(179 days)
For the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device.
The proposed device is a patient controlled epidural analgesia (PCEA) syringe set. It is a single use disposable device intended for the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device. It is a non-pyrogenic, sterile device that can be directly attached to a syringe. The PCEA syringe set consists of non-DEHP PVC tubing/bushing, female NRFit cap, female NRFit lock, anti-siphon valve, on-off clamp, male NRFit lock, and male NRFit cap. It is used to administer anesthetics and/or analgesics from a syringe to the patient's epidural space through an epidural access device.
Here's a breakdown of the acceptance criteria and study information for the Baxter Healthcare Corporation PCEA Syringe Set (K211649), based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ISO 80369-6 Tests on Male NRFit (Neuraxial Fit) Lock Connector | ISO 80369-6: 2016, Clause 5 (as applicable), and Clauses 6.1 through 6.6 | All tests met the acceptance criteria. |
| ISO 80369-6 Tests on Female NRFit (Neuraxial Fit) Lock Connector | ISO 80369-6: 2016, Clause 5 (as applicable), and Clauses 6.1 through 6.6 | All tests met the acceptance criteria. |
| Tensile Strength Test | ISO 8536-9:2015, Clause 5.3 | All tests met the acceptance criteria. |
| Leak Test | ISO 8536-9:2015, Clause A.4 | All tests met the acceptance criteria. |
| Counter Flow Test | ISO 8536-12:2007+A1:2013, Clause A.4 | All tests met the acceptance criteria. |
| Blocking Performance Test | ISO 8536-12:2007+A1:2013, Clause A.6 | All tests met the acceptance criteria. |
| Opening Pressure Test | ISO 8536-12:2007+A1:2013, Clause A.7.1 and per Baxter Test Method | All tests met the acceptance criteria. |
| Particulate Matter Test | USP Chapter <788> | All tests met the acceptance criteria. |
| Clamp Activation Force Test | Per Baxter Test Method | All tests met the acceptance criteria. |
| Clamp Shut-Off Test | ISO 8536-14:2018, Clause A.1 | All tests met the acceptance criteria. |
| Non-DEHP Claim Verification | Per Baxter Test Method (as tested in K161808) | All tests met the acceptance criteria. |
| Biocompatibility | ISO-10993-1 categorization (for prolonged contact, external communicating device, tissue/bone/dentin) and FDA-2013-D-0350 Guidance. Specific assays: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Intracutaneous (Irritation) Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material Mediated Pyrogen (ISO 10993-11), Genotoxicity (ISO 10993-3), Subacute Systemic Toxicity (ISO 10993-11). | The device met the designated ISO 10993-1 categorization and is biocompatible and appropriate for the intended use. |
| Sterility | Sterility Assurance Level (SAL) of ≤ 10-6 using ANSI/AAMI/ISO 11137-2. Endotoxin limit of 2.15 EU/device per USP <161>. | MSD (Minimum Sterilizing Dose) required to provide a 10-6 SAL was established and validated. Routine periodic pre-sterilization bioburden testing is performed. (Implied to have met criteria, as the conclusion states substantial equivalence). |
| Shelf Life | Not explicitly stated as a numerical acceptance criterion in the table, but "supports a shelf-life claim of 3 (three) years." | Aging testing performed to support a 3-year shelf-life claim. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document describes "bench tests" and does not specify a separate "test set" in the context of clinical data, human readers, or image analysis. The tests appear to be conducted on the device itself. The provenance of the data is from Baxter Healthcare Corporation's internal testing. There is no information regarding country of origin or retrospective/prospective nature as this refers to device performance testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. The "ground truth" for these tests relates to engineering and manufacturing standards (e.g., ISO standards, USP chapters) rather than human expert interpretation of medical images or conditions.
4. Adjudication Method for the Test Set:
Not applicable. The tests are based on objective measurements against established engineering and regulatory standards, not human opinion requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a medical administration set, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" is established by:
- International and national standards bodies (e.g., ISO 80369-6, ISO 8536-9, ISO 8536-12, ISO 8536-14, ISO 10993, ANSI/AAMI/ISO 11137-2)
- Pharmacopeial standards (e.g., USP Chapter <788>, USP <161>)
- Baxter Test Methods, which are company-specific internal procedures developed to ensure quality and compliance.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is used.
