(57 days)
Not Found
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.
No
The device is intended for visualization and diagnostic purposes, not for treating or curing a medical condition.
Yes
The device is intended for "intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology," which directly supports diagnosis by providing visual information about the body's internal structures and functions.
No
The device description explicitly refers to an "Ultrasound Catheter," which is a hardware component. The summary also mentions biocompatibility testing (ISO 10993-1), which is relevant to hardware that comes into contact with the body.
Based on the provided information, the Acuson Acunav Ultrasound Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- AcuNav's Intended Use: The AcuNav is described as being used for "intra-cardiac and intra-luminal visualization... as well as visualization of other devices in the heart". This clearly indicates that the device is used inside the body for direct visualization, not for testing samples taken from the body.
- Imaging Modality: The device uses Ultrasound, which is an imaging technique performed directly on the patient, not on a sample.
Therefore, the Acuson Acunav Ultrasound Catheter falls under the category of an in vivo diagnostic or imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
DOO, OBJ
Device Description
- 활 ISO 10993-1 Biocompatibility
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology
Indicated Patient Age Range
adult and pediatric patients
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 AcuNav 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.
Not Found
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
SECTION 11
| | | 510(k) Summary
Prepared April 30, 2007 | | JUN 2 9 2007 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--|--------------|
| Sponsor: | Siemens Medical Solutions USA, Inc.,
Ultrasound Division
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94039-7393 | | | |
| Contact Person: | Sheila W. Pickering Ph.D. | | | |
| | Telephone: | (650) 943 7187 | | |
| | Fax: | (650) 943 7053 | | |
| Submission Date: | February 16, 2007 | | | |
| Device Name: | AcuNav Diagnostic Ultrasound Catheter | | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | | |
| Classification: | | | | |
| Regulatory Class: | II | | | |
| Review Category: | Tier II | | | |
| Classification Panel: | Radiology | | | |
| | Ultrasonic Imaging Catheter ; 21C FR # 892.1550; Product Code DOO | | | |
A. Legally Marketed Predicate Devices
The AcuNav Ultrasound Imaging Catheter is substantially equivalent to original AcuNav Ultrasound Imaging Catheter.
B. Device Description:
- 활 ISO 10993-1 Biocompatibility
C. Intended Use
The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
D. Substantial Equivalence
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
E. Performance Data
The AcuNav modifications are verified and validated according to the company's design control process.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007
Siemens Medical Solutions USA, Inc. c/o Ms. Sheila Pickering, Ph.D. Senior Director of Regulatory Affairs P.O. Box 7393 1230 Shorebird Way Mountain View, CA 94039
Re: K071234
AcuNav Diagnostic Ultrasound Catheter 8F, 10F Regulation Number: 21 CFR 870.1200 Regulation Name: Intravascular Ultrasound Catheter Regulatory Class: Class II (two) Product Code: OBJ Dated: April 30, 2007 Received: May 3, 2007
Dear Dr. Pickering:
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.
2
Page 2- Ms. Sheila Pickering, Ph.D.
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 rorduct 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,
ura R. lochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 7 Intended Use of the Device
510(k) Number (if known):__Ko712-34
Device Name: AcuNav Diagnostic Ultrasound Catheter 8F, 10F
Indications For Use:
The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Prescription Use _ X = AND/OR (Part 21 CFR 801 Subpart D)
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)
Duma R. Achmes
(Division Sign-Off)
Division of Cardiovascuiar
510(k) Number_k631234
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