(174 days)
Reprocessed Diagnostic Ultrasound Catheters are intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. The device is intended for use in the right heart only.
Diagnostic Ultrasound Catheters are specially designed ultrasonic catheters that provide two-dimensional imaging using an ultrasound transducer. The ultrasound transducer is at the distal tip of the catheter and can be positioned for ultrasound imaging by a steering mechanism that rotates the catheter tip and variable deflection. Diagnostic Ultrasound Catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer. The Ultrasound Catheter is 10 French with 90 cm insertion length.
The provided text is related to the 510(k) submission for a Reprocessed Diagnostic Ultrasound Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a novel device to meet specific performance criteria. Therefore, most of the information requested in your prompt (e.g., sample sizes, expert ground truth, MRMC study, training set details) is not applicable or cannot be extracted from this type of document.
The document states that the reprocessed device is "identical to the predicate devices" in terms of design, materials, intended use, mechanism of action, and performance specifications. The performance data presented are primarily bench and laboratory tests to confirm that the reprocessing maintains the original device's performance, safety, and effectiveness.
Here's an attempt to answer your questions based on the provided text, with many fields marked as "Not Applicable" or "Not Provided" due to the nature of the submission.
Acceptance Criteria and Study Details for Reprocessed Diagnostic Ultrasound Catheter (K063076)
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by the need to demonstrate that the reprocessed device performs "as originally intended" and is "safe and effective" and "substantially equivalent" to the predicate device. Specific quantitative acceptance criteria are not explicitly stated in a table format in the provided text. The "reported device performance" is a general confirmation that these criteria were met through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility maintained | Biocompatibility testing conducted and passed |
| Reprocessing validation successful | Validation of reprocessing conducted and passed |
| Sterility maintained | Sterilization Validation conducted and passed |
| Functional performance equivalent to new device | Function test(s) conducted and passed |
| Packaging integrity maintained | Packaging Validation conducted and passed |
| Device is safe and effective when reprocessed | Performance testing demonstrates Reprocessed Ultrasound Catheters perform as originally intended. |
| Device is substantially equivalent to predicate device (K992631) | Ascent Healthcare Solutions concludes substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "bench and laboratory testing" but does not quantify the number of units or tests performed.
- Data Provenance: Not explicitly stated. Given it's internal testing for a 510(k) submission, it's presumed to be internal, prospective testing related to the reprocessing procedure. The country of origin of the data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. This type of submission relies on objective engineering and biological tests (biocompatibility, sterility, function) rather than expert interpretation of medical images or outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Adjudication methods like "2+1" typically apply to expert reviews of medical data, which is not the primary focus of this submission. The tests performed have definitive pass/fail criteria.
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
- MRMC Comparative Effectiveness Study: No, this was not done. The device is a diagnostic ultrasound catheter, not an AI-powered diagnostic tool.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (a reprocessed catheter), not an algorithm.
7. The type of ground truth used
The "ground truth" for this submission is established through objective engineering, chemical, and biological testing standards to confirm the device's physical and functional integrity, sterility, and biocompatibility after reprocessing. It relies on:
- Standardized methods for evaluating biocompatibility.
- Validation protocols for reprocessing efficacy (e.g., cleaning effectiveness).
- Sterilization validation protocols.
- Functional test specifications to ensure the catheter performs as intended (e.g., imaging capability, steering mechanism).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes the reprocessability validation of an existing device, not the development of a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
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K06a3076
..
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044 | MAR 2 9 2007 |
|---|---|---|
| Contact: | Jenn SelveyRegulatory Affairs Specialist(480) 763-6072 (o)(480) 763-6089 (f)jselvey@ascenths.com | |
| Date of preparation: | September 28, 2006 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Diagnostic UltrasoundCatheterClassification Name: Diagnostic Intravascular Catheter | |
| Predicate DeviceK992631 | 510(k) TitleAcuNav™ Diagnostic UltrasoundCatheter | ManufacturerAcuson Corp. |
| Device description: | Diagnostic Ultrasound Catheters are specially designedultrasonic catheters that provide two-dimensional imaging usingan ultrasound transducer. The ultrasound transducer is at thedistal tip of the catheter and can be positioned for ultrasoundimaging by a steering mechanism that rotates the catheter tipand variable deflection. Diagnostic Ultrasound Cathetersincorporate a handpiece, a flexible shaft and a distal tip sectioncontaining an ultrasound transducer. The Ultrasound Catheter is10 French with 90 cm insertion length. | |
| Indications for Use: | Reprocessed Diagnostic Ultrasound Catheters are intended forintravascular or intracardiac ultrasound imaging in order toprovide visualization of vascular anatomy, cardiac and greatvessel anatomy and physiology, or other devices in the heart.The device is intended for use in the right heart only. | |
| Technologicalcharacteristics: | The design, materials, and intended use of ReprocessedDiagnostic Ultrasound Catheters are identical to the predicatedevices. The mechanism of action of Reprocessed DiagnosticUltrasound Catheters is identical to the predicate devices in thatthe same standard mechanical design, materials, and size areutilized. There are no changes to the claims, intended use,clinical applications, patient population, performancespecifications, or method of operation. In addition, AscentHealthcare Solutions's reprocessing of Ultrasound Cathetersincludes removal of adherent visible soil and decontamination.Each individual Ultrasound Catheter is tested for appropriate | |
| CONFIDENTIAL | Ascent Healthcare SolutionsReprocessed Ultrasound CatheterTraditional 510(k) | Page 11 |
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function of its components prior to packaging and labeling operations.
Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Diagnostic Ultrasound Catheters. This included the following tests:
- Biocompatibility .
- Validation of reprocessing ●
- Sterilization Validation
- . Function test(s)
- . Packaging Validation
Performance testing demonstrates that Reprocessed Ultrasound Catheters perform as originally intended.
Conclusion:
Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Ultrasound Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.
CONFIDENTIAL
Ascent Healthcare Solutions Reprocessed Ultrasound Catheter Traditional 510(k)
Page 12
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Image /page/2/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 an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2007
Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, Arizona 85044
Re: K063076
Trade Name: Reprocessed Diagnostic Ultrasound Catheter (See Enclosed Model) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: NLI Dated: March 2, 2007 Received: March 5, 2007
Dear Ms. Bray:
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 application (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 such 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 - Ms. Katie Bray
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 begin 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) 276-0120. 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/industry/support/index.html.
Sincerely vours.
B/himmerman for
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Reprocessed AcuNav Ultrasound Catheter
Indications For Use: Reprocessed Diagnostic Ultrasound Catheters are indicated 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. The Reprocessed Diagnostic Ultrasound Catheter is intended for use in the right side of the heart only.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hemmema
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K063076
CONFIDENTIAL
Ascent Healthcare Solutions Reprocessed Ultrasound Catheter Traditional 510(k)
Page 10
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§ 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).