(213 days)
No
The document describes a standard vital signs monitor with no mention of AI or ML capabilities.
No.
The device is intended for monitoring vital signs, not for treating any medical condition or disease.
No
The device is intended to monitor patient vital signs (noninvasive blood pressure, pulse rate, temperature, and/or oxygen saturation), not to diagnose a condition or disease.
No
The device description explicitly mentions physical hardware components such as a monitor, battery, optional printer, and connections for other devices. It is a physical vital signs monitor, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- DINAMAP Compact Monitor Function: The DINAMAP Compact Monitor directly monitors vital signs on the patient's body (non-invasively). It measures parameters like blood pressure, pulse rate, temperature, and oxygen saturation by interacting with the patient's physical state, not by analyzing samples taken from the patient.
The description clearly states the device is for "monitoring a single adult, pediatric or neonatal patient's vital signs at the bedside." This is a direct, in-vivo (within the body) monitoring function, not an in-vitro diagnostic function.
N/A
Intended Use / Indications for Use
The DINAMAP Compact Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside. Vital signs parameters include noninvasive blood pressure (systolic, diastolic and mean arterial pressure), pulse rate, temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings, primarily in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor & delivery, endoscopy, cardiac step-down, etc. and can also be used during many specialized procedures in satellite areas, or in ambulatory surgery centers, physicians' offices or alternate care settings.
Product codes (comma separated list FDA assigned to the subject device)
74 MHX
Device Description
The DINAMAP Compact Monitor is a prescription device intended for use only by health care professionals. Three configurations of the monitor with the following vital signs parameters will be available: Noninvasive Blood Pressure and Heart Rate, Noninvasive Blood Pressure and Heart Rate, and Predictive Oral/Rectal Thermometry Noninvasive Blood Pressure and Heart Rate, Predictive Thermometry, and Nellcor® Pulse Oximetry and Heart Rate In addition, the currently-marketed Sherwood Medical Inc. FirstTemp™ Genius™ Infrared Tympanic Thermometry Unit (K920713) may be physically attached to the side of (but not electrically integrated with) the DINAMAP Compact Monitor.
The device is designed for monitoring adult, pediatric and neonatal patients in hospital, outpatient surgery center, physician office and/or alternate healthcare settings. It is portable and capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery. An optional printer is also available.
The Compact Monitor provides connection for the currently marketed Johnson & Johnson Medical, Inc. (JJMI, formerly Critikon, Inc.) OBSERVER* Central Station (K933404), other monitoring devices, a remote display, data collection system, remote alarm and/or host information system.
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 or neonatal
Intended User / Care Setting
health care professionals, hospital, outpatient surgery center, physician office and/or alternate healthcare settings.
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)
Several bench studies were conducted which demonstrate safety and effectiveness of the Compact Monitor and monitoring parameters: Pulse Oximetry Environmental Electromagnetic Compatibility
Several clinical studies were conducted which demonstrate safety and effectiveness of the Compact Monitor and monitoring parameters: Predictive Thermometry Accuracy Adult Noninvasive Blood Pressure Accuracy Pediatric Noninvasive Blood Pressure Accuracy Neonatal Noninvasive Blood Pressure Accuracy
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.
K943709, K912188, K942700, K913695
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.
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
§ 870.1025 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
Johnson Johnson
MEDICAL INC.
AUG 1 8 1997
510(k) Summary
(
| Date | January 16, 1997 |
|---|---|
| Contact | Annette M. Hillring |
| Director, Regulatory Affairs | |
| Johnson & Johnson Medical, Inc. | |
| 4110 George Road | |
| Tampa, Florida 33634 | |
| Telephone: (813) 887-2256 | |
| Telefax: (813) 887-2263 | |
| Device Name | DINAMAP* Compact Monitor |
| Common Names | Physiological or Vital Signs Monitor, Patient Monitor |
| Includes the following monitoring parameters: | |
| Noninvasive Blood Pressure & Heart RatePulse Oximetry & Heart RatePredictive Temperature An optional recorder is also available. | |
| Classification | The classification names, 21 Code of Federal Regulations (CFR) Part and |
| Paragraph numbers, and classification of the DINAMAP Compact Monitor | |
| and its monitoring parameters follow. The tier categorization based on the list | |
| (January 27, 1994) distributed by the Office of Device Evaluation is also | |
| included. |
Continued on next page
1
510(k) Summary, Continued
Classification (continued)
| Classification Name | 21 CFR § & Class | Tier |
|---|---|---|
| System, Measurement, Blood Pressure, | ||
| Noninvasive | 870.1130 II | 2 |
| Computer, Blood Pressure | 870.1110 II | 2 |
| Alarm, Blood Pressure | 870.1100 II | 2 |
| Oximeter | 870.2700 II | 2 |
| Oximeter, Ear | 870.2710 II | 2 |
| Thermometer, Clinical Electronic | 880.2910 II | 2 |
| Recorder, Paper Chart | 870.2810 II | 1 |
| Display, Cathode-Ray Tube, Medical | 870.2450 II | 1 |
