(126 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of an IV extension set, with no mention of AI or ML.
No
The device is described as an IV Extension Set, used for the administration of fluids into a patient's vascular system. It is an accessory for fluid delivery, not a device that directly treats or prevents a disease or condition.
No
The device is an IV Extension Set, used for administering fluids into a patient's vascular system. Its intended use and description focus on fluid delivery, not on collecting or analyzing data to diagnose a medical condition.
No
The device description clearly outlines physical components (tubing, clamp, Luers, caps) and the performance studies focus on bench tests and biocompatibility of these physical materials and connections, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the administration of fluids from a container into a patient's vascular system through a vascular access device." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description details an IV Extension Set used for fluid administration. It focuses on the physical components and their function in delivering fluids, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information.
- Predicate Device: The predicate device (K192366) is an "Intravascular Extension Sets and Accessories," which falls under the category of devices used for fluid administration, not diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for the delivery of fluids into the body.
N/A
Intended Use / Indications for Use
For the administration of fluids from a container into a patient's vascular system through a vascular access device.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The proposed device consists of an IV Extension Set (Light Resistant Extension Set). It is a single use disposable, non-pyrogenic, sterile device intended for the administration of fluids from a container into the patient's vascular system. This IV extension set can be directly attached to a syringe but also used as an extension set to a primary set that is connected to a syringe (primarily to add length). The Light Resistant Extension Set consists of non-DEHP (
§ 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.
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June 18, 2021
Baxter Healthcare Corporation Meaghan Bonn Senior Specialist Regulatory Affairs 25212 West Illinois Route 120 Round Lake, Illinois 60073
Re: K210430
Trade/Device Name: Intravascular Extension Set (Light Resistant Extension Set) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 11, 2021 Received: May 21, 2021
Dear Meaghan Bonn:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan M. Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Intravascular (IV) Extension Set (Light Resistant Extension Set)
Indications for Use (Describe)
For the administration of fluids from a container into a patient's vascular system through a vascular access device.
Type of Use (Select one or both, as applicable)
× | Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "Baxter" in a blue, sans-serif font. Below the word "Baxter" is the alphanumeric code "K210430" in a smaller, serif font. The code is left-aligned and positioned directly beneath the word "Baxter".
Section 5. 510(k) Summarv
February 10, 2021
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Meaghan Bonn Senior Specialist, Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, IL 60073 Telephone: (224) 270 6470
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Intravascular Extension Set (Light Resistant Extension Set) Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Set, Administration
Regulatory Class: Class II Product Code: FPA
Image /page/3/Figure/10 description: The image shows a medical device labeled as 'Light Resistant Micro-Volume Extension Set, 59" (150 cm), Vol 0.47 mL' with the code 2N3363. The device consists of a red tube with several components labeled with numbers 1 through 6. These components are identified as 'Non-Vented Cap for Female Luer', 'Female Luer Lock', 'Notch Clamp', 'Light Resistant Microbore Tubing', 'Male Luer Lock', and 'Filter Vented Cap for Male Luer'.
Table 1. Proposed IV Extension Set Configuration
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Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly slanted to the right, giving it a dynamic appearance. The background is plain white.
PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Intravascular Extension | |||
| Sets and Accessories | Baxter Healthcare | ||
| Corporation | K192366 (Model 2N3380) | July 20, 2020 |
REASON FOR SUBMISSION:
The basis for this premarket notification is the intent to market an Intravascular (IV) Extension Set (Light Resistant Extension Set). The proposed device is a single use disposable device, intended for the administration of fluids from a container into the patient's vascular system through a vascular access device.
DESCRIPTION OF THE DEVICE:
The proposed device consists of an IV Extension Set (Light Resistant Extension Set). It is a single use disposable, non-pyrogenic, sterile device intended for the administration of fluids from a container into the patient's vascular system. This IV extension set can be directly attached to a syringe but also used as an extension set to a primary set that is connected to a syringe (primarily to add length). See Figure 1 and Figure 2 for the clinical use set ups for the proposed device.
The Light Resistant Extension Set consists of non-DEHP (