(213 days)
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.
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.
The DINAMAP Compact Monitor is a prescription device intended for use by healthcare professionals for monitoring vital signs (noninvasive blood pressure, pulse rate, temperature, and/or oxygen saturation) in adult, pediatric, and neonatal patients in various clinical settings.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for the K970182 submission does not explicitly state numerical acceptance criteria for each vital sign parameter (e.g., specific accuracy ranges for blood pressure or temperature). Instead, it states that "Several clinical studies were conducted which demonstrate safety and effectiveness" for:
- Predictive Thermometry Accuracy
- Adult Noninvasive Blood Pressure Accuracy
- Pediatric Noninvasive Blood Pressure Accuracy
- Neonatal Noninvasive Blood Pressure Accuracy
- Pulse Oximetry (implicitly covering accuracy for this parameter, though "accuracy" isn't explicitly listed next to it as for the others)
The document concludes that the device is "safe, effective and substantially equivalent to the predicate devices." This implies that the performance in these clinical studies met the expected safety and effectiveness benchmarks, likely derived from the predicate devices or relevant standards at the time (though these specific benchmarks are not detailed).
Therefore, a table with specific numerical acceptance criteria and reported performance cannot be fully constructed from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Several clinical studies" for predictive thermometry accuracy, and adult, pediatric, and neonatal noninvasive blood pressure accuracy. However, no specific sample sizes for these test sets are provided in the current document. The data provenance (e.g., country of origin, retrospective or prospective nature) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for any of the clinical studies mentioned.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test sets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This device is a vital signs monitor, not an AI-assisted diagnostic imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed. The device itself performs the measurements; it does not assist human interpretation of complex cases in the same way AI might for medical imaging.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
The device is inherently a "standalone" system in its measurement function, as it provides direct readings of vital signs. The clinical studies mentioned (e.g., "Predictive Thermometry Accuracy," "Adult Noninvasive Blood Pressure Accuracy") would inherently assess the algorithm's performance in generating these measurements independently. There isn't a "human-in-the-loop" for the initial measurement generation itself; humans then interpret and act upon the device's numerical output. Therefore, yes, standalone performance (algorithm only) was assessed for each vital sign parameter.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for each parameter. However, for a vital signs monitor:
- Noninvasive Blood Pressure: Ground truth would typically be established by invasive blood pressure measurements (e.g., arterial line) or a highly accurate non-invasive reference standard (e.g., mercury sphygmomanometer with auscultation by trained observers), often performed simultaneously or sequentially with the device under test.
- Pulse Oximetry: Ground truth would typically involve co-oximetry of arterial blood samples.
- Predictive Temperature: Ground truth would likely be established by a continuous core body temperature measurement device or a highly accurate traditional thermometer (e.g., rectal probe for a set duration) against which the "predictive" algorithm's output is compared.
8. The Sample Size for the Training Set
The document does not specify any sample sizes for a "training set." This type of conventional "training set" concept is more common in modern machine learning-based devices. For this device, developed in the mid-1990s, the development process would have involved engineering design, calibration, and verification testing, rather than a distinct "training set" in the AI sense. The clinical studies mentioned serve as the validation evidence.
9. How the Ground Truth for the Training Set was Established
As no specific "training set" is described in the context of modern AI/ML development, the method for establishing ground truth for such a set is not applicable/described. The device's algorithms were likely developed and refined through engineering principles, calibration studies, and internal testing, with the clinical studies serving as external validation against observed clinical states (ground truth as described in point 7).
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Johnson Johnson
MEDICAL INC.
AUG 1 8 1997
510(k) Summary
(
| Date | January 16, 1997 |
|---|---|
| Contact | Annette M. HillringDirector, Regulatory AffairsJohnson & Johnson Medical, Inc.4110 George RoadTampa, Florida 33634Telephone: (813) 887-2256Telefax: (813) 887-2263 |
| Device Name | DINAMAP* Compact Monitor |
| Common Names | Physiological or Vital Signs Monitor, Patient MonitorIncludes 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 andParagraph numbers, and classification of the DINAMAP Compact Monitorand its monitoring parameters follow. The tier categorization based on the list(January 27, 1994) distributed by the Office of Device Evaluation is alsoincluded. |
Continued on next page
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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 | K943709K912188 |
| System | DINAMAP XL Monitor | K942700 |
| Temperature | DINAMAP XL Monitor | K942700 |
| NIBP | DINAMAP PLUS Monitor Model 9700 | K943709K912188 |
| DINAMAP XL Monitor | K942700 | |
| Oximetry | Nellcor® Model N-180 Pulse Oximeter | K913695 |
| DINAMAP PLUS Monitor Model 9700 | K943709K912188 |
Continued on next page
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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 |
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510(k) Summary, Continued
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| TechnologicalCharacteristics | The DINAMAP Compact Monitor and its monitoring parameters have thesame technological characteristics as the predicate devices. There are no newtechnological characteristics. The Compact Monitor and the predicate devicesare all software-driven electronic devices. The Compact monitoringparameters and predicate devices monitoring parameters utilize the followingtechnologies:Noninvasive Blood Pressure & Heart Rate: Oscillometry Pulse Oximetry & Heart Rate: Nellcor®, Inc., red & infraredspectroscopy Thermometry: Thermistor with predictive algorithm |
|---|---|
| NonclinicalTests | Several bench studies were conducted which demonstrate safety andeffectiveness of the Compact Monitor and monitoring parameters: Pulse Oximetry Environmental Electromagnetic Compatibility |
| Clinical Tests | Several clinical studies were conducted which demonstrate safety andeffectiveness 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 CFRPart 807, and based on the information provided in this premarket notification,Johnson & Johnson Medical concludes that the new device, the DINAMAPCompact Monitor is safe, effective and substantially equivalent to the predicatedevices as described herein. |
| OtherInformation | Johnson & Johnson Medical will update and include in this summary any otherinformation deemed reasonably necessary by the FDA |
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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.
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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
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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 AACDivision 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)
§ 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.