← Product Code [OBJ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ) · K033650
# ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER (K033650)
_Siemens Medical Solutions USA, Inc. · OBJ · Feb 24, 2004 · Cardiovascular · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K033650
## Device Facts
- **Applicant:** Siemens Medical Solutions USA, Inc.
- **Product Code:** [OBJ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ.md)
- **Decision Date:** Feb 24, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1200
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Pediatric
## Indications for Use
The AcuNav™ Diagnostic 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.
## Device Story
AcuNav 90/10 is a single-use, disposable ultrasonic phased-array imaging transducer integrated into a 10 Fr (3.33 mm) diameter, 90 cm long catheter. Distal tip features four-way deflection (160° range) in two orthogonal planes for precise positioning. Device connects to compatible ultrasound systems (Aspen, Cypress, Sequoia) via a reusable system cable. Operates by emitting ultrasound waves and receiving echoes to generate real-time images of cardiac/vascular anatomy and physiology, blood flow, and device placement. Used by clinicians in clinical settings (e.g., cath lab) to guide procedures and assess anatomy. Output displayed on ultrasound system monitor; assists in clinical decision-making by providing high-resolution visualization of intracardiac structures and hemodynamic data.
## Clinical Evidence
Bench testing only. Device safety and performance verified through compliance with electrical safety (UL 2601-1, IEC 601-1-1/2) and biocompatibility (ISO 10993) standards. No clinical trial data presented.
## Technological Characteristics
Phased-array ultrasonic transducer; 10 Fr (3.33 mm) diameter; 90 cm insertable length; 4-way deflection mechanism; reusable system cable interface. Complies with UL 2601-1, CSA C22.2 No. 601-1, CISPR 11, IEC 601-1-1/2, and ISO 10993 biocompatibility standards.
## Regulatory 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.
## Predicate Devices
- ACUSON AcuNav® 90/10 Diagnostic Ultrasound Catheter ([K992631](/device/K992631.md))
## Submission Summary (Full Text)
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# 510(k) SUMMARY
FEB 2-4 2004 .
# AcuNav 90/10 Diagnostic Ultrasound Catheter
This summary of safety and effectiveness is provided as part of this Fremarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR. Part 807.92. Content and Format of a 510(k) Summary.
#### 1. Submitted by:
Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, CA 94039
### Contact Person:
Iskra Mraković Manager, Regulatory Affairs
Phone: (650) 694-5004 Fax: (650) 961-6168
#### 2. Proprietary Name:
AcuNav 90/10 Diagnostic Ultrasound Catheter
### Common/Usual Name:
Intracardiac/Intravascular Ultrasound Catheter.
### Classification Name:
Regulatory Class: II Review Category: Tier II
| | FR Number | Product Code |
|-----------------------------------|-----------|--------------|
| Diagnostic Intravascular Catheter | 870.1200 | 74-DQO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
#### 3. Predicate Device:
ACUSON AcuNav® 90/10 Diagnostic Ultrasound Catheter
#### 4. Device Description:
As described in the previously cleared 510(k) submissions, (K992631 on December 15, 1999, and K010950 on June 27, 2001), the AcuNav catheter is comprised of a single-use, disposable ultrasonic phased-array imaging transducer and a catheter which is 10 Fr (3.33 mm) in diameter and 90 cm in insertable length. The device is capable of imaging at multiple frequencies and obtaining blood flow data in multiple ultrasound modes. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: leftright (in a plane perpendicular to the image plane) and anterior-posterior (in a
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plane coincident with the image plane). The range of deflection is 160° in each direction. The AcuNav catheter is comprised of three major components: (1) the catheter itself; (2) the steering mechanism; and (3) the reusable system cable.
The AcuNav 90/10 Diagnostic Ultrasound Catheter has been designed to meet the following product safety standards [as required by 21 CFR § 807.87(i)].
- UL 2601-1, Safety Requirements for Medical Equipment .
- . CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- . CISPR 11, Class A
- IEC 601-1-1 ●
- IEC 601-1-2 .
- . ISO 10993 Biocompatibility
#### Intended Use: 5.
The AcuNay catheter is intended for use in the visualization of vascular anatomy and physiology, cardiac and great vessel anatomy and physiology, visualization of other devices in the heart or vasculature, as well as measurements of blood flow, cardiac and vascular anatomic dimensions.
#### Technological Comparison to Predicate Device: 6.
The AcuNav 90/10 Diagnostic Ultrasound Catheter is substantially equivalent to the ACUSON AcuNav® 90/10 Diagnostic Ultrasound Catheter (K992631,
11/8/2001).
Both catheters are ultrasound-tipped catheter devices used directly within the vasculature and/or the heart for intravascular or intracardiac ultrasound imaging. Devices are specifically indicated for use in visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow.
### End of 510(k) Summary.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three human profiles facing to the right.
MAY 2 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solutions USA, Inc. c/o Dr. Iskra Mrakovic Regulatory Affairs Manager 1230 Shorebird Way P.O. Box 7393 Mountain View, CA 94043
Re: K033650
Trade/Device Name: Acunav 90/10 Diagnostic Ultrasound Catheter Regulation Number: 21 CFR 870.1200 and 892.1570 Regulation Name: Diagnostic Intravascular Catheter and Diagnostic Ultrasound Transducer
Regulatory Class: II Product Code: OBJ and ITX Dated: November 19, 2003 Received: November 20, 2003
Dear Dr. Mrakovic:
This letter corrects our substantially equivalent letter of February 24, 2004.
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 (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 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.
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Page 2 - Dr. Mrakovic
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 continue 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) 276-4008. 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/dsma/dsmamain.html
Sincerely yours,
fa
compe
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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### Diagnostic Ultrasound Indications for Use Form Aspen Diagnostic Ultrasound System
| 510(k) Number: | K033650 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | AcuNav 90/10 (IC10V5) Diagnostic Ultrasound Catheter |
| Indications for Use: | The AcuNav™ Diagnostic 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. |
| Ultrasound System: | Aspen |
| Transducer: | AcuNav |
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other:
Harmonic
Imaging |
| Ophtalmir | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
(Vascular) | | | | | | | | | | |
| Intraoperative
(Neurological) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | P |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | P | 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 |
P=Previously cleared by the FDA under premarket notification K992631.
#### 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+Rower Doppler, B+M+Power Doppler B+PWD+Power Doppler, B+CWD+Power Doppler
# (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. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) number k033650
{5}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form Cypress Diagnostic Ultrasound System
| 510(k) Number: | k033650 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | AcuNav 90/10 (IC10V5) Diagnostic Ultrasound Catheter |
| Indications for Use: | The AcuNav™ Diagnostic 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. |
| Ultrasound System: | Cypress |
| Transducer: | AcuNav |
| | 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 under premarket notification K992631.
#### Additional Comments:
:
| *The Cypress Ultrasound System does not provide combined modes where more than one scanning mode |
|--------------------------------------------------------------------------------------------------|
| is active simultaneously. |
# (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)
DUMKA R. Vochuel
(Division Dir. - OM
(Division Sign-Off) Division of Čardiovascular Devices
510(k) Number k033650
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### Diagnostic Ultrasound Indications for Use Form Sequoia Diagnostic Ultrasound System
| 510(k) Number: | K033650 | | | | | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Device Name: | AcuNav 90/10 (IC10V5) Diagnostic Ultrasound Catheter | | | | | | |
| Indications for Use: | The AcuNav™ Diagnostic 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. | | | | | | |
| Ultrasound System: | Sequoia | | | | | | |
| Transducer: | AcuNav | | | | | | |
| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|--|
| | 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* | P | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intra-Luminal | | P | 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 | |
P=Previously cleared by the FDA under premarket notification K992631.
Additional Comments:
*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler
# (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. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko 33650
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K033650](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OBJ/K033650)
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