(32 days)
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).
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".
This 510(k) summary for the Stabil-O-Graph Blood Pressure Monitor (K041313) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested format.
The document primarily focuses on establishing substantial equivalence to a predicate device (OMRON, Model HEM-711 (773AC), K021862) based on similar intended use, design, technological characteristics, materials, and components.
Here's why the requested information cannot be extracted from the provided text:
- No specific acceptance criteria are listed. The document states the device has "the same general design and performance characteristics as the predicate devices" but doesn't quantify what those performance characteristics are or what statistical thresholds constitute "acceptance."
- No study details are provided. There is no mention of a clinical trial or performance study conducted for the Stabil-O-Graph. The submission relies on the substantial equivalence to the predicate, implying that the predicate's performance data is sufficient without new testing.
Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided document.
Summary of what can be inferred from the document:
- Device Type: Noninvasive Blood Pressure Measurement System.
- Intended Use: For adults at home to measure blood pressure (systolic and diastolic) and pulse rate from the upper arm.
- Method: Oscillometric Principle.
- Comparison: Substantially equivalent to OMRON, Model HEM-711 (773AC) (K021862).
To fulfill the request, a document that describes the actual performance testing and the specific criteria used to evaluate the Stabil-O-Graph Blood Pressure Monitor would be required. This typically involves comparison to a reference standard (e.g., auscultatory measurements) and predefined accuracy standards (like those from ISO, AAMI, or BHS).
{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 GinsbergMedia Trade Corporation |
|---|---|
| Address: | 11820 Red Hibiscus DriveBonita 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 SystemProduct Code: DXNRegulation Number: 21 CFR 870.1130Class: 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 afully automatic table model device that measuresblood pressure in a human being by means of aninflatable cuff on the upper arm. It employs themethod of the "Oscillometric Principle". |
| Intended Use: | The Stabil-O-Graph Blood Pressure Monitor isintended to be used by adults at home to measureblood pressure (systolic and diastolic) and pulse ratefrom the upper arm. |
| Technological Characteristics: | The Stabil-O-Graph Blood Pressure Monitor hasthe same general design and performancecharacteristics as the predicate devices fromOmron. The main difference is the physical size,shape and weight.The Stabil-O-Graph Blood Pressure Monitor hasthe same intended use, general design andincorporates similar materials and components,hence should therefore raise no new questions ofsafety and effectiveness.This submitter concludes that the Stabil-O-GraphBlood Pressure Monitor is therefore substantiallyequivalent 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
§ 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).