(28 days)
Not Found
No
The summary describes a standard IV administration set and does not mention any AI or ML components or functionalities.
No
The device delivers fluids and drugs into the vascular system but does not perform a therapeutic function itself. Its purpose is for administration, not treatment.
No
Explanation: The device is described as an I.V. Administration Set used to deliver fluid and drugs into the vascular system, which is a therapeutic function, not a diagnostic one. It doesn't mention any capability to diagnose conditions or process diagnostic information.
No
The device description clearly states it is a "single-use, sterile device used for the administration of solutions and fully soluble drugs into the vascular system of a patient," indicating it is a physical hardware device (an I.V. administration set).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a pathway to deliver fluid into the vascular system." This describes a device used for administering substances into the body, not for testing samples from the body.
- Device Description: The description reinforces this by stating it's used for "administration of solutions and fully soluble drugs into the vascular system."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for delivery of fluids.
N/A
Intended Use / Indications for Use
The SELEC-3 I.V. Administration Set is used to provide a pathway to deliver fluid into the vascular system. This product is targeted for use by nurses and paramedics in pre-hospital, emergency room and field settings.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Biomedix SELEC-3 I.V. Administration Set is a single- use, sterile device used for the administration of solutions and fully soluble drugs into the vascular system of a patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nurses and paramedics in pre-hospital, emergency room and field settings.
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)
The SELEC-3 I.V. Administration Set has met Biomedix testing and acceptance criteria related to flow rate verification, leakage, microbial ingress, and pull force testing.
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.
SELEC-3 I.V Administration Set (K925645)
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
§ 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other. The profiles are stylized and appear to be connected, forming a single, unified shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2014
Biomedix, Inc. Ms. Myra J. Bender President 3895 West Vernal Pike Bloomington, IN 47404
Re: K142097
Trade/Device Name: Biomedix SELEC-3 I.V. Administration Set Regulation Number: 21 CFR 888.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 31, 2014 Received: August 1, 2014
Dear Ms. Bender:
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
1
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 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/Resourcesfor You/Industry/default.htm. 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 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 yours.
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Biomedix SELEC-3 I.V. Administration Set
Indications for Use (Describe)
The SELEC-3 I.V. Administration Set is used to provide a pathway to deliver fluid into the vascular system. This product is targeted for use by nurses and paramedics in pre-hospital, emergency room and field settings.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for BIOMEDIX, Inc. The text is in a bold, sans-serif font with horizontal lines running through each letter. The word "BIOMEDIX" is stacked on top of the word "quality medical products".
quality medical products
SPECIAL 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter/Contact Information | |
|---|---|
| Name | Biomedix, Inc. |
| Address | 3895 West Vernal Pike |
| Bloomington, IN 47404 | |
| Phone number | (812) 355-7000 |
| Fax number | (812) 355-4507 |
| Establishment Registration | |
| Number | 1833470 |
| Name of contact person | Myra J. Bender |
| Date prepared | July 31, 2014 |
| Name of device | |
| Trade or proprietary | |
| name | Biomedix SELEC-3 I.V. Administration Set |
| Common or usual name | Intravascular Administration Set |
| Classification name / Regulation | |
| number | Set, Administration, Intravascular (21 CFR § 888.5440) |
| Classification panel | General Hospital |
| Product Code(s) | FPA |
| Legally marketed device(s) to | |
| which equivalence is claimed | SELEC-3 I.V Administration Set (K925645) |
| Biomedix, Inc. | |
| Reason for 510(k) submission | Device modification |
| Device description | The Biomedix SELEC-3 I.V. Administration Set is a single- |
| use, sterile device used for the administration of solutions | |
| and fully soluble drugs into the vascular system of a patient. | |
| Indications for use | The SELEC-3 I.V. Administration Set is used to provide a |
| pathway to deliver fluid into the body via the vascular | |
| system. This product is targeted for use by nurses and | |
| paramedics in pre-hospital, emergency room and field | |
| settings. |
4
Summary of Technological Characteristics
The SELEC-3 I.V. Administration Set is constructed of biocompatible plastics. It incorporates a Selectable Drop Chamber that allows the user to choose between a flow rate of 10, 15, or 60 drops/cc at any time. Also included are Y-sites that allow the user to add medication. The intended use, basic design, and function are identical to the predicate device.
Testing Summary
The SELEC-3 I.V. Administration Set has met Biomedix testing and acceptance criteria related to flow rate verification, leakage, microbial ingress, and pull force testing.
Biocompatibility
Biocompatibility has been assessed in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. The SELEC-3 I.V. Administration Set has been categorized as an externally communicating device, indirect blood path, prolonged duration. Based on testing applicable to this categorization, biocompatibility has been demonstrated.
Sterility
SELEC-3 I.V. Administration Sets are provided as sterile, single use devices that are individually packaged. The device is gamma sterilized through a validated process with the dose set in conformance with ANSI/AAMI/ISO 11137-2: 2012, "Sterilization of health care products-Radiation- Part 2: Establishing the Sterilization Dose," Method-VDmax25.
Bacterial Endotoxins
The SELEC-3 I.V. Administration Set is monitored for bacterial endotoxins.
Conclusion
The SELEC-3 I.V. Administration Set met all established acceptance criteria for design verification testing. Testing demonstrated that the device is safe and effective when used as intended.