms such as "SpO2 probe off", "Leads off" (ECG), and "Px No 1 . transducer" (InvBP) transferred to the Central Station.
-
- Changed to include support for alarm silencing and alarm limits adjustment from Central Station.
-
- The alarm priority of "X module removed" message has been increased from note level to yellow level.
- Software can additionally send request for recording to Central Station. 4.
- న్. Snapshot printing speed 25 mm/s has been added.
-
- Rotating of the "ComWheel" now scrolls through different trend pages.
-
- Support for M-BIS (Bispectral Index) module has been added. M-BIS has a separate 510(k)
-
- Support for the M-MINIC (CO2 module has been added. The Mini CO2 module M-miniC is the subject of a separate 510(k) premarket notification.
- Support for the N-DIS external device interfacing modules has been added. த் Support is for interfacing the following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines. The N-DIS modules have a separate 510(k) number.
-
- Patient name menu items have been activated also when Anesthesia Record Keeper (ARK) is selected to be "OFF" from the monitor menu.
- Support for wireless LAN communication between the monitor and Datex-11. Ohmeda S/5 Central station.
The S/5TM CAM uses several types of plug-in measurement modules.
Modules are the subject of separate 510(k)'s and are not part of this notification. The S/5™ CAM is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5TM Compact Monitor frame and are automatically recognized by the monitor. The patient cables are connected to the module plug in jacks and then monitoring can begin. The S/5™ CAM can display measurements in the form of numeric values, traces and trends. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The S/5™ CAM is operated by a keyboard. Typically pressing a kev results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. The software L-CANE02 and L-CANE02A perform some module-related tasks like arrhythmia analysis. ST-values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, EEG spectrum analysis and evoked potential response averaging. All the module communication is also handled in the main software. The software L-CANE02 and L-CANE02A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthesia record, and the related events and medication can be easily entered with the same user interface as the monitor itself. There are various optional types of keyboards, some are like standard keyboards and another is a hand-held Remote controller (REMCO) which is still directly connected to the S/5TM Compact Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also available. The S/5TM Compact Anesthesia Monitor can be in a stand-alone or networked configuration. If networked, measurement data is sent to the network for central station or monitor-to-monitor viewing. Trends as well as the patient care documentation can be sent via a network to a central computer for archiving.
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
qualified medical personnel only, hospital setting
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)
The Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:
- IEC 60601-1:1988+ Amdt.:1:1991 + Amdt. 2:1995 .
- EN 60601-1: 1990 + A1:1993+A2:1995+A13:1996 .
- . CAN/CSA-C22.2 No.601.1-M90 +S1:1994+Amdt. 2:1998
- IEC 60601-2-27:1994/EN 60601-2-27:1994 .
- IEC 60601-2-30:1995/EN 60601-2-30:1995 .
- . IEC 60601-2-34:1994/EN 60601-2-34:1994
- IEC 60601-2-40:1998 .
- . IEC 60601-1-2(1993)/EN 60601-1-2
- IEC 60601-1-4: 1996+Amdt. 1:1999/EN 60601-1-4 .
- ISO 9918:1993/EN 864:1996 ●
- ISO 9919:1992/EN865:1997 .
- ISO 7767:1997/EN12598:1999 .
- . ISO 11196:1995 + Corr. 1:1997/EN ISO11196:1997
- IEC 601-2-10:1987/HD 395.2.10:1988 + Am.1:2000 ●
- IEC 60601-2-26:1994/EN60601-2-26 .
- . IEC 60068-2
- . UL 2601-1:1997
- ANSI/AAMI ES-1:1993 .
- . ANSI/AAMI EC57:1998
- . FDA 21 CFR 898.12
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
KGR2485
Page 1 of 5
Image /page/0/Picture/3 description: The image is a logo that features a stylized letter "D" inside of a circle. The circle is black, and the "D" is white, creating a contrast. There is a small black square in the upper right corner of the circle, resembling a camera flash or a design element. The overall design is simple and modern.
Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software
GENERAL COMPANY INFORMATION as required by 807.92(a)(1)
COMPANY NAME/ADDRESS/PHONE/FAX:
Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344
NAME OF CONTACT:
Mr. Joel Kent
DATE:
July 26, 2002
DEVICE NAME as required by 807.92(a)(2)
TRADE NAME:
Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software
COMMON NAME:
Patient Monitor
CLASSIFICATION NAME:
The following Class III classification appears applicable:
| DSI | Arrhythmia detector & alarm | 870.1025 |
|---|---|---|
| MLD | Monitor ST-segment & alarm | 870.1025 |
1
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)
The Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (S/5™ CAM) is substantially equivalent to the equivalent in safety and effectiveness to the legally marketed predicate Datex-Ohmeda S/5™ Compact Anesthesia Monitor with S-00A05, S-00A06, L-00A07, L-00A08 software (K002478).
DEVICE DESCRIPTION as required by 807.92(a)(4)
The intended use and indications for use for the modified device, Datex-Olumeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software, is similar to the predicate Datex-Ohmeda S/5TM Compact Anesthesia Monitor with S-00A05, S-00A06, L-00A07, L-00A08 software (K002478). There has been no change to the fundamental scientific technology from the predicate. The S/5™ Compact Anesthesia Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The caregiver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care, Modules perform the functions of parameter measurement and minor data processing. The S/5TM Compact Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5TM Compact Anesthesia Monitor: L-CANE02 and L-CANE02A. L-CANE02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities. this software option is identical to L-CANE02.
The modifications to the device are:
- Technical alarms such as "SpO2 probe off", "Leads off" (ECG), and "Px No 1 . transducer" (InvBP) transferred to the Central Station.
-
- Changed to include support for alarm silencing and alarm limits adjustment from Central Station.
-
- The alarm priority of "X module removed" message has been increased from note level to yellow level.
- Software can additionally send request for recording to Central Station. 4.
- న్. Snapshot printing speed 25 mm/s has been added.
-
- Rotating of the "ComWheel" now scrolls through different trend pages.
-
- Support for M-BIS (Bispectral Index) module has been added. M-BIS has a separate 510(k)
-
- Support for the M-MINIC (CO2 module has been added. The Mini CO2 module M-miniC is the subject of a separate 510(k) premarket notification.
- Support for the N-DIS external device interfacing modules has been added. த் Support is for interfacing the following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines. The N-DIS modules have a separate 510(k) number.
-
- Patient name menu items have been activated also when Anesthesia Record Keeper (ARK) is selected to be "OFF" from the monitor menu.
- Support for wireless LAN communication between the monitor and Datex-11. Ohmeda S/5 Central station.
The S/5TM CAM uses several types of plug-in measurement modules.
Modules are the subject of separate 510(k)'s and are not part of this notification. The S/5™ CAM is typically furnished with a module that measures ECG, invasive and non-invasive blood pressures, pulse oximetry and temperature. Modules are placed in the
2
Page 3 of 5
S/5TM Compact Monitor frame and are automatically recognized by the monitor. The patient cables are connected to the module plug in jacks and then monitoring can begin. The S/5™ CAM can display measurements in the form of numeric values, traces and trends. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The S/5™ CAM is operated by a keyboard. Typically pressing a kev results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. The software L-CANE02 and L-CANE02A perform some module-related tasks like arrhythmia analysis. ST-values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, EEG spectrum analysis and evoked potential response averaging. All the module communication is also handled in the main software. The software L-CANE02 and L-CANE02A also include the option of creating patient care documentation. The trend information is automatically transferred to the anesthesia record, and the related events and medication can be easily entered with the same user interface as the monitor itself. There are various optional types of keyboards, some are like standard keyboards and another is a hand-held Remote controller (REMCO) which is still directly connected to the S/5TM Compact Anesthesia Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. Using the Anesthesia Record Keeper software, patient related care events are documented using the keyboard. To facilitate quick access to menus, a bar code reader is also available. The S/5TM Compact Anesthesia Monitor can be in a stand-alone or networked configuration. If networked, measurement data is sent to the network for central station or monitor-to-monitor viewing. Trends as well as the patient care documentation can be sent via a network to a central computer for archiving.
INTENDED USE as required by 807.92(a)(5)
Intended use:
The S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A is intended for multiparameter patient monitoring with optional patient care documentation.
Indications for use:
The S/57M Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients.
The S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents*.(*Gan TJ, Glass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index Monitoring Allows Faster Emergence and Improved Recovery from Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:808-15.) The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is also indicated for documenting patient care related information.The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for use by qualified medical personnel only.
