(860 days)
This portable device, the ABPM Mobil-o- Graph "" Blood Pressure Monitor manufactured by I.E.M. GmbII is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate) systolic und diastolic data of a individual adult-patient (in the patient's environment) for a session which may last 24 to 48 hours.
ABPM Nobil-o- Graph™ Blood Pressure Monitor, Model ABP Control is a computerized blood pressure system designed for clinical applications to allow physicians or other health care providers to record, store, and playback patient data.
The provided text describes a 510(k) submission for the ABPM Mobil-o-Graph™ Blood Pressure Monitor, Model ABP Control, and references a predicate device. However, it does not contain specific acceptance criteria, performance metrics, or details of a study that proves the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device based on shared intended use, functionality (recording, storing, playing back patient data, displaying images, using mathematical computations and proprietary algorithms), and adherence to Good Manufacturing Practices.
Therefore, many of the requested details about acceptance criteria, performance, and study specifics cannot be extracted from this text.
Here's what can be gathered or inferred, with explicit mention of what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in the provided text. The primary "acceptance" is substantial equivalence to the predicate device. | No specific performance metrics are reported in the provided text. The document states, "This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy," but provides no data. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No MRMC study is mentioned. This device is a blood pressure monitor, not an AI-assisted diagnostic tool for "human readers."
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A standalone performance assessment would typically be implied for a blood pressure monitor, as it provides direct measurements. However, the results of such a study (e.g., accuracy against a gold standard) are not provided in this document. The text only mentions that "it has been tested to confirm safety and efficacy."
7. The type of ground truth used
- Type of Ground Truth: Not specified. For a blood pressure monitor, ground truth would typically be established by a reference standard measurement (e.g., invasive arterial line measurement or a highly calibrated manual sphygmomanometer reading) or a clinical standard of care.
8. The sample size for the training set
- Sample Size: Not applicable/Not specified. This document pertains to a blood pressure monitor, which is not described as an AI/ML device that requires a "training set" in the conventional sense for a model. While it uses "proprietary algorithms" and "mathematical computations," these are not explicitly described as machine learning algorithms requiring a distinct training pipeline.
9. How the ground truth for the training set was established
- How Ground Truth Established: Not applicable/Not specified, as no training set for an AI/ML model is described.
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Exhibit 16 Summary of Safety & Effectiveness for ABPM Mobil-o- Graph ™ Blood Pressure Monitor, Model ABP Control
ABPM Nobil-o- Graph™ Blood Pressure Monitor, Model ABP Control is a computerized blood pressure system designed for clinical applications to allow physicians or other health care providers to record, store, and playback patient data.
As such, this device is a Class II device, having Classification Name ABPM Mobil-o- Graph ™ Blood Pressure Monitor , Model ABP Control.
| Product Nomenclature | Classification Number | Regulation Number |
|---|---|---|
| Blood Pressure Computer | 74DSK | 870.1110 |
| Non-Invasive Blood PressureMeasurement System | 74DXN | 870.1130 |
I. E.M. GmbH has determined that this device is substantially equivalent to a predicate medical device which is currently in commerce as the Ultralite Ambulatory Blood Pressure Monitor, Model SL 90202, manufactured by Space Labs, Incorporated of Redwood, Washington (determined substantially equivalent via K 855127). A determination of substantial equivalence is based upon:
Both the ABPM Mobil-o- Graph tm Blood Pressure Monitor, Model ABP Control and Ultralite Ambulatory Blood Pressure Monitor, Model SL 90202 are blood pressure monitors for clinical applications, to allow physicians or other health care providers to record, store, and playback patient data. Both devices use a computer program to display a pre-digitized patient image file. Both devices run under a computer operating system. Both devices use the computer operating system to access the displayed image.
Both devices record, store, and playback patient data Both devices retain an electronically stored sample. Both act on that sample using mathematical computations. Both use a proprietary algorithm. Both use computer programming in a computer operating system.
The ABPM Mobil-o- Graph tm Blood Pressure Monitor, Model ABP Control has benefited from design, development, testing and procedures that conform to Good Manufacturing Procedures. This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended.
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. I.E.M. GmbH continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION:
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.
1 Mr. Uwe Korth Director, Product Services I.E.M. GmbH Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft mbH Cockerillstraße 69 D-52222 Stolberg
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines, representing health and human services.
MAR - 2 1999
Industrielle Entwicklung Medizintecknik und Vertriebsgesellschaft GmbH c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
K964235 Re: Mobil-O-Graph™ Blood Pressure Monitor, Model ABP Control Regulatory Class: II (Two) Product Code: 74 DXN February 5, 1999 Dated: Received: February 9, 1999
Dear Mr. Keen:
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 ecommerce p, 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 A substantially equivalent determination assumes compliance with 895. 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. 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 - Mr. Richard Keen
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 requlation entitled, "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,
Thomas J. Callahan
Thomas J. Calla Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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From :
10(K) number assigned 510(K) Number (If known): Device Name: __ ABPM Mobil-o- Graph "" Blood Pressure Monitors, Model ABI' Control __ Indications for Use
This portable device, the ABPM Mobil-o- Graph "" Blood Pressure Monitor manufactured by I.E.M. GmbII is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate) systolic und diastolic data of a individual adult-patient (in the patient's environment) for a session which may last 24 to 48 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thresl. Shruka
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number 1964) 55
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).