(29 days)
Not Found
No
The summary describes passive components for connecting tubing in a cardiopulmonary bypass circuit and makes no mention of AI or ML.
No
The device is described as "Connector Components" used to interconnect tubing and primary devices in an extracorporeal circuit. Its function is to provide a continuous pathway for blood flow, not to treat a medical condition directly.
No
This device is described as components for an extracorporeal circuit used during cardiopulmonary bypass surgery to interconnect tubing and provide a pathway for fluid flow. Its function is to facilitate the bypass procedure, not to diagnose a medical condition.
No
The device description clearly states the components are comprised of polycarbonate and Balance Biosurface materials, indicating physical hardware components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures." This describes a device used during a surgical procedure to manage blood flow outside the body.
- Device Description: The description focuses on the physical components (connectors, tubing) and their function in providing a pathway for blood flow. It does not mention any analysis of biological samples (blood, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, etc.)
- Providing diagnostic information
- Using reagents or assays
Instead, this device is clearly described as a component of a surgical system used to manage blood flow during a procedure.
N/A
Intended Use / Indications for Use
Medtronic Connector Components with Balance Biosurface are intended for use in the extracorporeal cardiopulmonary perfusion bypass circuit to interconnect tubing and the primary devices of the bypass circuit.
Medtronic Connector Components with Balance™ Biosurface are indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
DTL, DWF
Device Description
Medtronic Comector Components with Balance Biosurface are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect tubing and the primary devices of the bypass circuit. The lumen of the Connector Components with Balance Biosurface consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The Connector Components with Balance Biosurface are comprised of polycarbonate and Balance Biosurface materials and provided in Ytype, straight, reducer and adapter (luer) configurations.
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)
Not Found
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.
Not Found
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
§ 870.4290 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
K 122811
Image /page/0/Picture/1 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" in bold, black letters on the right. The circular symbol contains a stylized image of a person in motion.
510(k) Summary
OCT 1 2 2012
Date Prepared:
Submitter :
September 12, 2012
Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009
Contact Person:
Jacqueline A Hauge Senior Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: 763.514.9967 Fax: . 763.367.8360 Email: jacqueline.a.hauge@medtronic.com
Alternate Contact: Susan Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: 763.514.9839 Fax: 763.367.8360 Email: susan.c.fidler@medtronic.com
Device Name and Classification
Tubing, Connectors and Accessories with Balance® Biosurface Trade Name: Common Name: Cardiopulmonary bypass adapter, tubing, connector, stopcock, manifold or fitting Regulation Number: 21 CFR 870.4290 . DTL and DWF Product Codes: Product Classification: Class II
| Predicate Device | |
|---|---|
| ------------------ | -- |
Tubing, Connectors and Accessories with Balance® Biosurface
1
Image /page/1/Picture/0 description: The image shows the Medtronic logo. On the left is a circular symbol with a figure inside, and on the right is the word "Medtronic" in bold, sans-serif font. The logo is black and white.
Device Description
Medtronic Comector Components with Balance Biosurface are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect tubing and the primary devices of the bypass circuit. The lumen of the Connector Components with Balance Biosurface consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The Connector Components with Balance Biosurface are comprised of polycarbonate and Balance Biosurface materials and provided in Ytype, straight, reducer and adapter (luer) configurations.
Intended Use
Medtronic Comector Components with Balance Biosurface are intended for use in the extracorporeal cardiopulmonary perfusion bypass circuit to interconnect tubing and the primary devices of the bypass circuit.
Comparison to Predicate
When compared to the predicate device (K113845), the Medtronic Connector Components with Balance Biosurface presented in this submission have the same:
- Intended Use
- Technological characteristics
- Operating principle
- Design features .
- Performance
- Biological safety
- Base materials prior to coating
- Coating materials
- Packaging materials and configurations
- Method of sterilization and sterility assurance level
- Shelf life
Conclusion
Medtronic has demonstrated that Connector Components with Balance Biosurface for use in extracorporeal cardiopulmonary bypass perfusion systems (tubing sets/packs) are substantially equivalent to the predicate device based upon design, test results, and indications for use. The fundamental scientific principle, labeling and intended use are unchanged from the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 2 2012
Medtronic, Inc.
c/o Ms. Jacqueline Hauge
Senior Regulatory Affairs Specialist
7611 Northland Dr.
Minneapolis, MN 55428
Re: K122811
Trade/Device Names: Connector Components 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: September 12, 2012 Received: September 13, 2012
Dear Ms. Hauge:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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.
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
3
Page 2 - Ms. Jacqueline Hauge
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 (OS) 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 yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Connector Components with Balance™ Biosurface
Indications For Use:
Medtronic Connector Components with Balance™ Biosurface are indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _
(Division Sign-Off)
Division of Cardiovascular Devices