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November 23, 2021
Baxter Healthcare Corporation Jeffrey Thompson Manager, Regulatory Affairs 25212 West Illinois Route 120 Round Lake, Illinois 60073
Re: K211649
Trade/Device Name: PCEA Syringe Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: PWH Dated: October 20, 2021 Received: October 25, 2021
Dear Jeffrey Thompson:
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
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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 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 (OS) 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,
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
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Indications for Use
510(k) Number (if known) K211649
Device Name PCEA Syringe Set
Indications for Use (Describe)
For the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural 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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K211649
510(k) Summary
OWNER:
Baxter Healthcare Corporation 25212 W. IL Route 120 Round Lake, Illinois 60073
CONTACT PERSON:
Jeffrey E. Thompson Manager, Regulatory Affairs 25212 W. IL Route 120 Round Lake, Illinois 60073 Telephone: (224) 270 3806 Fax: (224) 270 4119
Date Preparation: November 23, 2021
SUBJECT DEVICE:
Trade/Device Name: PCEA Syringe Set Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Common Name: Administrations Sets with Neuraxial Connectors Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: PWH
| Code # | Device Description |
|---|---|
| 2P3334 | PCEA Syringe Set with Anti-Siphon Valve, 85" (216 cm),Vol 2.2 mLImage: [device]1: Female NRFit Cap2: Female NRFit Lock3: Anti-Siphon Valve4: On-Off Clamp5: Male NRFit Lock6: Male NRFit Cap7: Non-DEHP Tube Bushing8,9: Non-DEHP Tube |
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PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | ClearanceDate |
|---|---|---|---|
| CADD Yellow Extension Setswith NRFit™ connector | Smiths Medical ASD, Inc. | K162219 | July 20, 2017 |
Table 2: Predicate Device
REASON FOR SUBMISSION:
The basis for this premarket notification is the intent to market a patient controlled epidural analgesia (PCEA) syringe set. The proposed device in this submission is a single-use, disposable device, intended for the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device.
DESCRIPTION OF THE DEVICE:
The proposed device is a patient controlled epidural analgesia (PCEA) syringe set. It is a single use disposable device intended for the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device. It is a non-pyrogenic, sterile device that can be directly attached to a syringe.
The PCEA syringe set consists of non-DEHP PVC tubing/bushing, female NRFit cap, female NRFit lock, anti-siphon valve, on-off clamp, male NRFit lock, and male NRFit cap. It is used to administer anesthetics and/or analgesics from a syringe to the patient's epidural space through an epidural access device.
The anti-siphon valve component adds specific functionalities to facilitate the administration of anesthetics and/or analgesics to the patient's epidural access 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 epidural 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.
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INDICATIONS FOR USE:
For the administration of anesthetics and/or analgesics from a syringe into the patient's epidural space through an epidural access device.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed device is substantially equivalent to the predicate device, previously cleared under 510(k) premarket notification K162219 on July 20, 2017. The intended use and function of the proposed device is equivalent to the predicate device.
Table 3 is a device comparison table outlining the differences between the predicate and proposed devices.
| Feature | PredicateK162219 | Subject DeviceK211649 | Assessment of Differences |
|---|---|---|---|
| Indication for Use | CADD YellowExtension Sets withNRFitTM connectorsare designed for useonly with CADDYellow MedicationCassette Reservoirswith NRFitTMconnectors for thedelivery of regionalanesthetics ornarcotics. | For theadministration ofanesthetics and/oranalgesics from asyringe into thepatient's epiduralspace through anepidural accessdevice. | Both the proposed andpredicate device are intendedto deliver similarmedications to the patientthrough NRFit connections.The specified fluidcontainers for the proposedand predicate devices aredifferent; however, theconnections to both fluidcontainers claim complianceto the same ISO 80369-6standard ("NRFit"). Designcontrol activities have beenconducted and haveconfirmed that the differenttechnological characteristicsof the proposed device doesnot raise different questionsof safety and effectiveness. |
| Sterility | Sterile; EthyleneOxide | Sterile; GammaIrradiation | Both the proposed andpredicate devices have beenvalidated to a sterilityassurance level (SAL) of ≤10-6 using ISO 11137 for theproposed device and ISO11135 for the predicatedevice. The sterilizationmodalities for the proposedand predicate devices are |
| Feature | PredicateK162219 | Subject DeviceK211649 | Assessment of Differences |
| different (gamma irradiationand ethylene oxide,respectively); however, thevalidated SAL requirementfor both devices aligns withthe same ANSI/AAMI ST67standard (Sections 4.2.1 and4.2.1.1), and thetechnological differencesbetween the sterilizationmodalities do not raisequestions of safety andeffectiveness. | |||
