(125 days)
Not Found
No
The device description and performance studies focus solely on the physical and functional characteristics of a standard IV administration set. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
The device facilitates the administration of fluids into the vascular system, which is a supportive function rather than a direct therapeutic intervention. It does not treat or cure a disease or condition itself.
No
This device is an IV administration set designed for administering fluids like blood or solutions into a patient's vascular system. Its purpose is therapeutic/administrative, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (tubing, clamps, Luer locks, caps, filter) and the performance studies focus on the physical and functional characteristics of these components (tensile strength, leak tests, flow rate, biocompatibility, sterility, aging). There is no mention of software as part of the device or its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of substances (blood, blood components, solutions) into the patient's vascular system. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details the physical components of an administration set, designed for delivering fluids. It doesn't mention any components or functions related to analyzing samples or providing diagnostic information.
- Lack of Diagnostic Function: The device's purpose is to facilitate the delivery of substances, not to test or analyze samples from the patient to diagnose a condition or provide information about their health status.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device (luer connections, tensile strength, flow rate, biocompatibility, sterility, shelf-life). They do not involve evaluating the device's ability to accurately detect or measure substances in a sample.
- Key Metrics: The document explicitly states "Not Found" for key metrics like Sensitivity, Specificity, PPV, NPV, etc., which are standard metrics for evaluating the performance of diagnostic devices.
In Vitro Diagnostic (IVD) devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.
Product codes (comma separated list FDA assigned to the subject device)
BRZ
Device Description
The proposed device is an IV Administration Set (Blood Administration Set). It is a single use, non-pyrogenic, sterile disposable device intended for the administration of fluids from a container into the patient's vascular system. It can be used to administer solutions, blood, blood products to patients of all ages ranges - neonatal, pediatric, and adult.
The proposed set consists of non-DEHP PVC (. The sterilization process was established in accordance with ANSI/AAMI/ISO 11137-1.
Aging testing was performed to support a shelf-life claim of 3 (three) years.
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.
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.
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June 10, 2021
Baxter Healthcare Corporation James Vangeisen Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, Illinois 60073
Re: K210335
Trade/Device Name: Blood Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: BRZ Dated: May 4, 2021 Received: May 11, 2021
Dear James Vangeisen:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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.
Payal Patel Acting 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) K210335
Device Name Blood Administration Set
Indications for Use (Describe)
For the administration of blood, blood components or solutions from a container into the 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 bold, blue font. The font is slightly italicized, giving the word a sense of movement. The word is the logo for the company Baxter International, a global healthcare company.
510(k) Summary
K210335
June 10, 2021
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
James Vangeisen Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, IL 60073 Telephone: (224) 270 3308 Fax: (224) 270 4119
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Blood Administration Set Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: BRZ
| Code # | 2N3383 |
|---|---|
| Device Description | Blood Extension Set, 59" (150 cm), Vol. 4.7 mL |
| 1. | Non-Vented Cap for Female Luer Lock |
| 2. | Female Luer Lock |
| 3. | Notch Clamp |
| 4. | Tube |
| 5. | Male Luer Lock |
| 6. | Filter Vented Cap for Male Luer Lock |
Table 1. Proposed Set Configuration
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PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Blood Administration | |||
| Sets | Baxter Healthcare | ||
| Corporation | K993120 | November 17, 1999 |
Table 2. Predicate Device
REASON FOR SUBMISSION:
The basis for this premarket notification is the intent to market an Intravascular (IV) Administration Set (Blood Administration Set). The proposed device in this submission 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 is an IV Administration Set (Blood Administration Set). It is a single use, non-pyrogenic, sterile disposable device intended for the administration of fluids from a container into the patient's vascular system. It can be used to administer solutions, blood, blood products to patients of all ages ranges - neonatal, pediatric, and adult.
The proposed set consists of non-DEHP PVC ( |
| Flow Rate Testing | ISO 1135-4:2015, Section 5.9 |
| ISO 1135-4 Blood Component Compatibility Test | ISO 1135-4, Clause 7.6 and 7.7 |
Table 4. Performance Data
All tests met the acceptance criteria.
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Biocompatibility:
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged duration, external communicating device, indirect blood path and FDA-2013-D-0350 Guidance for Industry and FDA Staff, "Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,"" as recommended in the Intravascular Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]." Biocompatibility assessments were conducted on a worst case/representative final, finished device for all fluid path materials of the proposed device. The following tests were conducted as part of the biocompatibility assessment for the proposed device:
- . Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10
- Intracutaneous (Irritation) Reactivity ISO 10993-10
- . Acute Systemic Toxicity ISO 10993-11
- . 30 Day Systemic Repeat Dose Toxicity Study ISO 10993-11
- Material Mediated Pyrogen ISO 10993-11
- Hemocompatibility ISO 10993-4
Based upon the results, the data supports an ISO 10993-1 categorization of external communicating device, indirect blood path, prolonged contact duration. The proposed device is biocompatible and appropriate for its intended use.
Sterility:
The proposed device is sterilized with gamma radiation. The product is in the bioburden (sub) category "General Sets Labeled Sterile". The Minimum Sterilizing Dose (MSD) required to provide a 106 Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility as described in ANSI/AAMI/ISO 11137-2, "Sterilization of health care products – Radiation-Part 2: Establishing the sterilization dose." The dose setting method used includes, but is not limited to, Method 1 or VDmax. Generally, the MSDs are between 14.2 - 25.0 kGy. The continued validity of the MSD for this (sub) category is confirmed via periodic dose audit studies. Bacterial endotoxins tests were conducted in conformance to USP . 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
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device was established in accordance with ANSI/AAMI/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.
CONCLUSION:
The non-clinical data demonstrate that the subject device is substantially equivalent and performed comparably to the predicate device that is legally marketed for the same intended use.