(30 days)
No
The device description and intended use focus on a physical medical device (a cannula) for delivering cardioplegia solution. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies described are in vitro and functional testing of the physical product.
No.
The device is used to deliver a therapeutic solution, but it is a delivery tool, not the therapy itself.
No
Explanation: The device is described as a cannula intended for the delivery of cardioplegia solutions during cardiac bypass surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical, hand-held cannula with a spherical tip, intended for use in surgery. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of cardioplegia solutions directly to the coronary arteries during cardiopulmonary bypass surgery. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a cannula designed to physically deliver a solution to a specific anatomical site. It does not perform any tests on biological samples to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
- Performance Studies: The performance studies mentioned are "in vitro and functional testing" to ensure product integrity and function, which is typical for a medical device used in a procedure, not for an IVD which would focus on analytical and clinical performance related to diagnosis.
In summary, the device is a tool used in a surgical procedure for delivering a therapeutic solution, not for diagnosing a condition.
N/A
Intended Use / Indications for Use
The Spherical Tip Coronary Ostial Cannula is intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less, for delivery of cardioplegia solutions directly to the coronary arteries.
Product codes
DWF
Device Description
The Spherical Coronary Artery Ostial Cannula is a line extension of existing Meditonic The Sphorour Soronary Artery Ostial Cannulae and features a uniquely shaped spherical tip. This product is used for the delivery of antegrade cardioplegia solution through the coronary artery ostia during cardiac bypass surgery. The Spherical Coronary Artery Ostial Cannula is intended as an addition to the current line of hand-held cardioplegia perfusion cannulae. Prior products included flanged basket and conforming silicone tips as a means to seal against the ostial opening and deliver cardioplegia.
The distal end of the cannula features a dual-diameter, spherical bulb tip rather than a flanged basket tip for interface to the ostial opening. The released models feature a basket tip with a ring flange that is pressed up against the ostial opening by the physician during cardioplegia delivery. Delivery using the proposed design would, similarly, require the spherical bulb to be pressed against the ostial opening while solution is dispensed through the smaller tip extension.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary arteries, coronary artery ostia
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)
In vitro and functional testing was completed on the modified product to ensure that the product integrity and function is maintained.
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
JAN 2 9 2004
K034058
p 1/2
510(k) Summary
| Date Prepared: | December 19, 2003 |
|---|---|
| Submitter: | Medtronic Perfusion Systems |
| 7611 Northland Boulevard | |
| Brooklyn Park, MN 55428 | |
| Contact Person: | Preeti Jain |
| Senior Manager, Regulatory/Clinical Affairs | |
| Phone: (763)-391-9533 | |
| Fax: (763) 391-9603 | |
| Device Name and Classification: | |
| Trade Name: | Spherical Tip Coronary Ostial Cannula |
| Model 30011 - 12 French | |
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or |
| tubing | |
| Classification: | Class II |
| Predicate Devices: | Coronary Cannula – K821149 |
Models 30010,30012,30014 - French 10, 12 and 14 French
Device Description:
The Spherical Coronary Artery Ostial Cannula is a line extension of existing Meditonic The Sphorour Soronary Artery Ostial Cannulae and features a uniquely shaped spherical tip. This product is used for the delivery of antegrade cardioplegia solution through the coronary artery ostia during cardiac bypass surgery. The Spherical Coronary Artery Ostial Cannula is intended as an addition to the current line of hand-held cardioplegia perfusion cannulae. Prior products included flanged basket and conforming silicone tips as a means to seal against the ostial opening and deliver cardioplegia.
The distal end of the cannula features a dual-diameter, spherical bulb tip rather than a flanged basket tip for interface to the ostial opening. The released models feature a basket tip with a ring flange that is pressed up against the ostial opening by the physician during cardioplegia delivery. Delivery using the proposed design would, similarly, require the
1
Image /page/1/Picture/0 description: The image shows the text "K03v053" on the top line and "p2/2" on the second line. The text appears to be handwritten and is slightly blurred. The background is white.
spherical bulb to be pressed against the ostial opening while solution is dispensed through the smaller tip extension.
Indication for Use
The Spherical Tip Coronary Ostial Cannula is intended for use in conjunction with Fire Dpheriour ry bypass surgery up to six hours or less, for delivery of cardioplegia solutions directly to the coronary arteries.
Comparison to Predicate Device
The Coronary cannula is intended for providing cardioplegia solutions to the coronary The Coronal y camary ith the cardiopulmonary bypass. The product featured flanged, attery in conjunction with the to a malleable stainless steel body. The device is a sterile, non pyrogenic , single use product. The cannulae have a female lucr connection site. The malleable handle provides the surgeons the flexibility to bend the cannula to a convenient muniouolo nanare pro rassist the submitted model is the tip configuration. The Indications for Use are the same.
Summary of Performance Data
In vitro and functional testing was completed on the modified product to ensure that the product integrity and function is maintained.
Conclusion
Medtronic Perfusion Systems has demonstrated that the Spherical Tip Coronary Ostial Cannula , Model 30011 is substantially equivalent to predicate devices based upon design, and indications for use.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2004
Medtronic Perfusion Systems c/o Ms. Preeti Jain Senior Manager, Regulatory/Clinical Affairs 7611 Northland Boulevard Brooklyn Park, MN 55428
Re: K034058
Spherical Tip Coronary Ostial Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: 21 CF CF CF 8701 - 27 - 37 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 Regulatory Class: Class II (two) Product Code: DWF Dated: December 23, 2003 Received: December 30, 2003
Dear Ms. Jain:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 210(x) premaince is substantially equivalent (for the indications
referenced above and have determined the devices devices marketed in interstat referenced above and have determined the devices marketed in interstate for use stated in the enclosire) to the envant date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the envirtish areavision of the Federal Food. Drue commerce pror to May 28, 1976, the enactively and of exprevisions of the Federal Food, Drug, devices that have been reclassified in accordance who was proval application (PMA).
and Cosmetic Act (Act) that do not require approval of the Act. The and Cosmetic Act (Act) that do not require approval on the provisions of the Act. The Act. The Act. The
You may, therefore, market the device, subject to the general regi You may, therefore, market the device, subject of the genting for annual registration, listing of
general controls provisions of the Act include requirements mishranding and general controls provisions of the Act mende requirementibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo cities end regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA In may be subject to such additional controlis. Existing major regalato be found in the Code of Federal Regarations, Fros 24, 2017 and Register.
3
Page 2 - Ms. Preeti Jain
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualice of a succession of the requirements of the Act
that FDA has made a determination that your device complies with one must that FDA has made a determination administered by other Federal agencies. You must or any Federal statutes and regulations daminities, but not limited to : registration and listing (21 l comply with an the Act 3 requirements, morading, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820), and if applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050. product radiation control provisions (Declems Described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your device to 1 leg I his letter will anow you to oegni manxality of substantial equivalence of your device to a legally premarket nother 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 If you desire specific advice for your do novels at (301) 594-4646. Additionally, for questions of the contact the Office of Compitance at (s) { = } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (301) 394-4039. Also, picase note the regation may obtain. Other general information on your premarket notification - (21 OF F Far obtained from the Division of Small Manufactures, responsibilities that the Acchiner of Souther in the free number (800) 638-2041 or (301) 443-6597 International and Consumtion://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
O. Mello
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): K034658
Spherical Tip Coronary Ostial Cannula Device Name:
Model : 30011, French Size 12.
Indications for Use:
The Spherical Tip Coronary Ostial Cannula is intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less, for delivery of cardioplegia solutions directly to the coronary arteries.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
prescription Jse
Qma
510(k) Number