(156 days)
Not Found
No
The document describes a standard multi-parameter patient monitor and does not mention any AI or ML capabilities.
No
The device is a patient monitor, intended for continuously monitoring vital signs, not for treating a disease or condition.
No
The device is described as a "Patient Monitor" and its intended use is to "continuously monitor" various physiological parameters. Monitoring devices provide data, but do not inherently diagnose conditions. While the data collected can be used by a healthcare professional for diagnosis, the device itself performs monitoring, not diagnosis.
No
The device description explicitly details hardware components such as a capnograph, pulse oximeter, ECG/Respiration/Temperature module, and non-invasive blood pressure measurement technology, indicating it is a physical patient monitor, not software-only.
Based on the provided information, the 750E Patient Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for continuously monitoring a patient's physiological parameters (ECG, heart rate, NIBP, SpO2, respiration rate, temperature, and EtCO2). This involves directly measuring and displaying these parameters from the patient's body.
- Device Description: The description details the components and functions of a patient monitor, which are designed to acquire and process signals from the patient.
- Lack of In Vitro Activity: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue, etc.) outside of the body (in vitro). The 750E Patient Monitor does not perform any such tests on samples. It directly monitors the patient's vital signs.
Therefore, the 750E Patient Monitor falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 750E Patient Monitor is intended to continuously monitor a patients ECG, heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (Sp02), respiration rate, temperature and end tidal carbon dioxide (C02). The monitor is designed as a continuous monitor and is intended for use on adult, pediatric and neonatal patients in the care of health care professionals.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DRT, BZQ, FIL
Device Description
The CAS 750E Series Monitor is a multi-parameter patient monitor based on the exterior design and platform of the CAS 750C. The 750E features a capnograph (Oridion Microstream® Capnograph) for the continuous non-invasive measurement and monitoring of carbon dioxide concentration in expired and inspired breath. Monitors in the series also have a choice of MasimoSET® or Nellcor® OxiMAX® SpO2 technology. In addition, the monitor measures ECG, heart rate, respiration rate and temperature.
All ten monitors in the 750E series have ECG, respiration and temperature, as one module. Eight of the ten monitors in the series feature non-invasive blood pressure measurement which is based on the CAS series oscillometric technology. The fourth parameter available on three of the ten monitors in the series is a capnograph to measure EtCO2. With the exception of the ECG/Respiration/Temperature module, all sub-assemblies for the 750E Series Monitor are present in the CAS 750C Series Monitor -(K050844).
The 750E 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, and a backlit LCD display with both waveform and a numeric display.
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, pediatric and neonatal patients
Intended User / Care Setting
health care professionals.
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)
Nonclinical Performance Testing: The CAS 750E Series Monitor was tested in accordance with standards including UL60601-1, IEC60601-1, EN60601-1-2, IEC60601-2-30, IEC60601-2-49, EN 865, EN 864, ANSI/AAMI SP10: 2002, NIBP Monitor Guidance V1.0 March 1997, IEC68-2-6, -27 and 34.
Clinical Testing:
- OEM parameter suppliers (EtCO2 and SpO2) demonstrated successful clinical performance within their own premarket submissions, and these modules are unchanged for inclusion in the 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: Based on substantial clinical and non-clinical testing, the 750E is substantially equivalent to the predicate devices.
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the text "K051896" in a large, bold font. Below this, the text "p. 114" is written in a smaller font. The text appears to be handwritten or printed with a slightly rough or uneven quality.
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 |
| Phone - (203) 488-6056 Fax - (203) 488-9438 | |
| Email - rjeffrey@casmed.com | |
| Prepared: | July 11, 2005 |
| Trade Name: | CAS 750E Series Monitor |
| Common Name: | Multi-Function Patient Monitor |
| Classification Name: Oximeter (74DQA) |
1
EQUIVALENCE (Predicate Device)
The CAS 750E Series Monitor is equivalent to the following devices:
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 | |
| (750EM-1) | ECG, respiration and temperature, 100 - 240VAC 50/60Hz, AC power supply and battery; |
| (same but with 12VDC power input and battery, Mounting clamp included). | |
| 750E-2 | |
| (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, | |
| (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:
2
Image /page/2/Picture/0 description: The image shows a handwritten text "K051896" on the top and "p.4" on the bottom. The text is written in a simple, slightly shaky hand, suggesting it may have been written quickly or by someone with less steady handwriting. The contrast between the text and the background is clear, making the text easily readable.
| Model(s) | Parameters (Variations) |
|---|---|
| 750E-2NL, | |
| (750EM-2NL) | ECG, respiration and temperature & Nellcor SpO2, 100-240VAC 50/60Hz, AC power supply |
| and battery; (same but with 12VDC power input and battery, Mounting clamp included). | |
| 750E-3MSC | |
| (750EM-3MSC) | ECG, respiration and temperature, Masimo SpO2, and EtCO2, 100 – 240VAC 50/60Hz, AC |
| power supply and battery; (same but with 12VDC power input and battery, Mounting clamp | |
| included). | |
| 750E-3NLC | |
| (750EM-3NLC) | ECG, respiration and temperature, Nellcor SpO2, and EtCO2, 100-240VAC 50/60Hz, AC |
| power supply and battery; (same but with 12VDC power input and battery, Mounting clamp | |
| included). | |
| 750E-3MS | |
| (750EM-3MS) | ECG, respiration and temperature, Masimo SpO2, & NIBP, 100 - 240VAC 50/60Hz, AC power |
| supply and battery; (same but with 12VDC power input and battery, Mounting clamp | |
| included). | |
| 750E-3NL | |
| (750EM-3NL) | ECG, respiration and temperature, Nellcor SpO2, & NIBP, 100 - 240VAC 50/60Hz, AC power |
| supply and battery; (same but with 12VDC power input and battery, Mounting clamp | |
| included). | |
| 750E-4MS | |
| (750EM-4MS) | ECG, respiration and temperature, Masimo SpO2, EtCO2 & NIBP, 100 - 240VAC 50/60Hz, AC |
| power supply and battery; (same but with 12VDC power input and battery, Mounting clamp | |
| included). | |
| 750E-4NL | |
| (750EM-4NL) | ECG, respiration and temperature, Nellcor SpO2, EtCO2 & NIBP, 100 - 240VAC 50/60Hz, AC |
| power supply and battery; (same but with 12VDC power input and battery, Mounting clamp | |
| 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
3
+4/4
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.
4
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.
5
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 (240) 276-0120. 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 (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (80 Manufacturers, International and Consumer Assistance at to tor 11-01-2017
(301) 443-6597 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
6
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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