750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL

K050844 · Cas Medical Systems, Inc. · DQA · Jun 23, 2005 · Cardiovascular

Device Facts

• Record ID: K050844
• Device Name: 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL
• Applicant: Cas Medical Systems, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The 750C monitor is intended to continuously calculate and display the following physiological vital signs: end tidal carbon dioxide, respiration rate, capnograph waveform, functional arterial oxygen saturation, pulse rate, plethysmograph waveform, and an optional non-invasive blood pressure measurement of systolic, diastolic, mean arterial pressures along with pulse rate derived from a NIBP pressure waveform. The 750C is intended for monitoring of adult, pediatric and neonatal patients in the care of health care professionals.

Device Story

CAS 750C Series Monitor is a portable, multi-parameter patient monitor; provides continuous non-invasive measurement of end-tidal CO2, SpO2, pulse rate, and optional NIBP. Inputs include CO2 gas sampling, pulse oximetry sensors, and NIBP cuffs. Device utilizes OEM modules for EtCO2 (Oridion), SpO2 (Masimo or Nellcor), and CAS oscillometric technology for NIBP. Outputs displayed on backlit LCD as numeric values and waveforms; includes wireless infrared printer communication. Used in clinical settings for spot-checking or continuous monitoring by healthcare professionals. Provides real-time physiological data to assist clinicians in patient assessment and monitoring. Benefits include portability and multi-parameter integration for improved patient oversight.

Clinical Evidence

Bench testing only. The device utilizes unchanged OEM modules for EtCO2 and SpO2, which were previously cleared. Performance of the NIBP parameter was verified to meet AAMI SP10:2002 clinical accuracy standards. Fully configured 750C units underwent performance testing by OEM module manufacturers.

Technological Characteristics

Portable monitor with backlit LCD; features EtCO2 (capnometry), SpO2 (pulse oximetry), and NIBP (oscillometric). Powered by 100-240VAC or 12VDC with rechargeable NiMH battery. Connectivity includes wireless infrared printer port. Complies with UL60601-1, IEC60601-1, IEC60601-1-2, IEC60601-1-4, IEC60601-2-30, EN865, EN864, and ANSI/AAMI SP10:2002.

Indications for Use

Indicated for continuous monitoring of vital signs (EtCO2, respiration rate, SpO2, pulse rate, NIBP) in adult, pediatric, and neonatal patients by healthcare professionals.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Oridion Polaris 2004 (K040011)
• Masimo SET 2000 Pulse Oximeter (K990966)
• Nellcor N-595 Pulse Oximeter (K012891)
• CAS 740 Series Patient Monitor (K033048)

Submission Summary (Full Text)

{0}------------------------------------------------

K050844

JUN 2 3 2005

S MEDICAL SYSTEMS, INC. r technology applied to medicine 44 EAST INDUSTRIAL ROAD, BRANFORD, CONNECTICUT 06405

203-488-6056 (FAX) 203-488-9438

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitter: | CAS Medical Systems, Inc. |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Address: | 44 East Industrial Rd. Branford CT. 06405 USA |
| Contact: | Ron Jeffrey - Director, Regulatory Affairs<br>Phone - [phone] Fax - [phone]<br>Email - [e-mail] |
| Prepared: | April 1, 2005 |
| Trade Name: | CAS 750C Series Monitor |
| Common Name: | Multi-Function Patient Monitor |
| Classification Name: Carbon Dioxide Gas Analyzer (73CCK) | |

:《

{1}------------------------------------------------

#### EQUIVALENCE (Predicate Device)

The CAS 750C Series Monitor is equivalent to the following devices:

- * Oridion Polaris 2004 (K040011);
- * Masimo SET 2000 Pulse Oximeter (K990966);
- * Nellcor N-595 Pulse Oximeter (K012891).
- * CAS 740 Series Patient Monitor (K033048);

