(44 days)
The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, singleuse, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271).
The Drainage Cannula Kit includes the following accessories:
QTY Kit Component
1 Drainage (Venous) Cannula Body
1 Connector, 3/8-inch, barbed
1 Apical Sewing Ring with Umbilical Tape
1 Apical Sewing Ring Handle
1 Cap (with Umbilical Tape)
1 Apical Support Cuff
4 Suture Rings (large)
4 Suture Rings (medium)
This document is a 510(k) premarket notification for a medical device, specifically the Thoratec CentriMag Drainage (Venous) Cannula Kit. It describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative "acceptance criteria" against which specific numerical performance metrics are compared. Instead, it lists various "performance and functional verification tests" that were successfully conducted. The implicit acceptance criterion for each test is "successful results," indicating compliance with the design requirements for that particular test.
| Acceptance Criteria (Implicit: "Successful Results") | Reported Device Performance |
|---|---|
| Flex Test | Successful |
| Tensile Strength Test | Successful |
| Chemical Resistance Test | Successful |
| Pressure Test | Successful |
| Suture Ring and Apical Sewing Ring Security and Deformation Test | Successful |
| Dimensional Verification Examination | Successful |
| Cannula Body Material Examination | Successful |
| Chemical Characterization (of materials) | Successful |
| Biocompatibility (of materials) | Successful |
| Microbiological Performance Qualification (revalidation) | Successful |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample size used for the test set for any of the listed performance tests. It also does not explicitly state the data provenance (country of origin, retrospective/prospective). However, the general context of a 510(k) submission typically implies that such testing is conducted by the device manufacturer (Thoratec Corporation, based in Pleasanton, CA) as part of their design verification and validation process, which would be prospective for the purpose of the submission.
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. The performance tests described (Flex, Tensile Strength, Chemical Resistance, etc.) are typically engineering and material science tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes. Therefore, "ground truth" in this context would likely be established by engineering specifications and objective measurements, rather than expert consensus in a medical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is not applicable to the types of performance tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple experts. The tests mentioned are objective engineering and material tests.
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:
No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (a cannula kit), not an AI-powered diagnostic or assistive tool. Clinical testing was explicitly stated as "not performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device is a physical medical device (cannula kit), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests listed would be based on engineering specifications, material science standards, and predefined acceptance limits for each test (e.g., a specific tensile strength value, a certain pressure resistance, dimensional tolerances, chemical inertness). It is not based on expert consensus, pathology, or outcomes data, as these are non-clinical (bench and material) tests.
8. The sample size for the training set:
This information is not applicable. The document describes a physical medical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable, as there is no "training set" for this type of device.
In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical device (a cannula kit) through non-clinical performance and functional verification tests. It does not involve AI development, clinical trials, or expert-based ground truth establishment in the way typically seen for diagnostic algorithms.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three overlapping profiles facing right, with flowing lines suggesting movement or connection. The profiles are rendered in a single color, creating a unified and recognizable emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Thoratec Corporation Lori DonDiego Senior Manager, Regulatory Affairs 6035 Stoneridge Drive Pleasanton, VA 94588
Re: K152190
Trade/Device Name: Thoratec CentriMag Drainage (Venous) Cannula Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: August 31, 2015 Received: September 2, 2015
Dear Ms. DonDiego:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
M.A. Willehemen
for 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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4.0 Indications for Use Statement
| Applicant: | Thoratec Corporation |
|---|---|
| 510(k) Number (if known): | K152190 |
| Device Name: | Thoratec CentriMag® Drainage (Venous) Cannula Kit |
Indications for Use:
The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
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)
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5.0 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92.
A. Application Information
| Date Prepared: | July 31, 2015 |
|---|---|
| Submitter's Name & Address: | Thoratec Corporation6035 Stoneridge DrivePleasanton, CA 94588Establishment Registration No.: 2916596Owner / Operator No.: 9045196 |
| Contact Person: | Lori DonDiegoSr. Manager, Regulatory AffairsPh: 925-734-6921Fax: (925) 847-8628Thoratec Corporation6035 Stoneridge DrivePleasanton, CA 94588 |
| Device Information | |
| Trade or Proprietary Name: | CentriMag Drainage (Venous) Cannula Kit |
| Common or Usual Name: | Cardiopulmonary bypass cannula |
| Classification Name: | Cardiovascular bypass vascular catheter,cannula, or tubing (DWF, 21 CFR –870.4210), Class II |
| Performance Standard: | Performance standards do not currently |
Performance standards do not currently exist for these devices. None established under section 514 of the Food, Drug and Cosmetic Act.
C. Legally Marketed Predicate Device
Thoratec CentriMag Drainage Cannula Kit (K110983)
B.
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Device Description D.
The Thoratec CentriMag® Drainage (Venous) Cannula Kit consists of the drainage (venous) cannula and several accessories used in the surgical placement procedure. The cannula and all kit its accessories are sterile, singleuse, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271).
The Drainage Cannula Kit includes the following accessories:
| QTY | Kit Component |
|---|---|
| 1 | Drainage (Venous) Cannula Body |
| 1 | Connector, 3/8-inch, barbed |
| 1 | Apical Sewing Ring with Umbilical Tape |
| 1 | Apical Sewing Ring Handle |
| 1 | Cap (with Umbilical Tape) |
| 1 | Apical Support Cuff |
| 4 | Suture Rings (large) |
| 4 | Suture Rings (medium) |
E. Intended Use
The CentriMag Cannulae are designed to serve as conduits to transport blood between the heart and the extracorporeal blood pump. The Cannulae are intended for use for circulatory support during cardiac surgery for cardiopulmonary surgical procedures for up to six hours.
ட் Technological Characteristics
The technological characteristics of the modified CentriMag Drainage (Venous) Cannula Kit are the same as the predicate device.
G. Comparison to Predicate Device
The modified CentriMag Drainage (Venous) Cannula Kit has the same indication for use, technological characteristics, and performance attributes which essentially renders the modified device equivalent to the predicate device. Moreover, the new device raises no new questions concerning safety or effectiveness. The modification improves upon the reliability of the connection between the connector and the cannula body.
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Summary of Performance Data H.
The modified CentriMag Drainage (Venous) Cannula Kit has successfully undergone performance testing to demonstrate substantial equivalence to the predicate device.
The following performance and functional verification tests have been conducted on the redesigned cannula with successful results:
- Flex Test ●
- Tensile Strength Test ●
- Chemical Resistance Test ●
- Pressure Test ●
- Suture Ring and Apical Sewing Ring Security and Deformation Test
- Dimensional Verification Examination ●
- Cannula Body Material Examination ●
All testing employed devices that were exposed to 2x sterilized, acceleratedaging to simulate a real-time equivalent of 1-year, and heated saline soak for 30days.
Additional verification involved materials evaluation for chemical characterization and biocompatibility to address raw material supplier changes. Lastly, a reduced confirmatory microbiological performance qualification revalidation) was conducted.
The risk management methods used to assess the design modifications to the CentriMag Drainage (Venous) Cannula were a Risk Analysis and a Failure Modes and Effects Analysis (FMEA).
l. Clinical Performance
Clinical testing was not performed.
J. Conclusion
The redesigned CentriMag Drainage (Venous) Cannula Kit is substantially equivalent to the current CentriMag Drainage Cannula Kit (K110983).
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).