(440 days)
No
The device description and performance studies focus on the mechanical and material properties of disposable PCA syringe sets, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a PCA syringe set used for the administration of fluids (including analgesics) into the patient's vascular system. It is a delivery system for medication, not a therapeutic agent or device itself that performs therapy.
No
The device is a PCA syringe set intended for the administration of fluids and analgesics, not for diagnostic purposes. Its description and performance studies focus on fluid delivery and safety, not on identifying diseases or conditions.
No
The device description explicitly lists physical components like tubing, valves, clamps, and connectors, and the performance studies focus on bench tests of these physical attributes and biocompatibility. There is no mention of software as a component or function of the device.
No, 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". This describes a device used on the patient for treatment or delivery, not a device used to test samples from the patient to diagnose a condition.
- Device Description: The description details components like tubing, luers, valves, and clamps, all of which are consistent with a device used for fluid delivery into the body. There is no mention of reagents, samples (like blood, urine, etc.), or analysis of biological specimens, which are hallmarks of IVD devices.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device (leak tests, tensile strength, flow, etc.), biocompatibility, sterility, and shelf-life. These are relevant to a device that interacts directly with the patient's body, not a device that analyzes samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information, all of which are key characteristics of IVD devices.
This device is clearly intended for therapeutic or supportive purposes (administering fluids/analgesics), not for diagnosing a condition.
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. For use in adult populations only.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The proposed devices are patient controlled analgesia (PCA) syringe sets. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular access device. They are non-pyrogenic, sterile devices that can be directly attached to a syringe.
The PCA syringe sets consist of non-DEHP PVC tubing/bushing, female luer cap, antisiphon valve with female luer, on-off clamp(s), male luer lock, male luer cap, back check valve with female luer (2P3331 and 2P3332 only), and y-connector (2P3331 and 2P3332 only). They are used to administer analgesics from a syringe to the patient IV access device (2P3331 and 2P3332 only) or from a syringe to a primary administration set (2P3333 only); and are also used to administer fluids from a container at the y-type connector (2P3331 and 2P3332 only).
The anti-siphon valve and back check valve components add specific functionalities to facilitate the administration of fluid to the patient's vascular device, as described below:
- Anti-siphon valve: reduces the risk of any inadvertent free flow of solution to the . patient. The higher opening pressure does not allow administration of flow into the patient's vascular access device, unless the stipulated pressure is applied. Another safety feature is that the valve does not allow any backflow. This prevention of backflow is achieved through the valve's ability to withstand a counterflow pressure.
- Back check valve: does not allow any backflow. This prevention of backflow is . achieved through the valve's ability to withstand a counterflow pressure.
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
adult populations only.
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 were conducted to evaluate the functional performance of the proposed devices:
- ISO 80369-7 Tests on Male Luer Lock Connector
- ISO 80369-7 Tests on Female Luer Lock Connector
- Tensile Strength Test
- Leak Test
- Counter Flow Test
- Blocking Performance Test
- Opening Pressure Test (Back Check Valve and Anti-Siphon Valve)
- Particulate Matter Test
- Clamp Activation Force Test
- Clamp Shut-Off Test
- Non-DEHP Claim Verification
All tests met the acceptance criteria.
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged contact duration, external communicating device, indirect blood path, and FDA-2013-D-0350 Guidance for Industry & FDA Staff, Use of ISO 10993-1, "Biological evaluation and medical devices - Part 1: Evaluation and testing within a risk management process, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing', as recommended in the Intravascular Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]". Biocompatibility assessments include the following assays:
- Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10
- Intracutaneous (Irritation) Reactivity ISO 10993-10
- Systemic Toxicity (acute and repeat dose) ISO 10993-11
- Material Mediated Pyrogen ISO 10993-11
- Genotoxicity ISO 10993-3
- Hemolysis ISO 10993-4
Based upon the results the device met the designated ISO 10993-1 categorization and is biocompatible and appropriate for the intended use.
The device is sterilized with gamma radiation. The Minimum Sterilizing Dose (MSD) required to provide a 10^-6 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." Bacterial endotoxins tests were conducted in conformance to USP . The endotoxin limit is 20 EU/device per USP . Routine periodic pre-sterilization bioburden testing is performed. The sterilization process for the proposed devices was established in accordance with ANSI/AAMI/ISO 11137-1.
Baxter has performed aging testing to support a shelf-life claim of 3 (three) years.
Baxter has conducted testing on all the potential points of microbial entry into the sterile fluid pathway of the proposed devices. The potential microbial entry points consist of male and female Luer connector sites. The Luer connector sites were tested following Baxter's testing strategy (as previously cleared under K180739 (cleared on May 28, 2019)) of challenging the connections 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 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.
