For use directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The device is 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. The company anticipates that the device will be used for a variety of intravascular and intracardiac imaging applications, consistent with its intended use, including vascular stent placement, monitoring left ventricular function post-surgery; identifying congenital abnormalities before therapeutic procedures; visualizing the relative orientation of diagnostic and therapeutic catheters; and visualizing procedures such as transseptal insertions of other catheters, valvuloplasties, balloon septostomies, septal defect closures, and pacemaker or defibrillator lead insertion or extraction.

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. The AcuNav™ is intended for use in right heart only.

Device Description

The AcuNav is an ultrasound-tipped catheter device which is used directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The AcuNav incorporates a single-use, disposable ultrasonic phased-array imaging transducer, which must be used in conjunction with an Acuson ultrasound imaging platform to generate the acoustic waves and process the information for display to the physician. The catheter is 10 French in diameter and 90 cm in insertable length. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to the image plane) and anterior-posterior (in a plane coincident with the image plane). The distal end of the catheter contains the transducer, which is oriented to provide a two-dimensional (90 degree vector) image in a plane parallel to the axis of the catheter. The transducer offers all imaging modes at frequencies between 4.0 and 10.0 MHz.

AI/ML Overview

This 510(k) summary for the AcuNav™ Diagnostic Ultrasound Catheter does not contain specific acceptance criteria or an explicit study that proves the device meets such criteria in a quantitative manner. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance metrics against predefined acceptance criteria.

However, based on the provided text, we can infer the overarching "acceptance criterion" to be Substantial Equivalence to the identified predicate devices, meaning the device performs equivalently in terms of safety and effectiveness. The study supporting this is described as performance testing, animal testing, and human clinical testing.

Below is an attempt to structure the information, acknowledging the limitations of the provided text in terms of detailed, quantitative acceptance criteria and study specifics.

Acceptance Criteria and Device Performance

The core acceptance criterion for this 510(k) submission is the demonstration of substantial equivalence to predicate devices. This implies that the device's technological characteristics and performance do not raise new questions of safety or effectiveness. The reported "performance" is implicitly deemed equivalent to the predicate devices through the testing conducted.

Acceptance Criterion (Inferred from 510(k) process)	Reported Device Performance
Substantial Equivalence to Predicate Devices	Confirmed by performance testing, animal testing, and human clinical testing. The device has the same intended use and very similar principles of operation and technological characteristics as the predicate devices. Minor technological differences (acoustic parameters, transducer configuration, imaging format, steering mechanism, materials, sterilization methods) do not raise new questions of safety or effectiveness.
Biocompatibility	Demonstrated to be biocompatible.
Non-pyrogenicity	Demonstrated to be non-pyrogenic.

Study Information

Due to the nature of a 510(k) summary, detailed study parameters are not typically included. The document refers generally to "performance testing, animal testing, and human clinical testing" to support substantial equivalence. Specifics on each of these are absent.

Sample size used for the test set and the data provenance: Not specified in the provided text. The document mentions "human clinical testing" but does not provide details on the number of subjects or the geographical origin of the data (e.g., country of origin, retrospective or prospective nature).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
Adjudication method for the test set: Not specified in the provided text.
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: Not applicable. This device is an ultrasound catheter, not an AI-powered diagnostic tool. The concept of "human readers improve with AI vs without AI assistance" does not apply to this type of medical device submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound catheter requiring human operation and interpretation; it is not an algorithm-only standalone diagnostic tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For "human clinical testing," the ground truth would typically come from a combination of clinical assessments, other imaging modalities, and potentially pathology or procedural outcomes, but this is not detailed. For "performance testing" and "animal testing," the ground truth would be based on controlled experimental conditions and established biological models.
The sample size for the training set: Not applicable. This device is an ultrasound catheter, not a machine learning or AI model that requires a "training set" in the conventional sense.
How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device.

