(35 days)
No
The device description and performance studies focus on the physical properties and packaging of a simple tubing adapter, with no mention of software, data processing, or AI/ML terms.
No.
The device is described as an adapter used for connecting tubing and/or devices during procedures, not for therapeutic action itself.
No
This device is described as an adapter for connecting tubing and devices during cardiopulmonary bypass procedures, and its performance studies relate to packaging integrity, not to diagnostic capabilities.
No
The device description explicitly states it consists of a flexible tubing segment and luer adapters, 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 "connecting tubing and/or devices during cardiopulmonary bypass procedures." This describes a device used in vivo (within the body) during a surgical procedure, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details a flexible tubing segment with luer lock adapters for connecting other medical devices. This aligns with a surgical accessory, not a diagnostic test.
- Lack of Diagnostic Information: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on packaging integrity and sterilization, which are relevant for sterile surgical devices, not typically the primary focus for IVD performance studies (which would involve analytical and clinical performance).
In summary, the device's function and intended use clearly place it outside the realm of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Affinity Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.
Product codes
DTL
Device Description
The flexible luer lock adapters are single use only devices that consist of a flexible tubing segment with an inner diameter of 0.32 cm (0.125 in) with a male luer adapter on one end and a female luer adapter on the other end. This device is currently packaged with the Affinity Pixie Cardiotomy/Venous Reservoir device. It is also available as a standalone device (subject of this submission).
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
The packaging for these products was tested to demonstrate compliance to ISO 11607-1 and 11607-2, 2006.
The packaged samples were sterilized twice and subjected to climactic conditioning prior to testing. After being subjected to the distribution simulation and testing (ASTM D4169-08), the packaging was visually inspected. The seals are then subjected to the dye penetration test to ensure integrity of the seals. In addition, seals then undergo a peel test to ensure the proper level of adherence between the Tyvek lid and the blister tray.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
| Date Prepared: | September 28, 2012 |
|---|---|
| Applicant: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Contact Person: | Julia A. Nelson |
| Principal Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: 763-514-9844 | |
| Fax: 763-367-8360 | |
| E-Mail: julia.a.nelson@medtronic.com | |
| Alternate contact: | |
| Sue Fidler | |
| Senior Regulatory Affairs Manager | |
| Medtronic Perfusion Systems | |
| Phone: 763-514-9839 | |
| Fax: 763-367-8360 | |
| E-Mail: susan.c.fidler@medtronic.com |
Device Name and Classification:
Affinity® Flexible Luer Lock Adapters with Carmeda BioActive Trade Name: Surface (Model CBPT1830) or Balance Biosurface (Model BBPT1830) Common Name: Adapter, stopcock, manifold or fitting; cardiopulmonary bypass Regulation Number: 21 CFR 870.4290 Product Code: DTL Classification: Class II Classification Panel: Cardiovascular
Predicate Device
The predicate device is the Affinity Flexible Luer Lock Adapters, accessory packaged with the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) (K100645).
Device Description
The flexible luer lock adapters are single use only devices that consist of a flexible tubing segment with an inner diameter of 0.32 cm (0.125 in) with a male luer adapter on one end and a female luer adapter on the other end. This device is currently packaged with the Affinity Pixie Cardiotomy/Venous Reservoir device. This device is currently packaged
1
with the Affinity Pixie Cardiotomy/Venous Reservoir device. It is also available as a standalone device (subject of this submission).
| Product Family | Model | Description |
|---|---|---|
| Adapters | CBPT1830 | Flexible Luer Lock Adapter with Carmeda BioActive |
| Surface | ||
| BBPT1830 | Flexible Luer Lock Adapter with Balance Biosurface |
Intended Use
Affinity Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.
Comparison to Predicate Devices
The Affinity Flexible Luer Lock Adapters has the same intended use, design and materials, and principles of operation and technology when compared to the predicate devices.
- . Intended Use: Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.
- Design: There is no change in the device design of the Affinity Luer Lock Adapters ● as compared to the predicate, only the packaging has changed.
- Materials: There are no changes to the device design, additional materials are ● included in the Affinity Luer Lock Adapters in comparison to the predicate devices as it is packaged in a different configuration.
- Principles of Operation and Technology: The flexible luer lock adapters are for . connecting tubing and or components together in an extracorporeal circuit which is used in the same manner of operation as the predicate connectors.
- Performance: The performance of the adapters did not change from the predicate . device.
The Affinity Flexible Luer Lock Adapters are identical to the predicate device, with the exception of packaging. The predicate device is currently an accessory which is packaged . and sterilized with the Affinity Pixie Cardiotomy/Venous Reservoir.
The stand-alone flexible luer lock adapters will be sold as a ten (10) pack of Tyvek lidded sealed blister trays in a paperboard carton with 1 Instruction For Use (IFU). These trays are overpacked in a corrugated shipper box.
Summary of Performance Data
The packaging for these products was tested to demonstrate compliance to ISO 11607-1 and 11607-2, 2006.
The packaged samples were sterilized twice and subjected to climactic conditioning prior to testing. After being subjected to the distribution simulation and testing (ASTM D4169-08), the packaging was visually inspected. The seals are then subjected to the dye penetration test to ensure integrity of the seals. In addition, seals then undergo a peel test to ensure the proper level of adherence between the Tyvek lid and the blister tray.
2
Conclusion
Medtronic has demonstrated that the Affinity Flexible Luer Lock Adapters are substantially equivalent to the predicate devices based upon design, test results, and indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble ribbons or waves, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 1 3 2012
Medtronic, Inc. c/o Ms. Julia A. Nelson, MS. RAC Principal Regulatory Affairs Specialist 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 55112
Re: K123448
Trade/Device Name: Affinity Flexible Luer Lock Adapters Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II Product Code: DTL Dated: November 7, 2012 Received: November 8, 2012
Dear Ms. Nelson:
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.
4
Page 2 – Ms. Julia A. Nelson
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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Matthew G. Hjllebrenner
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): _ K123448
Device Name:
Affinity® Flexible Luer Lock Adapters with Balance™ Biosurface Affinity® Flexible Luer Lock Adapters with Carmeda® BioActive Surface
Indications for Use:
Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.
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)
Cus Hillebeure
Cardiovascular Devices
510(k) Number