(71 days)
The Endoarterial Return Cannula with and without a hemostasis valve is , indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.
The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport™ Endoarterial Return™ Cannula and the BioMedicus® Cannula.
This document describes the premarket notification for the Heartport™ Endoarterial Return™ Cannula. The information provided is for a medical device and, as such, the concept of "acceptance criteria" and "device performance" as might be found in a software AI/ML context is not directly applicable in the same way. Instead, for a medical device submitted for 510(k) clearance, the primary "acceptance criterion" is substantial equivalence to a predicate device, demonstrated through performance testing against established specifications.
Here's an analysis based on the provided text, reformulating the AI/ML-centric questions for a medical device context:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a cannula, "acceptance criteria" relate to engineering specifications and performance characteristics, rather than diagnostic accuracy metrics. The document only provides a high-level statement.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Established specifications (e.g., fluid flow, pressure tolerance, material strength, biocompatibility) | "Performance testing demonstrated that the Heartport Endoarterial Return™ Cannula meets established specifications." |
| Biocompatibility | "The materials used in the Heartport Endoarterial Return Cannula have proven biocompatibility." |
| Intended Use | "Substantially equivalent in intended use and method of operation to the currently marketed Heartport™ Endoarterial Return™ Cannula and the BioMedicus® Cannula." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not specified. Performance testing for medical devices often involves a series of physical tests with multiple samples, but the exact numbers are not detailed in this summary.
- Data provenance: Not specified. These would typically be internal laboratory tests conducted by the manufacturer (Heartport, Inc., USA).
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 question is not applicable to a non-AI medical device like a cannula. "Ground truth" in this context would be defined by engineering standards and validated test methods, not expert medical opinion on diagnostic images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Device performance testing is based on objective measurements and established protocols, not expert adjudication.
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. This is not an AI/ML device, and no human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" would be established by:
- Engineering specifications and standards: These define what constitutes acceptable material properties, dimensions, fluid dynamics, and mechanical integrity for a cardiovascular cannula.
- Biocompatibility testing standards: These define methods and criteria for assessing the device's interaction with biological systems.
- Clinical experience with predicate devices: The "substantial equivalence" claim implies that the established safety and effectiveness profile of the predicate devices serves as a benchmark.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
Not applicable. As above, there is no AI/ML training set.
Summary of the Study (as presented in the 510(k) summary):
The provided document is a 510(k) summary for the Heartport™ Endoarterial Return™ Cannula. The "study" referenced is the collection of non-clinical performance testing and biocompatibility testing conducted by Heartport, Inc. to demonstrate the device's safety and effectiveness and its substantial equivalence to legally marketed predicate devices (Heartport™ Endoarterial Return™ Cannula and BioMedicus® Cannula).
The key findings reported are:
- "Performance testing demonstrated that the Heartport Endoarterial Return™ Cannula meets established specifications."
- "The materials used...have proven biocompatibility."
The FDA's letter (K971291) confirms that based on this information, the device was found substantially equivalent to predicate devices. This means it met the regulatory acceptance criteria for market clearance, rather than specific performance metrics against an AI model's "ground truth."
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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Applicant Information:
JUN 17 1997
| Date Prepared: | April 4, 1997 |
|---|---|
| Name: | Heartport, Inc. |
| Address: | 200 Chesapeake Drive |
| Redwood City, CA 94063 |
| Contact Person: | Marianne C. Drennan |
|---|---|
| Phone Number: | (415) 482-4405 |
| Fax Number: | (415) 482-4346 |
Device Information:
| Classification | Class II |
|---|---|
| Trade Name: | Heartport™ Endoarterial Return™ Cannula |
| Classification Name: | Cardiovascular Surgical Devices - Cardiopulmonary bypass vascularcannula |
| 21 CFR 870.4210 |
Equivalent Devices:
The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport™ Endoarterial Return™ Cannula and the BioMedicus® Cannula.
Intended Use:
The Endoarterial Return Cannula, with or without hemostasis valve, is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.
Non-Clinical Test Results:
Performance testing demonstrated that the Heartport Endoarterial Return™ Cannula meets established specifications. The materials used in the Heartport Endoarterial Return Cannula have proven biocompatibility.
Summary:
Based on the intended use, product performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to currently marketed predicate devices.
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Image /page/1/Picture/2 description: The image shows a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the left side of the seal. To the right of the text is a stylized symbol consisting of three curved lines that resemble a person with outstretched arms. The symbol is black and the text is in a sans-serif font.
JUN 17 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marianne C. Drennan Requlatory Affairs Specialist HeartPort, Inc. 200 Chesapeake Drive Redwood City, California 94063
Re: K971291 - Novaro----------------------------------------------------------------------------------------------------------------------------------------------------------------------Requlatory Class: II (Two) Product Code: 74 DWF Dated: April 4, 1997 Received: April 7, 1997
Dear Ms. Drennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requiation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Marianne C. Drennan
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address"dsmo@fdadr.cdrh.fda.qov."
Sincerely yours,
Thomas J. Callahon, Ph.D.
Thomas J. Callad Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 870.4210 | - CPB Vascular Catheter, Cannula |
|---|---|
| or Tubing | |
| DWF II |
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
The Endoarterial Return Cannula with and without a hemostasis valve is , indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bette R. Gemperle
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109) OR
Over- The Counter Use (Optional Format 1-2-96)
§ 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).