(203 days)
No
The device description and performance studies focus on the mechanical and material properties of a disposable fluid administration set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
This device is used for the administration of fluids into the epidural space to reduce pain, which is a therapeutic purpose.
No
Explanation: The device is a solution set for administering fluids into the epidural space, typically for pain management. Its function is to deliver substances, not to diagnose a condition.
No
The device description clearly outlines physical components like a spike, drip chamber, tubing, clamps, and a connector, and the performance studies focus on the physical and functional characteristics of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the administration of fluids from a container into the patient's epidural space with Baxter infusion pumps." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose a condition.
- Device Description: The description details a set of components for fluid administration (spike, drip chamber, tubing, clamps, connector). This aligns with a medical device used for therapy or delivery, not for diagnostic testing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for diagnosis.
- Performance Studies: The performance studies focus on the functional aspects of fluid delivery and safety (flow rate, occlusion, strength, biocompatibility, sterility), not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
For the administration of fluids from a container into the patient's epidural space with Baxter infusion pumps.
Product codes
FPA
Device Description
The Solution Set for Epidural Use is a single use disposable device intended for the administration of fluids from a container into the epidural space. The set is used for epidural infusions of fluids (typically analgesic or anesthetic) as an intermittent or continuous infusion to reduce chronic or post-operative pain. The set consists of a nonvented spike, 60 drops per mL drip chamber, minidrip adapter, tubing, fixtured slide clamp, on-off roller clamp, and a male epidural lock connector. The connector is compliant to the provisional AAMI/CN6:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
The following bench tests were conducted to evaluate the functional performance of the Solution Set for Epidural Use:
- Drop Volume Test
- Cannula Pull Out Test
- Spike Insertion Test
- Spike Removal Test
- Roller Clamp Force Test
- Roller Clamp Shut-Off and Tubing Leak Test
- Slide Clamp Shut Off Test
- Solvent Bond Tensile Strength Test (for all bonds)
- Solvent Bond Air/Water Pressure Test (for all bonds)
- AAMI/CN6:2015 Connector Tests on Male Epidural Lock Connectors
- Pump Tests
- Flow Rate Accuracy
- Upstream/Downstream Occlusion
- Tubing Crimping/Flexion When Used with Infusion Pumps
All tests met the acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 30, 2016
Baxter Healthcare Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K161323
Trade/Device Name: Solution Set for Epidural Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: November 15, 2016 Received: November 16, 2016
Dear Mark Job:
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. 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.
1
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name Solution Set for Epidural Use
Indications for Use (Describe)
For the administration of fluids from a container into the patient's epidural space with Baxter infusion pumps.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5. 510(k) Summary
November 30, 2016
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Tiffany Lin Manager, Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 270-4343 Fax: (224) 270-4119
IDENTIFICATION OF THE DEVICE:
Common Name: IV Administration Set Trade Name or Proprietary Name: Solution Set for Epidural Use Classification Panel: 80 General Hospital Classification: Set, Administration, Intravascular (21 CFR 880.5440) Class: Class II Product Code: FPA
Table 1. Product Code for Solution Set for Epidural Use
| Code Number | Name |
|---|---|
| 2E7554 | Solution Set for Epidural Use |
PREDICATE DEVICE:
Table 2. Predicate Device
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Bard Epidural Spike | |||
| Tubing Set | C.R. Bard, Inc. | ||
| (Bard MedSystems)a | K925058 | August 3, 1993 |
a Bard MedSystems, a division of C.R. Bard, Inc., was acquired by Baxter in 1993.
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DESCRIPTION OF THE DEVICE:
The Solution Set for Epidural Use is a single use disposable device intended for the administration of fluids from a container into the epidural space. The set is used for epidural infusions of fluids (typically analgesic or anesthetic) as an intermittent or continuous infusion to reduce chronic or post-operative pain. The set consists of a nonvented spike, 60 drops per mL drip chamber, minidrip adapter, tubing, fixtured slide clamp, on-off roller clamp, and a male epidural lock connector. The connector is compliant to the provisional AAMI/CN6:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
INDICATIONS FOR USE:
For the administration of fluids from a container into the patient's epidural space with Baxter infusion pumps.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed device has equivalent technological characteristics as Baxter's legally marketed epidural set cleared under 510(k) premarket notification K925058 (cleared August 3, 1993). The intended use and function of the proposed device are 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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| | Predicate Device
(K925058): | Proposed Device:
(K161323) | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Bard Epidural Spike Tubing Seta | Solution Set for Epidural Useb | Assessment of Difference |
| Intended Use | For the administration of fluids from a
container into the patient's epidural
space. | Same. | N/A |
| Indications for Use | The Bard Epidural Spike Tubing Set is
intended for use with Bard ambulatory
infusion pumps to provide epidural
delivery of anesthetic or analgesic
drugs for periods of up to 96 hours. | For the administration of fluids
from a container into the patient's
epidural space with Baxter infusion
pumps. | The indications for use are being modified
from the predicate device to clarify its use and
remove reference to a pump that is no longer
being marketed. The modification to the
indications statement does not impact the
safety or efficacy of the proposed device. It
represents a clarification only as both devices
are intended for the administration of epidural
therapy through a disposable solution set, both
are intended to administer fluids from a source
container to the patient's epidural space, and
both are intended for pump administration.
