MODEL 750E SERIES MONITOR

K051896 · Cas Medical Systems, Inc. · MWI · Dec 16, 2005 · Cardiovascular

Device Facts

• Record ID: K051896
• Device Name: MODEL 750E SERIES MONITOR
• Applicant: Cas Medical Systems, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The 750E Patient Monitor is intended to continuously monitor a patients ECG, heart rate, functional arterial oxygen saturation (Sp02), respiration rate, temperature and end tidal carbon dioxide (C02). The monitor is designed for use on adult, pediatric and neonatal patients in the care of health care professionals.

Device Story

The CAS 750E Series Monitor is a multi-parameter patient monitor for clinical settings; used by healthcare professionals for spot-checking or continuous monitoring. Inputs include ECG leads, pulse oximetry sensors (Masimo SET or Nellcor OxiMAX), temperature probes, NIBP cuffs, and capnography sampling lines. The device processes these physiological signals to provide real-time numeric values and waveforms on a backlit LCD display. It operates on AC power or a rechargeable Nickel Metal Hydride battery. The monitor aids clinicians in assessing patient status, facilitating clinical decision-making through continuous vital sign tracking. Benefits include portable, ruggedized monitoring across diverse patient populations.

Clinical Evidence

No clinical trials performed. OEM modules for EtCO2 and SpO2 were previously validated in their respective premarket submissions. NIBP accuracy was validated against AAMI SP10:2002 standards. ECG, impedance respiration, and temperature modules were validated through in-house performance testing.

Technological Characteristics

Multi-parameter monitor; backlit LCD display; Nickel Metal Hydride battery; AC/DC power input. Parameters: ECG, impedance respiration, temperature (skin surface), NIBP (oscillometric), SpO2 (Masimo SET or Nellcor OxiMAX), and EtCO2 (capnography). Safety standards: UL60601-1, IEC60601-1, IEC60601-2-30, IEC60601-2-49, EN 865, EN 864, ANSI/AAMI SP10:2002.

Indications for Use

Indicated for continuous monitoring of ECG, heart rate, SpO2, respiration rate, temperature, and EtCO2 in adult, pediatric, and neonatal patients under the care of healthcare professionals.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• CAS 750C Monitor (K050844)
• Welch Allyn Atlas Monitor (K022084)

Submission Summary (Full Text)

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# DEC 1 6 2005

S MEDICAL SYSTEMS, INC. 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: | July 11, 2005 |
| Trade Name: | CAS 750E Series Monitor |
| Common Name: | Multi-Function Patient Monitor |
| Classification Name: Oximeter (74DQA) | |

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#### EQUIVALENCE (Predicate Device)

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

- * CAS 750C Monitor (K050844);
- * Welch Allyn Atlas Monitor (K022084).

#### DESCRIPTION

The CAS 750E Scries Monitor is a multi-parameter patient monitor based on the exterior The CAS 750E Series Monitor is a mani paramove partico. The 750E features a capnograph design and platform of the CAS 7500 Phal Digital C02 for the continuous non-invasive equivalent to the Ondion I blars 2004 Liar Production of expired and inspired breath.
measurement and monitoring of carbon dioxide conceentration N. Howev OriMAX® Sw02 measurement and monitoring of carbon anomes in the simoSET® or Nellcor® OxiMAX® Sp02
Monitors in the series also have a choice of MasimoSET® or Nellcords addrion Montors in the series also have a choloo of master of master. In addition, the technology, and a CCG, heart rate, respiration rate and temperature.

All ten monitors in the 750E series have ECG, respiration and temperature, as one module. All ten filomfors in the 730E sortes have been consisting of a pulse oximenter with a Elgh of the ten have an additional soccharger of the ten monitors in the series feature non-invasive blood pressure measurement is based on the CAS series reallie holl-mivasted blood pressurer Drace of the ten monitors in the series osollometric technology. The fourth partinents from of the ECG/Respiration/Temperature
is a capnograph to measure EtC02. With the exception of the ECG/Respira Marciter is a capliograph to measure Eco2. "What the enception in the CAS 750C Series Monitor -(K050844). Scc the matrix bclow.

