(29 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a cannula, with no mention of AI or ML.
No.
The device is a cannula used for perfusion, which is a supportive function, not a direct therapeutic intervention to treat a disease or condition.
No
The device, an arterial cannula, is used for perfusion during cardiopulmonary bypass, which is a therapeutic intervention, not for diagnosing conditions.
No
The device description clearly describes a physical, hardware-based medical device (cannula) and its components. 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 "perfusion of the ascending aorta during cardiopulmonary bypass." This is a procedure performed on a living patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a physical cannula designed for insertion into the body. This is consistent with a surgical or medical device used in vivo, not a device used for testing samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, this device is a medical device used in a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The One Piece Pediatric Arterial Cannula Models 77006 and 77106 are 6 Fr., flexible, thin-walled cannula with wire wound bodies and a 9" overall length. They have a beveled tip that is made as part of the PVC body. There are depth markings located at 1 cm increments. A tip orientation line indicates the direction of the bevel for location once the cannula is inside the body. The proximal end of the cannula terminates in a 1/4" barbed connector that can be either vented or non-vented. The model 77006 is vented and the model 77106 is non-vented. The proximal end connector on these models is also molded as part of the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aorta
Indicated Patient Age Range
Pediatric
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)
In vitro visual, dimensional, simulated use and functional testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices. Visual inspection for defects, dimensional testing of the cannula and markings, water and air leak testing, and various bend tests were performed and the results found acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K∅24∅69
JAN 0 8 2003
510(k) Summary
| Date Prepared: | December 6, 2002 |
|---|---|
| Submitter: | Medtronic Perfusion Systems |
| 7611 Northland Boulevard | |
| Brooklyn Park, MN 55428 | |
| Contact Person: | Ronald W. Bennett |
| Principal Regulatory Affairs Specialist |
Phone: (763)-391-9086
Fax: (763) 391-9603 |
Device Name and Classification:
| Trade Name: | One Piece Pediatric Arterial Cannula
Models 77006 and 77106 |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or
tubing |
| Classification: | Class II |
| Predicate Devices: | K840001
Arterial Cannula
7000 Series
8, 10, 12, 14, 16, 18, 20, 22, 24, 26 Fr.
Pediatric and Adult Sizes |
Device Description:
The One Piece Pediatric Arterial Cannula Models 77006 and 77106 are 6 Fr., flexible, thin-walled cannula with wire wound bodies and a 9" overall length. They have a beveled tip that is made as part of the PVC body. There are depth markings located at 1 cm increments. A tip orientation line indicates the direction of the bevel for location once the cannula is inside the body. The proximal end of the cannula terminates in a 1/4" barbed connector that can be either vented or non-vented. The model 77006 is vented and the model 77106 is non-vented. The proximal end connector on these models is also molded as part of the body.
1
Indication for Use
These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.
Comparison to Predicate Device
The predicate devices are cannulae with a thin walled tip attached to a flexible PVC body and having both 1/4 " and 3/8" connectors. There was an indexing line for determining tip orientation when the cannula is in the aorta. There was a molded plastic vent plug to allow venting before connection to the perfusion line. The overall length of the cannula was 7". The predicate devices had the same indication for use.
Summary of Performance Data
In vitro visual, dimensional, simulated use and functional testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices. Visual inspection for defects, dimensional testing of the cannula and markings, water and air leak testing, and various bend tests were performed and the results found acceptable.
Conclusion
Medtronic Perfusion Systems has demonstrated that the Arterial One Piece Pediatric Cannula Models 77006 and 77106 are substantially equivalent to predicate devices based upon design, test results, and indications for use.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three overlapping profiles, suggesting a sense of community or interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2003
Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Drive N. Minneapolis, MN 55428-1088
Re: K024069
Trade Name: One Piece Pediatric Arterial Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular cannula Regulatory Class: Class II (two) Product Code: DWF Dated: December 6, 2002 Received: December 10, 2002
Dear Mr. Bennett:
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.
3
Page 2 - Mr. Ronald Bennett
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 (301) 594-4646. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
K. Oa. Till
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1_
510(k) Number (if known):
One Piece Pediatric Arterial Cannula Device Name:
Models 77006 and 77106
Indications for Use:
These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
(Optional Format 3-10-98)
V. Oettel
iovascular Devices
510(k) Number K024069