(246 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the technology used as oscillometric for blood pressure and predictive for temperature, without mentioning any AI/ML components.
No
The device is described as a vital signs monitor, intended for non-invasive monitoring of physiological parameters, rather than providing therapy or treatment.
No
This device is a vital signs monitor that measures physiological parameters (blood pressure, oxygen saturation, pulse, and temperature). While these measurements are used by health professionals in patient care, the device itself does not provide a diagnosis. Instead, it provides data that can aid in diagnosis.
No
The device description explicitly states it is a "monitor" and describes physical components like a battery pack, wireless printer communication, and the use of oscillometric technology for blood pressure, pulse oximetry modules, and a temperature parameter utilizing predictive technology. These are all hardware components.
Based on the provided information, the CAS 740 Series Vital Signs Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- CAS 740 Function: The CAS 740 Series Vital Signs Monitor measures physiological parameters directly from the patient's body (in vivo). It uses non-invasive methods to monitor blood pressure, oxygen saturation, pulse, and temperature. These measurements are taken from the arm, leg, fingers, toes, mouth, or rectum.
Therefore, since the device measures vital signs directly from the patient and does not perform tests on samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CAS 740 Series Vital Signs Monitor is indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients, in the care of health professionals.
Product codes
MHX
Device Description
The CAS 740 Monitor is a replacement monitor based on the existing 9303 Vital Signs Monitor, and the CAS 9001 or 9002 EMS monitors. The 740 are primarily a repackaging of these monitors. The primary parameter is non-invasive blood pressure, which is included in all models. Blood pressure measurement is based on oscillometric technology. The additional two parameters are pulse oximetry and temperature. A purchaser has pulse oximetry choices that include modules manufactured by Masimo, Nellcor or Nonin. The temperature parameter utilizes predictive technology from SureTemp™ (Welch Allyn Inc.). The monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, features include an easily replaccable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication, and many more.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood pressure - arms and thigh (Neonates – arm and leg)
Sp02 – fingers and toes
Temperature – Orally or rectally (neonates – axillary)
Indicated Patient Age Range
adult, pediatric and neonatal patients
Intended User / Care Setting
In the care of health professionals.
Hospitals, intra-hospital and inter-hospital transport, clinics, doctor's office, dental offices, emergency vehicles, and first responders. Not indicated for home use
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)
Study Type: Bench test simulations and clinical studies in accordance with AAMI SP10:2002.
Key Results: CAS has tested and demonstrated ND Plus performance equivalent to the NB module in bench test simulations. No new issues of safety and effectiveness were raised. The 740 monitor has undergone a series of clinical studies in accordance with AAMI SP10:2002, with results meeting the requirements of the standard. Performance equivalence has been demonstrated.
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
§ 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
MEDICAL SYSTEMS, INC. TECHNOLOGY APPLIED TO MEDICINE
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Ref.: | K033048 |
|---|---|
| Submitter: | CAS Medical Systems, Inc. |
| Address: | 44 East Industrial Rd. Branford CT. 06405 USA |
| Contact: | Ron Jeffrey - Director, Regulatory Affairs |
| Phone - (203) 488-6056 Fax - (203) 488-9438 | |
| Email - rjeffrey@casmed.com | |
| Prepared: | September 25, 2003 Revised January 30, 2004 / June 1, 2004 |
| Trade Name: | CAS 740 Series Monitor |
| Common Name: | Vital Signs Monitor |
| Classification Name: Noninvasive Blood Pressure Measurement System |
1
EQUIVALENCE
The CAS 740 Monitor is equivalent to the following devices:
-
- CAS 9303 Neonatal / Adult Vital Signs Monitor (K982776);
-
- CAS 9001 EMS NIBP Monitor (K982135);
-
- CAS 9002 EMS NIBP / Sp02 Monitor (K980879);
-
- Nellcor Puritan Bennett N-550 Pulse Oximeter (K021090);
-
- Nellcor Puritan Bennett N-595 Pulse Oximeter (K012891);
-
- Masimo Set 2000 Pulse Oximeter / accessories (K990966)
DESCRIPTION
The CAS 740 Monitor is a replacement monitor based on the existing 9303 Vital Signs Monitor, and the CAS 9001 or 9002 EMS monitors. The 740 are primarily a repackaging of these monitors. The primary parameter is non-invasive blood pressure, which is included in all models (see below). Blood pressure measurement is based on oscillometric technology. The additional two parameters are pulse oximetry and temperature.
A purchaser has pulse oximetry choices that include modules manufactured by Masimo, Nellcor or Nonin.
The temperature parameter utilizes predictive technology from SureTemp™ (Welch Allyn Inc.)
The monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, features include an easily replaccable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication,
and many more. The table below defines the different models within the 740 series and the relationship to the CAS predicate devices
2
The monitor, its equivalent and parameters:
| Model(s) | CAS Equiv. | Parameters (Variations) |
|---|---|---|
| 740-3MS, | ||
| 740M-3MS | 9303, 9001 | ND NIBP, Masimo Sp02 & W/A Temp - domestic and international versions |
| 100 – 240 VAC, and RS 232; (12VDC version; mounting versions available) | ||
| 740-3NL, | ||
| 740M-3NL | 9303, 9001 | ND NIBP, Nellcor Sp02 & W/A Temp - domestic and international versions |
| 100 – 240 VAC, and RS 232; (12VDC version; mounting versions available) | ||
| 740-3NN, | ||
| 740M-3NN | 9303, 9001, 9002 | ND NIBP, Nonin Sp02 & W/A Temp - domestic and international versions |
| 100 – 240 VAC, and RS232; (12VDC version; mounting versions available) |
740 Series Intended Use
The CAS 740 Series Vital Signs Monitor is indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients, in the care of health professionals.
3
SUBSTANTIAL EQUIVALANCE COMPARISON – PREDICATE(S) VS. 740
| CATEGORY | CAS 9303, 9001 AND 9002
(predicate) | CAS 740 SERIES |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The CAS predicate devices are
indicated for use for non-invasive
monitoring of blood pressure,
oxygen saturation, pulse and
temperature of adult, pediatric and
neonatal patients in the care of
health professionals. The 9001 and
9002 monitors are further indicated
for use with the EMS / transport
user, relying on a rechargeable
battery and charger. These models
have no direct mains AC input. | The CAS 740 Series devices are
indicated for use for non-invasive
monitoring of blood pressure, oxygen
saturation, pulse and temperature of
adult, pediatric and neonatal patients
in the care of health professionals.
In summary, the 740 series monitor
has all of the same indications for use
as its predicate device. This includes:
condition or disease monitored,
prescription vs. over the counter, part
of the body applied to, frequency of
use, physiological purpose and patient |
| Target
population | 9303 family - adults, pediatric and
neonatal patients. 9001 and 9002 -
adults and pediatric patients only. | population.
740 series - adults, pediatric, infant
and neonatal patients. |
| Design | 9303 family is comprised of three
models: 9301 – non-invasive blood
pressure only; 9302 - non-invasive
blood pressure and pulse oximeter
only; 9303 - non-invasive blood
pressure, pulse oximeter and
temperature. The 9001 is similar
to the 9301 and the 9002 is similar
to the 9302. All predicate CAS
monitors are small lightweight and
portable.
The entire line of predicate
monitors utilizes modular
components for non-invasive blood
pressure, pulse oximetry and
temperature, if included.
In all cases the non-invasive blood
pressure module is a CAS design
and the same item; (NB non-
invasive blood pressure module). | The 740 series is designed to be a
multi-parameter monitor. The 740
series will replace the 9301, 9302,
9303, 9001 and 9002 monitors. The
740 series is small lightweight and
portable.
Like its predicate, the 740 utilize
modular parameters for non-invasive
blood pressure, pulse oximetry and
temperature.
CAS designs the blood pressure
component, called the ND Plus. The
primary difference with the ND Plus,
as compared to the predicates NB
board, is its smaller size and its lower
power use. Also, there is the
additional of a secondary safety
processor. The boards are similar in
that ND Plus has the same front-end
control and the same basic algorithm
as the NB board. |
| CATEGORY | CAS 9303, 9001 AND 9002 | CAS 740 SERIES |
| | (predicate) | |
| | Where a pulse oximeter is included
it is a purchased OEM module
from Nonin Medical Systems. | Where a pulse oximeter is included,
CAS provides three possible OEM
options. The predicate device
provided only one. The customer has
the option of selecting the pulse
oximeter of their choice. Available
are the Masimo, Nellcor and Nonin
(same as predicate) pulse oximeters.
The FDA in the manufacturers own
finished medical devices has cleared
all three of these pulse oximeters. |
| | The temperature function is only
available in the 9303 monitors and
is an OEM purchased predictive
temperature module manufactured
by Welch Allyn. | The temperature function is available
if desired. Like the predicate, it is an
OEM purchased predictive
temperature module manufactured by
Welch Allyn. The FDA has cleared
this module, in the manufacturers
monitor, for marketing.