The 750E monitor is a rugged, portable and lightweight unit widely adaptable for many The 750E momor is a rugged, portacts and righter continuous montinuous monitoring, its
applications and mounting schemes. Used for spot-checking or continuous montontoney an applications and mounting schemes. Nickel Metal Hydride rechargeable battery pack, features include an easily replacedors : nexts. In backlit LCD display with both waveform and a numeric display.

| Model(s) | Parameters (Variations) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 750E-1<br>(750EM-1) | ECG, respiration and temperature, 100 - 240VAC 50/60Hz, AC power supply and battery;<br>(same but with 12VDC power input and battery, Mounting clamp included). |
| 750E-2<br>(750EM-2) | ECG, respiration and temperature & NIBP, 100 - 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included). |
| 750E-2MS,<br>(750EM-2MS) | ECG, respiration and temperature & Masimo SpO2, 100 - 240VAC 50/60Hz, AC power supply and battery; (same but with 12VDC power input and battery, Mounting clamp included). |

The monitor and parameters:

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| Model(s) | Parameters (Variations) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 750E-2NL,<br>(750EM-2NL) | ECG, respiration and temperature & Nellcor SpO2, 100-240VAC 50/60Hz, AC power supply<br>and battery; (same but with 12VDC power input and battery, Mounting clamp included). |
| 750E-3MSC<br>(750EM-3MSC) | ECG, respiration and temperature, Masimo SpO2, and EtCO2, 100 – 240VAC 50/60Hz, AC<br>power supply and battery; (same but with 12VDC power input and battery, Mounting clamp<br>included). |
| 750E-3NLC<br>(750EM-3NLC) | ECG, respiration and temperature, Nellcor SpO2, and EtCO2, 100-240VAC 50/60Hz, AC<br>power supply and battery; (same but with 12VDC power input and battery, Mounting clamp<br>included). |
| 750E-3MS<br>(750EM-3MS) | ECG, respiration and temperature, Masimo SpO2, & NIBP, 100 - 240VAC 50/60Hz, AC power<br>supply and battery; (same but with 12VDC power input and battery, Mounting clamp<br>included). |
| 750E-3NL<br>(750EM-3NL) | ECG, respiration and temperature, Nellcor SpO2, & NIBP, 100 - 240VAC 50/60Hz, AC power<br>supply and battery; (same but with 12VDC power input and battery, Mounting clamp<br>included). |
| 750E-4MS<br>(750EM-4MS) | ECG, respiration and temperature, Masimo SpO2, EtCO2 & NIBP, 100 - 240VAC 50/60Hz, AC<br>power supply and battery; (same but with 12VDC power input and battery, Mounting clamp<br>included). |
| 750E-4NL<br>(750EM-4NL) | ECG, respiration and temperature, Nellcor SpO2, EtCO2 & NIBP, 100 - 240VAC 50/60Hz, AC<br>power supply and battery; (same but with 12VDC power input and battery, Mounting clamp<br>included). |

#### 750E Series Indications for Use

The 750E Patient Monitor is intended to continuously monitor a patients ECG, heart rate, I he 7 JUL i anchi Montor is intenter functional arterial oxygen saturation (Sp02), respiration rate, temperature and end tidal carbon dioxide (C02). The monitor is designed as a rate, temperature and ond traded for use on adult, pediatric and nconatal patients in the care of health care professionals.