October 3, 2022
Baxter Healthcare Corporation Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, Illinois 60073
Re: K212262
Trade/Device Name: PCA Syringe Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: September 1, 2022 Received: September 2, 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 Wolloscheck, Ph.D. For Payal Patel 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) K212262
Device Name PCA Syringe Sets
Indications for Use (Describe)
For the administration of fluids from a container into the patient's vascular system through a vascular access device. For use in adult populations only.
| 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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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.
K212262 510(k) Summary
DATE:
October 3, 2022
OWNER:
Baxter Healthcare Corporation 25212 W. IL Route 120 Round Lake, Illinois 60073
CONTACT PERSON:
Meaghan Bonn Principal Specialist, Regulatory Affairs 25212 W. IL Route 120 Round Lake, Illinois 60073 Telephone: (224) 270 6470 Fax: (224) 270 4119
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: PCA Syringe Sets Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Set, Administration, Intravascular Regulatory Class: Class II Product Code: FPA
| Code # | Device Description |
|---|---|
| 2P3331 | PCA Mini-Volume Syringe Set with Anti-Siphon Valve |
| and Y-Type Connector with Back Check Valve, 74" (188 cm), Vol 1.2 mL | |
| Image: [Device Description Image] | |
| 1: Female Luer Cap | |
| 2: Anti-Siphon Valve w/ Female Luer | |
| 3: Back Check Valve w/ Female Luer | |
| 4: On-Off Clamp | |
| 5: Y-Connector | |
| 6: Male Luer Lock | |
| 7: Male Luer Cap | |
| 8: Non-DEHP Tube Bushing |
Table 1. Proposed PCA Syringe Sets Configurations
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| Code # | Device Description | |
|---|---|---|
| 9,10,11: Non-DEHP Tube | ||
| 2P3332 | PCA Mini-Volume Syringe Set with Anti-Siphon Valve and Y-Type Connector with Back Check Valve, 98" (249 cm), Vol 1.5 mL | |
| Image: [PCA Mini-Volume Syringe Set with Anti-Siphon Valve and Y-Type Connector with Back Check Valve, 98" (249 cm), Vol 1.5 mL] | 1: Female Luer Cap | |
| 2: Anti-Siphon Valve w/ | ||
| Female Luer | ||
| 3: Back Check Valve w/ | ||
| Female Luer | ||
| 4: On-Off Clamp | ||
| 5: Y-Connector | ||
| 6: Male Luer Lock | ||
| 7: Male Luer Cap | ||
| 8: Non-DEHP Tube Bushing | ||
| 9,10,11: Non-DEHP Tube | ||
| 2P3333 | PCA Mini-Volume Syringe Set with Anti-Siphon Valve, 92" (234 cm), Vol 1.3 mL | |
| Image: [PCA Mini-Volume Syringe Set with Anti-Siphon Valve, 92" (234 cm), Vol 1.3 mL] | 1: Female Luer Cap | |
| 2: Anti-Siphon Valve w/ | ||
| Female Luer | ||
| 3: On-Off Clamp | ||
| 4: Male Luer Lock | ||
| 5: Male Luer Cap | ||
| 6: Non-DEHP Tube Bushing | ||
| 7: Non-DEHP Tube |
Table 1. Proposed PCA Syringe Sets Configurations
PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance
Date |
|------------------------------------------------------------------------------------------|----------------------------------|---------------------------|---------------------|
| Clearlink Luer Activated
Valve, Clearlink System Non-
DEHP Catheter Extension Sets | Baxter Healthcare
Corporation | K112893 (model
2N8374) | October 18,
2011 |
REASON FOR SUBMISSION:
The basis for this premarket notification is the intent to market patient controlled analgesia (PCA) syringe sets. The proposed devices in this submission are single-use, disposable devices, 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 devices are patient controlled analgesia (PCA) syringe sets. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular access device. They are non-pyrogenic, sterile devices that can be directly attached to a syringe.
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Image /page/5/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 word is likely a logo or brand name.
The PCA syringe sets consist of non-DEHP PVC tubing/bushing, female luer cap, antisiphon valve with female luer, on-off clamp(s), male luer lock, male luer cap, back check valve with female luer (2P3331 and 2P3332 only), and y-connector (2P3331 and 2P3332 only). They are used to administer analgesics from a syringe to the patient IV access device (2P3331 and 2P3332 only) or from a syringe to a primary administration set (2P3333 only); and are also used to administer fluids from a container at the y-type connector (2P3331 and 2P3332 only).