3
SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)
The Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software (S/5TM CAM) is substantially equivalent to the predicate Datex-Ohmeda S/5™ Compact Anesthesia Monitor with S-00A05, S-00A06,L-00A07, L-00A08 software (K002478).
The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents*. (*Gan TJ, Glass P, Windsor A. Payne F. Rosow C. Sebel P. Manberg P. Bispectral Index Monitoring Allows Faster Emergence and Improved Recovery from Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:808-15.) The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is also indicated for documenting patient care related information.
There are two software options available for the S/5TM Compact Anesthesia Monitor: L-CANE02 and L-CANE02A (collectively referred to as L-CANE02(A) ). (Note: L- refers to software license). Only one software can be used at any given time in the monitor. The software is preloaded in the factory and can also be later loaded in the customer site.
The new device with different software options. S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A, is compared to predicates as outlined below.
The basic model of the monitor is the S/5TM Compact Anesthesia Monitor with L-CANE02, which is a new revision of the predicate devices, S/5TM Compact Anesthesia Monitor with S-00A05, S-00A06, L-00A07, L-00A08 software (K002478). The S/5™ Compact Anesthesia Monitor with L-CANE02 may be equipped with extended bedside arrhythmia analysis capability and in this case the monitor is called S/5™ Compact Anesthesia Monitor with L-CANE02A. The arrhythmia analysis functionality of the S/5M Compact Anesthesia Monitor with L-CANE02A is substantially equivalent to the functionality of the predicate device S/5™ Compact Anesthesia Monitor with L-00A08. The S/5™ CAM is a modular multiparameter patient monitor providing connections to measurement modules. The general construction, indications for use and intended use of the S/5™ CAM are the same as for the predicate S/5™ Compact Anesthesia Monitor with S-00A05, S-00A06, L-00A07, L-00A08 software (K002478).
Based on the above and a detailed analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of the S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software are substantially equivalent to the predicate S/5™ Compact Anesthesia Monitor with S-00A05, S-00A06,L-00A07, L-00A08 software (K002478).
4
SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
The Datex-Ohmeda S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:
- IEC 60601-1:1988+ Amdt.:1:1991 + Amdt. 2:1995 .
- EN 60601-1: 1990 + A1:1993+A2:1995+A13:1996 .
- . CAN/CSA-C22.2 No.601.1-M90 +S1:1994+Amdt. 2:1998
- IEC 60601-2-27:1994/EN 60601-2-27:1994 .
- IEC 60601-2-30:1995/EN 60601-2-30:1995 .
- . IEC 60601-2-34:1994/EN 60601-2-34:1994
- IEC 60601-2-40:1998 .
- . IEC 60601-1-2(1993)/EN 60601-1-2
- IEC 60601-1-4: 1996+Amdt. 1:1999/EN 60601-1-4 .
- ISO 9918:1993/EN 864:1996 ●
- ISO 9919:1992/EN865:1997 .
- ISO 7767:1997/EN12598:1999 .
- . ISO 11196:1995 + Corr. 1:1997/EN ISO11196:1997
- IEC 601-2-10:1987/HD 395.2.10:1988 + Am.1:2000 ●
- IEC 60601-2-26:1994/EN60601-2-26 .
- . IEC 60068-2
- . UL 2601-1:1997
- ANSI/AAMI ES-1:1993 .
- . ANSI/AAMI EC57:1998
- . FDA 21 CFR 898.12
Conclusion:
The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software as compared to the predicate device.
5
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2002
Datex-Ohmeda c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492
Re: K022485
Trade Name: S/5TM Compact Anesthesia Monitor with L-CANE02 and L-CANE02A Software Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor Regulatory Class: Class II (two) Product Code: MHX Dated: July 26, 2002 Received: July 29, 2002
Dear Mr. Kent:
This letter corrects our substantially equivalent letter of October 3, 2002, regarding the incorrect Indications for Use.
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
6
Page 2 - Mr. Joel C. Kent
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Eliao Mallio
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K022485 510(k) Number (if known): ___
Device Name: S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software
The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients.
The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents.
The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is also indicated for documenting patient care related information.
The S/5™ Compact Anesthesia Monitor with L-CANE02 and L-CANE02A software is indicated for use by qualified medical personnel only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use_ OR (Per 21 CFR 801.109) (Optional Format 1-2-96)