(46 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not contain any other language suggestive of AI/ML technology.
No
The device is described as an ultrasound imaging system intended for diagnostic purposes (measurement and analysis for clinical diagnosis), not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system provides "analysis packages that provide information that is used for clinical diagnosis purposes." The "Device Description" section reiterates this, confirming its role in providing information for clinical diagnosis.
No
The device is described as modifications to software features of Siemens ultrasound imaging systems, which are hardware devices. The summary does not indicate the software is a standalone medical device.
Based on the provided information, this Siemens ultrasound imaging 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.
- Device Description and Intended Use: The description clearly states that this is an ultrasound imaging system used for visualizing anatomical structures and providing information for clinical diagnosis. Ultrasound is an in vivo imaging modality, meaning it is performed on a living organism, not on a sample taken from the body.
- Lack of Mention of Samples: There is no mention of analyzing biological samples or performing tests on bodily fluids or tissues.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Siemens ultrasound imaging systems are intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, IYN, IYO
Device Description
The modified software features provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
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)
The Auto Ejection Fraction (Auto EF) and Velocity Vector Imaging (VVI) Clinical Applications modifications are verified and validated according to the company's design control process.
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.
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
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Siemens Medical Solutions USA, Inc. Ultrasound Division CONFIDENTIAL
syngo Auto Left Heart and VVI Features Special 510(k) Submission
SECTION 11
510(k) Summary
| Sponsor: | Siemens Medical Solutions USA, Inc.,
Ultrasound Division
1230 Shorebird Way
Mountain View, California 94043 | | |
|------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------|--|
| Contact Person: | Kristen Dorrough
Telephone:
Fax: | (650) 965 0965
(650) 943 7053 | |
| Submission Date: | July 27, 2007 | | |
| Device Name: | Siemens Diagnostic Ultrasound Systems | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | |
| Classification: | Regulatory Class: | II | |
| | Review Category: | Tier II | |
| | Classification Panel: | Radiology | |
Ultrasonic Pulsed Doppler Imaging System FR # 892.1550 Product Code 90-IYN Ultrasonic Pulsed Echo Imaging System FR # 892.1560 Product Code 90-IYO
A. Legally Marketed Predicate Devices
The modified software is substantially equivalent to the software cleared in K061980, K071036 and K052410.
B. Device Description:
The modified software features provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
C. Intended Use
The Siemens ultrasound imaging systems is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The software provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
D. Substantial Equivalence
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
1
Siemens Medical Solutions USA, Inc. Ultrasound Division
CONFIDENTIAL
E. Performance Data
.
The Auto Ejection Fraction (Auto EF) and Velocity Vector Imaging (VVI) Clinical Applications modifications are verified and validated according to the company's design control process.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text around the perimeter reads "Ministry of Health & Human Services USA". The symbol in the center consists of three stylized lines that resemble a bird in flight or a caduceus, a symbol often associated with medicine and healthcare.
SEP 1 4 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Kristen Dorrough Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 1230 Shorebird Way MOUNTAIN VIEW CA 94043
Re: K072090
Trade/Device Name: Siemens Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN and IYO Dated: August 29, 2007 Received: August 31, 2007
Dear Ms. Dorrough:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below this text is the acronym "FDA" in large, bold letters. Underneath the acronym, the word "Centennial" is written in a cursive font. At the bottom of the logo, there are three stars and the text "U.S.A." The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
3
Page 2 -
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosur
4
Indications for Use
510(k) Number (if known):
Device Name:Siemens Diagnostic Ultrasound Systems_________________________________________________________________________________________________________________________
Indications For Use:
The Siemens ultrasound imaging systems are intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Remmer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices RO72080 510(k) Number __
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