(325 days)
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
The proposed devices consist of IV Extension sets and IV set accessories. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system. They are non-pyrogenic, sterile devices that can be used with or without a syringe. The extension sets consist of PVC tubing or polyethylene lined PVC tubing, a notch clamp, female luer, non-vented cap, male luer, and filter vented cap. They are used to administer solutions, drugs, antibiotics, lipids to the patient. The accessories consists of an anti-siphon valve, back check valve, and 1.2 µm Filter. They attach to the proposed sets to add a specific feature to facilitate the administration of fluid when used with a syringe. The anti-siphon valve reduces the risk of free flow from the syringe and backflow into the primary infusion line. The back check valve prevents backflow into the primary infusion line. The 1.2 um Filter prevents particulate matter and eliminates air bubbles.
The provided document is a 510(k) Summary for Baxter Healthcare Corporation's Intravascular Extension Sets and Accessories (K192366). It describes a Class II medical device intended for the administration of fluids into a patient's vascular system.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests conducted and generally states that "All tests met the acceptance criteria" without providing specific numeric results for each test. The acceptance criteria themselves are primarily referenced by external standards, not internal performance metrics.
| Test | Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|---|
| ISO 80369-7 Luer Tests on male Luer Lock Connector | BS EN ISO 80369-7:2016 (Clauses 6.1.2, 6.1.3, 6.2, 6.3, 6.4, 6.5, 6.6, 5), ISO 80369-20:2015 Annex E, ISO 594-1:1986 Clause 3, ISO 594-2:1998 Clause 3 (as applicable) | Met acceptance criteria |
| ISO 80369-7 Luer Tests on female Luer Lock Connector | BS EN ISO 80369-7:2016 (Clauses 6.1.2, 6.1.3, 6.2, 6.3, 6.4, 6.5, 6.6, 5), ISO 80369-20:2015 Annex E, ISO 594-1:1986 Clause 3, ISO 594-2:1998 Clause 3 (as applicable) | Met acceptance criteria |
| Tensile Strength Test | BS EN ISO 8536-9 Clause 5.3, BS EN ISO 8536-10 Clause 4.3, BS EN ISO 8536-11 Clause 5.3, BS EN ISO 8536-12 Clause 6.2 | Met acceptance criteria |
| Leak Test | BS EN ISO 8536-9:2015 Section A.4, BS EN ISO 8536-11:2015 Section A.4, ISO 8536-10:2015 Section A.4 | Met acceptance criteria |
| Counter Flow Test | ISO 8536-12:2007+A1:2013 Clause A.4 | Met acceptance criteria |
| Blocking Performance Test | ISO 8536-12:2007+A1:2013 Clause A.6 | Met acceptance criteria |
| Opening Pressure Test | ISO 8536-12:2007+A1:2013 Clause A.7.1 and per Baxter Test Method | Met acceptance criteria |
| Notch Clamp Activation Force Test | Per Baxter Test Method | Met acceptance criteria |
| Notch Clamp Shut-Off Test | ISO 8536-14:2015 | Met acceptance criteria |
| Filter Tests | EN ISO 8536-11 Clause 5.1 and per Baxter Test Method | Met acceptance criteria |
| Non-DEHP Claim Verification (<0.1% DEHP) | Per Baxter Test Method (as tested in K161808) | Met acceptance criteria |
| Biocompatibility Assessment (Cytotoxicity, Sensitization, etc.) | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-17, ISO 10993-4, ISO 10993-18 | Biocompatible and appropriate for intended use |
| Sterility | ANSI/AAMI/ISO 11137-2 (Method 1 or VDmax) to establish a 10^6 Sterility Assurance Level (SAL). | MSDs between 14.2 - 25.0 kGy established and validated |
| Shelf-Life | Aging testing to support claim. | 3 (three) years |
| Microbial Ingress Testing | Per Baxter's test method. | Met acceptance criteria |
| Particulate Matter Testing | Per <USP 788>. | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the individual performance tests (e.g., Luer tests, tensile strength, leak test, etc.). It only states that tests were conducted.
