(179 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a disposable syringe set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a PCEA syringe set, which is a delivery system for administering therapeutic substances (anesthetics and/or analgesics), rather than providing therapy itself.
No
Explanation: The device is intended for the administration of anesthetics and analgesics, which is a therapeutic function, not a diagnostic one. It does not gather information about the patient's condition for diagnosis.
No
The device description explicitly states it is a "single use disposable device" consisting of physical components like tubing, caps, locks, and valves, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a patient controlled epidural analgesia (PCEA) syringe set. Its function is to administer substances (anesthetics and/or analgesics) into the patient's body. It is a delivery system, not a diagnostic test.
- Intended Use: The intended use clearly states "For the administration of anesthetics and/or analgesics... into the patient's epidural space". This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The components listed (tubing, connectors, valves, clamp) are all related to the physical delivery of a substance. There are no components or processes described that would involve analyzing a biological sample.
Therefore, based on the provided information, this device is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PWH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's epidural space
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)
Bench tests were conducted to evaluate the functional performance of the proposed device. All tests met the acceptance criteria.
Tests conducted:
- ISO 80369-6 Tests on Male NRFit (Neuraxial Fit) Lock Connector
- ISO 80369-6 Tests on Female NRFit (Neuraxial Fit) Lock Connector
- Tensile Strength Test
- Leak Test
- Counter Flow Test
- Blocking Performance Test
- Opening Pressure Test
- Particulate Matter Test
- Clamp Activation Force Test
- Clamp Shut-Off Test
- Non-DEHP Claim Verification
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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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
1
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
2
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 mL | |
| Image: [device] | |
| 1: Female NRFit Cap | |
| 2: Female NRFit Lock | |
| 3: Anti-Siphon Valve | |
| 4: On-Off Clamp | |
| 5: Male NRFit Lock | |
| 6: Male NRFit Cap | |
| 7: Non-DEHP Tube Bushing | |
| 8,9: Non-DEHP Tube |
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PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance
Date |
|-----------------------------------------------------|--------------------------|------------------|-------------------|
| CADD Yellow Extension Sets
with 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 | Predicate
K162219 | Subject Device
K211649 | Assessment of Differences |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | CADD Yellow
Extension Sets with
NRFitTM connectors
are designed for use
only with CADD
Yellow Medication
Cassette Reservoirs
with NRFitTM
connectors for the
delivery of regional
anesthetics or
narcotics. | For the
administration of
anesthetics and/or
analgesics from a
syringe into the
patient's epidural
space through an
epidural access
device. | Both the proposed and
predicate device are intended
to deliver similar
medications to the patient
through NRFit connections.
The specified fluid
containers for the proposed
and predicate devices are
different; however, the
connections to both fluid
containers claim compliance
to the same ISO 80369-6
standard ("NRFit"). 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. |
| Sterility | Sterile; Ethylene
Oxide | Sterile; Gamma
Irradiation | Both the proposed and
predicate devices have been
validated to a sterility
assurance level (SAL) of ≤
10-6 using ISO 11137 for the
proposed device and ISO
11135 for the predicate
device. The sterilization
modalities for the proposed
and predicate devices are |
| Feature | Predicate
K162219 | Subject Device
K211649 | Assessment of Differences |
| | | | different (gamma irradiation
and ethylene oxide,
respectively); however, the
validated SAL requirement
for both devices aligns with
the same ANSI/AAMI ST67
standard (Sections 4.2.1 and
4.2.1.1), and the
technological differences
between the sterilization
modalities do not raise
questions of safety and
effectiveness. |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Length | 90" | 85" (216 cm) | The proposed device length
is nominally shorter than the
predicate device length.
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.
Lengths were calculated
using nominal values from
component and tubing part
specifications per Baxter
procedure. |
| Tubing Inner / Outer
Diameter | Information not
available | Inner Diameter - 1.1
mm
Outer Diameter - 2.5
mm | The information is not
available for the predicate
device. Design control
activities have been
conducted on the proposed
device and have confirmed
that if there are different
technological characteristics
to the predicate device, they
would not raise different
questions of safety and
effectiveness.
Tensile strength and leakage
were evaluated per ISO
8536-9. |
| Feature | Predicate
K162219 | Subject Device
K211649 | Assessment of Differences |
| Priming Volume | 2.3 mL | 2.2 mL | The proposed device priming
volume is nominally less
than the predicate device
priming volume. 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 was
determined per Baxter test
method. |
| 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 does
not have tube bushings.
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.
Biocompatibility
assessments were conducted
per ISO-10993-1. |
| Female NRFit Lock | Not Applicable | Copolyester | The predicate device does
not have a female NRFit |
| Feature | Predicate
K162219 | Subject Device
K211649 | Assessment of Differences |
| | | | lock. 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.
Biocompatibility
assessments were conducted
per ISO-10993-1.
Functional performance was
evaluated per ISO 80369-6. |
| Male NRFit Lock | Acrylonitrile
Butadiene Styrene | Copolyester | 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
|
| Male NRFit Cap | Linear Low Density
Polyethylene | Acrylic | 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 device does not
raise different questions of
safety and effectiveness.
Biocompatibility
assessments were conducted
per ISO-10993-1. |
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Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be italicized, with the letters slightly slanted to the right. The word is the logo for the Baxter International Inc. company.
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Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be italicized, with the letters slightly slanted to the right. The word is the logo for the Baxter International Inc. company.
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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) 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 | |
| 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.7.1 |
| and per Baxter Test Method | |
| Particulate Matter Test | USP Chapter |
| 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 in |
| K161808) |
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 .
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.