(53 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a surgical cannula, with no mention of AI or ML capabilities. Performance studies are based on in vitro testing of physical properties.
No.
The device is described as a cannula used for delivering solutions or aspirating air during surgery, rather than for treating a disease or condition itself.
No
This device is a cannula used for delivering solutions and aspirating air during cardiopulmonary bypass surgery. It is a tool for treatment and procedure, not for diagnosis.
No
The device description clearly outlines a physical medical device (cannula) with hardware components (flange, tube, luer fittings, introducer). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the cannula is used in conjunction with cardiopulmonary bypass surgery for delivering solutions and aspirating air directly from the aorta. It is a surgical tool used within the body during a procedure.
- No Specimen Analysis: There is no mention of this device being used to collect or analyze specimens outside the body.
Therefore, based on the intended use and device description, this Pediatric Aortic Root Cannula is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.
Product codes
DWF
Device Description
a flange and two side holes. The tip is attached to a flexible tapered tube that terminates in a female luer fitting. A stainless steel 18 gauge introducer with needle tip and locking male luer fitting is supplied inside the cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta
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
In vitro dimensional and functional testing was used to establish the performance characteristic of the new device. The biocompatibility, sterilization, and packaging were evaluated. Accelerated aged dimensional and functional testing was also performed. All testing passed.
Key Metrics
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
MAR 1 9 2004
Image /page/0/Picture/1 description: The image shows the text "K040173 p. 1/2" in a handwritten style. The text appears to be a document or record identifier, possibly indicating a page number or a reference code. The handwriting is clear and legible, with the characters and numbers well-formed.
510(k) Summary
| Date Prepared: | March 2, 2004 |
|---|---|
| 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: | Pediatric Aortic Root Cannula
(18 Gauge) |
|-----------------|----------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or
tubing |
| Classification: | Class II |
| | Predicate Devices: |
Predicate Devices:
Aortic Root Cannulae K790565, K810548, K831591
1
Device Description:
Dorice Decliption. a flange and two side holes. The tip is attached to a flexible tapered tube that terminates in a female luer fitting. A stainless steel 18 gauge introducer with needle tip and locking male luer fitting is supplied inside the cannula.
Indication for Use
This cannula is intended for short term use (six hours or less) in conjunction with I mo cannala is may bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.
Comparison to Predicate Device
The predicate devices are Aortic Root Cannulae with the same design characteristics and indications for use. The predicate cannulae had similar design and materials. The new cannula varies from the predicates in tip length and color, in having a ribbed body, in overall length and in featuring an over-molded ABS introducer needle sheath.
Summary of Performance Data
In vitro dimensional and functional testing was used to establish the performance characteristic of the new device. The biocompatibility, sterilization, and packaging were evaluated. Accelerated aged dimensional and functional testing was also performed. All testing passed.
Conclusion
Medtronic Perfusion Systems has demonstrated that the modified Pediatric Aortic Root Cannula (18 Gauge) is substantially equivalent to the predicate devices based upon design, test results, and indications for use.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.
MAR 1 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Drive N Minneapolis, MN 55428-1088
Re: K040173
Pediatric Aortic Root Cannula (18 Gauge) Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: March 3, 2004 Received: March 4, 2004
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 W. 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/dsmamain.html
Sincerely yours,
Ashley B. Beam
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K040173 Device Name: Pediatric Aortic Root Cannula
Indications for Use:
This cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashley B. Baan
510(k) Number K040173 (SM. K)