(22 days)
The ACUSON AcuNav™ 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 catheter is comprised of a single-use, disposable ultrasonic phasedarray imaging transducer and a catheter which is 8 Fr in diameter and 110 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: left-right (in a plane perpendicular to the image rour directions in two over of the a plane coincident with the image plane). The range of pume) and a 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 provided document is a 510(k) premarket notification letter from the FDA for a medical device: the ACUSON AcuNav 8F Ultrasound Catheter. This type of document is typically used to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing extensive de novo clinical trial data with acceptance criteria and detailed study designs.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving device performance in the format of a clinical study with detailed statistical results, sample sizes, expert qualifications, or comparative effectiveness.
However, I can extract information related to the device, its intended use, and the basis for its clearance, which can be interpreted within the context of a 510(k) submission.
Here's a breakdown of why the requested information is absent and what can be inferred:
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Acceptance Criteria and Reported Device Performance: This document doesn't provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or a table of reported device performance metrics from a clinical study. Instead, the "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence to existing predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The reported "performance" is implicitly tied to meeting safety and performance standards for ultrasound devices and catheters, as well as being comparable to the predicate devices.
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Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth for Test Set: These are all elements of a robust clinical study to assess new diagnostic device performance. A 510(k) generally relies on bench testing, engineering analysis, and performance data compared to a predicate device, rather than a full-scale clinical trial to establish de novo performance metrics. The document references adherence to various safety and performance standards (e.g., UL, IEC, ISO, AIUM/NEMA UD-2/UD-3), which serve as the implicit "acceptance criteria" for the device's fundamental function and safety.
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Training Set Sample Size and Ground Truth: Since this is a 510(k) for an ultrasound catheter, it's not an AI/ML device that requires a "training set" in the conventional sense of machine learning. The device is hardware that processes and displays ultrasound images. The "ground truth" for its performance would be assessed through its ability to accurately visualize anatomical structures and blood flow, which is established through engineering validation and comparison to predicate devices, not typically a large, separately labeled training dataset.
Summary of available information (and absence of requested details):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied for 510(k) clearance): Substantial equivalence to predicate devices (K033650, K992631, K010950) in terms of intended use, technological characteristics, and no new questions of safety or effectiveness. Adherence to various national and international safety and performance standards (listed in the document).
- Reported Device Performance: Not explicitly stated as quantitative metrics from a clinical study. The device is described as "capable of imaging at multiple frequencies and obtaining blood flow data in multiple ultrasound modes" (Page 6). Its performance is considered substantially equivalent to the predicate devices, which are already marketed and assumed to be safe and effective for their intended use.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. Typical 510(k) submissions for devices like this primarily rely on bench testing, engineering validation, and comparison to predicate device specifications. If clinical data were used, details are not provided in this excerpt.
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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):
- Not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an ultrasound catheter, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For an ultrasound catheter, ground truth for its functional performance would typically involve comparison to established imaging standards, physical phantoms, and potentially animal or human studies where anatomical and physiological accuracy can be verified through other means (e.g., direct observation during surgery, other imaging modalities, or known physiological parameters). The document does not detail how "ground truth" was established for any specific performance assessment.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
In conclusion, this document primarily serves as an FDA clearance letter for a medical device demonstrating substantial equivalence to existing devices, and therefore does not contain the detailed clinical study information typically required to answer the questions about acceptance criteria, study design, and performance metrics as if it were a novel diagnostic algorithm or a device requiring a de novo clinical efficacy study.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, with the profiles overlapping each other. The profiles are arranged in a way that they also resemble a bird in flight. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2007
Siemens Medical Solutions USA, Inc. c/o Dr. Iskra Mrakovic Manager, Regulatory Affairs 1230 Shorebird Way P.O. Box 7393 Mountain View, CA 94039
Re: K042593
Trade/Device Name: ACUSON AcuNav 8F Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II Product Code: OBJ Dated: September 22, 2004 Received: September 23, 2004
Dear Dr. Mrakovic:
This letter corrects our substantially equivalent letter of October 15, 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 v
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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Siemens Medical Solutions USA. Inc. Ultrasound Division
ACUSON AcuNav™ 8F Ultrasound Catheren 510(k) Submission
| 510(k) Number (if known): | K042593 |
|---|---|
| --------------------------- | --------- |
Device Name: ACUSON AcuNav™ 8F Ultrasound Catheter
Indications for Use:
The ACUSON AcuNav™ 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4.2593
(Division Sign-Off) Bhaminuma
Division of Cardiovascular Devices 510/k) Number
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Diagnostic Ultrasound Indications for Use Form Cypress Ultrasound System
| 510(k) Number: | K042593 |
|---|---|
| Device Name: | ACUSON AcuNav™ 8F Ultrasound Catheter |
| Indications for Use: | The AcuNav™ Ultrasound Catheter is intended for intra-cardiac andintra-luminal visualization of cardiac and great vessel anatomy andphysiology as well as visualization of other devices in the heart. |
| Ultrasound System: | Cypress |
| Transducer: | AcuNav 8F Ultrasound Catheter |
| 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* | ||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | P | P | P | P | P | P* | ||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P* |
the FDA under premarket notification K992631. DV
Additional Comments:
*The Cypress Ultrasound System does not provide combined modes where more than one scanning mode is netive simultancously
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
Prescription Use (Per 21 CFR SO 1.109)
510(k) Number K042593
.. . . . . . .
