(86 days)
These shunts (Clearview® Intracoronary Shunts) are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.
Clearview® Intracoronary Shunts consist of a flexible tube. Both ends of the tube feature a teardrop shaped tip made from radiopaque material. Tip diameters range from 1.00 mm to 3.00 mm. A tether with a tag made of radiopaque material is permanently attached to the shunts. The sizes of the shunts are indicated on the tag. These shunts are starile, nonpyrogenic, disposable and single use only.
The provided text describes a 510(k) summary for the Medtronic Clearview® Intracoronary Shunts. This document is for a medical device that has been modified, specifically a change in the radiopaque material from organic barium sulfate to synthetic barium sulfate. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| No discernible difference due to material change | - X-ray of the radiopaque material showed no discernible difference.- Biocompatibility testing of the material showed acceptable results.- Suture pull test of the material showed acceptable results. |
| No change to technological characteristics | Confirmed: "The technological characteristics have not changed from the predicate device." |
| No change to operating principle | Confirmed: "No change to the operating principle was made." |
| No change to design features | Confirmed: "No design features have changed." |
| Shelf life not impacted | Confirmed: "Shelf life has not been impacted by the change." |
| Substantial equivalence to predicate device | Concluded: "Medtronic has demonstrated that the Clearview® Intracoronary Shunts are substantially equivalent to the predicate device based upon design and test results. Any noted differences do not raise new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing (non-clinical) for demonstrating substantial equivalence. It does not provide specific sample sizes for the "test set" for X-ray, biocompatibility, or suture pull tests. The provenance of this data (e.g., country of origin) is not mentioned. Given it's bench testing, it would be prospective data generated for the purpose of this submission. No clinical testing was conducted or required.
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 section is not applicable as the study involved bench testing of material properties, not clinical data requiring expert review or establishment of ground truth in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the study involved bench testing of material properties, not clinical data requiring adjudication by experts.
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
No, an MRMC comparative effectiveness study was not done. This device is a medical shunt, not an AI-powered diagnostic tool, and the submission does not involve human readers interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a medical shunt, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench testing would be established by the definitions and standards of the specific tests conducted:
- For X-ray: radiopacity equivalence against a control or predefined standard.
- For Biocompatibility: compliance with ISO standards for biological evaluation of medical devices.
- For Suture pull test: meeting predefined mechanical strength specifications.
8. The sample size for the training set
This section is not applicable as the document describes a 510(k) submission for a physical medical device, not a machine learning model, hence there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for a machine learning model.
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Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a stylized globe on the left and the word "Medtronic" in a bold, sans-serif font on the right. The globe is made up of interconnected lines and shapes, giving it a modern and technological feel. The overall design is clean and professional, reflecting the company's focus on medical technology.
MAY 25 2012
510(k) Summary
| Date Prepared: | May 24, 2012 |
|---|---|
| Submitter: | Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009 |
| Contact Person: | Kelley BreheimAssociate Regulatory Affairs SpecialistPhone: (763) 514-9831Fax: (763) 367-8360Email: Kelley.c.breheim@medtronic.com |
Device Name and Classification
| Trade Name: | Clearview® Intracoronary Shunts |
|---|---|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Classification: | Class II |
Predicate Devices
Medtronic Clearview® Intravascular Arteriotomy Shunt (K993677)
Alleviating Puin · Restoring Health · Extending Life
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Device Description
Clearview® Intracoronary Shunts consist of a flexible tube. Both ends of the tube feature a teardrop shaped tip made from radiopaque material. Tip diameters range from 1.00 mm to 3.00 mm. A tether with a tag made of radiopaque material is permanently attached to the shunts. The sizes of the shunts are indicated on the tag. These shunts are starile, nonpyrogenic, disposable and single use only.
Image /page/1/Picture/2 description: The image shows four medical devices on a reflective surface. Each device consists of a small, round, white sensor with numbers printed on it, connected by a thin black wire to a white, T-shaped connector. The devices are scattered across the surface, with their shadows visible, suggesting a light source from above.
Indications for Use
These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.
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Comparison to Predicate Devices
A comparison of the modified product and the currently marketed Clearview® Intracoronary Shunts indicates the following similarities to the device which received 510(k) clearance:
- The technological characteristics have not changed from the predicate device. The t same radiopaque material is used (organic barium sulfate to synthetic barium sulfate).
- No change to the operating principle was made. .
- . No design features have changed.
- Shelf life has not been impacted by the change. .
Performance Testing Summary
Bench testing (non-clinical) was used to demonstrate that there was no discernible difference when changed from organic barium sulfate to synthetic barium sulfate.
Testing included:
- · X-ray of the radiopaque material
- · Biocompatibility testing of the material
- · Suture pull test of the material
Clinical testing was not required to establish substantial equivalence.
Conclusion
Medtronic has demonstrated that the Clearview® Intracoronary Shunts are substantially equivalent to the predicate device based upon design and test results. Any noted differences do not raise new issues of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing segments. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 5 2012
Medtronic, Inc. c/o Ms. Kelley Breheim 8200 Coral Sea St. NE Mounds View, MN 55119
Re: K120612
Trade/Device Name: Clearview Intracoronary Shunt Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: April 27, 2012 Received: April 30, 2012
Dear Ms. Breheim,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Kelley Breheim
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
M. A. Killehen
- C. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K120612
Device Name: Clearview® Intracoronary Shunts
Indications For Use:
These shunts (Clearview® Intracoronary Shunts) are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.
Prescription Use __X _________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.J. Hillman
livision Sign-Off) (Division Sign-Om)
Division of Cardiovascular Devices
K120612 510(k) Number_
§ 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).