Who is the manufacturer of PCA Syringe Sets?

Baxter Healthcare Corporation filed the 510(k) submission for PCA Syringe Sets (K212262).

What is the FDA product code for PCA Syringe Sets?

FPA. It is classified under 21 CFR 880.5440 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for PCA Syringe Sets?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PCA Syringe Sets?

Clearlink Luer Activated Valve, Clearlink System Non-DEHP Catheter Extension Sets (K112893).

Who can help prepare an FDA 510(k) submission like PCA Syringe Sets?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PCA Syringe Sets

K212262 · Baxter Healthcare Corporation · FPA · Oct 3, 2022 · General Hospital

Device Facts

Record ID	K212262
Device Name	PCA Syringe Sets
Applicant	Baxter Healthcare Corporation
Product Code	FPA · General Hospital
Decision Date	Oct 3, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5440
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

PCA Syringe Sets are single-use, sterile, non-pyrogenic disposable devices used to administer analgesics or fluids from a syringe to a patient's IV access device or primary administration set. Components include non-DEHP PVC tubing, female luer caps, anti-siphon valves, back check valves, on-off clamps, and y-connectors. The anti-siphon valve prevents inadvertent free flow and backflow; the back check valve prevents backflow. Used in clinical settings by healthcare providers. The device facilitates controlled fluid delivery, reducing risk of free flow and backflow, thereby enhancing patient safety during analgesic administration.

Clinical Evidence

Bench testing only. Performance evaluations included ISO 80369-7 luer connector testing, tensile strength, leak testing, counter flow, blocking performance, opening pressure, particulate matter (USP <788>), clamp activation/shut-off, and non-DEHP claim verification. Biocompatibility was assessed per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, hemolysis). Sterility was validated per ANSI/AAMI/ISO 11137. Microbial ingress testing confirmed the integrity of luer connections.

Technological Characteristics

Materials: Polymethyl methacrylate (acrylic), silicone (membranes), PVC (tubing/bushing), ABS (y-connector), HDPE (caps). Components: Anti-siphon valve, back check valve, luer connectors. Sterilization: Gamma radiation (SAL 10^-6). Standards: ISO 80369-7 (connectors), BS EN ISO 8536-9/14, BS ISO 8536-12, USP <788>, ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for the administration of fluids from a container into the patient's vascular system through a vascular access device in adult populations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Clearlink Luer Activated Valve, Clearlink System Non-DEHP Catheter Extension Sets (K112893)

Reference Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and has a slightly italicized appearance. The word is the logo for the healthcare company Baxter International. | 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is a dark blue color. The letters are slightly slanted to the right, giving the word a dynamic appearance. | 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. | {7}------------------------------------------------ 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. {8}------------------------------------------------ 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. {9}------------------------------------------------ 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. {10}------------------------------------------------ Image /page/10/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. ### 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 $<788>$ | | 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, {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is colored in a bright blue. The letters are slightly slanted to the right, giving the word a dynamic appearance. 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 <85>. The endotoxin limit is 20 EU/device per USP <161>. 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. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is in blue and appears to be a logo. The letters are closely spaced, giving the word a solid, unified appearance. ### 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.

PCA Syringe Sets

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