(162 days)
No
The device description and performance studies focus on the mechanical properties and flow characteristics of a physical cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates venous drainage during cardiopulmonary bypass surgery, which is a supportive function during a medical procedure rather than a direct treatment of a disease or condition. Its purpose is to assist in the bypass circuit, not to achieve a therapeutic effect on a patient's health.
No
Explanation: The device, a venous return cannula, is described as facilitating venous drainage during cardiopulmonary bypass surgery. Its function is to manage blood flow during surgery, not to diagnose a condition or disease.
No
The device description clearly describes a physical medical device (cannula) with hardware components and performance studies related to physical properties. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery." This describes a device used in vivo (within the body) for a surgical procedure.
- Device Description: The description details a physical cannula designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis of samples.
Therefore, this device is a surgical instrument used directly on a patient, not an IVD.
N/A
Intended Use / Indications for Use
These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Product codes
DWF
Device Description
The Three Stage Venous Return Cannula consists of a single tube body with a 3/8" flared end to allow for connection to the bypass circuit. These cannulae have three open areas for venous drainage. An obturator is included. Its purpose is to decrease blood loss during insertion depth markers are printed on each cannula and aid in positioning the cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right atrium and vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison studies of the performance specifications of the Three Stage Venous Return Cannula and the unmodified predicate Dual Stage Venous Return Cannula have been conducted and have shown to be substantially equivalent to the predicate (unmodified) Dual Stage Venous Return Cannula. These tests include:
- . Connector attachment
- Clamp test .
- Obturator Seal Test
- Kink test .
- Collapse test .
- Tensile test .
- Flow Testing .
- . Simulated use test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Koso034
:
SECTION 03: 510(k) SUMMARY (807.92c)
:
510(k) Summary | JUN 17 2008 | |
---|---|---|
Submitter Information | 2 | |
Device Name | 2 | |
Identification of Predicate Device | 2 | |
Device Description | 2 | |
Intended Use | 2 | |
Technological Characteristics | 2 - 3 | |
Performance Evaluations | 3 | |
Conclusion for 510(K) Summary | 3 |
:
1
Three Stage Venous Return Cannula
Submitter Information
This Premarket Notification is submitted by:
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, Michigan 48103
Contact: | Andrea N. Wallen |
---|---|
Telephone: | 1-800-262-3304, Ext. 6395 |
Fax: | 734-741-6030 |
Date: | January 3, 2008 |
Device Name
Trade Name: Three Stage Venous Return Cannula Common Name: Venous Cannula Classification Name: CPB vascular catheters, cannulae, or tubing are classified as Class II devices per 21 CFR § 870.4210.
Predicate Device
The unmodified predicate device is identified as Terumo's current line of Dual Stage Venous Return Cannulae, which fall under 510(k) # K810415.
Device Description
The Three Stage Venous Return Cannula consists of a single tube body with a 3/8" flared end to allow for connection to the bypass circuit. These cannulae have three open areas for venous drainage. An obturator is included. Its purpose is to decrease blood loss during insertion depth markers are printed on each cannula and aid in positioning the cannula.
Intended Use
These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Technological Characteristics
The Three Stage Venous Return Cannula is used in open heart surgery. During open heart surgery, blood is drained into a venous cannula upstream of the heart at the superior/ inferior vena cava and right atrium. The cannula is connected to tubing that routes the blood to a heart/ lung machine where the blood is pumped and oxygenated. The blood then continues through this perfusion circuit back to
2
the outlet side of the heart (the patient's aorta), where the blood re-enters the patient's circulatory system via an arterial cannulae.
There are three major differences between the modified and unmodified devices.
- . The distal portion of the three stage spring reinforced body maintains a single outside diameter to allow for a smaller incision site, whereas the dual stage cannula has a step-up in the outer diameter.
- . The (unmodified) dual stage device has a 1/2" connection site. whereas the (modified) three stage device has a 3/8" connection site which allows for a smaller blood volume to prime the bypass circuit.
- . The modified device includes a third basket which has been added to allow the smaller diameter to maintain comparable flow characteristics to the dual stage venous return cannulae.
Performance Evaluation
Comparison studies of the performance specifications of the Three Stage Venous Return Cannula and the unmodified predicate Dual Stage Venous Return Cannula have been conducted and have shown to be substantially equivalent to the predicate (unmodified) Dual Stage Venous Return Cannula. These tests include:
- . Connector attachment
- Clamp test .
- Obturator Seal Test �
- Kink test .
- Collapse test .
- Tensile test .
- Flow Testing .
- . Simulated use test
Conclusion
In summary, the Three Stage Venous Return Cannula performed as intended and is substantially equivalent in intended use, principles of operation, technology, design, materials, and performance to the predicate (unmodified) Dual Stage Venous Return Cannula. Any noted differences between the devices do not raise new issues of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2008
Terumo Cardiovascular Systems Corporation c/o Ms. Andrea Wallen Specialist, Regulatory Management 6200 Jackson Road Ann Arbor, MI 48103
Re: K080034
Three Stage Venous Return Cannula, Model 816460 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheters, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 7, 2008 Received: April 8, 2008
Dear Ms. Wallen:
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 it may of receiver to one of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Andrea Wallen
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/cdrb/industry/support/index.html.
Sincerely yours,
Duna R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: Three Stage Venous Return Cannula
Indications For Use:
These cannulae are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Andres N. Wallen
Andres N. Wallen
Andrea N. Wallen Regulatory Affairs Specialist Terumo Cardiovascular Systems
Prescription Use X OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K080034