(34 days)
No
The device description and performance studies focus on mechanical components and their physical properties, with no mention of AI/ML terms or functionalities.
No
The device is described as an "Insertion Kit" used to assist in vessel cannulation for cardiopulmonary bypass circulation. It contains tools for insertion (needle, guidewire, dilators) rather than providing a therapeutic effect itself. Its function is to facilitate the use of another device (Bio-Medicus™ cannula) which presumably provides the therapeutic action.
No
The device is an insertion kit for cannulas used during cardiopulmonary bypass circulation. Its purpose is to facilitate the physical insertion of a cannula, not to diagnose a medical condition.
No
The device description explicitly lists physical components such as a Seldinger needle, guidewire, scalpel blade, stepped dilators, and a catheter tip syringe, indicating it is a hardware kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in vessel cannulation for cardiopulmonary bypass circulation." This is a surgical procedure performed directly on a patient's body, not a test performed on a sample of bodily fluid or tissue outside the body.
- Device Description: The components listed (needle, guidewire, scalpel, dilators, syringe) are all tools used for a surgical insertion procedure. They are not reagents, calibrators, or other components typically found in an IVD kit used for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
This kit is intended for use by trained physicians only, to assist in vessel cannulation for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This kit is intended for use for up to 6 hours.
Product codes
DWF
Device Description
Bio-Medicus Insertion Kits contains the necessary components to achieve insertion of a Bio-Medicus cannula and introducer. The included items are: a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and a catheter tip syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians only
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)
Testing has demonstrated that the Bio-Medicus Insertion Kits are substantially equivalent to the predicate. The following tests were conducted to demonstrate substantial equivalence of proposed Insertion kits to the current Insertion kit (1 and 4 year data).
Dilator: Follows Guidewire - Pass
Dilator / Guidewire: Kink - Pass
Dilator Luer: Body Separation - Pass
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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be emerging from a single point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2015
Medtronic, Inc. Bruce Backlund Principal Regulatory Affairs Specialist 7611 Northland Dr. Minneapolis, MN 55428
Re: K150567
Trade/Device Name: Bio-Medicus Insertion Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: March 2, 2015 Received: March 13, 2015
Dear Mr. Bruce Backlund,
This letter corrects our substantially equivalent letter dated April 9, 2015.
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
M.A. Willemen
for 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) K150567
Device Name Bio-Medicus Insertion Kit
Indications for Use (Describe)
This kit is intended for use by trained physicians only, to assist in vessel cannulation for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This kit is intended for use for up to 6 hours.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date Prepared: | April 7, 2015 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Bruce J. Backlund |
| Principal Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: (763) 526-2357 | |
| Fax: (763) 367-8360 | |
| Email: bruce.j.backlund@medtronic.com |
Alternate Contact:
Susan C. Fidler
Sr. Regulatory Affairs Manager
Medtronic Perfusion Systems
Phone: (763) 514-9839
Fax: (763) 367-8360
Email: susan.c.fidler@medtronic.com |
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing. |
| Proprietary Name: | Bio-Medicus™ Insertion Kit |
| Classification: | Classification: Class II
Panel: Cardiovascular
Regulation: 21 CFR 870.4210
Product Code: DWF |
| Predicate Device: | Medtronic Bio-Medicus™ Cannula Insertion Kit (K924643) |
Device Description
Bio-Medicus™ Insertion Kits contains the necessary components to achieve insertion of a Bio-Medicus™ cannula and introducer. The included items are: a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and a catheter tip syringe.
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Indications for Use
This kit is intended for use by trained physicians only, to assist in vessel cannulation for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This kit is intended for use for up to 6 hours.
Comparison to Predicate Device
A comparison of the proposed product to the currently marketed Medtronic Bio-Medicus™ Cannula Insertion Kit (K924643) indicates the following similarities:
- Same intended use/indications
- Same operating principle
- Same fundamental technological characteristics
- Same overall design and performance
- Same materials
- Same packaging materials and design
- Same sterilization requirements
- Three (3) new models include additional dilator, guidewire and syringe sizes as shown in the following table:
| Kit Configurations | |||
|---|---|---|---|
| Model 96550 | |||
| (currently marketed | |||
| device K924643 S.E. | |||
| December 8, 1992) | Model 96551 (Subject | ||
| of this submission) | Model 96552 (Subject | ||
| of this submission) | Model 96553 (Subject | ||
| of this submission) | |||
| 60-cc syringe | 10-cc syringe | 10-cc syringe | 10-cc syringe |
| 18 ga Seldinger style | |||
| needle | 18 ga Seldinger style | ||
| needle | 18 ga Seldinger style | ||
| needle | 18 ga Seldinger style | ||
| needle | |||
| 8/10 Fr and 12/14 Fr | |||
| stepped dilator | 8 Fr/10 Fr, 12 Fr/14 Fr, | ||
| and 16 Fr/18 Fr | |||
| stepped dilator | 8 Fr/10 Fr, 12 Fr/14 Fr, | ||
| and 16 Fr/18 Fr | |||
| stepped dilator | 8/10 Fr and 12/14 Fr | ||
| stepped dilator | |||
| 0.038-in (0.1 cm) x 180 | |||
| cm (70.87-in) | |||
| guidewire | 0.038-in (0.965-mm) x | ||
| 180-cm (70.87-in) | |||
| guidewire | 0.038-in (0.965-mm) x | ||
| 100-cm (39.37-in) | |||
| guidewire | 0.025-in (0.535-mm) x | ||
| 60-cm (23.62-in) | |||
| guidewire | |||
| #11 scalpel blade | #11 scalpel blade | #11 scalpel blade | #11 scalpel blade |
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Summary of Performance Data
Testing has demonstrated that the Bio-Medicus™ Insertion Kits are substantially equivalent to the predicate.
The following tests were conducted to demonstrate substantial equivalence of proposed Insertion kits to the current Insertion kit (1 and 4 year data).
| Component | Verification/Validation | Results |
|---|---|---|
| Dilator | Follows Guidewire | Pass |
| Dilator / Guidewire | Kink | Pass |
| Dilator Luer | Body Separation | Pass |
Conclusion
Compared to the predicate device, the fundamental scientific technology, operating principles, design features and intended use are unchanged. As such, it has been demonstrated that the modifications made to the Bio-Medicus™ Insertion Kit described in this submission result in a substantially equivalent device.