The data provenance is retrospective testing performed by Baxter Healthcare Corporation to verify the functional performance of the proposed devices. No information about the country of origin of the data is provided beyond the submitting company being U.S.-based (Illinois).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device submission. The tests are bench tests verifying physical and chemical properties of the device, not clinical performance requiring expert medical review or ground truth establishment in a diagnostic context.
4. Adjudication Method for the Test Set
This section is not applicable. As mentioned above, the tests are primarily bench tests against engineering standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is an intravenous extension set and accessories, which are physical medical components.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the performance tests, the "ground truth" or reference is established by the acceptance criteria outlined in various international standards (e.g., ISO, BS EN ISO) and Baxter's internal test methods. For biocompatibility, it's the biological response against established toxicology and biocompatibility standards. For sterility, it's the validation against a specified Sterility Assurance Level (SAL).
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical device. There is no "training set" in the context of an algorithm or AI system. The manufacturing process and quality control would involve ongoing sampling and testing, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
July 20, 2020
Baxter Healthcare Corporation Gary Chumbimune Associate Director, Regulatory Affairs 32650 N. Wilson Road Round Lake, Illinois 60073
Re: K192366
Trade/Device Name: Intravascular Extension Sets and Accessories Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA, FPB Dated: June 16, 2020 Received: June 19, 2020
Dear Gary Chumbimune:
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 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-devices/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Acting 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) K192366
Device Name
Intravascular Extension Sets and Accessories
Indications for Use (Describe)
For the administration of fluids from a container into the patient's vascular system through a vascular 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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 has a slightly italicized appearance. The word is the logo for the healthcare company Baxter International.
510(k) Summary-K192366
July 20, 2020
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Gary Chumbimune Associate Director, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073 Telephone: (224) 270 3312 Fax: (224) 270 4119
IDENTIFICATION OF THE DEVICE:
Trade/Device Name: Intravascular Extension Sets and Accessories Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name : Set, Administration, Intravascular Regulatory Class: Class II Product Code: FPA, FPB
| Code # | Device Description |
|---|---|
| 2N3354 | Micro-Volume Extension Set, 79" (200 cm), Vol 0.47 mL |
| 1: Non-Vented Cap |
|---|
| 2: Female Luer Lock |
| 3: Notch Clamp |
| 4: Tubing |
| 5: Male Luer Lock |
| 6: Male Luer Cap |
Table 1. Proposed IV Extension Set Configurations
{4}------------------------------------------------
Image /page/4/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 evenly spaced and the overall design is simple and modern. The image is clear and well-defined.
| Code # | Device Description | |
|---|---|---|
| 2N3380 | Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mLImage: [Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mL] | 1: Non-Vented Cap2: Female LuerLock3: Notch Clamp4: Tubing5: Male Luer Lock6: Male Luer Cap |
| 2N3358 | Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mLImage: [Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mL] | 1: Non-Vented Cap2: Female LuerLock3: Tubing4: Male Luer Lock5: Male Luer Cap |
| 2N3357 | Micro-Volume Extension Set with 0.2 µm Filter, 79" (200 cm), Vol 0.88 mLImage: [Micro-Volume Extension Set with 0.2 µm Filter, 79" (200 cm), Vol 0.88 mL] | 1: Non-Vented Cap2: Female LuerLock3, 6: Tubing4: 0.2µm Filter5: Notch Clamp7: Male Luer Lock8: Male Luer Cap |
| 2N3382 | Micro-Volume Extension Set with 0.2 µm Filter, 59" (150 cm), Vol 0.75 mLImage: [Micro-Volume Extension Set with 0.2 µm Filter, 59" (150 cm), Vol 0.75 mL] | 1: Non-Vented Cap2: Female LuerLock3, 6: Tubing4: 0.2µm Filter5: Notch Clamp7: Male Luer Lock8: Male Luer Cap |
| 2N3386 | Micro-Volume Catheter Extension Set with 0.2 µm Filter, 10" (25 cm), Vol 0.44 mLImage: [Micro-Volume Catheter Extension Set with 0.2 µm Filter, 10" (25 cm), Vol 0.44 mL] | 1: Non-Vented Cap2: Female LuerLock3, 6: Tubing4: 0.2µm Filter5: Notch Clamp7: Male Luer Lock8: Male Luer Cap |
| 2N3355 | Mini-Volume Extension Set, 59" (150 cm), Vol 0.91 mLImage: [Mini-Volume Extension Set, 59" (150 cm), Vol 0.91 mL] | 1: Non-Vented Cap2: Female LuerLock3: Notch Clamp4: Tubing |
Table 1. Proposed IV Extension Set Configurations
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly italicized, giving it a sense of movement. The font is sans-serif and the letters are evenly spaced.
