(32 days)
K 021862
Not Found
No
The document describes a standard oscillometric blood pressure monitor and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for descriptions of training or test sets.
No.
The device is a monitor designed to measure blood pressure and pulse rate, not to treat a condition.
Yes
This device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly states it is a "fully automatic table model device that measures blood pressure in a human being by means of an inflatable cuff on the upper arm," indicating it includes hardware components (table model, inflatable cuff).
Based on the provided information, 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 Stabil-O-Graph Blood Pressure Monitor measures blood pressure and pulse rate directly from the upper arm using an inflatable cuff and the oscillometric principle. This is a non-invasive measurement of a physiological parameter within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it measures blood pressure and pulse rate from the upper arm.
Therefore, the Stabil-O-Graph Blood Pressure Monitor falls under the category of a non-invasive medical device used for monitoring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stabil-O-Graph Blood Pressure Monitor is intended to be used by adults at home to measure blood pressure (systolic and diastolic) and pulse rate from the upper arm.
The I.E.M. Stabil-O-Graph is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Stabil-O-Graph Blood Pressure Monitor is a fully automatic table model device that measures blood pressure in a human being by means of an inflatable cuff on the upper arm. It employs the method of the "Oscillometric Principle".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
adults
Intended User / Care Setting
adults at home
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.
K 021862
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JUN 1 8 2004
MTC
Media Trade Corporation
K 04/13/3
page 1 of 2
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: | Guenter Ginsberg
Media Trade Corporation |
|--------------------|-----------------------------------------------------------------------------------------------------------------------|
| Address: | 11820 Red Hibiscus Drive
Bonita Springs, FL 34135 |
| Phone: | (239) 948-2001 |
| Fax: | (239) 948-2002 |
| E-mail: | mediatradecorp@gmx.net |
| Contact: | Guenter Ginsberg |
| Date of Summary: | May 7, 2004 |
| Trade Name: | Stabil-O-Graph, Blood Pressure Monitor |
| Classification: | Noninvasive Blood Pressure Measurement System
Product Code: DXN
Regulation Number: 21 CFR 870.1130
Class: II |
| Predicate Devices: | OMRON, Model HEM-711 (773AC)
K 021862 (Predicate) |
1
K041313
page 2 of 2
. .
.
| Page -2- (510k Summary) | |
|---|---|
| Device Description: | The Stabil-O-Graph Blood Pressure Monitor is a |
| fully automatic table model device that measures | |
| blood pressure in a human being by means of an | |
| inflatable cuff on the upper arm. It employs the | |
| method of the "Oscillometric Principle". | |
| Intended Use: | The Stabil-O-Graph Blood Pressure Monitor is |
| intended to be used by adults at home to measure | |
| blood pressure (systolic and diastolic) and pulse rate | |
| from the upper arm. | |
| Technological Characteristics: | The Stabil-O-Graph Blood Pressure Monitor has |
| the same general design and performance | |
| characteristics as the predicate devices from | |
| Omron. The main difference is the physical size, | |
| shape and weight. | |
| The Stabil-O-Graph Blood Pressure Monitor has | |
| the same intended use, general design and | |
| incorporates similar materials and components, | |
| hence should therefore raise no new questions of | |
| safety and effectiveness. | |
| This submitter concludes that the Stabil-O-Graph | |
| Blood Pressure Monitor is therefore substantially | |
| equivalent to the predicate device from Omron. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2004
I.E.M. GMBH c/o Mr. Guenter Ginsberg Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, FL 34135
Re: K041313
Trade Name: I.E.M. Stabil-O-Graph Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 07, 2004 Received: May 17, 2004
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 for assessment 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 may or subject to vacan would Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 – Mr.Guenter Ginsberg
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualited on a substitution with other requirements of the Act
that FDA has made a determination that your device also concepcies. You must that FDA has made a delefinination in your deress by other Federal agencies. You must
or any Federal statutes and regulations administered by other to registration and list or any Federal statules and regulations administers, but not limited to: registration and listing (21 l comply with all the Act STEQuiltents, menames warmacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if emplicable, the electronic CFR Part 807); labeling (21 CFR Fatl ovi ); good manatasaan.g
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Sections 95 % = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = This letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, p premarket notification. The FDA imaling of substance of 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
rs the regulation in 161 1161 at 11 1616 at has note the rogulation entitle If you desire specific advice for your ac (301) 594-4646. Also, please note the regulation entitled, conlact the Office of Comphalled at (50 ) et St 807.97). You may obtain " Misbranding by relefence to prematic its time ander the Act from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the themators attrack Manifiacturers, International and Consulter Pressow.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
urna R. lochner
(JA Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K0413i3
Page / of /
510(k) NUMBER (IF KNOWN) : K04/3/3/3
DEVICE NAME: I.E.M.Stabil-O-Graph
INDICATIONS FOR USE:
The I.E.M. Stabil-O-Graph is intended to be used by adults at home to monitor Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).
Prescription Use (Per 21 CFR 801.109) ાર
Over - The - Counter - Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dmna R Vochner
(Division Sign-Off)
Division of Cigh-Oil)
Division of Cardiovascular Devices
510(k) Number K041313