Summary

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199263

DEC 1 2 1999

510(k) Summary

Sponsor:

Acuson Corporation 1220 Charleston Road PO Box 7393 Mountain View, California 94039-7303 Telephone: (650) 969-9112 Facsimile: (650) 962-8018

Contact Person:

Gladys May-Cooper Acuson Corporation 1220 Charleston Road PO Box 7393 Mountain View, California 94039-7303 Telephone: (650) 969-9112 Facsimile: (650) 962-8018

or

Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, DC 20004 Tel: (202) 637-5813 Fax: (202) 637-5910

Submission Date:

August 5, 1999

Device Name:

AcuNav™ Diagnostic Ultrasound Catheter

Classification:

Diagnostic intravascular catheters and ultrasonic transducers-class II (21 C.F.R. §§ 870.1200 and 892.1570)

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Predicate Devices:

1. Boston Scientific Corporation's Sonicath Ultra™ Imaging Catheter (9 Fr/ 9 MHz) (K970049), (used in conjunction with EP Technologies' Galaxy Intravascular Ultrasound Imaging System (K980851))
1. Cardiovascular Imaging Systems' (CVIS) Insight Catheter for Intracardiac Use (10 Fr) (K921148).

Device Description:

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Intended Use:

Substantial Equivalence:

Acuson's AcuNav Catheter and the predicate devices have the same intended use and very similar principles of operation and technological characteristics. All of the devices are intended for use in intravascular and/or intracardiac imaging. The minor technological differences between the AcuNav Catheter and the predicate devices, i.e., in acoustic parameters, transducer configuration, imaging format, steering mechanism, materials, or

{3}------------------------------------------------

sterilization methods, do not raise any new questions of safety or effectiveness, as confirmed by performance testing, animal testing, and human clinical testing. The AcuNav Catheter also has been demonstrated to be biocompatible and non-pyrogenic. Therefore, Acuson's AcuNav Catheter is substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 8 2001

8 2001

Acuson Corporation c/o Mr. Howard M. Holstein Hogan and Hartson, L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, D.C. 20004

Re: K992631

Trade Name: AcuNav Diagnostic Ultrasound Catheter Regulation Number: 21 CFR 870.1200 and 892.1570 Regulation Name: Intravascular Diagnostic Catheter Diagnostic Ultrasound Transducer Regulatory Class: II (two)

Product Code: DQO and ITW Dated: November 12, 1999 Received: November 12, 1999

Dear Mr. Holstein:

This letter corrects our substantially equivalent letter of December 15, 1999, regarding the indications for use.

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). 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 - Mr. Howard M. Holstein

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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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AcuNav™ Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Applications	A	B	M	PWD	CWD	Color Doppler	Power (Ampl.) Doppler	Combined (Specify)	Other Harmonic Imaging
Ophthalmic
Fetal		P	P	P	P	P	P	*P	P
Abdominal		P	P	P	P	P	P	*P	P
Intra-operative(vascular)		P	P	P	P	P	P	*P	P
Intra-operativeNeurological
Pediatric		P	P	P	P	P	P	*P	P
Small Organ- Thyroid -- Breast- Testicle		P	P	P	P	P	P	*P	P
Neonatal Cephalic		P	P	P	P	P	P	*P	P
Adult Cephalic		P	P	P	P	P	P	*P	P
Cardiac		P	P	P	P	P	P	*P	P
Trans-esophageal		P	P	P	P	P	P	*P	P
Trans-Rectal
Trans-Vaginal		P	P	P	P	P	P	*P	P
Trans-Urethral
Intra-Luminal		N	N	N	N	N	N	*N	N
Peripheral Vascular		P	P	P	P	P	P	*P	P
Laparoscopic
Musculo-SkeletalConventional		P	P	P	P	P	P	*P	P
Musculo-SkeletalSuperficial		P	P	P	P	P	P	*P	P
Other (Intra-Cardiac)		N	N	N	N	N	N	*N	N

Diagnostic Ultrasound Indications for Use Form

For

Suration; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

Adultional Colinnents:

Combinations: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+Color Doppler, B+PWD+Color Contonations: D+M, B+P+ver Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler

