(262 days)
No
The device description and performance studies focus on the physical components and functional performance of a standard IV administration set, with no mention of AI or ML capabilities.
No
The device is described as an IV administration set for delivering fluids, blood components, or solutions into a patient's vascular system, not for treating a disease or condition itself.
No
This device is for the administration of blood components or solutions into a patient's vascular system, not for diagnosis.
No
The device description clearly outlines physical components like tubing, filters, valves, and clamps, indicating it is a hardware-based medical 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 blood components or solutions into the patient's vascular system. This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The device is described as a disposable device for administering fluids. It contains components like tubing, filters, and valves, which are all related to the physical delivery of fluids.
- No Mention of Diagnostic Function: There is no mention of the device being used to analyze samples, detect substances, or provide diagnostic information about a patient's condition.
- Anatomical Site: The anatomical site is the patient's vascular system, which is where the fluids are being delivered, not where a diagnostic test would typically be performed on a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances to the body, not to analyze substances from the body.
N/A
Intended Use / Indications for Use
Applicable to Product Code 2N3383: For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
Applicable to Product Code 2N3385: For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device. Only for use with Neonates and Pediatrics. Not for use in Trauma situations.
Product codes (comma separated list FDA assigned to the subject device)
BRZ
Device Description
Baxter's IV Administration Sets (Blood Administration Sets) are single use, nonpyrogenic, sterile disposable devices intended for the administration of fluids from a container into the patient's vascular system. They can be used to administer solutions, blood, and blood products to patients. The proposed blood set configuration (Product Code 2N3385) consists of non-DEHP PVC (. The endotoxin limit is 20 EU/device per USP . In addition, routine periodic pre-sterilization bioburden testing is performed for each (sub) category. The sterilization process for the proposed device was established in accordance with ANSVAAMI/ISO 11137-1, "Sterilization of health care products-Radiation-Part 1; Requirements for development, validation and routine control of a sterilization process for medical devices."
Shelf-Life: Baxter has performed aging testing to support a shelf-life claim of 3 (three) years.
Microbial Ingress Testing: Baxter has conducted testing on all potential points of microbial entry into the sterile fluid pathway of the proposed device. The potential microbial entry points consist of the Clearlink Luer Activated Valve (LAV), the male Luer connector site, and the spike interface. Microbial ingress testing was conducted on the Clearlink LAV following section 8 of FDA's Guidance for Industry and Staff, Intravascular Administration Sets Premarket Notification Submissions [510(k)], issued July 11, 2008. The male Luer connector site was tested following Baxter's test method (as previously cleared under K180739) of challenging the connections during simulated clinical use to ensure the absence of microbial ingress to the sterile fluid path. The spike interface was tested following Baxter's test method (as previously cleared under K180739) of challenging the interface during simulated clinical use to ensure the absence of microbial ingress to the sterile fluid path. All test results met their acceptance criteria and support that the proposed device is appropriately designed for its intended use.
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.
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
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November 17, 2022
Baxter Healthcare Corporation Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, Illinois 60073
Re: K220558
Trade/Device Name: Blood Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: BRZ Dated: October 17, 2022 Received: October 21, 2022
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,
David Walloschek
David Wolloscheck, Ph.D. For Joyce M. Whang, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K220558
Device Name
Blood Administration Sets
Indications for Use (Describe)
Applicable to Product Code 2N3383: For the administration of blood components or solutions from a container into the patient's vascular system through a vascular access device.
Applicable to Product Code 2N3385: For the administration of blood components or solutions from a container into the patient's vascular system through a vasular access device. Only for use with Neonates and Pediatios. Not for use in Trauma situations.
| 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 bold, blue font. The font is sans-serif and appears to be italicized. The word is the logo for the healthcare company Baxter International.
K220558 510(k) Summary
November 17, 2022
OWNER:
Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073
CONTACT PERSON:
Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, IL 60073 Telephone: (224) 270 6470 Fax: (224) 270 4119
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Blood Administration Sets Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Common Name: Blood Transfusion Set Regulation Name: Intravascular Administration Sets Regulatory Class: Class II Product Code: BRZ
Image /page/3/Figure/9 description: This image shows a medical device called a Blood Extension Set. The code for the device is 2N3383, and the device is 59 inches (150 cm) long with a volume of 4.7 mL. The image shows the different parts of the device, including a Non-Vented Cap for Female Luer Lock, Female Luer Lock, Notch Clamp, Tube, Male Luer Lock, and Filter Vented Cap for Male Luer Lock.
Table 1. Current Product Line
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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 and slightly italicized. The word is the logo for the healthcare company Baxter International.