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Length | 90" | 85" (216 cm) | The proposed device lengthis nominally shorter than thepredicate device length.Design control activitieshave been conducted andhave confirmed that thedifferent technologicalcharacteristics of theproposed device does notraise different questions ofsafety and effectiveness.Lengths were calculatedusing nominal values fromcomponent and tubing partspecifications per Baxterprocedure. |
| Tubing Inner / OuterDiameter | Information notavailable | Inner Diameter - 1.1mmOuter Diameter - 2.5mm | The information is notavailable for the predicatedevice. Design controlactivities have beenconducted on the proposeddevice and have confirmedthat if there are differenttechnological characteristicsto the predicate device, theywould not raise differentquestions of safety andeffectiveness.Tensile strength and leakagewere evaluated per ISO8536-9. |
| Feature | PredicateK162219 | Subject DeviceK211649 | Assessment of Differences |
| Priming Volume | 2.3 mL | 2.2 mL | The proposed device primingvolume is nominally lessthan the predicate devicepriming volume. Designcontrol activities have beenconducted and haveconfirmed that the differenttechnological characteristicsof the proposed device doesnot raise different questionsof safety and effectiveness.Priming volume wasdetermined per Baxter testmethod. |
| Fluid Path Components/Materials | |||
| Anti-Siphon Valve | Polycarbonate(Housing)Silicone(Membrane) | Same | N/A |
| Tubing | Polyvinyl Chloride | Same | N/A |
| Tube Bushing | Not Applicable | Polyvinyl Chloride | The predicate device doesnot have tube bushings.Design control activitieshave been conducted andhave confirmed that thedifferent technologicalcharacteristics of theproposed device does notraise different questions ofsafety and effectiveness.Biocompatibilityassessments were conductedper ISO-10993-1. |
| Female NRFit Lock | Not Applicable | Copolyester | The predicate device doesnot have a female NRFit |
| Feature | PredicateK162219 | Subject DeviceK211649 | Assessment of Differences |
| lock. Design controlactivities have beenconducted and haveconfirmed that the differenttechnological characteristicsof the proposed device doesnot raise different questionsof safety and effectiveness.Biocompatibilityassessments were conductedper ISO-10993-1.Functional performance wasevaluated per ISO 80369-6. | |||
| Male NRFit Lock | AcrylonitrileButadiene Styrene | Copolyester | The predicate device doesnot have the same type ofmaterial formulation.Design control activitieshave been conducted andhave confirmed that thedifferent technological |
| Male NRFit Cap | Linear Low DensityPolyethylene | Acrylic | The predicate device doesnot have the same type ofmaterial formulation.Design control activitieshave been conducted andhave confirmed that thedifferent technologicalcharacteristics of theproposed device does notraise different questions ofsafety and effectiveness.Biocompatibilityassessments were conductedper ISO-10993-1. |
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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 device is appropriately designed for its intended use.
Performance Data:
The following bench tests (Table 4) were conducted to evaluate the functional performance of the proposed device:
| Test | Acceptance Criteria |
|---|---|
| ISO 80369-6 Tests on Male NRFit (Neuraxial Fit) LockConnector | ISO 80369-6: 2016, Clause 5 (as applicable),ISO 80369-6:2016, Clause 6.1,ISO 80369-6:2016, Clause 6.2,ISO 80369-6:2016, Clause 6.3,ISO 80369-6:2016, Clause 6.4,ISO 80369-6:2016, Clause 6.5,ISO 80369-6:2016, Clause 6.6 |
| ISO 80369-6 Tests on Female NRFit (Neuraxial Fit)Lock Connector | ISO 80369-6: 2016, Clause 5 (as applicable),ISO 80369-6:2016, Clause 6.1,ISO 80369-6:2016, Clause 6.2,ISO 80369-6:2016, Clause 6.3,ISO 80369-6:2016, Clause 6.4,ISO 80369-6:2016, Clause 6.5,ISO 80369-6:2016, Clause 6.6 |
| Tensile Strength Test | ISO 8536-9:2015, Clause 5.3 |
| Leak Test | ISO 8536-9:2015, Clause A.4 |
| Counter Flow Test | ISO 8536-12:2007+A1:2013, Clause A.4 |
| Blocking Performance Test | ISO 8536-12:2007+A1:2013, Clause A.6 |
| Opening Pressure Test | ISO 8536-12:2007+A1:2013, Clause A.7.1and per Baxter Test Method |
| Particulate Matter Test | USP Chapter <788> |
| Clamp Activation Force Test | Per Baxter Test Method |
| Clamp Shut-Off Test | ISO 8536-14:2018, Clause A.1 |
| Non-DEHP Claim Verification | Per Baxter Test Method (as tested inK161808) |
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 contact duration, external communicating device, tissue/bone/dentin, 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
- Acute Systemic Toxicity ISO 10993-11
- . Material Mediated Pyrogen ISO 10993-11
- Genotoxicity ISO 10993-3
- Subacute Systemic Toxicity ISO 10993-11
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. In addition, routine periodic pre-sterilization bioburden testing is performed for each (sub) category. The endotoxin limit is 2.15 EU/device per USP <161>.
Shelf Life:
Baxter has performed aging testing to support a shelf-life claim of 3 (three) years.
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CONCLUSION:
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device that is legally marketed for the same intended use.
§ 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.