(28 days)
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedures.
Tubing, Connectors, and Accessories with Balance™ Biosurface are used in cardiopulmonary bypass for connecting the primary devices of the bypass circuit. The functionality and intended use of these devices are the same as those for the coated (Trillium® Biosurface) and uncoated tubing, connectors, and accessories that are FDA cleared. Balance™ Biosurface has been previously FDA cleared (K100646) and is commercially available. Balance™ Biosurface is a non-leaching biocompatible surface that reduces platelet adhesion and activation and preserves platelet function.
The manufacturer of the "Tubing, Connectors, and Accessories with Balance™ Biosurface" conducted a study to demonstrate its substantial equivalence to predicate devices. The study focused on assessing the device's performance across various parameters relevant to its intended use in cardiopulmonary bypass.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test were implied by a "Pass" result, indicating the device met the required performance standards for substantial equivalence.
| Verification/Validation | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Balance™ Biosurface coverage | Met coverage requirements | Pass |
| Balance™ Biosurface leaching | Met non-leaching requirements | Pass |
| Hemolysis | Met hemolysis limits | Pass |
| White Blood Cell (WBC) Retention | Met WBC retention limits | Pass |
| Platelets Retention/Platelet Activation | Met platelet performance | Pass |
| Kallikrein Generation | Met kallikrein limits | Pass |
| Tubing kink resistance | Met kink resistance | Pass |
| Pressure integrity | Maintained pressure integrity | Pass |
| Pressure decay | Met pressure decay limits | Pass |
| Tubing pull force | Met pull force requirements | Pass |
| No tubing pull off during static force | Maintained secure connection | Pass |
| Tubing Life | Met tubing life requirements | Pass |
| Tubing Spallation | Met spallation limits | Pass |
| Biocompatibility Assessment | No impact to biocompatibility | Pass |
| Packaging and Sterilization Assessment | No impact to P&S | Pass |
| Shelf-Life Verification | Met shelf-life requirements | Pass |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test. The data provenance is internal to Medtronic, Inc., a U.S.-based company, and the tests were likely conducted prospectively as part of the device's design verification and validation process prior to 510(k) submission. No information about country of origin of the data is provided beyond the submitting company's location.
3. Number of Experts and Qualifications for Ground Truth
This type of submission for tubing and connectors does not typically involve human expert consensus for "ground truth" in the way a diagnostic imaging device would. The ground truth for these performance tests is based on established engineering and biocompatibility standards and test methods. Therefore, the concept of "number of experts" for ground truth establishment, in this context, is not applicable. The expertise would lie in the engineers and scientists who designed the tests and interpreted the results against defined criteria.
4. Adjudication Method
Adjudication methods like 2+1 or 3+1 are used for studies involving subjective human interpretation (e.g., image analysis). For the objective performance tests listed in this submission, an adjudication method is not applicable. The results are quantitative (e.g., measurements, counts) or qualitative (e.g., visual inspection) against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic devices where human readers interpret medical images or data, and the effect of AI on their performance is evaluated. This device (tubing and connectors) is a component of a medical system and does not involve human interpretation in a diagnostic context that would necessitate such a study.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The device is a physical medical component, not an algorithm. Therefore, the concept of an "algorithm only" performance study is not applicable. The performance studies assessed the physical and biological characteristics of the device itself.
7. Type of Ground Truth Used
The "ground truth" for the performance tests was based on:
- Engineering Specifications and Standards: For physical tests like kink resistance, pressure integrity, pull force, and tubing life.
- Biocompatibility Standards: For tests related to biological interactions such as hemolysis, WBC retention, platelet retention/activation, kallikrein generation, and biocompatibility assessment.
- Material Science Principles: For tests like Biosurface coverage and leaching.
8. Sample Size for the Training Set
This product is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of machine learning model development. The tests performed are verification and validation tests for the physical product.
9. How Ground Truth for the Training Set Was Established
As there is no training set for an AI or machine learning model, this question is not applicable.
