(13 days)
Not Found
No
The description focuses solely on data transfer and interfacing capabilities using standard protocols, with no mention of AI/ML algorithms for analysis, interpretation, or decision support.
No
The device is described as an "interfacing system" indicated for "data transfer" of physiological parameters from monitors and scales to external information systems. It does not perform any therapeutic function.
No
The device is described as an "Interfacing System" that transfers data from physiological monitors and scales to external information systems. It does not perform any diagnostic functions itself; it only facilitates data transfer.
Yes
The device description explicitly states "The SMDIE Device Interfacing System Software is intended for use with standalone physiological monitor and Scale-Tronix 5002 scales to transfer data...". While it interfaces with hardware, the device itself is described as software. The performance studies section also only mentions "Software Testing".
Based on the provided information, the SMDIE Device Interfacing System 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.
- SMDIE Function: The SMDIE Device Interfacing System's intended use and description clearly state its purpose is to transfer data from external physiological monitors and scales to external clinical information systems. It collects data like non-invasive blood pressure, temperature, blood oxygenation level, and weight.
- No Sample Analysis: The SMDIE does not perform any analysis on biological samples. It simply facilitates the movement of data already collected by other devices.
Therefore, the SMDIE falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SMDIE Device Interfacing System is indicated for data transfer between standalone physiological monitors that collect noninvasive blood pressure, temperature, and blood oxygenation level through external cuffs and thermometers to external clinical information systems. The SMDIE is also indicated for patient weight transfer between Scale-Tronix 5002 class physician office scales. The SMDIE Device Interfacing System is not intended for continuous vital sign monitoring purposes.
For Prescription Use Only.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
The SMDIE Device Interfacing System Software is intended for use with standalone physiological monitor and Scale-Tronix 5002 scales to transfer data from the physiological monitor and scale to external devices via Health Level Seven data exchange protocols for vitals results and patient information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Software Testing was performed on the SMDIE Device Interfacing System and was determined to be acceptable.
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.
K012094, K021454, K032142, K980688, K033283
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
JUN 2 1 2006 Siemens Medical Solutions Health Services Corporation Traditional 510(k) Premarket Submission SMDIE Device Interfacing System
SECTION 5 - 510(k) SUMMARY
| Submission Correspondent:
Address: | Emergo Group, Inc.
2454 McMullen Booth Road
Suite 427
Clearwater, FL 33759 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------|
| Phone:
Fax:
E Mail: | (727) 797-4727
(727) 797-4757
igordon@emergogroup.com |
| Contact: | Mr. Ian Gordon
Senior Vice President |
| Submission Sponsor: | Siemens Medical Solutions Health Services Corporation
51 Valley Stream Parkway
Malvern, PA 19355 |
| Date Prepared: | May 19, 2006 |
| Trade Name: | SMDIE Device Interfacing System |
| Common Name: | Physiological device data retriever and translator |
| Classification: | Monitor, Physiological, Patient (Without Arrhythmia
Detection Or Alarms) |
| Regulation #: 870.2300, Class II | Product Code: MWI |
Description: The SMDIE Device Interfacing System Software is intended for use with standalone physiological monitor and Scale-Tronix 5002 scales to transfer data from the physiological monitor and scale to external devices via Health Level Seven data exchange protocols for vitals results and patient information.1
" Health Level Seven is one of several Ancrican National Standards Institute (ANSI) -accredited Standards Developing Organizations (SDOs) operating in the healtheare arena. Most SDOs produce standards (sometimes of protocols) for a particular healtheare domain such as pharmacy, medical devices, imaging or insurance (claims processing) transactions. Health Level Seven's domain is clinical and administrative data." Source: http://www.hl7.org.
1
Serial interfaces between physiological monitors and the SMDIE allow patient weight, non-invasive blood pressure, blood oxygenation level, and temperature to be communicated to the Device Connectivity & User Interface Component.
061590
List of Classification names and numbers of externally connected devices are as follows:
- Cardiac Monitor 870.2300 .
- Clinical Electronic Thermometer 880.2910 .
- . Oximeter - 870.2700
- Non-Invasive Blood Pressure Measurement System -- 870.1130 .
- Breathing Frequency Monitor 868.2375 ●
The SMDIE Device Interfacing System is indicated for data Intended Use: transfer between standalone physiological monitors that collect noninvasive blood pressure, temperature, and blood oxygenation level through external cuffs and thermometers to external clinical information systems. The SMDIE is also indicated for patient weight transfer between Scale-Tronix 5002 class physician office scales. The SMDIE Device Interfacing System is not intended for continuous vital sign monitoring purposes.
For Prescription Use Only.
Predicate Devices:
The SMDIE Device Interfacing System substantially equivalent to the following predicate devices.
M2367A Device Link System by Agilent Technologies, Inc. 510(k) #: K012094 Decision: Substantially Equivalent (SE)
Unity Network ID by General Electric Medical Systems Information Technology 510(k) #: K021454 Decision: Substantially Equivalent (SE)
DataCaptor by Capsule Technologie 510(k) #: K032142 Decision: Substantially Equivalent (SE)
Integriti Patient Monitor by Alliance Instruments 510(k) #: K980688 Decision: Substantially Equivalent (SE)
Centra View Device Link System by ICU Data Systems, Inc. 510(k) #: K033283 Decision: Substantially Equivalent (SE)
2
K061590
P 3/3
Siemens Medical Solutions Health Services Corporation Traditional 510(k) Premarket Submission SMDIE Device Interfacing System
Safety and Effectiveness and Summary and Conclusion Regarding Substantial Equivalence:
By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
The minor differences between the SMDIE Device Interfacing System and the predicate devices cited do not raise any additional questions regarding safety and effectiveness. Software Testing was performed on the SMDIE Device Interfacing System and was determined to be acceptable.
The device, as designed, is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate devices.
3
Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The figure is composed of three abstract shapes that resemble a person's head, torso, and legs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
JUN 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solutions Health Services Corporation. c/o Mr. Daniel W. Lehtonen Responsible Third party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd. Unit B7 Twinsburg, OH 44087
Re: K061590
Trade Name: SMDIE Device Interfacing System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm). Regulatory Class: II (two) Product Code: MWI Dated: June 7, 2006 Received: June 8, 2006
Dear Mr. Daniel W. Lethtonen:
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.
4
Page 2 Mr. Daniel W. Lethtonen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devilode that I Drimination that your device complies with other requirements of the Act that I Dr Hab Intact a and regulations administered by other Federal agencies. You must or any I odolar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 8077, laceming (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) I mis loter will anow you to ought inding of substantial equivalence of your device to a legally prematic is notificate 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 If you desire 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 other general 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,
Bffmmimor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SMDIE Device Interfacing System
Indications for Use:
The SMDIE Device Interfacing System is indicated for data transfer between standalone physiological monitors that collect noninvasive blood pressure, temperature, and blood oxygenation level through external cuffs and thermometers to external clinical information systems. The SMDIE is also indicated for patient weight transfer between Scale-Tronix 5002 class physician office scales. The SMDIE Device Interfacing System is not intended for continuous vital sign monitoring purposes.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
B.Bennumton
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