(91 days)
The Mobil-O-Graph ABPM system is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 to 48 hours.
The Mobil-O-Graph NG ABPM (24 hour Automatic Blood Pressure Monitor) is a fully automatic table model device that measures blood pressure by means of an inflatable cuff on the upper arm. It employs the Oscillometric Principle.
This 510(k) summary states that the Mobil-O-Graph NG ABPM is substantially equivalent to a predicate device (ABPM Mobil-O-Graph Blood Pressure Monitor, K964235) manufactured by the same company. The basis for this equivalency is stated to be similar intended use, general design, materials, components, and performance characteristics.
When a device is determined to be substantially equivalent to a predicate device, it typically means that specific new clinical studies to prove effectiveness are often not required if the new device does not raise new questions of safety or effectiveness. Instead, the focus is on demonstrating that the new device performs as well as, or better than, the predicate device through comparative data.
However, the provided text does not contain any specific acceptance criteria or details of a study with performance data that directly measure device accuracy (e.g., against a reference standard like intra-arterial blood pressure measurements) or clinical effectiveness. The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use.
Here's an analysis based on the provided text, while noting the absence of detailed study information:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the document. For blood pressure monitors, acceptance criteria typically involve accuracy standards (e.g., ISO 81060-2 or AAMI/ANSI SP10) for mean difference and standard deviation between the device and a reference method for systolic and diastolic blood pressure.
- Reported Device Performance: Not reported in the document. The document states that the new device "has the same general design and performance characteristics as the predicate device," implying similar performance to the already cleared predicate. However, no specific performance metrics are provided for the Mobil-O-Graph NG.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified, as no specific performance study is detailed in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable, as no specific performance study with expert ground truth establishment is described.
4. Adjudication Method for the Test Set
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary, as it's not relevant for a blood pressure monitor.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- The document implies that performance is expected to be similar to the predicate device due to shared technological characteristics. However, a specific standalone performance study for the Mobil-O-Graph NG is not described in this summary. Blood pressure monitors are inherently "standalone" in their measurement function, but validation typically involves comparison to a gold standard.
7. The Type of Ground Truth Used
- Not applicable, as no specific performance study with ground truth is described. For blood pressure devices, the "ground truth" for accuracy studies is typically intra-arterial blood pressure measurement or auscultation by trained observers using a mercury sphygmomanometer, according to recognized standards.
8. The Sample Size for the Training Set
- Not applicable, as this device's clearance appears to be based on substantial equivalence to a predicate device, rather than a de novo algorithm development that would involve a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
In conclusion, the document emphasizes that the Mobil-O-Graph NG ABPM is substantially equivalent to a previously cleared predicate device due to shared fundamental characteristics. While this is sufficient for 510(k) clearance in many cases, this specific summary does not provide details about a performance study with acceptance criteria, reported performance, sample sizes, or ground truth establishment for the Mobil-O-Graph NG itself. The assumption is that the predicate device met the necessary performance standards, and thus, the substantially equivalent new device will also perform adequately.
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K072446/51
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Media Trade Corporation
11820 Red Hibiscus Drive - Bonita Springs, FL 34135 Tel (239) 948-2001 -- Fax (239) 948-2002 E-mail: mediatradecorp@gmx.net Web: www.mediatradecorp.com
510(k) Summary
| Submitter's Name: | NOV 29 2007Guenter GinsbergMedia Trade Corporation |
|---|---|
| Address: | 11820 Red Hibiscus DriveBonita Springs, FL 34135 |
| Phone: | (239) 948-2001 |
| Fax: | (239) 948-2002 |
| E-mail: | mediatradecorp@gmx.netg.ginsberg@gmx.net |
| Contact: | Guenter Ginsberg |
| Date of Summary: | August 10, 2007 |
| Trade Name: | Mobil-O-Graph NG, 24 h ABP-Control |
| Establishment: | I.E.M. GmbHRegistration No. 9617476Cockerillstrasse 6952222 Stolberg, Germany |
| Classification | System, Measurement, Blood Pressure, Non-InvasiveProduct Code: DXNRegulation No. 870.1130Class: IIPanel: 74 (Cardiovascular) |
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K072446/51
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Page -2- (510k Summary)
| Predicate Device: | ABPM Mobil-O-Graph Blood Pressure MonitorK 964235Also manufactured by I.E.M. GmbH of Stolberg,Germany |
|---|---|
| Device Description: | The Mobil-O-Graph NG ABPM (24 hourAutomatic Blood Pressure Monitor) is a fullyautomatic table model device that measures bloodpressure by means of an inflatable cuff on the upperarm. It employs the Oscillometric Principle. |
| Intended Use: | The Mobil-O-Graph NG ABPM system is anautomated, microprocessor controlled bloodpressure monitor which monitors, accumulates andstores: heart beat (rate), systolic and diastolic dataof an individual adult patient (in the patient'senvironment) for a session which may last 24 to 48hours. |
| Technological Characteristics: | The Mobil-O-Graph NG ABPM has the samegeneral design and performance characteristics asthe predicate device from I.E.M. GmbH. The maindifference is the physical size, shape and weight,as well as the option to be interfaced with regularcomputers via infrared or Bluetooth technology.The Mobil-O-Graph NG ABPM has the sameintended use, general design and incorporatessimilar materials and components, hence shouldtherefore raise no new questions of safety andeffectiveness.This submitter concludes that the Mobil-O-GraphNG ABPM is therefore substantially equivalent tothe predicate device "ABPM Mobil-O-Graph BloodPressure Monitor by the same Establishment: I.E.M.GmbH of Stolberg, Germany. |
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned in the upper right portion of the seal. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", arranged in a circular fashion around the edge of the seal.
NDV 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Media Trade Corporation c/o Mr. Guenter Ginsberg President 11820 Red Hibiscus Drive Bonita Springs, FL 34135
Re: K072446
Mobil-O-Graph NG 24h ABP-Control Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system. Regulatory Class: Class II (two) Product Code: DXN Dated: November 14, 2007 Received: November 15, 2007
Dear Mr. Ginsberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Guenter Ginsberg
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmlmon fo
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use: The Mobil-O-Graph ABPM system is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate), systolic and diastolic data of an individual adult patient (in the patient's environment) for a session which may last 24 to 48 hours.
Prescription Use X AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Blumstein
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number 122440
§ 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).