(34 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Medtronic Bio-Medicus Insertion Kit. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria for a new device's performance in a clinical setting. Therefore, many of the requested categories for AI/device performance studies (like sample size for test sets, expert qualifications, MRMC studies, training set details, etc.) are not applicable to this type of submission.
However, I can extract the information related to the performance testing conducted to support the substantial equivalence claim.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., "device must achieve X% accuracy"). Instead, the performance evaluation for this submission is based on verifying that the modified components of the Bio-Medicus Insertion Kit function as intended and are comparable to the predicate device. The "acceptance criteria" can be inferred as "Pass" meaning the component performed acceptably according to the test.
| Component | Verification/Validation Test | Performance (Implied Acceptance) |
|---|---|---|
| Dilator | Follows Guidewire | Pass |
| Dilator / Guidewire | Kink Test | Pass |
| Dilator Luer | Body Separation Test | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document refers to "Testing has demonstrated..." but does not detail the number of units tested.
- Data Provenance: Not specified. This would typically be internal laboratory testing (prospective), but no specific location or retrospective/prospective nature is stated.
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)
Not applicable. This is a medical device submission focused on physical properties and functionality, not diagnostic interpretation or clinical outcome assessed by experts in the context of ground truth establishment for an AI/diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for establishing ground truth from expert consensus in diagnostic studies, which is not the nature of this submission. The "Pass" results imply a pre-defined standard or threshold was met during the testing.
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
Not applicable. This is not an AI-powered device, nor is it a diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (insertion kit), not an algorithm. The device "performance" is its mechanical function.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" here is the expected physical performance and integrity of the components as measured by standard engineering and device testing methods. The "Pass" indicates that the tested component met the predetermined specifications or performance characteristics defined for that test. This would be based on engineering specifications and perhaps comparison to the predicate device, although the specific criteria are not detailed beyond the test name.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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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
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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 Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009 |
| Contact Person: | Bruce J. BacklundPrincipal Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: (763) 526-2357Fax: (763) 367-8360Email: bruce.j.backlund@medtronic.comAlternate Contact:Susan C. FidlerSr. Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: (763) 514-9839Fax: (763) 367-8360Email: susan.c.fidler@medtronic.com |
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing. |
| Proprietary Name: | Bio-Medicus™ Insertion Kit |
| Classification: | Classification: Class IIPanel: CardiovascularRegulation: 21 CFR 870.4210Product 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 marketeddevice K924643 S.E.December 8, 1992) | Model 96551 (Subjectof this submission) | Model 96552 (Subjectof this submission) | Model 96553 (Subjectof this submission) |
| 60-cc syringe | 10-cc syringe | 10-cc syringe | 10-cc syringe |
| 18 ga Seldinger styleneedle | 18 ga Seldinger styleneedle | 18 ga Seldinger styleneedle | 18 ga Seldinger styleneedle |
| 8/10 Fr and 12/14 Frstepped dilator | 8 Fr/10 Fr, 12 Fr/14 Fr,and 16 Fr/18 Frstepped dilator | 8 Fr/10 Fr, 12 Fr/14 Fr,and 16 Fr/18 Frstepped dilator | 8/10 Fr and 12/14 Frstepped dilator |
| 0.038-in (0.1 cm) x 180cm (70.87-in)guidewire | 0.038-in (0.965-mm) x180-cm (70.87-in)guidewire | 0.038-in (0.965-mm) x100-cm (39.37-in)guidewire | 0.025-in (0.535-mm) x60-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.
§ 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).