Image /page/5/Figure/1 description: The image shows a table with different medical devices and their descriptions. The first device is a Mini-Volume Extension Set, 79" (200 cm), Vol 1.1 mL, with code 2N335 6. The second device is a Mini-Volume Extension Set, 118" (300 cm), Vol 1.4 mL, with code 2N335 9. The third device is a Polyethylene (PE) Lined Micro-Volume Extension Set, 59" (150 cm), Vol 0.40 mL, with code 2N336 0.
Table 1. Proposed IV Extension Set Configurations
{6}------------------------------------------------
Image /page/6/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 | |
|---|---|---|
| 2N3364 | Anti-Siphon Valve, Vol 0.24 mLImage: Anti-Siphon Valve | 1: Non-Vented Cap to Female Luer2: Anti-Siphon Valve3: Touch Contamination Protector |
| 2N3365 | Back Check Valve, Vol 0.28 mLImage: Back Check Valve | 1: Non-Vented Cap to Female Luer2: Back Check Valve3: Touch Contamination Protector |
| 2N3368 | Air-Eliminating 1.2 μm Solution Filter, Vol 0.80 mLImage: Air-Eliminating 1.2 μm Solution Filter | 1: Non-Vented Cap to Female Luer2: 1.2 μm Filter3: Touch Contamination Protector |
Table 2. Proposed IV Set Accessories
PREDICATE DEVICE:
Table 3. Predicate De vice
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Clearlink LuerActivated Valve,Clearlink SystemNon-DEHP CatheterExtension Sets | Baxter HealthcareCorporation | K112893 | October 18, 2011 |
REASON FOR SUBMISSION:
The basis for this premarket notification is the intend to market Intravascular (IV) Extension Sets and Accessories. 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.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and the letters are slightly italicized. The word is likely a logo or brand name.
DESCRIPTION OF THE DEVICE:
The proposed devices consist of IV Extension sets and IV set accessories. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system. They are non-pyrogenic, sterile devices that can be used with or without a syringe.
The extension sets consist of PVC tubing or polyethylene lined PVC tubing, a notch clamp, female luer, non-vented cap, male luer, and filter vented cap. They are used to administer solutions, drugs, antibiotics, lipids to the patient.
The accessories consists of an anti-siphon valve, back check valve, and 1.2 µm Filter. They attach to the proposed sets to add a specific feature to facilitate the administration of fluid when used with a syringe. The anti-siphon valve reduces the risk of free flow from the syringe and backflow into the primary infusion line. The back check valve prevents backflow into the primary infusion line. The 1.2 um Filter prevents particulate matter and eliminates air bubbles.
INDICATIONS FOR USE:
For the administration of fluids from a container into the patient's vascular system through a vascular access device.
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 are equivalent to the predicate device.
Table 4 is a device comparison table outlining the differences between the predicate and proposed devices.
