(131 days)
Not Found
No
The document describes standard ultrasound imaging technology and processing for display, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is described as an imaging tool intended for visualization and diagnostic purposes, not for providing therapy.
Yes
The device is explicitly named "AcuNav™ Diagnostic Ultrasound Catheter" and its intended use is for "visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow," which are diagnostic purposes.
No
The device description explicitly states it is an "ultrasound-tipped catheter device" and incorporates a "single-use, disposable ultrasonic phased-array imaging transducer," which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states the device is an "ultrasound-tipped catheter device which is used directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging." It is used inside the body to visualize structures and measure blood flow.
- Intended Use: The intended use is for "intravascular or intracardiac ultrasound imaging," "visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart," and "measurement of blood flow." These are all in vivo (within the living body) applications.
- No Specimen Analysis: There is no mention of collecting or analyzing specimens from the body.
Therefore, the AcuNav Diagnostic Ultrasound Catheter is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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-vessel anatomy and physiology as well as visualization of other devices in the heart. The AcuNav™ is intended for use in right heart only.
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.
Product codes
DQO, ITW
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Within the vasculature and/or the right heart, intra-cardiac, intra-vessel, intra-luminal
Indicated Patient Age Range
Not Found
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)
Performance testing, animal testing, and human clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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)
1
Predicate Devices:
-
- Cardiovascular Imaging Systems' (CVIS) Insight Catheter for Intracardiac Use (10 Fr) (K921148).
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.
2
Intended Use:
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.
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
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.
4
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.
5
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
6
| 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-operative | |||||||||
| Neurological | |||||||||
| 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-Skeletal
Conventional | | P | P | P | P | P | P | *P | P |
| Musculo-Skeletal
Superficial | | 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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7
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™
| Clinical
Applications | A | B | M | PWD | CWD | Color
Doppler | Power
(Ampl.)
Doppler | Combined
(Specify) | Other
(Specify) | |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|-----------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
- vascular | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| 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-Skeletal
Conventional | | | | | | | | | | |
| Musculo-Skeletal
Superficial | | | | | | | | | | |
| 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: | |||||||||
| Clinical | |||||||||
| Applications | A | B | M PWD CWD | Color | |||||
| Doppler | Power Doppler (Ampl.) | Combined | |||||||
| (Specify) | Other | ||||||||
| Harmonic | |||||||||
| Imaging | |||||||||
| 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-operative | |||||||||
| Neurological | |||||||||
| 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-Skeletal
Conventional | | P | P | P | P | *P | P | | |
| Musculo-Skeletal
Superficial | | 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
V
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™
| Clinical
Applications | A | B | M | PWD | CWD | Color
Doppler | Power
(Ampl.)
Doppler | Combined
(Specify) | Other
(Specify) |
|----------------------------------------------------|---|---|---|-----|-----|------------------|-----------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative
- vascular | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | |
| 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-Skeletal
Conventional | | | | | | | | | |
| Musculo-Skeletal
Superficial | | | | | | | | | |
| 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)
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