(119 days)
No
The device description and performance studies focus on the physical properties and performance of tubing and connectors, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
Explaination: The device is described as "Tubing Packs" used to connect primary devices within the extracorporeal circuit during cardiopulmonary bypass. It facilitates the bypass procedure but does not directly treat a disease or condition itself.
No
The device is described as "Tubing Packs" used in cardiopulmonary bypass procedures for connecting primary devices of the bypass circuit. Its function is to transport blood in an extracorporeal circuit, not to diagnose a condition or disease.
No
The device description explicitly states it consists of "coated and uncoated tubing, connectors and various medical devices" which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures." This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details tubing, connectors, and other components used to connect primary devices in a bypass circuit. This is consistent with a medical device used for blood circulation during surgery, not for diagnostic testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status. The focus is on facilitating blood flow during surgery.
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 entirely within the realm of supporting a surgical procedure.
N/A
Intended Use / Indications for Use
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
The Medtronic Tubing Pack is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Product codes
DWF
Device Description
Medtronic Tubing Packs are used in cardiopulmonary bypass procedures for connecting the primary devices of the bypass circuit. The functionality and intended use of these devices are the same as those for the listed in the Table 2-1.
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. This submission is to add additional tubing and connectors for use in Tubing Pack and is changing as part of continual process improvement efforts. The component additions include tubing and connectors that may be coated or uncoated. The coating types include: Cortiva, Trillium and Balance and these three types of coatings are identical to the cleared existing components for Tubing Packs (K891687, K012538 and K122811). The components being added do not have any changes in materials, technology or labeling than previously cleared components for Tubing Packs. These additional components are representative of currently cleared components and do not add any additional risk to patients therefore, Medtronic believes these components may be added to the Tubing Packs. All packaging components remain unchanged (peel pouches, ties, bands, trays, lids and shipper). There is no change to the sterile barrier, sterilization and test methods used for these components. The type of components being added are outlined in Table 2-2.
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
Verification and validation testing demonstrated that the tubing and connectors are substantially equivalent to the predicate. Medtronic conducted the following testing for the tubing and connector components:
- . Pressure Integrity
- Pressure Decay
- Spallation (Tubing)
- Kink Resistance (Tubing)
- Tubing Life
- Biocompatibility
- Pull Force
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K800178, K883956, K924529, K891687, K012538, K113845, K122811, K151523
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2017
Medtronic, Inc. Renee Cveykus Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE (MVS83) Mounds View, Minnesota 55112
Re: K171979
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: October 18, 2017 Received: October 19, 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-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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 (DICE) 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 (DICE) 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,
Nicole G. Ibrahim -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)
K171979
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
| Date Prepared: | June 29, 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 3 | 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:
K171308 Tubing Pack
Device Description
Medtronic Tubing Packs are used in cardiopulmonary bypass procedures for connecting the primary devices of the bypass circuit. The functionality and intended use of these devices are the same as those for the listed in the Table 2-1.
| 510(k)
Number | Date of
Clearance | Device |
|------------------|----------------------|----------------------------------------------------------------|
| K800178 | 02/21/1980 | Uncoated Tubing Packs |
| K883956 | 10/28/1988 | Biomedicus Tubing Packs |
| K924529 | 06/23/1993 | Signature Tubing Packs |
| K891687 | 05/31/1989 | Carmeda Coated Tubing Packs |
| K012538 | 23/08/2001 | Trillium Coated Tubing Packs |
| K113845 | 01/25/2012 | Tubing, Connectors, and Accessories with Balance™ Biosurface |
| K122811 | 10/12/2012 | Balance Coated Connector Components |
| K151523 | 07/16/2015 | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass |
| K171308 | 06/02/2017 | Tubing Pack – New Packaging Trays |
Table 2-1: Tubing Packs 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 device, the Tubing Packs have the same:
-
Intended Use
-
Performance ●
-
Technological characteristics ●
-
Base materials ●
-
Operating principle
-
Method of sterilization and sterility assurance level .
-
Design features
-
Shelf life
5
- Coatings
- Biocompatibility
Addition of Components (Tubing and Connectors)
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. This submission is to add additional tubing and connectors for use in Tubing Pack and is changing as part of continual process improvement efforts. The component additions include tubing and connectors that may be coated or uncoated. The coating types include: Cortiva, Trillium and Balance and these three types of coatings are identical to the cleared existing components for Tubing Packs (K891687, K012538 and K122811). The components being added do not have any changes in materials, technology or labeling than previously cleared components for Tubing Packs. These additional components are representative of currently cleared components and do not add any additional risk to patients therefore, Medtronic believes these components may be added to the Tubing Packs. All packaging components remain unchanged (peel pouches, ties, bands, trays, lids and shipper). There is no change to the sterile barrier, sterilization and test methods used for these components. The type of components being added are outlined in Table 2-2.
| Component | Quantity | Uncoated | Coated | ||
|---|---|---|---|---|---|
| Cortiva | Trillium | Balance | |||
| Connectors | 121 | 39 | |||
| Type: Cap, luer, stopcock, monitoring line, connectors | 28 | 24 | 30 | ||
| Tubing | 86 | 35 | |||
| Size: .085x.062x, .107x.040x, 1/2X1/8, 1/2x3/32x, 1/4X1/16, 3/16x1/16, and | |||||
| 5/16x3/32x | 0 | 23 | 28 | ||
| Total | 207 |
Table 2-2: Types of Components being Added
A detailed list of the new components can be found within Appendix 2.
Summary of Performance and Biological Testing
Verification and validation testing demonstrated that the tubing and connectors are substantially equivalent to the predicate. Medtronic conducted the following testing for the tubing and connector components:
- . Pressure Integrity
Pressure Decay
●
- Spallation (Tubing) ●
- Kink Resistance (Tubing) ●
- ●
- Tubing Life Biocompatibility ●
- ●
Pull Force
6
The testing completed was a representative of worse case testing for tubing and connectors and the verification results were leveraged based on most challenging components. Each of the components in scope of this submission were reviewed against the product specification and the following rationalization documentation was completed:
- . Mechanical Requirements (10561942DOC)
- Coating Requirements (10552508DOC) ●
- . Design Verification for Non-stacked conditioning and Pressure Integrity (10571289DOC)
- Biocompatibility per product specifications (10560838DOC) ●
Based on this evaluation Medtronic considers these tubing and connectors are substantially equivalent to the predicate.
Conclusion
Medtronic has demonstrated that the Tubing Pack with the additional components used in extracorporeal cardiopulmonary bypass perfusion systems is substantially equivalent to the predicate device based upon design, testing, and indications for use. The fundamental scientific principle, labeling and the intended use are unchanged because of this device modification.