In summary, with the exceptions
noted above, and the new look of its
case design, the 740 is essentially the
same as the predicate devices. |
| Materials | Monitor case – ABS U.L.
approved material; | Monitor case – ABS U.L. approved
injection molded material. This
monitor is a custom industrial design |
| | Monitor interior – Series of PC
boards (Control / Display, interface
and non-invasive blood pressure) If
ordered with pulse oximeter or
temperature, these would be
additional PC board modules. | Monitor interior – Series of PC boards
(Control / Display, interface and non-
invasive blood pressure) If ordered
with pulse oximeter or temperature,
these would be additional PC board
modules. |
| | Power center – 9303 family has
AC mains input and a rechargeable
lead acid type battery. 9001/9002
monitors have no AC mains and
get power from a rechargeable
power supply (or direct DC from
transport vehicle) and lead acid
battery. | Power center – 740 series has AC
mains and a rechargeable Nickel
Metal Hydride customer replaceable
battery. A DC version is part of the
series where the power is obtained
from the transport vehicle. |
| | Non-invasive blood pressure | Non-invasive blood pressure module
(NIBP) – Of the three possible |
| CATEGORY | CAS 9303, 9001 AND 9002
(predicate) | CAS 740 SERIES |
| | module (NIBP) -- Of the three
possible parameters offered, this
module is the only one designed
and manufactured by CAS. All
monitors in this group contain the
NB NIBP module version which
consists of microprocessor,
circuitry, software, valves, pump
transducer, and hardware. | parameters offered, this module is the
only one designed and manufactured
by CAS. All monitors in this group
contain the ND Plus NIBP module
version, which consists of
microprocessor, circuitry, software,
valves, pump transducer, and
hardware.
The "design" section contains
reference to the subtle differences. |
| | Pulse oximeter module - This
parameter is an option in the 9302
and 9002 only. It is the same
module in both cases and is
manufactured by Nonin Medical
Systems. | Pulse oximeter module - As with the
predicate monitors, the same Nonin
module is one of the three types
offered. The other two types of pulse
oximeters are Masimo and Nellcor
(Tyco Healthcare). These are actively
marketed OEM devices designed for
use by other manufacturers as well as
the company's own branded devices.
All three types of pulse oximeter
occupy the same footprint and
consume the same power. |
| | Temperature module (9303 only) -
See design section. | Temperature module - The 740 has
this parameter. See "Design" section. |
| | Components / Accessories -
Included are blood pressure cuffs,
inflation tube, power cord, users
manual, at a minimum. For
monitors with the options of pulse
oximeter and temperature, the
manufacturers recommended
accessories are included. | Components / Accessories - Included
are blood pressure cuffs, inflation
tube, power cord, users manual, at a
minimum. These are the same as the
predicate devices. For pulse oximetry
and temperature, the manufacturers
recommended accessories are
included. |
| CATEGORY | CAS 9303, 9001 AND 9002
(predicate) | CAS 740 SERIES |
| Performance
(Clinical and non-clinical) | With regard to non-invasive blood pressure, CAS has tested and passed performance qualification to the SP10 requirements.
There is historical acceptance of these monitors from an accuracy viewpoint. CAS has very few complaints related to accuracy issues. | With regard to non-invasive blood pressure, CAS has tested and demonstrated ND Plus performance equivalent to the NB module in bench test simulations. No new issues of safety and effectiveness were raised.
Note: Predicate devices use NB NIBP module. 740 Series uses the ND Plus NIBP module.
In addition, the 740 monitor has undergone a series of clinical studies in accordance with AAMI SP10:2002, with results meeting the requirements of the standard
In summary, performance equivalence has been demonstrated. |
| Sterility | None of the equipment or its accessories is sterilized. | None of the equipment or its accessories is sterilized. |
| Biocompatibility | All patient contact equipment and accessories have been tested, at some level, for biocompatibility. | All patient contact equipment and accessories have been tested for biocompatibility. Where the accessories are provided "ready for sale" by the manufacturer of the pulse oximeter and temperature components, there is documentation showing that the manufacturer has obtained adequate biocompatibility results. |
| Mechanical Safety | These predicate devices have undergone mechanical safety testing as part of the successful, and ongoing evaluation by Underwriters Laboratories as well as testing to the medical equipment safety standard, IEC60601-1 and its applicable collateral and particular standards. | The 740 series monitors have been evaluated to the following standards: UL2601-1, IEC 60601-1, IEC 60601-2-30, IEC 60601-2-49, AAMI SP10 and other collateral and particular safety standards. A follow-up services program is planned for quarterly inspection for these standards.
In summary, the 740 has received greater testing for mechanical safety than the predicate devices. |
| Chemical Safety | Not applicable to these products | Not applicable to these products |
| CATEGORY | CAS 9303, 9001 AND 9002
(predicate) | CAS 740 SERIES |
| Anatomical Sites | Blood pressure - arms and thigh
(Neonates – arm and leg)
Sp02 – fingers and toes
Temperature – Orally or rectally
(neonates – axillary) | Blood pressure – arms and thigh
(Neonates – arm and leg)
Sp02 – fingers and toes
Temperature – Orally or rectally
(neonates – axillary)
In summary, there is no difference in
anatomical sites. |
| Human Factors | With these monitors human factors
issues were not monumental from
the beginning. Human factors
were considered during the
development of the monitors.