The specific pump compatibility information
and duration of use is referenced in the
product labeling for the proposed device. |
| Sterile | Yes | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| FLUID PATH MATERIALS: | | | |
| Non-Vented Spike | Acrylonitrile Butadiene Styrene | Same | N/A |
| Features | Predicate Device
(K925058):
Bard Epidural Spike Tubing Seta | Proposed Device:
(K161323)
Solution Set for Epidural Useb | Assessment of Difference |
| Drip Chamber | N/A | Polyvinyl Chloride | The predicate device does not have a drip chamber. A drip chamber is included on the proposed device for the end user to verify drops are falling within the drip chamber. Design control activities confirmed there was no impact to the safety or effectiveness of the device due to this change. |
| Minidrip Adapter | N/A | Synthetic Polyisoprene and
Stainless Steel | The predicate device does not have minidrip adapter. A minidrip adapter is included on the proposed device to allow more accurate visibility of drops falling, since epidural infusion tends to be towards the lower side of infusion rates. Design control activities confirmed there was no impact to the safety or effectiveness of the device due to this change. |
| Tubing | Silicone and Polyvinyl Chloride | Polyvinyl Chloride | The predicate device is used with a Bard pump and has a separate tubing segment made of silicone that interfaces with that pump. The proposed device utilizes PVC tubing throughout the device. A section of this PVC tubing interfaces with Baxter pumps. This same PVC tubing is used in other Baxter IV sets cleared for use with the same Baxter pumps with which the proposed device will be used. Design control activities confirmed there was no impact to the safety or effectiveness of the device due to this change. |
| | Predicate Device
(K925058): | Proposed Device:
(K161323) | |
| Features | Bard Epidural Spike Tubing Seta | Solution Set for Epidural Useb | Assessment of Difference |
| Anti-Siphon Valve | Polycarbonate and Silicone | N/A | Not present. The proposed device does not have an anti-siphon valve. This valve has been removed as it was a design specifically for the Bard pump, and to align with the design of other currently marketed Baxter administration sets. Design control activities confirmed there was no impact to the safety or effectiveness of the device due to this change. |
| Two-Piece Male Luer
Lock Connector | Polymethyl Methacrylate | N/A | Not present. The proposed device has an epidural lock connector instead. |
| One-Piece Male Epidural
Lock Connector | N/A | Acrylonitrile Butadiene Styrene | The epidural lock is made of the same material type as the Luer lock's body in K142011, but differs in dimensions due to the dimensional requirements of AAMI/CN6:2015. Design control activities confirmed there was no impact to the safety or effectiveness of the device due to this change. |
Table 3. Device Comparison
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Table 3. Device Comparison
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Table 3. Device Comparison
4 Bard MedSystems, a division of C.R. Bard, Inc., was acquired by Baxter in 1993.
b Similar IV sets have been previously cleared in 510(k) premarket notification K142011. These sets have and one of the proposed device, the only difference being the epidural lock connector, which is the same material type as the K142011 Luer lock connector, but just differs in dimension due to the dimensional requirements of AAMI/CN6:2015.
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DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the results 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 were conducted to evaluate the functional performance of the Solution Set for Epidural Use:
- Drop Volume Test
- . Cannula Pull Out Test
- Spike Insertion Test
- Spike Removal Test
- Roller Clamp Force Test
- Roller Clamp Shut-Off and Tubing Leak Test
- Slide Clamp Shut Off Test
- Solvent Bond Tensile Strength Test (for all bonds) ●
- Solvent Bond Air/Water Pressure Test (for all bonds) ●
- AAMI/CN6:2015 Connector Tests on Male Epidural Lock Connectors
- Pump Tests
- -Flow Rate Accuracy
- Upstream/Downstream Occlusion -
- Tubing Crimping/Flexion When Used with Infusion Pumps -
All tests met the acceptance criteria.
Biocompatibility:
All patient-contacting components meet the category of External Communicating Device, Indirect Blood Path, Prolonged Duration in accordance with ISO 10993-1 and FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," as recommended in the IV administration sets guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)].
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Biocompatibility assessment has been conducted on a representative final, finished device for all materials of the Solution Set for Epidural Use. The following tests were conducted as part of the biocompatibility testing:
- Cytotoxicity
- Systemic Toxicity
- Irritation/Intracutaenous Reactivity
- Sensitization
- Hemocompatibility
- USP Physiochemical ●
- USP Material Mediated Pyrogen
Sterility:
The Solution Set for Epidural Use is sterilized with gamma radiation. The Minimum Sterilizing Dose (MSD) required to provide a 10th Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility using Method 1 as described in ANSI/AAMI/ISO 11137-2 Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose.
This product is labeled "Sterile, nonpyrogenic." Package verification testing is based on Visual Inspection, ASTM F88 Seal Strength, and ASTM F2096 Bubble Leak.
Shelf-Life:
Baxter has provided aging tests to support a shelf-life claim of one (1) year. Baxter intends to perform testing to expand the shelf-life up through a period of five (5) years.
CONCLUSION:
The nonclinical data support the substantial equivalence of the proposed device and demonstrate that the proposed device performs comparably to the predicate device that is legally marketed for the same intended use.