Predicate Devices
The following table summarizes the predicate devices for the Compact Monitor and its monitoring parameters and 510(k) numbers:
| Compact | Predicate Device & Model | 510(k)
Number(s) |
|-------------|-------------------------------------|---------------------|
| System | DINAMAP PLUS Monitor Model 9700 | K943709
K912188 |
| System | DINAMAP XL Monitor | K942700 |
| Temperature | DINAMAP XL Monitor | K942700 |
| NIBP | DINAMAP PLUS Monitor Model 9700 | K943709
K912188 |
| | DINAMAP XL Monitor | K942700 |
| Oximetry | Nellcor® Model N-180 Pulse Oximeter | K913695 |
| | DINAMAP PLUS Monitor Model 9700 | K943709
K912188 |
Continued on next page
2
510(k) Summary, Continued
ーーーーーー
| Device Description | The DINAMAP Compact Monitor is a prescription device intended for use only by health care professionals. Three configurations of the monitor with the following vital signs parameters will be available: Noninvasive Blood Pressure and Heart Rate,Noninvasive Blood Pressure and Heart Rate, and Predictive Oral/Rectal Thermometry Noninvasive Blood Pressure and Heart Rate, Predictive Thermometry, and Nellcor® Pulse Oximetry and Heart Rate In addition, the currently-marketed Sherwood Medical Inc. FirstTemp™ Genius™ Infrared Tympanic Thermometry Unit (K920713) may be physically attached to the side of (but not electrically integrated with) the DINAMAP Compact Monitor. The device is designed for monitoring adult, pediatric and neonatal patients in hospital, outpatient surgery center, physician office and/or alternate healthcare settings. It is portable and capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery. An optional printer is also available. The Compact Monitor provides connection for the currently marketed Johnson & Johnson Medical, Inc. (JJMI, formerly Critikon, Inc.) OBSERVER* Central Station (K933404), other monitoring devices, a remote display, data collection system, remote alarm and/or host information system. |
|---|---|
| Indications | The DINAMAP Compact Monitor is intended to monitor a single patient's vital signs at the bedside. The patient populations include adult, pediatric and neonatal. |
| Continued on next page |
3
510(k) Summary, Continued
ーーーーーーーーーーーーーー
(
| Technological
Characteristics | The DINAMAP Compact Monitor and its monitoring parameters have the
same technological characteristics as the predicate devices. There are no new
technological characteristics. The Compact Monitor and the predicate devices
are all software-driven electronic devices. The Compact monitoring
parameters and predicate devices monitoring parameters utilize the following
technologies:
Noninvasive Blood Pressure & Heart Rate: Oscillometry Pulse Oximetry & Heart Rate: Nellcor®, Inc., red & infrared
spectroscopy Thermometry: Thermistor with predictive algorithm |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nonclinical
Tests | Several bench studies were conducted which demonstrate safety and
effectiveness of the Compact Monitor and monitoring parameters: Pulse Oximetry Environmental Electromagnetic Compatibility |
| Clinical Tests | Several clinical studies were conducted which demonstrate safety and
effectiveness of the Compact Monitor and monitoring parameters: Predictive Thermometry Accuracy Adult Noninvasive Blood Pressure Accuracy Pediatric Noninvasive Blood Pressure Accuracy Neonatal Noninvasive Blood Pressure Accuracy |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR
Part 807, and based on the information provided in this premarket notification,
Johnson & Johnson Medical concludes that the new device, the DINAMAP
Compact Monitor is safe, effective and substantially equivalent to the predicate
devices as described herein. |
| Other
Information | Johnson & Johnson Medical will update and include in this summary any other
information deemed reasonably necessary by the FDA |
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
AUG 1 8 1997
Ms. Annette M. Hillring Johnson & Johnson Medical Inc. 4110 George Road Tampa, Florida 33634
Re: к970182 DINAMAP* Compact Monitor Requlatory Class: II (two) Product Code: 74 MHX Dated: May 19, 1997 Received: May 20, 1997
Dear Ms. Hillring:
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 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 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 (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 to 895. A substantially equivalent determination assumes compliance 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 Failure to comply with the GMP regulation may result in assumptions. 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 for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Ms. Annette M. Hillring
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 (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: K970182
Device Name: DINAMAP* Compact Monitor
Indications for Use:
The DINAMAP Compact Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside. Vital signs parameters include noninvasive blood pressure (systolic, diastolic and mean arterial pressure), pulse rate, temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings, primarily in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor & delivery, endoscopy, cardiac step-down, etc. and can also be used during many specialized procedures in satellite areas, or in ambulatory surgery centers, physicians' offices or alternate care settings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Christy Foreman for AAC
| Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K970182 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use |
(Optional Format 1-2-96)