The anti-siphon valve and back check valve components add specific functionalities to facilitate the administration of fluid to the patient's vascular device, as described below:
- Anti-siphon valve: reduces the risk of any inadvertent free flow of solution to the . patient. The higher opening pressure does not allow administration of flow into the patient's vascular access device, unless the stipulated pressure is applied. Another safety feature is that the valve does not allow any backflow. This prevention of backflow is achieved through the valve's ability to withstand a counterflow pressure.
- Back check valve: does not allow any backflow. This prevention of backflow is . achieved through the valve's ability to withstand a counterflow pressure.
INDICATIONS FOR USE:
For the administration of fluids from a container into the patient's vascular system through a vascular access device. For use in adult populations only.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed devices are substantially equivalent to the predicate device, previously cleared under 510(k) premarket notification K112893 on October 18, 2011. The intended use and function of the proposed devices is equivalent to the predicate device.
Table 3 is a device comparison table outlining the differences between the predicate and proposed devices.
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| Features | Predicate Device
Cleared under
K112893 (Model
2N8374) | Proposed Devices | Assessment of Differences |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use with a
vascular access device
for the administration
of drugs and
solutions. The
Clearlink Luer
Activated Valve is an
in-line injection site,
which can be
connected to the
standard male Luer
adapters (e.g.,
syringes or sets) for
continuous or
intermittent fluid
administration or the
withdrawal of fluid. | For the
administration of
fluids from a
container into the
patient's vascular
system through a
vascular access
device. | Same
Minor rewording of the
Intended 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.
The general purpose of the
device and its function
remain unchanged.
The minor rewording of the
Intended Use statement does
not raise different questions
of safety and effectiveness. |
| Indications for Use | For use with a
vascular access device
for the administration
of drugs and
solutions. The
Clearlink Luer
Activated Valve is an
in-line injection site,
which can be
connected to the
standard male Luer
adapters (e.g.,
syringes or sets) for
continuous or
intermittent fluid
administration or the
withdrawal of fluid. | For the
administration of
fluids from a
container into the
patient's vascular
system through a
vascular access
device. For use in
adult populations
only. | Same
Minor rewording of the
Intended 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
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.
The minor rewording of the
Intended Use statement does
not raise different questions
of safety and effectiveness. |
| Regulation Number | 21 CFR 880.5440 | Same | N/A |
| Product Code | FPA | Same | N/A |
| Features | Predicate Device
Cleared under
K112893 (Model
2N8374) | Proposed Devices | Assessment of Differences |
| Sterile | Gamma Radiation | Same | N/A |
| Sterility Assurance
Level (SAL) | $10^{-6}$ | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Length | 8.2" (21 cm) | 74" (188 cm) - 98" (249 cm) | The predicate
device comparatively has a
shorter length than all of the
proposed devices. The
proposed devices offer
sets with different lengths,
allowing the clinician to
select the appropriate one for
the intended therapy. For
different therapies, clinicians
might require sets with
longer lengths, to ensure
delivery of solutions without
excessive manipulation of
the set.
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. |
| Tubing Inner / Outer
Diameter | 0.039" (0.99 mm) /
0.089" (2.26 mm) | 0.0315" (0.8 mm) /
0.0866" (2.2 mm) | The proposed devices tubing
inner / outer diameters are
nominally less than the
predicate device tubing inner
/ outer diameter. Design
control activities have been
conducted and have
confirmed that the different
technological characteristics
of the proposed device does
not raise different questions
of safety and effectiveness. |
| Priming Volume | 0.5 mL | 1.2 mL - 1.5 mL | Due to longer tubing lengths,
the priming volumes of the |
| Features | Predicate Device
Cleared under
K112893 (Model
2N8374) | Proposed Devices | Assessment of Differences |
| | | | proposed devices are larger
than the predicate device.
Design control activities
have been conducted and
have confirmed that the
different technological
characteristics of the
proposed device does not
raise different questions of
safety and effectiveness. |
| Fluid Path Components/Materials | | | |
| Anti-Siphon Valve | Not Applicable | Polymethyl
methacrylate
(Acrylic)
[Female Luer and
Tube Port]
Silicone
(Membrane)
(2P3331, 2P3332,
2P3333) | The predicate device does
not have an anti-siphon
valve. 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 |
| Back Check Valve | Not Applicable | Polymethyl
methacrylate
(Acrylic)
[Female Luer
and Tube Port]
Silicone
(Membrane)
(2P3331, 2P3332) | The predicate device does
not have a back check
valve. 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 |
| Tubing | Polyvinyl Chloride
(2N8374) | Same
(2P3331, 2P3332,
2P3333) | N/A |
| Tube Bushing | Not Applicable | Polyvinyl Chloride | The predicate device does
not have a tube
bushing. Design control
activities have been |
| Features | Predicate Device
Cleared under
K112893 (Model
2N8374) | Proposed Devices | Assessment of Differences |
| Y-Connector | Not Applicable | Acrylonitrile
Butadiene Styrene
(2P3331, 2P3332) | The predicate device does
not have a y-
connector. Design control
activities have been
conducted and have
confirmed that the
different technological chara
cteristics of the proposed
devices do not raise different
questions of safety and
effectiveness. |
| Male Luer Lock | Acrylonitrile
Butadiene Styrene
(2N8374) | Same
(2P3331, 2P3332,
2P3333) | N/A |
| Male Luer Cap | Polypropylene
(2N8374) | High Density
Polyethylene (Cap)
Hydrophobic Filter,
Acrylic (W/Non-
Woven
Nylon Substrate)
(Filter
Membrane)
(2P3331, 2P3332,
2P3333) | The predicate device does
not have the same type of
material formulation. Design
control activities have been
conducted and have
confirmed that the different
technological characteristics
of the proposed devices does
not raise different questions
of safety and effectiveness. |
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Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be a company logo. The word is slightly slanted to the right.