Some of the issues that did persist
were designed out during the
product lifetime | With the 740 series monitor additional
human factors were employed.
Examples of these are:
✓ Easier battery access for
replacement;
✓ Visible battery state of
condition;
✓ Auto off to save battery life;
✓ Attached label explaining
symbols used;
✓ All cables and cords better
located to avoid tangling;
✓ Designed for ease of
assembly;
✓ Numerous mounting
opportunities - tables, pole,
wall or rail;
✓ Wireless communication to
printer;
✓ More rugged than predicates;
✓ Additional languages offered. |
| | | |
| CATEGORY | CAS 9303, 9001 AND 9002
(predicate) | CAS 740 SERIES |
| Energy used | The 9303 monitor contains a
switching power supply which
handles input of 100 to 250VAC
50/60 Hz at 0.3A. This power runs
the monitor and charges a 6VDC
lead acid battery. | The 740 series contains the same
power supply, essentially the same as
the 9303 with the exception of the
battery, which in this case is a 7.2 volt
Nickel Metal Hydride (NiMH) battery
pack. |
| | The 9001 & 9002 monitors do not
have internal power supplies.
These monitors, designed with
portability EMS conditions in
mind, contain a 6VDC Lead Acid
battery, which is charged by a
120VAC power supply. | A version of the monitor is available
for transport use where its power is
derived from a vehicles 12VDC
power. In this case there is no internal
power supply or a mains connection.
This version also uses the same
battery pack. |
| | | In summary, the move to NiMH
greatly improves capacity and charge
time. |
| Compatibility
with
environment and
other devices | In general these devices do not
represent environmental
compatibility challenges.
Compatibility with other devices is
clearly specified by the
manufacturer in the user manuals.
Product safety and EMC rules
require that limits be established
by testing and documented. | In general these devices do not
represent environmental compatibility
challenges. Compatibility with other
devices is clearly specified by the
manufacturer in the user manuals.
Product safety and EMC rules require
that limits be established by testing
and documented. |
| | | In general there is equivalence here,
however the safety and EMC testing
authority has required that tighter
controls be placed on connection to
other devices. |
| | Where used | Hospitals, intra-hospital and inter-
hospital transport, clinics, doctor's
office, dental offices, emergency
vehicles, and first responders. Not
indicated for home use |
| | | In summary, there is no difference
here. |
| CATEGORY | CAS 9303, 9001 AND 9002 (predicate) | CAS 740 SERIES |
| Standards met | UL2601 or 544, EN 60601-1, EN
60601-1-2, EN 60601-2-30, EN
1061 and SP10 (accuracy) | UL2601-1, IEC60601-1, IEC60601-1-
1, IEC60601-1-2, IEC60601-1-4,
IEC60601-2-30, IEC60601-2-49, EN
865, and AAMI SP10:2002.
In summary, There were more
standards met and in some cases they |
| Electrical Safety | These predicate devices have
undergone mechanical safety
testing as part of the successful,
and ongoing evaluation by
Underwriters Laboratories as well
as testing to the medical equipment
safety standard, IEC60601-1 and
its applicable collateral and
particular standards. | The 740 monitor has undergone
electrical safety testing as part of the
successful, and ongoing evaluation by
Underwriters Laboratories as well as
testing to the medical equipment
safety standard, IEC60601-1 and its
applicable collateral and particular
standards.
In summary, the 740 has received
greater testing for electrical safety
than the predicate devices. |
| Thermal Safety | These devices do not present
thermal safety risks. Some aspects
of over-temperature are evaluated
during safety testing. | These 740 series does not present
thermal safety risks. Some aspects of
over-temperature are evaluated during
safety testing.
In summary, there are no differences. |
| Radiation safety | Not a risk | Not a risk |
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Image /page/10/Picture/1 description: The image shows the seal for 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 image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
Mr. Ron Jeffrey Director, Regulatory Affairs CAS Medical Systems, Incorporated 44 East Industrial Road Branford, Connecticut 06405
Re: K033048
Trade/Device Name: CAS 740 Series Monitor Models 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, 740M-3NN Regulation Number: 870.1025 Regulation Name: Patient Physiologic Monitor Regulatory Class: II Product Code: MHX Dated: May 13, 2004 Received: May 14, 2004
Dear Mr. Jeffrey:
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.
11
Page 2 - Mr. Jeffrey
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 requirely as as tronic 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,
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
12
Indications for Use
510(k) Number: K033048
Device Name: 740 Series monitor
The CAS 740 Series Vital Signs Monitor is indicated for use for non-Indications for use: invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients, in the care of health professionals.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: Jum
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