(205 days)
No
The device description and performance studies focus on the physical components and biocompatibility of the extension sets and accessories, with no mention of AI or ML capabilities.
No
Explanation: This device is for administrating fluids, not for treating a disease or condition. It aids in the delivery of substances for various purposes, which may include therapeutic agents, but the device itself is not therapeutic.
No
The device is described as administering fluids, not collecting information for diagnosis.
No
The device description clearly outlines physical components like tubing, clamps, and valves, indicating it is a hardware device for fluid administration.
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 the 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 or monitor a condition.
- Device Description: The components listed (tubing, clamps, Luers, valves, filter) are all consistent with devices used for fluid administration, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing or monitoring a disease or condition in vitro (outside the living organism).
The device described is a medical device used for fluid administration, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
Product codes
FPA, FPB
Device Description
Micro-Volume Extension Set (79" (200cm))
Mini-Volume Extension Set (59" (150cm))
Mini-Volume Extension Set (79" (200cm))
Extension Set, Micro-Volume with 0.2µm filter (79" (200cm))
Mini-Volume Extension Set (118" (300cm))
Micro-Volume Extension Set (59" (150 cm))
Anti-Siphon Valve
Back Check Valve
Air-Eliminating 1.2 µm Solution Filter
Micro-Volume Extension Set (59" (150 cm)) (with clamp)
Micro-Volume Extension Set with 0.2µm filter (59" (150cm))
Micro-Volume Catheter Extension Set with 0.2µm filter (10" (25cm))
Polyethylene (PE) Lined Micro-Volume Extension Set (59" (150 cm))
Polyethylene (PE) Lined Micro-Volume Extension Set (79" (200 cm))
Polyethylene (PE) Lined Mini-Volume Extension Set (118" (300 cm))
The proposed devices are single use disposable devices intended for the administration of fluids from a container to the patient's vascular system. The extension sets consist of a combination of the following components: PVC or PE lined PVC tubing, a clamp, female Luer with non-vented cap, male Luer with filter vented cap. The accessories consist of an anti-siphon valve, back check valve, and 1.2 µm Filter. The accessories are used in combination with IV sets to administer solutions directly from a container to a patient's vascular system.
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
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 following testing was performed in support of the proposed devices: - Biocompatibility testing. Clinical testing is not applicable for this submission. The results of biocompatibility testing from these studies support the removal of caution statement on Direction here related to body weight, which is the basis for this submission.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2025
Baxter Healthcare Corporation Bernhard Bartmer Sr. Regulatory Affairs Specialist 25212 W. IL Route 120 Round Lake, Illinois 60073
Re: K242339
Trade/Device Name: Intravascular Extension Sets and Accessories Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA, FPB Dated: January 29, 2025 Received: January 30, 2025
Dear Bernhard Bartmer:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant 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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Indications for Use
510(k) Number (if known) K242339
Device Name
Intravascular Extension Sets and Accessories
Indications for Use (Describe)
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: | 510(k) Summary | Prepared on: 2025-02-28 |
|---|---|---|
| ----------- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Baxter Healthcare Corporation |
| Applicant Address | 25212 W. IL Route 120 Illinois Round Lake IL 60073 United States |
| Applicant Contact Telephone | 224-270-2054 |
| Applicant Contact | Mr. Bernhard Bartmer |
| Applicant Contact Email | bernhard_bartmer@baxter.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| Device Trade Name | Intravascular Extension Sets and Accessories |
| Common Name | Intravascular administration set |
| Classification Name | Set, Administration, Intravascular |
| Regulation Number | 880.5440 |
| Product Code(s) | FPA, FPB |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K192366 | Intravascular Extension Sets and Accessories | FPA, FPB |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
Micro-Volume Extension Set (79" (200cm))
Mini-Volume Extension Set (59" (150cm))
Mini-Volume Extension Set (79" (200cm))
Extension Set, Micro-Volume with 0.2µm filter (79" (200cm))
Mini-Volume Extension Set (118" (300cm))
Micro-Volume Extension Set (59" (150 cm))
Anti-Siphon Valve
Back Check Valve
Air-Eliminating 1.2 µm Solution Filter
Micro-Volume Extension Set (59" (150 cm)) (with clamp)
Micro-Volume Extension Set with 0.2µm filter (59" (150cm))
Micro-Volume Catheter Extension Set with 0.2µm filter (10" (25cm))
Polyethylene (PE) Lined Micro-Volume Extension Set (59" (150 cm))
Polyethylene (PE) Lined Micro-Volume Extension Set (79" (200 cm))
Polyethylene (PE) Lined Mini-Volume Extension Set (118" (300 cm))
The proposed devices are single use disposable devices intended for the administration of fluids from a container to the patient's
vascular system. The extension sets consist of a combination of the following components: PVC or PE lined PVC tubing, a clamp, female
Luer with non-vented cap, male Luer with filter vented cap. The accessories consist of an anti-siphon valve, back check valve, and 1.2 µm
Filter. The accessories are used in combination with IV sets to administer solutions directly from a container to a patient's vascular
system.
5
Intended Use/Indications for Use
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
Indications for Use Comparison
The indications for use are the same as the predicate devices.
Technological Comparison
The proposed devices are substantially equivalent to the predicate devices previously cleared under 510(k) Premarket Notification K192366 on July 20, 2020. The proposed devices have technical characteristics as the predicate devices. There are no changes in design, material, sterility, or chemical compared to the predicate devices. The only change is the removal of a caution statement on the Direction Insert related to body weight.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following testing was performed in support of the proposed devices: - Biocompatibility testing
Clinical testing is not applicable for this submission.
The results of biocompatibility testing from these studies support the removal of caution statement on Direction here related to body weight, which is the basis for this submission.
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)