(324 days)
Not Found
Not Found
No
The summary describes a mechanical system for drug preparation and transfer and contains no mention of AI or ML.
No
The device is used to prepare and administer drugs, not to directly treat a medical condition or disease in a patient.
No
The device, a "Closed Drug Reconstitution and Transfer System," is described for preparing and administering drugs, not for diagnosing conditions or diseases.
No
The intended use describes a "Closed Drug Reconstitution and Transfer System," which inherently implies physical components for handling and transferring drugs. This is not consistent with a software-only device.
Based on the provided information, the SureConnect Closed Drug Reconstitution and Transfer System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a system for preparing and administering drugs for intravenous infusion or injection. This is a process related to drug delivery and patient treatment, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended use clearly points away from diagnostic testing.
- Lack of IVD Characteristics: The provided information does not mention any activities typically associated with IVDs, such as analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided text, the SureConnect Closed Drug Reconstitution and Transfer System falls under the category of a medical device used for drug preparation and administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SureConnect Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare and administer drugs, including cytotoxic drugs, for intravenous infusion or injection.
Product codes
LHI
Device Description
Not Found
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
pharmacists or other healthcare professionals
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and a circular border around the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is written around the border of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jim Morgan Regulatory Affairs Contractor Baxa Corporation 14445 Grasslands Drive Englewood, Colorado 80112-7062
FEB 1 9 2010
Re: K090917
Trade/Device Name: SureConnect® Closed Drug Reconstitution and Transfer System Regulation Number: 21CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: January 18, 2010 Received: January 19, 2010
Dear Mr. Morgan:
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.
1
Page 2- Mr. Morgan
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runover
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 4: INDICATIONS FOR USE
510(k) Number:
Device Name: SureConnect® Closed Drug Reconstitution and Transfer System
Indications for use:
The SureConnect Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare and administer drugs, including cytotoxic drugs, for intravenous infusion or injection.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over the Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF · NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRH, O
Division Sign-Off livision of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K910917
Page 1 of 1
0000016