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Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is in blue color. The letters are closely spaced together.
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Image /page/9/Picture/0 description: The image shows the word "Baxter" in a stylized, sans-serif font. The word is rendered in a vibrant blue color. The font appears bold and slightly italicized, giving it a dynamic and modern look.
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.
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Performance Data:
The following bench tests (Table 4) were conducted to evaluate the functional performance of the proposed devices:
| Test | Acceptance Criteria |
|---|---|
| ISO 80369-7 Tests on Male Luer Lock Connector | ISO 80369-7:2016, Clause 5 (as applicable), |
| ISO 80369-7:2016, Clause 6.1, | |
| ISO 80369-7:2016, Clause 6.2, | |
| ISO 80369-7:2016, Clause 6.3, | |
| ISO 80369-7:2016, Clause 6.4, | |
| ISO 80369-7:2016, Clause 6.5, | |
| ISO 80369-7:2016, Clause 6.6 | |
| ISO 80369-7 Tests on Female Luer Lock Connector | ISO 80369-7: 2016, Clause 5 (as applicable), |
| ISO 80369-7:2016, Clause 6.1, | |
| ISO 80369-7:2016, Clause 6.2, | |
| ISO 80369-7:2016, Clause 6.3, | |
| ISO 80369-7:2016, Clause 6.4, | |
| ISO 80369-7:2016, Clause 6.5, | |
| ISO 80369-7:2016, Clause 6.6 | |
| Tensile Strength Test | BS EN ISO 8536-9:2015, Clause 5.3 |
| Leak Test | BS EN ISO 8536-9:2015, Clause A.4 |
| Counter Flow Test | BS ISO 8536-12:2007+A1:2013, Clause A.4 |
| Blocking Performance Test | BS ISO 8536-12:2007+A1:2013, Clause A.6 |
| Opening Pressure Test (Back Check Valve and Anti- | |
| Siphon Valve) | BS ISO 8536-12:2007+A1:2013, Clause |
| A.7.1 and per Baxter Test Method | |
| Particulate Matter Test | USP Chapter $$ |
| Clamp Activation Force Test | Activation force $≤$ 50N |
| Clamp Shut-Off Test | BS EN ISO 8536-14:2018, Clause A.1 |
| Non-DEHP Claim Verification | Per Baxter Test Method (as tested in |
| K161808) |
| Table 4. Performance Data | ||
|---|---|---|
| -- | --------------------------- | -- |
All tests met the acceptance criteria.
Biocompatibility:
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged contact duration, external communicating device, indirect blood path, and FDA-2013-D-0350 Guidance for Industry & FDA Staff,
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Use of ISO 10993-1, "Biological evaluation and medical devices - Part 1: Evaluation and testing within a risk management process, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing', as recommended in the Intravascular Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]". Biocompatibility assessments include the following assays:
- Cytotoxicity ISO 10993-5 ●
- Sensitization ISO 10993-10
- Intracutaneous (Irritation) Reactivity ISO 10993-10
- Systemic Toxicity (acute and repeat dose) ISO 10993-11
- Material Mediated Pyrogen ISO 10993-11
- Genotoxicity ISO 10993-3
- Hemolysis ISO 10993-4
Based upon the results the device met the designated ISO 10993-1 categorization and is biocompatible and appropriate for the 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 devices 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.
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Microbial Ingress Testing:
Baxter has conducted testing on all the potential points of microbial entry into the sterile fluid pathway of the proposed devices. The potential microbial entry points consist of male and female Luer connector sites. The Luer connector sites were tested following Baxter's testing strategy (as previously cleared under K180739 (cleared on May 28, 2019)) of challenging the connections 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 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 device that is legally marketed for the same intended use.