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 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 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.

AI/ML Overview

The provided 510(k) summary for the AcuNav 90/10 Diagnostic Ultrasound Catheter (K033650) details the device's technological comparison to a predicate device and its intended use. However, it does not include information on acceptance criteria for specific performance metrics, nor does it describe a study demonstrating how the device meets such criteria.

The document primarily focuses on regulatory categorization, device description, and a comparison to a previously cleared predicate device (ACUSON AcuNav® 90/10 Diagnostic Ultrasound Catheter, K992631) to establish substantial equivalence.

Therefore, many of the requested details about acceptance criteria and a study to prove their fulfillment cannot be extracted from this document, as they are not present.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance acceptance criteria and results from a study against those criteria. It states that the device has been designed to meet certain safety standards (UL 2601-1, CSA C22.2 No. 601-1, CISPR 11, IEC 601-1-1, IEC 601-1-2, ISO 10993 Biocompatibility), but it does not list measurable acceptance criteria or reported performance results for these.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The 510(k) summary does not describe any specific clinical or performance test sets, their sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. No test sets or ground truth establishment processes are described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No test sets or adjudication methods are described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. The device is a diagnostic ultrasound catheter, not an AI-assisted diagnostic tool. No MRMC studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided in the document. The device is a hardware catheter, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document, as no specific performance studies are detailed.

8. The sample size for the training set

This information is not provided in the document. No training sets are mentioned.

9. How the ground truth for the training set was established

This information is not provided in the document. No training sets or ground truth establishment processes are described.

Summary of what the document does provide regarding the device's safety and effectiveness:

The 510(k) summary establishes substantial equivalence of the AcuNav 90/10 Diagnostic Ultrasound Catheter to the predicate ACUSON AcuNav® 90/10 Diagnostic Ultrasound Catheter (K992631). The basis for this equivalence is a direct technological comparison, noting that both are ultrasound-tipped catheter devices used for intravascular or intracardiac ultrasound imaging.

The document states that the new device has been designed to meet the following product safety standards:

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

However, the document does not include a study explicitly demonstrating the device meets quantitative "acceptance criteria" related to specific performance metrics beyond stating conformance to these general safety and biocompatibility standards. The approval is based on the finding of substantial equivalence to a legally marketed predicate device, implying that the safety and effectiveness are similar to the already approved device, rather than a de novo evaluation against novel performance criteria.

Summary

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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:

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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,

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 vesselanatomy and physiology as well as visualization of other devices in theheart.
Ultrasound System:	Aspen
Transducer:	AcuNav

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
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-skeletalConventional
Musculo-skeletalSuperficial
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

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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 vesselanatomy and physiology as well as visualization of other devices in theheart.
Ultrasound System:	Cypress
Transducer:	AcuNav

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
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-skeletalConventional
Musculo-skeletalSuperficial
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 vesselanatomy and physiology as well as visualization of other devices in theheart.
Ultrasound System:	Sequoia
Transducer:	AcuNav

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
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-skeletalConventional
Musculo-skeletalSuperficial
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

Regulation Number and Section

§ 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).