(30 days)
No
The device description and performance studies focus on the physical components and packaging of tubing packs for cardiopulmonary bypass, with no mention of AI or ML.
No
The device is used to connect primary devices in a cardiopulmonary bypass circuit, and its functionality is the same as cleared tubing and accessories. It enables the bypass procedure but does not directly perform a therapeutic function on the patient.
No
The device is described as "Tubing Packs" used in an extracorporeal circuit during cardiopulmonary bypass. Its function is to connect devices and form a perfusion circuit, not to diagnose conditions.
No
The device description explicitly states it consists of "coated and uncoated tubing, connectors and various medical devices that are pre-assembled". This indicates a physical, hardware-based device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being "in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures." This involves the direct handling and circulation of blood outside the body during surgery, not the analysis of samples in vitro (in a lab setting).
- Device Description: The description focuses on tubing, connectors, and other components used to create a circuit for blood flow during bypass. It describes a system for moving and processing blood extracorporeally, not for analyzing its properties or components.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and related to the physical process of circulating blood during surgery.
N/A
Intended Use / Indications for Use
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
Medtronic Tubing Packs 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 (Cortiva - Coated Tubing Packs(K891687), Trillium BioPassive Surface Coated Tubing Packs (K012538), and Balance BioSurface Coated Tubing Packs(K122811) and uncoated tubing, connectors, and accessories that are FDA cleared.
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
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)
Medtronic conducted the following packaging system retesting for new tray:
- Process Characterization
- Shelf Life
- Process Validation
- Packaging Performance
- Sterilization
- Biocompatibility
Medtronic has demonstrated that the Tubing Pack with the new tray used in extracorporeal cardiopulmonary bypass perfusion systems is substantially equivalent to the predicate device based upon design, test results, and indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
June 2, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic, Inc. Renee Cveykus Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K171308
Trade/Device Name: Tubing Pack Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: May 2, 2017 Received: May 3, 2017
Dear Renee Cveykus:
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 of medical device
1
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 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" (21 CFR 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,
Fernando
Aguel -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Tubing Pack
Indications for Use (Describe)
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
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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3
510(k) Summary of Safety and Effectiveness
| Date Prepared: | May 2, 2017 |
|---|---|
| Submitter's Name and Address: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Person: | Renee L. Cveykus |
| Principal Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: (763) 505-3059 | |
| Fax: (763) 367-0401 | |
| Email: renee.l.cveykus@medtronic.com | |
| Alternate Contact: | Jake Roeller |
| Sr. Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: (763) 526-0404 | |
| Fax: (763) 514-9521 | |
| Email: jake.w.roeller@medtronic.com |
Proprietary Name:
| Models | Description |
|---|---|
| See Appendix 2 | Tubing Pack |
Device Name and Classification:
| Trade Name: | Tubing Pack |
|---|---|
| Common Name: | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
| Classification Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing. |
| Classification Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.4210 |
| Product Code: | DWF |
| Classification: | Class II |
4
Predicate Device:
K151523 Uncoated Tubing and Connector Components
Device Description
Medtronic Tubing Packs 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 (Cortiva - Coated Tubing Packs(K891687), Trillium BioPassive Surface Coated Tubing Packs (K012538), and Balance BioSurface Coated Tubing Packs(K122811) and uncoated tubing, connectors, and accessories that are FDA cleared.
Indications for Use
There is no change to the intended use of the devices/components. The current Indications for Use statement for these devices is listed below:
The Medtronic Tubing Pack is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
●
Comparison to Predicate Devices
When compared to the predicate devices, the Tubing Packs have the same:
- o Intended Use
- Performance ●
- Technological characteristics ●
- Base materials
Method of sterilization and sterility assurance level
- Operating principle ●
- Design features ●
- Shelf life ●
Packaging Change - New Trays
Medtronic Tubing Packs consist of coated and uncoated tubing, connectors and various medical devices that are pre-assembled into user-specified extracorporeal cardiopulmonary bypass perfusion circuits. Tubing Packs are intended for use within the extracorporeal blood pathway during cardiopulmonary bypass surgical procedures. Medtronic Tubing Packs are currently packaged into qualified clear tray and sterile packaging systems. The packaging trays for the Tubing Pack is changing as part of continual process improvement efforts. The trays are available in three sizes and include the Universal tray, the MIDI Deep tray and MIDI Low tray, for the remainder of this submission they will be referred to as tray(s) and includes all three models. The tray size for a particular tubing pack is based upon the pack contents (size and volume of the pack components). The tray modification includes material, supplier, mold and slight dimension changes. All other packaging components remain unchanged (peel pouches, ties, bands and shipper). There is no change to the sterilization and test methods
1 Brand Name Change from Carmeda to Cortiva.
5
used for the new trays (Sterilization, Biocompatibility, Stability and Performance testing). The packaging tray changes are summarized in Tables 1.
| Feature | Current: | Future: | Model Number | Change | |
|---|---|---|---|---|---|
| Tray | |||||
| Dimension | Universal | 27.75Lx23.79Wx21.77H | 27.78Lx23.79Wx21.72H | 999505-04 old | |
| M057602T001 new | Yes | ||||
| MIDI Deep | 29.92Lx16.02Wx8.21H | 29.83Lx 15.73W x 8.33H | 999505-02 old | ||
| M972494A001 new | Yes | ||||
| MIDI Low | 29.92Lx16.02Wx6.36H | 29.75Lx 15.68W x 6.37H | 999505-03 old | ||
| M972495A001 new | Yes | ||||
| Supplier | Nelipak | C&J Tech | N/A | Yes | |
| Technology (Mold) | Thermoformed Molded | Injection Molded | N/A | Yes | |
| Material | Resin | ||||
| Eastman Spectar | |||||
| PETG 14471 | |||||
| Copolyester | Resin | ||||
| Resirene | |||||
| CET® 265 | |||||
| Styrene Methyl | |||||
| Methacrylate Acrylic | |||||
| Copolymer | N/A | Yes | |||
| Additional Packaging Components | |||||
| Lid | Tyvek 1073B coated | ||||
| with Oliver Tolas | |||||
| TPT-0260 | Tyvek 1073B coated | ||||
| with Oliver Tolas | |||||
| TPT-0260 | See Appendix 2 | No | |||
| Peel Pouches | Tyvek 1073B / 48 GA | ||||
| PET, 28 LBS LDPE (RLE- |
- | Tyvek 1073B / 48 GA
PET, 28 LBS LDPE (RLE- -
| See Appendix 2 | No |
| Straps, velcros, and tie
bands, foam,etc | | Various | Various | See Appendix 2 | No |
| Shipper Box | | Various | Various | See Appendix 2 | No |
| Sterilization | | Ethylene oxide
sterilization | Ethylene oxide
sterilization | N/A | No |
| Testing | | Biocompatibility,
Stability and
Performance | Biocompatibility,
Stability and
Performance | N/A | No |
Table 1: Package Component Details
Summary of Performance and Biological Testing
Medtronic conducted the following packaging system retesting for new tray:
- Process Characterization
- Shelf Life
- Process Validation
- ●
- Packaging Performance
- Sterilization
- Biocompatibility
Conclusion
Medtronic has demonstrated that the Tubing Pack with the new tray used in extracorporeal cardiopulmonary bypass perfusion systems is substantially equivalent to the predicate device based upon design, test results, and indications for use. The fundamental scientific principle, labeling and the intended use are unchanged because of this device modification.