(150 days)
No
The description focuses on the physical components and intended use of standard intravenous administration sets, with no mention of AI or ML capabilities.
No
The device is used for fluid administration into the vascular system, not for treating a disease or condition.
No
The device is described as an Intravascular Administration Set, intended for the administration of fluids into a patient's vascular system. Its components and intended use focus on dispensing fluids, not on identifying a medical condition or disease.
No
The device description explicitly lists numerous physical components (spike tip protector, tubing, clamps, valves, etc.) and describes bench tests and biocompatibility assessments, indicating it is a hardware-based medical device.
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 in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body).
- Device Description: The description details components of an administration set used for delivering fluids directly to a patient's vascular system. This aligns with an in vivo application.
- Anatomical Site: The anatomical site is the "patient's vascular system," which is an in vivo location.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on testing samples outside the body.
Therefore, this device is an intravascular administration set, which is a medical device used for therapeutic or supportive purposes in vivo, not for in vitro diagnostic testing.
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 (comma separated list FDA assigned to the subject device)
FMG
Device Description
The proposed devices consist of Intravascular Administration Sets. They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.
The proposed devices consist of a spike tip protector, non-vented spike, drip chamber, tubing, check valve, slide clamp, regulating roller clamp, Clearlink Luer activated valve (LAV), Interlink injection site, 3 Port Manifold, Stopcock, female Luer, two-piece male Luer lock and male Luer cap. The proposed devices are used to administer solution directly from a container to a patient vascular system. These sets can be used with or without a Baxter infusion pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following bench tests (Table 3) were conducted for the Intravascular Administration Sets with Stopcock and Manifold and were found to be in conformance with the following FDA recognized standards:
- ISO 80369-7 Luer Tests on male Luer Lock Connector "Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications"
- ISO 594-1 "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements"
- ISO 594-2 "Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings"
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices 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," All tests were conducted on final, finished device. The biocompatibility tests that were conducted are: Cytotoxicity, Sensitization, Intracutaneous (Irritation) Reactivity, Acute Systemic Toxicity, 30 Day Systemic Repeat Dose Toxicity Study, Material Mediated Pyrogen, Hemolysis.
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP Acceptance criteria.
The proposed devices are sterilized with gamma radiation. The Minimum Sterilizing Dose (MSD) required to provide a 10° Sterility Assurance Level (SAL) for these (sub) categories 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 14.3 - 22.4 kGy.
Baxter has performed aging testing to support a shelf-life claim of 2 (two) years.
Baxter has conducted testing on all potential points of microbial entry into the sterile fluid pathway of the proposed devices subject to this premarket notification. The spike, injection sites and Luer Connector Sites were tested following Baxter's testing strategy (as previously cleared under K203609 (cleared on Sept 30, 2021)) of challenging the connections during simulated clinical use to ensure the absence of microbial ingress into the sterile fluid path. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their 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.
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Image /page/0/Picture/0 description: The image shows 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 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.
March 10, 2023
Baxter Healthcare Corporation Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, Illinois 60073
Re: K223175
Trade/Device Name: Intravascular Administration Sets with Stopcock and Manifold Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FMG Dated: January 31, 2023 Received: February 9, 2023
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,
Danil Walloschek
David Wolloscheck, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K223175
Device Name
Intravascular Administration Sets with Stopcock and Manifold
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K223175- 510(k) Summary
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, IL 60073 Telephone: (847) 217 6197 Fax: (224) 270 4119
DATE PREPARED: March 10, 2023
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Intravascular Administration Sets with Stopcock and Manifold Common/Usual Name: Stopcock I.V. Set Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Set, Administration, Intravascular Regulatory Class: Class II Product Code: FMG
PREDICATE DEVICE:
Table 1. Predicate Device
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Stopcock and I.V. | |||
| Solution Administration | |||
| Sets with Stopcocks | Baxter Healthcare | ||
| Corporation | K130245 (Codes: | ||
| 2C6607 and 2C6255) | March 1, 2013 |
REASON FOR SUBMISSION:
The basis for this premarket notification is a change which involves the inclusion of an expiry date on all packaging configuration of the proposed devices and update to the two
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piece luer to be dimensionally compliant to ISO80369-7. Additionally, updates are being made to the product labels, including a minor rewording of the indications for use, an update to the pump compatibility statement and implementation of other clarifying information to comply with Baxter's labeling standards. These modifications do not impact the intended use or the fundamental scientific technology of the devices.