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K113845 pa 10+ 3
JAN 2 5 2012
510(k) Summary of Safety and Effectiveness
| Date Prepared: | December 22, 2011 |
|---|---|
| Submitter: | Medtronic, Inc.Medtronic Perfusion Systems611 Northland DriveMinneapolis, MN 55428 |
| Contact Person: | Kevin T. LamSenior Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: 763-526-2360Fax: 763-367-8360E-Mail: kevin.t.lam@Medtronic.com |
| Alternate contact:Sue FidlerSenior Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: 763-514-9839 |
Fax:
Device Name and Classification:
| Trade Name: | Tubing, Connectors and Accessories with Balance™ Biosurface |
|---|---|
| Common Name: | Cardiopulmonary bypass adapter tubing, connector, stopcock, manifold or fitting |
| Regulation Number: | 21 CFR 870.4290 |
| Product Code: | DWF and DTL |
| Product Code: | Class II |
763-367-8360
E-Mail: susan.c.fidler@medtronic.com
Predicate Devices
Intersept Custom Tubing Pack (K800178) Bio-Medicus Tubing Connectors (K883956) Signature Custom Tubing Pack (K924529) Trillium Coated Tubing and Connectors (K012538) Affinity Pixie™ Arterial Filter with Balance™ Biosurface (K100646)
Device Description
Tubing, Connectors, and Accessories with Balance™ Biosurface are used in cardiopulmonary bypass for connecting the primary devices of the bypass circuit. The
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K113845 pg 2 of 3
functionality and intended use of these devices are the same as those for the coated (Trillium® Biosurface) and uncoated tubing, connectors, and accessories that are FDA cleared. Balance™ Biosurface has been previously FDA cleared (K100646) and is commercially available. Balance™ Biosurface is a non-leaching biocompatible surface that reduces platelet adhesion and activation and preserves platelet function.
Intended Use
There is no change to the indication for use for these devices/components.
The Medtronic Custom Perfusion System is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedures.
Comparison to Predicate Devices
A comparison of the modified product and the currently marketed tubing, connectors, and accessories with Trillium® Biosurface (K012538), Intersept Custom Tubing Pack (K800178), Bio-Medicus Tubing Connectors (K883956), and Signature Custom Tubing Pack (K924529) indicates the following similarities to the product which received 510/k) clearance:
- ◆ Same intended use
- . Same technological characteristics
- Same operating principle .
- Same design features (with the exception that Balance™ Biosurface will not contain . heparin in the coating)
- Same base materials prior to coating .
- Same shelf life .
A comparison of the modified product and the currently marketed Affinity Pixie™ Arterial Filter with Balance™ Biosurface (K100646) indicates the following similarities to the product which received 510(k) clearance:
- Same Balance™ Biosurface coating .
Summary of Performance Data
Verification and validation testing has demonstrated that the tubing, connectors, and accessories with Balance™ Biosurface are substantially equivalent to the predicates. The following performance tests were conducted:
| Verification/Validation | Results |
|---|---|
| Balance™ Biosurface coverage | Pass |
| Balance™ Biosurface leaching | Pass |
| Hemolysis | Pass |
| White Blood Cell (WBC) Retention | Pass |
| Platelets Retention/ Platelet Activation | Pass |
| Kallikrein Generation | Pass |
| Tubing kink resistance | Pass |
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| Pressure integrity | Pass |
|---|---|
| Pressure decay | Pass |
| Tubing pull force | Pass |
| No tubing pull off during static force | Pass |
| Tubing Life | Pass |
| Tubing Spallation | Pass |
| Biocompatibility Assessment | Pass - no impact to biocompatibility |
| Packaging and Sterilization Assessment | Pass - no impact to packaging and sterilization |
| Shelf-Life Verification | Pass |
Conclusion
Medtronic has demonstrated that the tubing, connectors, and accessories with Balance™ Biosurface for use in custom perfusion system are substantially equivalent to the predicate devices based upon design, test results and indications for use. The fundamental scientific principle, labeling and the intended use are unchanged as a result of these device modifications.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 5 2012
Medtronic, Inc. c/o Mr. Kevin T. Lam Senior Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428
Re: K113845
Trade/Device Name: Tubing, Connectors, and Accessories with Balance™ Biosurface Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II Product Code: DTL Dated: December 22, 2011 Received: December 28, 2011
Dear Mr. Lam:
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
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Page 2 - Mr. Kevin T. Lam
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 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Killebrew
്യം 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 Statement
510(k) Number (if known): _K113845
Device Name: Tubing, Connectors, and Accessories with Balance™ Biosurface
Indications for Use:
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
.y. Kleban
(Division Sian-Off) (Division of Cardiovascular Devices
k11 3845 510(k) Number_
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.