Image /page/4/Figure/1 description: The image shows a table with two rows describing medical devices. The first row describes a "Blood Extension Set, 59" (150 cm), Vol. 4.7 mL" with code "2N3383", and it includes a diagram of the device with numbered components, along with a numbered list describing each component. The second row describes an "Integrated Blood Set, 71" (180 cm), Vol 6.3 mL" with code "2N3385", and it also includes a diagram of the device with numbered components, along with a numbered list describing each component.
Table 2. Proposed Product Line
PREDICATE DEVICE:
Table 3. Predicate Device
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Blood Administration | |||
| Sets | Baxter Healthcare | ||
| Corporation | K210335 | ||
| (Model 2N3383) | June 10, 2021 |
REASON FOR SUBMISSION:
The basis for this premarket notification is the addition of another blood set configuration (Product Code 2N3385) to the current product line to provide an additional option to the clinician. The proposed device is a single use, non-pyrogenic, sterile, 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:
Baxter's IV Administration Sets (Blood Administration Sets) are single use, nonpyrogenic, sterile disposable devices intended for the administration of fluids from a container into the patient's vascular system. They can be used to administer solutions, blood, and blood products to patients.
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Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is the primary focus of the image and is positioned horizontally.
The proposed blood set configuration (Product Code 2N3385) consists of non-DEHP PVC ( 14.7 kPa |
| 9 | Blood Filter Tests (Uniform Pore Size Dimensional
Compliance Test) | ISO 1135-5, Clause 6.6 |
| 10 | Blood Filter Tests (Particle Retention Test) | ISO 1135-5, Clause 6.6 |
| 11 | Chamber Squeezing Test | Force required to squeeze ≤ 91 N |
| 12 | ISO Spike Tests (Dimensional Compliance Test) | ISO 8536-4:2013+A1:2013, Section 6.4 |
| 13 | ISO Spike Tests (Spike Secure Connection Test) | ISO 1135-5, Clause 6.4.
No water leakage after spike to container
connection of 5 hours |
| 14 | ISO Spike Tests (Spike Coring test) | ISO 1135-5, Clause 6.4 |
| 15 | ISO Spike Tests (Spike to Blood Bag Traction Test) | ISO 1135-5, Clause 6.4.3 |
Table 5. Performance Data
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Image /page/11/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is slightly italicized, giving the word a sense of movement. The word is the main focus of the image and is set against a white background.
| Line
Item
| Test | Acceptance Criteria |
|-------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 16 | ISO Spike Tests (Spike to Blood Bag Leak Test) | ISO 1135-5, Clause 6.4.4 |
| 17 | Clearlink LAV Tests (Clearlink LAV Leak Test - Post
100 Actuations) | No leakage when subjected to 200kPa for 15
sec after 100 actuations |
| 18 | Particulate Matter Test | USP |
| 19 | Non-DEHP Claim Verification (. The endotoxin limit is 20 EU/device per USP . In addition, routine periodic pre-sterilization bioburden testing is performed for each (sub) category. The sterilization process for the proposed device was established in accordance with ANSVAAMI/ISO 11137-1, "Sterilization of health care products-Radiation-Part 1; Requirements for development, validation and routine control of a sterilization process for medical devices."
Shelf-Life:
Baxter has performed aging testing to support a shelf-life claim of 3 (three) years.
Microbial Ingress Testing:
Baxter has conducted testing on all potential points of microbial entry into the sterile fluid pathway of the proposed device. The potential microbial entry points consist of the Clearlink Luer Activated Valve (LAV), the male Luer connector site, and the spike interface. Microbial ingress testing was conducted on the Clearlink LAV following section 8 of FDA's Guidance for Industry and Staff, Intravascular Administration Sets Premarket Notification Submissions [510(k)], issued July 11, 2008. The male Luer connector site was tested following Baxter's test method (as previously cleared under K180739) of challenging the connections during simulated clinical use to ensure the absence of microbial ingress to the sterile fluid path. The spike interface was tested following Baxter's test method (as previously cleared under K180739) of challenging the
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Image /page/13/Picture/0 description: The image shows the word "Baxter" in a bold, blue, sans-serif font. The letters are slightly slanted to the right, giving the word a dynamic appearance. The color of the text is a vibrant blue, which contrasts well against the white background.
interface during simulated clinical use to ensure the absence of microbial ingress to the sterile fluid path. All test results met their acceptance criteria and support that the proposed device is appropriately designed for its intended use.
CONCLUSION:
The differences between the predicate and the subject device do not raise any new or different questions of safety and effectiveness. The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device that is legally marketed for the same intended use.