(171 days)
Not Found
Not Found
No
The summary describes a standard patient monitoring module measuring physiological parameters and does not mention any AI/ML capabilities or related concepts like image processing, DNN, or training/test sets.
No
The device is indicated for "monitoring of hemodynamic parameters", not for treating medical conditions.
Yes
Explanation: The device is indicated for "monitoring of hemodynamic parameters," which includes ECG, arrhythmia, respiration, temperature, SpO2, and invasive blood pressure. Monitoring these parameters is a form of diagnosis, as it helps identify and track physiological conditions.
No
The device description explicitly mentions a "module" and "accessories," which are hardware components used for monitoring various physiological parameters. The summary does not indicate that the device is solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states the device monitors "hemodynamic parameters" like ECG, respiration, temperature, SpO2, and invasive blood pressure. These are measurements taken directly from the patient's body, not from samples analyzed outside the body.
- Lack of mention of samples: There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, the Datex-Ohmeda NE12STPR module is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Datex-Ohmeda NE12STPR module (model family M-NE12STPR) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG including ST-segment and arrhythmia, Impedance respiration, Including 3 temperature, SpO2 and invasive blood pressure.
Impedance Respiration measurement is indicated for patient's ages 3 and up.
Thy NIBP measurement is indicated for patients with weight from 5kg (11lb.) up.
ages 9 and up:
The device is indicated for use by qualified medical personnel only.
Product codes
MHX
Device Description
NE12STPR Module (Model family M-NE12STPR) and accessories
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
all hospital patients; Impedance Respiration measurement is indicated for patient's ages 3 and up; NIBP measurement for patients with weight from 5kg (11lb.) up, and ages 9 and up.
Intended User / Care Setting
qualified medical personnel only; all hospital patients.
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)
Not Found
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.
Not Found
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
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2000
Mr. Joel C. Kent DATEX-OHMEDA, INC. 3 Highwood Drive Tewksbury, MA 01876
K993608 Re: DATEX-OHMEDA NE12STPR Module (Model Family M-NE12STPR) Requlatory Code: III (three) Product Code: MHX Dated: February 18, 2000 Received: February 22, 2000
Dear Mr. Kent:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
1
Page 2 - Mr. Joel C. Kent
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Repsai Magnh
far
James E Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): _
Device Name: NE12STPR Module (Model family M-NE12STPR) and accessories
Indications For Use:
The Datex-Ohmeda NE12STPR module (model family M-NE12STPR) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG including ST-segment and arrhythmia, Impedance respiration, Incruding 31 comperature, SpO2 and invasive blood pressure.
Impedance Respiration measurement is indicated for patient's ages 3 and up.
ages 9 and up:
The NIBP measurement is indicated for patients with weight from 5kg (11lb.) up.
The device is indicated for use by qualified medical personnel only.
Messes Manh for Jim Dillard
(Dasion Sign-Off)
Desior of Cardiovascular, Respiratory,
ano Neurological Devices
510(k) Number K993608
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)