DESCRIPTION OF THE DEVICE:
The proposed devices consist of Intravascular Administration Sets. They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.
The proposed devices consist of a spike tip protector, non-vented spike, drip chamber, tubing, check valve, slide clamp, regulating roller clamp, Clearlink Luer activated valve (LAV), Interlink injection site, 3 Port Manifold, Stopcock, female Luer, two-piece male Luer lock and male Luer cap. The proposed devices are used to administer solution directly from a container to a patient vascular system. These sets can be used with or without a Baxter infusion pump.
These sets were previously cleared under 510(k) premarket notification K932512 on Feb 22, 1994. The devices covered in this submission are substantially equivalent to the predicate devices, previously cleared under 510(k) premarket notification K130245 on March 1, 2013. The intended use and function of the proposed devices are equivalent to the predicate devices.
INDICATIONS FOR USE:
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed devices are substantially equivalent to the predicate devices K130245 (Codes 2C6607 and 2C6255), previously cleared under 510(k) premarket notification on March 1, 2013. The intended use and function of the proposed devices are equivalent to the predicate devices.
Table 2 is a device comparison table outlining the differences between the predicate and proposed devices.
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| Features | Predicate Devices
Stopcock and I.V.
Solution Administration
Sets with Stopcocks.
K130245
(Codes: 2C6607 and
2C6255) | Proposed Devices
Intravascular
Administration Set
with Manifold and
Stopcock
K223175 | Assessment of Differences |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indication for
Use | To administer fluids
from a container into the
patient's vascular system
through a vascular access
device. | For the administration of
fluids from a container
into the patient's
vascular system through
a vascular access device. | Similar - See Comment # 1 |
| Regulation
Number | 21 CFR 880.5440 | Same | N/A |
| Product Code | FMG | Same | N/A |
| Sterility | Sterile; Gamma
Irradiation | Same | N/A |
| Sterility
Assurance
Level | 10-6 | Same | N/A |
| Non-
Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Length | 41" (103 cm) - 123" (316
cm) | 40" (101 cm) - 130" (333
cm) | Different- See Comment # 2 |
| Priming
Volume | 6.2 mL - 19.8 mL | 6.2 mL - 21.8 mL | Different - See Comment # 3 |
| Inner
Diameter | 0.102" (0.26 cm) -
0.111" (0.28cm) | Same | N/A |
| Outer
Diameter | 0.133" (0.34 cm) - 0.152"
(0.39 cm) | Same | N/A |
| Fluid path Components/Materials | | | |
| Spike & Drip
Chamber
Assembly | Acrylonitrile butadiene
styrene (Spike) | Same (Spike) | N/A |
| | Polyvinyl Chloride
(PVC) (Drip Chamber) | Same (Drip Chamber) | N/A |
| Tubing | Polyvinyl chloride (PVC) | Same | N/A |
| Check Valve | Polymethyl methacrylate
(acrylic) (PMMA)
(Inlet/Outlet) | Same | N/A |
| | Silicone rubber (SI)
(Disk) | | |
| | Copolyester
(Housing) | | |
| Interlink
Injection Site | Silicone lubricant,
(Lubricant) | Same | N/A |
| | Natural synthetic
polyisoprene rubber,
(Septum) | | |
| | Polycarbonate
(Inlet/Outlet) | | |
| Clearlink | Silicone (Gland) | Same | N/A |
| | Polycarbonate (Center
Post) | | |
| | Polysulfone (Housing) | | |
| 4-way
stopcock
(Large Bore) | Polyethylene (Handle) | Same | N/A |
| | Polycarbonate (Luer
Lock Nut) | | |
| | N/A | Polyester (Housing) | Different - See Comment #4 |
| 3-Port
Manifold | N/A | Silicone rubber (SI)
(Disk) | |
| | N/A | Acrylonitrile butadiene
styrene (Collar) | |
| Male Luer | Acrylonitrile butadiene
styrene (ABS)
(Luer Body) | Same | N/A |
| Female Luer | Polyester (PES) | Same | N/A |
Table 2. Device Comparison
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Discussion of difirences in technological characteristics.