#### DESCRIPTION

The CAS 750C Series Monitor is a multi-parameter patient monitor based on the exterior design and platform of the CAS 740 Vital Signs Monitor. The 750C features a capnograph equivalent to the Oridion Polaris 2004 End-Tidal C02 for the continuous non-invasive measurement and monitoring of carbon dioxide concentration of expired and inspired breath. Monitors in the series also have a choice of MasimoSET® or Nellcor® OxiMAX® Sp02 technology, and CAS MAXNIBP®. All four monitors in the 750C series have end-tidal C02 and a pulse oximeter. Two of the four have an additional third parameter consisting of noninvasive blood pressure. Blood pressure measurement is based on the CAS oscillometric technology, and is identical to that which is found in the CAS 740 series vital signs monitors (K033048).

The 750C monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, its features include an easily replaceable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication, and a backlit LCD display with both waveform and a numeric display.

| Model(s) | Parameters (Variations) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 750C-2MS<br>(750CM-2MS) | Oridion EtCO2 and Masimo SpO2, 100 – 240VAC 50/60Hz, AC power supply and battery;<br>(same but with 12VDC power input and battery, Mounting clamp included) |
| 750C-2NL,<br>(750CM-2NL) | Oridion EtCO2 and Nellcor SpO2, 100 – 240VAC 50/60Hz, AC power supply and battery;<br>(same but with 12VDC power input and battery, Mounting clamp included) |
| 750C-3MS,<br>(750CM-3MS) | Oridion EtCO2, Masimo SpO2, and CAS NIBP, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included) |
| 750C-3NL,<br>(750CM-3NL) | Oridion EtCO2, Nellcor SpO2, and CAS NIBP, 100 – 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included) |

The monitor and parameters:

{2}------------------------------------------------

#### 750C Series Intended Use

The 750C monitor is intended to continuously calculate and display the following physiological vital signs: end tidal carbon dioxide, respiration rate, capnograph waveform, functional arterial oxygen saturation, pulse rate, plethysmograph waveform, and an optional non-invasive blood pressure measurement of systolic, diastolic, mean arterial pressures along with pulse rate derived from a NIBP pressure waveform. The 750C is intended for monitoring of adult, pediatric and neonatal patients in the care of health care professionals.

### Comparison of Technological Characteristics

The 750C monitor is derived from the CAS 740 (K033048) with regard to form factor and general overall look. A number of identical components are found in both products, most especially the non-invasive blood pressure MAXNIBP® parameter, choice of pulse oximeters; Masimo SET® or Nellcor® OxiMax®. In the 740 predicate, NIBP is the primary parameter, and the secondary are the same two possible pulse oximeters. The 750C series adds a new primary parameter of a Carbon Dioxide Gas Analyzer (Capnometer). The predicate for this portion of the device is the Oridion Polaris 2004 (K040011). CAS makes use of the OEM modules, and appropriate accessories in accordance with the manufacturer's recommendation with no modifications. Some key differences between 740 and 750 are the increased wattage of the switching medical grade power supply and the graphical display capable of numeric characters and waveforms.

### Nonclinical Performance Testing to Show Substantial Equivalence

The model 750C will be tested in accordance with the following standards as per CAS Product Performance Specifications prior to release to market. The following non-clinical tests will be performed:

- UL60601-1 (w/ CSA 22.2 No. 60601-1) Safety testing for use of the UL Classified . mark;
- IEC60601-1 Safety of Medical Electrical Equipment; �
- EN60601-1-2:2001 Safety of Medical Electrical Equipment with regard to EMC . Emissions and EMC Immunity;
- . IEC60601-1-4 Medical Electrical Equipment - Collateral standard: Programmable Electrical Medical Systems;