Section 6
Indications for Use Form
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Diagnostic Ultrasound Indications for Use Form Sequoia Diagnostic Ultrasound System
| 510(k) Number: | K042593 |
|---|---|
| Device Name: | ACUSON AcuNav m 8F Ultrasound Catheter |
| Indications for Use: | The AcuNav TM 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:Transducer: | SequoiaAcuNav 8F Ultrasound Catheter |
| 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: *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+Pawer Doppler
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
WODELMAN
Prescription Use (Per 21 CFR 801.109)
Division of Cardiovascular Devices
510(k) Number L042593
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ACUSON AcuNay™ 8F 510(k) Submission
OCT 15 2004
SECTION 11
510(k) Summary of Safety and Effectiveness
| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division1230 Shorebird WayP.O. Box 7393Mountain View, California 94039-7393 |
|---|---|
| Contact Person: | Iskra MrakovićManager of Regulatory AffairsTelephone: (650) 694-5004Fax: (650) 943-7053 |
| Submission Date: | September 22, 2004 |
| Device Name: | ACUSON AcuNav 8F Ultrasound Catheter |
| Common Name: | Intracardiac/Intravascular Ultrasound Catheter |
Classification:
Regulatory Class: II Review Category: Tier II
| FR # | Product Code | |
|---|---|---|
| Diagnostic Intravascular Catheter | 870.1200 | 74-DQO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
Predicate Devices:
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K033650 (February 24, 2004), cleared as ACUSON AcuNav® 90/10 Diagnostic . Ultrasound Catheter.
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K992631 (November 8, 2001), cleared as ACUSON AcuNav® Diagnostic . Ultrasound Catheter.
- #K010950 (June 27, 2001), cleared as Cypress Ultrasound System with AcuNav . Diagnostic Ultrasound Catheter.
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Device Description:
The AcuNav catheter is comprised of a single-use, disposable ultrasonic phasedarray imaging transducer and a catheter which is 8 Fr in diameter and 110 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: left-right (in a plane perpendicular to the image rour directions in two over of the a plane coincident with the image plane). The range of pume) and a 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 8F ultrasound catheter is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification numbers:
-
K033650 (February 24, 2004), cleared as ACUSON AcuNav 90/10 Diagnostic ● Ultrasound Catheter.
-
K992631 (November 8, 2001), cleared as ACUSON AcuNav Diagnostic . Ultrasound Catheter.
- #K010950 (June 27, 2001), cleared as Cypress Ultrasound System with AcuNav . Diagnostic Ultrasound Catheter.
The AcuNav 8F Ultrasound Catheter has been designed to conform to the following product safety standards [as required by 21 CFR § 807.87(j)]:
- UL 60601-1, Safety Requirements for Medical Equipment .
- EN 60601-1: 1990+A1 (1992) +A2 (1995) .
- IEC 60601-2-37: 2001+AM1 (2004) .
- CAN/CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ●
- CISPR 11, Class A .
- ISO 10555-1: 1995+AM1 (1999) .
- EN 60601-1-2: 2001 ●
- EN 55011:1991 (Radiated and Conducted Emissions) Class A or B, Group 1 .
- EN 61000-3-2, edition 2.1 (Harmonic Current Emissions) .
- EN 61000-3-3:1994, plus AM1 (2001) (Voltage Fluctuations, Flicker Emissions) .
- IEC 61000-4-2, edition 1.2 (ESD) .
- IEC 61000-4-3, edition 2.1 (Radiated RF) .
- IEC 61000-4-4:1995, plus AM1 (2000) and AM 2 (2001) (EFT/Burst) .
- IEC 61000-4-5, edition 1.1 (Surge) ●
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- IEC 61000-4-6, edition 2.0 (Conducted RF Immunity) ◆
- IEC 61000-4-8, edition 1.1 (PF Magnetic Fields) .
- IEC 61000-4-11, edition 1.1 (Voltage Dips and Interruptions) �
- AIUM/NEMA UD-2: 1998: Acoustic Output Measurement Standard for . Diagnostic Ultrasound
- AIUM/NEMA UD-3: 1998: Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- Declaration of Acoustic Power . IEC 1157:
- Biological evaluation of medical devices Part 1: ISO 10993-1, 2003: . Evaluation and Testing
- Biological evaluation of medical devices Part 7: Ethylene ISO 10993-7, 1995: . oxide sterilization residuals
- Sterilization (Medical devices-Validation and routine ISO 11135, 1994: . control of ethylene oxide sterilization)
- Medical Devices -- Application of Risk Management to Medical ISO 14971: . Devices
- Medical Device Directive . 93/42/EEC
Indications for Use:
The AcuNav™ 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.
Technological Comparison to Predicate Device:
The AcuNav 8F Ultrasound Catheter is substantially equivalent in its technologies and functionality to the AcuNav 90/10 Diagnostic Ultrasound Catheter that is already cleared under 510(k) premarket notification numbers K033650 (Feb. 24, 2004), K992631 (Nov. 8, 2001), and K010950 (June 27, 2001).
Both, AcuNav 8F and AcuNav 90/10 catheters are ultrasound-tipped catheter devices used directly within the vasculature and/or the heart for intravascular or intracardiac ultrasound imaging, as well as for the measurement of blood flow.
Devices are specifically indicated 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.
§ 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).