(15 days)
Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
The Vortex Medical AngioVac Cardiopulmonary Bypass Circuit and Accessories consists of: Tuohy Borst Adapter, Non-Vented Spike, Vented Cap, PVC tubing .375"ID, PVC tubing .500" ID, PVC tubing .250" ID, Y Connectors, Colder MPX Series Coupling Body (In-Line Hose Barb with Lock - Male), Colder MPX Series Coupling Insert (In-Line Hose Barb - Female), Reducers, Adhesive backed tubing holder, Pinch Clamps ("Roberts").
The provided text [K092486](https://510k.innolitics.com/search/K092486) describes a device for "Cardiopulmonary Bypass Tubing and Accessories." This is a mechanical device, not an AI/ML-driven software device. Therefore, the questions about acceptance criteria for AI models, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, ground truth definitions, and training set information are not applicable.
The document indicates that substantial equivalence was determined based on non-clinical performance data and no clinical tests were performed. The non-clinical tests focused on connection strength and system integrity to verify the integrity of the fittings and the assembled system.
Here's the information that can be extracted relevant to acceptance criteria and performance for this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| System Integrity | Connection strength testing | Integrity of fittings and system | Verified integrity of fittings and the assembled system. |
| System Integrity | System integrity testing | Integrity of fittings and system | Verified integrity of fittings and the assembled system. |
Note: The document only broadly states "Connection strength and system integrity testing was performed to verify the integrity of the fittings and the assembled system." It does not specify quantitative acceptance thresholds (e.g., minimum burst pressure, tensile strength limits) or detailed reported values, only that the tests were performed and the integrity verified.
2. Sample sized used for the test set and the data provenance: Not applicable. This is a non-clinical evaluation of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device testing typically involves engineering specifications and direct measurement, not expert clinical consensus in the way an AI model would be evaluated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this physical medical device, the "ground truth" for the non-clinical tests would be established engineering specifications and performance benchmarks for connection strength and system integrity of similar predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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K092486
pg 1 of 2
3.0 510(k) Summary
| Date: | April 16, 2009 | AUG 2 8 2005 |
|---|---|---|
| Sponsor of the 510(k): | Vortex Medical | |
| 50 Loring Drive | ||
| Norwell, MA 02061 | ||
| Contact: | Brian Kunst, Regulatory Affairs Consultant | |
| 518-796-6346 |
Device Identification:
| Trade Name | Vortex Medical AngioVac Cardiopulmonary Bypass Circuit | |
|---|---|---|
| Common Name | Cardiopulmonary Bypass Tubing and Accessories | |
| Classification Names | Tubing, Pump, Cardiopulmonary Bypass21 CFR §870.4390, Cardiovascular, 74 DWE (Class II) | |
| Adaptor, Stopcock, Manifold, or Fitting, Cardiopulmonary Bypass21 CFR §870.4290, Cardiovascular, 74 DTL (Class II) |
Legally marketed devices to which equivalence is claimed:
Terumo Pump Tubing K013578 Gish Biomedical Tubing Connectors K833322, K030077 Terumo Circuit Connectors K041697 Cobe Cardiovascular Tubing Sets K881330, K771692 Maquet Cardiopulmonary Jostra HLM Tubing Set K053025
Intended Use / Indications
Intended for use in procedures requiring extracorporeal circulatory support for periods of up to six hours. This is the same intended use as other commercially available cardiopulmonary bypass procedure kits and accessories.
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Device Description
| Component | |
|---|---|
| Tuohy Borst Adapter | Y Connectors |
| Non-Vented Spike | Colder MPX Series Coupling Body (In-Line Hose Barb with Lock - Male) |
| Vented Cap | Colder MPX Series Coupling Insert (In-Line Hose Barb - Female) |
| PVC tubing .375"ID | Reducers |
| PVC tubing .500" ID | Adhesive backed tubing holder |
| PVC tubing .250" ID | Pinch Clamps ("Roberts") |
The Vortex Medical AngioVac Cardiopulmonary Bypass Circuit and Accessories consists of:
Substantial Equivalence
The subject and predicate devices are substantially similar in configuration, dimensions, and materials. The types of components in the kit are well known and have a long history of safe and effective medical application.
Summary of the non-clinical performance data
Connection strength and system integrity testing was performed to verify the integrity of the fittings and the assembled system.
Summary of the clinical performance data
No clinical tests were performed to determine substantial equivalence.
Conclusions drawn from the non-clinical performance data
The non-clinical tests demonstrate that the device is equivalent to the performance of currently available cardiopulmonary bypass tubing sets and accessories and is considered as safe and effective as the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
AUG 2 8 2009
Vortex Medical, Inc. c/o Mr. Morten Christensen Underwriters Laboratories, Inc. 455 E. Trimble Road San Jose, CA 98131
Re: K092486
Trade/Device Name: Vortex Medical AngioVac Cardiopulmonary Bypass Circuit Regulation Number: 21 CFR 870.4390 Regulation Name: Cardiopulmonary bypass pump tubing Regulatory Class: Class II Product Code: DWE Dated: August 7, 2009 Received: August 13, 2009
Dear Mr. Christensen:
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 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
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Page 2 - Mr. Morten Christensen
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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17-19
2.0 Indications for Use Statements
Indications for Use
510(k) Number (if known):
Vortex Medical AngioVac Cardiopulmonary Bypass Circuit Device Name:
Indications for Use:
Indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.
Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)
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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 4092486
Vortex Circuit 510(k) Confidential Page 7 of 24 April 16, 2009
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).