### Comparison of Technological Characteristics

The 750E monitor is derived from the CAS 750C (K050844) with regard to form factor and The 750L monton is derred nom ins institution in both products are found in both products, most general overall look. 71 hamber of facilities of pulse oximeters; Masimo SET® or Nellcor® espectary the Lnd Trual Co2 (DCOD), enter MAXNIBP® parameter. The 750E series adds the new parameter(s) ECG, Impedance Respiration and temperature (skin surface). The the for this portion of the device is the Atlas 220 monitor from Welch Allyn (K022084). predicate for this portion of the owles, and appropriate accessories in accordance with the manufacturer's recommendation with no modifications

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K051396

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# Nonclinical Performance Testing to Show Substantial Equivalence

The model 750E will be tested in accordance with the following standards as per CAS ITIc model 7502 win be teeted in assorior 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;
- IEC60601-2-30 Safety of Medical Electrical Equipment --- Particular Requirements for . Automatic Cycling Indirect blood Pressure Monitoring Equipment;
- IEC60601-2-49 Safety of Medical Electrical Equipment -- Particular Requirements for . the Safety of multifunctional Patient Monitoring Equipment;
- EN 865 Pulsc 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 OEM paranteer within their own premarket submissions. Those modules are unchanged for inclusion within the model 750E.

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

The ECG, impedance respiration and temperature portion of the monitor have been validated for performance through in-house validation plans.

#### Conclusions Drawn from Clinical and Nonclinical Testing

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

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Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2005

CAS Medical System, Inc. c/o Mr. Ron Jeffrey Director, Regulator Affairs 44 East Industrial Rd. Branford, CT 06405

Re: K051896

Trade Name: Model 750E Series Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: 21 CF CF CF CF CF CF C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. Regulatory Class: Class II (two) Product Code: MWI, DRT, BZQ, FI.L Dated: November 23, 2005 Received: November 25, 2005

Dear Mr. Jeffrey:

We have reviewed your Section 510(k) premarket notification of intent to market the device timindiati we have reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manager in the Medical Device Amendments, or to
r beys. The May 28, 1976, the enactment date of the Medical Forley of Food. Food. commerce prior to May 28, 1776, the enacement with the provisions of the Federal Food. Drug. devices that have been recuasified in acceraanse who f a premarket approval application (PMA). and Cosment Act (Act) that of hot require approvise the general controls provisions of the Act. The You may, inerelore, market the device, saloject to the go
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the 1100 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 If your device is classified (sec above) into extisting major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entroling to 800 to 898. In addition, FDA may be found in the Code of Peacharing your device in the Federal Register.

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Page 2 - Mr. Ron Jeffrey

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Act Please be advised that FDA's issuance of a substance of atther requirements of the Act
that FDA has made a determination that your device and reconces. You must that FDA has made a determination inalyon in the Federal agencies. You must
or any Federal statutes and regulations administered by other Federal on and listin or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not irements as set comply with all the Act's requirements, including, our managuring practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirem CFR Part 807); labeling (21 CFR Part 601); good manufacture, pad if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1000-1050. forth in the quality systems (QS) regulation (2) -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action 5 product radiation control provisions (Sections 551 device as described in your Section 5 (0(k)
This letter will allow you to begin marketing your device to a leval This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA inding of substantial equive 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
rs in the are and and and 10, 2019 - Also, mace the regulation entitled. If you desire specific advice for your device on our nooming the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulation in contact the Office of Compliance at (240) 270 other 1200, person 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarkst notification" (2) Co. Set from the Division of Small
other general information on your responsibilities under the Act from the UNIC (80 other general information on your responsibilities and its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free number (80 Manufacturers, International and Consumer Assistance at to tor 11-01-2017
[phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blummenauer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known):

Device Name:

750E Series monitor

Indications for Use: The 750E Patient Monitor is intended indications for on onitor a patients ECG, heart rate, nonto continuoubly moniker (NIBP), functional arterial oxygen invasive blood p), respiration rate, temperature and end saturation (Open), . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . tidal carbon dioxiao (Star and is intended for use on adult, bediatric 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)

Blumuma

Sh Slgn-Off Division of Cardiovascular Devloes 510(k) Number

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