(92 days)
Not Found
Not Found
No
The provided text does not mention AI, ML, or any related terms, and the device description focuses on safety standards and compatibility with existing systems.
No
The device is described as imaging for visualization and diagnostic purposes, not for treating conditions.
Yes
The device is described as an "Ultrasound Catheter" intended for "intra-luminal visualization" of anatomical structures and physiology, and its safety standards explicitly include "IEC 60601-2-37 Diagnostic Ultrasound Safety Standards" and "AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment." These phrases clearly indicate its use for diagnostic purposes.
No
The device description explicitly states it is an "Ultrasound Catheter" and mentions compliance with hardware safety standards (UL 60601-1, IEC 60601-2-37, etc.), indicating it is a physical medical device with hardware components, not software-only.
Based on the provided information, the Acuson AcuNav V Ultrasound Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart". This describes a device used within the body for imaging, not a device used to examine samples outside the body (in vitro).
- Device Description: The description focuses on safety standards related to medical equipment used on patients (e.g., ultrasound safety, biocompatibility, sterilization). There is no mention of analyzing biological samples.
- Input Imaging Modality: The input is "Diagnostic Ultrasound", which is an imaging technique applied to the patient's body.
- Anatomical Site: The anatomical sites are "intra-luminal, cardiac, great vessel", all locations within the living patient.
IVD devices are used to examine specimens such as blood, urine, tissue, etc., to provide information about a person's health status. The AcuNav V is a diagnostic imaging device used directly on the patient.
N/A
Intended Use / Indications for Use
The Acuson AcuNav V Ultrasound Catheter is intended for 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.
The AcuNav™ V Ultrasound 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.
Product codes
OBJ
Device Description
The AcuNav V has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1
- EN/IEC 60601-1-1 o
- EN/IEC 60601-1-2 o
- IEC 61157 Declaration of Acoustic Power
- ISO 10993-1 Biocompatibility
- ISO 14971 Risk Management
- ISO 11607 Packaging for terminally sterilized medical devices
The AcuNav V catheter is to be used only on systems with which it has been tested and found compatible. Each of these system/transducer combinations shall be cleared through the 510(k) process and have a subsequent special report submitted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac and great vessel
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)
The modified AcuNav Diagnostic Ultrasound Catheter is substantially equivalent to the original AcuNav Ultrasound Imaging Catheter.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K081808
pg # 1 of 2
SEP 2 6 2008
SECTION 11
510(k) Summary Prepared June 24, 2008
Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043
Contact Person: Shelly Pearce Telephone: (650) 694-5988 Fax: (650) 694-5580
Submission Date: June 24, 2008
Modified Device Name: AcuNav V Ultrasound Catheter
Common Name: Diagnostic Ultrasound Catheter
Classification:
Regulatory Class: ============================================================================================================================================================================== Review Category: Tier 11 Classification Panel: Radiology Ultrasonic Imaging Catheter ; 21C FR # 892.1200; Product Code OBJ
A. Legally Marketed Predicate Devices
The modified AcuNav Diagnostic Ultrasound Catheter is substantially equivalent to the original AcuNav Ultrasound Imaging Catheter.
B. Device Description:
The AcuNav V has been designed to meet the following product safety standards:
- UL 60601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 피 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- I Safety and EMC Requirements for Medical Equipment
- o EN/IEC 60601-1
- EN/IEC 60601-1-1 o
- EN/IEC 60601-1-2 o
- IEC 61157 Declaration of Acoustic Power
- 프 ISO 10993-1 Biocompatibility
- ISO 14971 Risk Management
- I ISO 11607 Packaging for terminally sterilized medical devices
1
K0818e8
pg # 2 of 2
The AcuNav V catheter is to be used only on systems with which it has been tested and found compatible. Each of these system/transducer combinations shall be cleared through the 510(k) process and have a subsequent special report submitted.
C. Intended Use
The Acuson AcuNav V Ultrasound Catheter is intended for 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.
2
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2008
Siemens Medical Solutions USA, Inc. c/o Ms. Shelly Pearce Regulatory Affairs P.O. 7393 1230 Shorebird Way Mountain View, CA 94039
Re: K081808
Trade Name: ACUSON AcuNav V 10F Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: September 5, 2008 Received: September 5, 2008
Dear Ms. Pearce:
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.
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
3
Page 2 - Ms. Shelly Pearce
systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact . CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
uma R.bacher
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 6 Diagnostic Ultrasound Indications for Use Form
510(k) Number: KQ81803
Device Name: ACUSON AcuNav V 10F Ultrasound Catheter
Indications for Use: The AcuNav™ V Ultrasound 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.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Power | |||||||||
| (Amplitude) | ||||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (Specify) | Other: | |||||||||
| Harmonic | ||||||||||
| Imaging | ||||||||||
| Ophtalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative | ||||||||||
| (Vascular) | ||||||||||
| Intraoperative | ||||||||||
| (Neurological) | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | P | P* | |||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | P | P | P | P | P | P | P* | |||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P* |
P=Previously cleared by the FDA.
ﻟﻠﺘﻌﻠﻴﻤﻴﺔ ﺍﻟﺘﺎﺭﻳﺦ ﺍﻟﺘﺎﺭﻳﺦ ﺍﻟﻤﺘﻮﺳﻴ AdditIonal Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NECESSARY)
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
Donna R. Vachner
(Division Sian of Cardiovascular Devices
510(k) Number
Page 12 of 23
Page 1 of 2
5
SECTION 7 Intended Use of the Device
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: AcuNav V Ultrasound Catheter, 10F
Indications For Use:
The Acuson AcuNav V Ultrasound Catheter is intended for intra-cardiac and intraluminal 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 × (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)
Duma R. Sohner
(Division Sign-Off Division of Cardiovascular Devices
510(k) Number