Comment# 1- Minor rewording of the Indications for Use statement has been made to better align with 21 CFR 880.5440 and for the purpose of streamlining the information provided to the user. This minor modification does not alter the disease or condition the device will diagnose, treat, prevent, cure/mitigate, or the patient population for which the
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device is intended to be used. In addition, the minor rewording does not reflect a different anatomical site from which a disease state or population may be inferred.
Comment # 2: The proposed devices offer sets with different lengths and injection sites. allowing the clinician to select the appropriate one for the administration of the intended therapy. Design control activities have been conducted and have confirmed that the different technological characteristics of the proposed devices do not raise different questions of safety and effectiveness.
Comment # 3: The proposed devices offer sets with different lengths and injection sites, allowing the clinician to select the appropriate one for the administration of the intended therapy. Design control activities have been conducted and have confirmed that the different technological characteristics of the proposed devices do not raise different questions of safety and effectiveness.
Comment # 4: This material has been used in another Baxter cleared device (cleared in K932512 (22/02/1994)) with the same/similar intended use and with the same type and duration of contact. Design control activities have been conducted and confirmed that there is no impact to safety or effectiveness for this application.
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.
Performance Data:
The following bench tests (Table 3) were conducted for the Intravascular Administration Sets with Stopcock and Manifold and were found to be in conformance with the following FDA recognized standards:
| Test |
|---|
| ISO 80369-7 Luer Tests on male Luer Lock Connector |
| "Small-bore connectors for liquids and gases in healthcare applications - Part |
| 7: Connectors for intravascular or hypodermic applications" |
| ISO 594-1 |
| "Conical fittings with a 6% (Luer) taper for syringes, needles and certain |
| other medical equipment - Part 1: General requirements" |
| ISO 594-2 |
Table 3. Performance Data
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| Test |
|---|
| "Conical fittings with a 6% (Luer) taper for syringes, needles and certain |
| other medical equipment - Part 2: Lock fittings" |
Biocompatibility:
In accordance with ISO 10993-1, the IV Administration Set with stopcock and manifold is classified as: external communicating device, indirect blood path, prolonged contact duration. The proposed devices are biocompatible and appropriate for its intended use.
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices 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," All tests were conducted on final, finished device. The biocompatibility tests that were conducted are:
- Cytotoxicity
- Sensitization
- Intracutaneous (Irritation) Reactivity
- Acute Systemic Toxicity
- 30 Day Systemic Repeat Dose Toxicity Study
- Material Mediated Pyrogen
- Hemolysis
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP Acceptance criteria.
Sterility:
The proposed devices are sterilized with gamma radiation. The products are in the bioburden (sub) category "General Sets Labeled Sterile" or "General Small Devices Labeled Sterile". The Minimum Sterilizing Dose (MSD) required to provide a 10° Sterility Assurance Level (SAL) for these (sub) categories 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 14.3 - 22.4 kGy. The continued validity of the MSD for each (sub)
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category is confirmed via periodic dose audit studies. In addition, routine periodic presterilization bioburden testing is performed for each (sub) category.
Shelf Life:
Baxter has performed aging testing to support a shelf-life claim of 2 (two) years.
Microbial Ingress Testing:
Baxter has conducted testing on all potential points of microbial entry into the sterile fluid pathway of the proposed devices subject to this premarket notification. The spike, injection sites and Luer Connector Sites were tested following Baxter's testing strategy (as previously cleared under K203609 (cleared on Sept 30, 2021)) of challenging the connections during simulated clinical use to ensure the absence of microbial ingress into the sterile fluid path. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.
CONCLUSION:
The non-clinical data demonstrate that the subject devices are substantially equivalent and perform comparably to the predicate devices that are legally marketed for the same intended use.