{3}------------------------------------------------

- IEC60601-2-30 Safety of Medical Electrical Equipment Particular Requirements for . Automatic Cycling Indirect blood Pressure monitoring Equipment;
- Attomatic Cyoling Electrical Electrical Equipment -- Particular Requirements for . the Safety of multifunctional Patient Monitoring Equipment;
- EN 865 Pulse Oximeters Particular Requirements; .
- EN 864 Capnometers for use with Humans Particular Requirements; .
- ANSI/AAMI SP10:2002 -- Electric or Automated Sphygmomanometers (accuracy, . performance and environmental);
- NIBP Monitor Guidance V1.0 March 1997; .
- IEC68-2-6, -27 and -34 Mechanical Shock and Vibration; ●

# Clinical Testing to Show Substantial Equivalence

The OEM parameter suppliers (EtC02 an Sp02) have demonstrated successful clinical The OLM partificate beppose remarket submissions. Those modules are unchanged for inclusion within the model 750. Fully configured model 750 devices were sent to each OEM module manufacturer for performance testing.

The NIBP parameter has been demonstrated to meet the clinical accuracy of AAMI SP10: 2002

## Conclusions Drawn from Clinical and Nonclinical Testing

With the substantial testing of a non-clinical and clinical nature, it is the conclusion that the 750C is substantially equivalent to the predicate devices cited above.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUN 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ron Jeffrey Director, Regulatory Affairs CAS Medical Systems, Incorporated 44 East Industrial Road Branford, Connecticut 06405

Re: K050844

K0506++
Trade/Device Name: 750C Series Monitor Regulation Number: 870.2700 Regulation Name: Pressure Regulator Regulatory Class: II Product Code: DQA, CCK Dated: April 1, 2005 Received: April 12, 2005

Dear Mr. Jeffrey:

We have reviewed your Section 510(k) premarket notification of intent to market the device the device We have reviewed your Section 310(x) prefect is substantially equivalent (for the referenced above and have delimited the developedicated predicate devices marketed in
indications for use stated in the enclosure in the Medical Device indications for use stated in the enclosure, to tegally ment date of the Medical Device
interstate commerce prior to May 28, 1976, the econdance with the provision interstate commerce prior to Way 20, 1970, the cided in accordance with the provisions of
Amendments, or to devices that have been receasified in accordance with the provisio Amendments, or to devices that have been recapited in at require approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do require approval of a premarke the Federal Food, Drug, and Cosment Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, market the det include approval application (PMA). 100 may, including of the Act include controls provisions of the Act. The general of devices, good manufacturing practice,
requirements for annual registration, listing of devices and edulterstion requirements for anifall registration, montgeranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
nto entrols (see a book in a blicing december regulations affect If your device is classified (see above) into club in (special) in the major regulations affecting (PMA), it may be subject to such additional controls: Ditions, Title 21, Press 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, Pageral your device can be found in the Code of Federal Regalations, The Legal and Courtes in the Federal Register.

{5}------------------------------------------------

Page 2 - Mr. Jeffrey

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled on that your device complies with other requirements mean that FDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statutes and regations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . You must comply with an the Act 3 requirements and 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practices and ifsung (21 CFR Part 007), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your bection 510(k) I his letter will anow you to begin marketing your device of your device to a premarket notification. The PDF militing of basians on 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 de router at [phone]. Also, please note the regulation of please contact the Other of Ochiphiane we memarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sinas 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylvie y. Mahaim Dm.D.

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

{6}------------------------------------------------

# Indications for Use

## 510(k) Number (if known): K050844

Device Name:

750C Series monitor

Indications for Use:

The 750C monitor is intended to continuously calculate and display the following physiological vital signs: end tidal carbon dioxide, respiration rate, capnograph waveform, functional arterial oxygen saturation, pulse rate, plethysmograph waveform and an optional non-invasive blood pressure measurement of systolic, diastolic, mean arterial pressures along with pulse rate derived from a NIBP pressure waveform. The 750C is intended for monitoring of adult, pediatric and neonatal patients in the care of health care professionals.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use_ (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)

Ouy Saloon

(Division Sign-Off) Division of Anesthesiology General Hospital, Infection Control, Dentai Devices KOSO844

510(k) Number.

Page 1 of