WEI DOPPIET
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Device Use

(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K992631

Acuson Corporation IIIARDC - 59177/1 - #981901 v1

May 6, 1999

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Diagnostic Ultrasound Indications for Use Form For AcuNav™ Diagnostic Ultrasound Catheter

Intended Use: The AcuNav™ Diagnostic Ultrasound Catheter is intended for intra-cardiac and intra-Intended Ose. The Acarder - Diagnosat vessel anatomy and physiology as well as visualization of other devices in the heart. The AcuNav™ is intended for use in right heart only. Ultrasound System: Aspen™

Transducer: AcuNav™

ClinicalApplications	B	M	PWD	CWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative- vascular
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal Cephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	*N	N
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal	N	N	N	N	N	N	*N	N
Peripheral Vascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Intra-Cardiac)	N	N	N	N	N	N	*N	N

N = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments:

Combinations: B+M, B+PWD, B+Color Doppler, B+M+Color Doppler, B+PWD+Color Contonations: D+M)/ D 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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Device Use

(Per 21 CFR 801.109)

Acuson Corporation

\\ARDC - 59177/1 - #981901 v1

May 6, 1999

{8}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

For

Sequoia™ Diagnostic Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
ClinicalApplications	A	B	M PWD CWD	ColorDoppler	Power Doppler (Ampl.)	Combined(Specify)	OtherHarmonicImaging
Ophthalmic
Fetal		P	P	P	P	*P	P
Abdominal		P	P	P	P	*P	P
Intra-operative(vascular)		P	P	P	P	*P	P
Intra-operativeNeurological
Pediatric		P	P	P	P	*P	P
Small Organ- Thyroid-- Breast- Testicle		P	P	P	P	*P	P
Neonatal Cephalic		P	P	P	P	*P	P
Adult Cephalic		P	P	P	P	*P	P
Cardiac		P	P	P	P	*P	P
Trans-esophageal		P	P	P	P	*P	P
Trans-Rectal
Trans-Vaginal		P	P	P	P	*P	P
Trans-Urethral
Intra-Luminal		N	N	N	N	*N	N
Peripheral Vascular		P	P	P	P	*P	P
Laparoscopic
Musculo-SkeletalConventional		P	P	P	P	*P	P
Musculo-SkeletalSuperficial		P	P	P	P	*P	P
Other (Intra-Cardiac)		N	N	N	N	*N	N

Caranae)
N = new indication; P = previously cleared by FDA; E = added under Appendix E

Additional Comments:

Adultional Colinnents:

Combinations: B+M, B+PWD, B+Color Doppler, B+M+Color Doppler, B+PWD+Color " Commilations: DTM, DTTWD, B+CWD, B+CHD, B+Color Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler

WEIT DOPPIE!
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Device Use_

(Per 21 CFR 801.109)

Acuson Corporation \\ARDC - 59177/1 - #981904 v1

May 6, 1999

{9}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form For AcuNav™ Diagnostic Ultrasound Catheter

Intended Use: The AcuNav™ Diagnostic Ultrasound Catheter is intended for intra-cardiac and intra-Intelided Ose. The Acurav - Blaglioste Oxase anatomy and physiology as well as visualization of other luminal viSualization of carants ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Ultrasound System: SequoiaTM

Transducer: AcuNav™

ClinicalApplications	B	M	PWD	CWD	ColorDoppler	Power(Ampl.)Doppler	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative- vascular
Intra-operativeNeurological
Pediatric
Small Organ- Thyroid- Breast- Testicle
Neonatal Cephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	*N	N
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal	N	N	N	N	N	N	*N	N
Peripheral Vascular
Laparoscopic
Musculo-SkeletalConventional
Musculo-SkeletalSuperficial
Other (Intra-Cardiac)	N	N	N	N	N	N	*N	N

N = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments:

Additional Colinnents.

Combinations: B+M, B+PWD, B+Color Doppler, B+M+Color Doppler, B+PWD+Color Collibulations: D+WD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler

WEIT DOPPIEI
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Device Use

Acuson Corporation

\\ARDC - 59177/1 - #981904 v1

May 6, 1999

(Per 21 CFR 801.109)

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).