| Features | Predicate DeviceCleared underK112893 | Proposed Devices | Assessment of Differences |
|---|---|---|---|
| Intended Use | For use with a vascularaccess device for theadministration of drugsand solutions. TheClearlink LuerActivated Valve is anin-line injection site. | For the administrationof fluids from acontainer into thepatient's vascularsystem through avascular access device. | SameMinor rewording of the IntendedUse statement has been made tobetter align with 21 CFR880.5440 and for the purpose of |
| Predicate DeviceCleared underK112893 | Proposed Devices | Assessment of Differences | |
| Features | which can beconnected to thestandard male Lueradapters (e.g., syringesor sets) for continuousor intermittent fluidadministration or thewithdrawal of fluid. | streamlining the informationprovided to the user.The general purpose of thedevice and its function remainunchanged.The minor rewording of theIntended Use statement does notraise different questions of safetyand effectiveness. | |
| Indication forUse | For use with a vascularaccess device for theadministration of drugsand solutions. TheClearlink LuerActivated Valve is anin-line injection site,which can beconnected to thestandard male Lueradapters (e.g., syringesor sets) for continuousor intermittent fluidadministration or thewithdrawal of fluid. | For the administrationof fluids from acontainer into thepatient's vascularsystem through avascular access device. | SameMinor rewording of theIndications for Use statement hasbeen made to better align with 21CFR 880.5440 and for thepurpose of streamlining theinformation provided to the user.This minor modification does notalter the disease or condition thedevice will diagnose, treat,prevent, cure/mitigate, or thepatient population for which thedevice is intended to be used. Inaddition, the minor rewordingdoes not reflect a differentanatomical site from which adisease state or population maybe inferred.The minor rewording of theIntended Use statement does notraise different questions of safetyand effectiveness. |
| Sterile | Yes | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Fluid path Components/Materials | |||
| Anti-SiphonValve | Not Applicable | Polymethylmethacrylate (Acrylic)[Female and Male Luer]Silicone (Membrane) | The predicate device does nothave an anti-siphon check valve.Design control activities havebeen conducted and haveconfirmed that the differenttechnological characteristics ofthe proposed devices do not raise |
| Features | Predicate DeviceCleared underK112893 | Proposed Devices | Assessment of Differences |
| Back CheckValve | Not Applicable | (2N3364)Polymethylmethacrylate (Acrylic)[Female and Male Luer]Silicone (Membrane)(2N3365) | different questions of safety andeffectivenessThe predicate device does nothave a check valve. Designcontrol activities have beenconducted and have confirmedthat the different technologicalcharacteristics of the proposeddevices do not raise differentquestions of safety andeffectiveness |
| 0.2 μm Filter | Not Applicable | Polymethylmethacrylate (Acrylic)[Housing]Polyvinylidene fluoride(Air Vent Membrane)Polyethersulfone(Solution Membrane)(2N3382, 2N3357,2N3386) | The predicate device does nothave a 0.2 μm Filter. Thesematerials have been used inanother Baxter cleared device(cleared in K113227, 12/08/11)with the same/similar intendeduse and with the same type andduration of contact. Designcontrol activities have beenconducted and have confirmedthat the different technologicalcharacteristics of the proposeddevices do not raise differentquestions of safety andeffectiveness. |
| Air-Eliminating1.2 μmSolution Filter | Not Applicable | Polymethylmethacrylate (Acrylic)[Housing]Polytetrafluoroethylene(Air Vent Membrane)Polyethersulfone(Solution Membrane)(2N3368) | The predicate device does nothave a 1.2 μm Filter. Designcontrol activities have beenconducted and have confirmedthat the different technologicalcharacteristics of the proposeddevices do not raise differentquestions of safety andeffectiveness. |
| Tubing | Polyvinyl Chloride(2N8374) | Same(2N3358, 2N3380,2N3354, 2N3382,2N3357, 2N3355,2N3356, 2N3359,2N3386) | N/A |
| Features | Predicate DeviceCleared underK112893 | Proposed Devices | Assessment of Differences |
| Tri-LayerTubing | Not Applicable | Low-DensityPolyethyleneEthylene vinyl acetatePolyvinyl chloride(2N3360, 2N3361,2N3362) | The predicate device does nothave the same type of materialformulation. Design controlactivities have been conductedand have confirmed that thedifferent technologicalcharacteristics of the proposeddevices do not raise differentquestions of safety andeffectiveness. |
| Female LuerLock | Copolyester(2N8374) | Polymethylmethacrylate (Acrylic)(2N3358, 2N3380,2N3354, 2N3382,2N3357, 2N3355,2N3356, 2N3359,2N3360, 2N3361,2N3362, 2N3386) | The predicate device does nothave the same type of materialformulation. Design controlactivities have been conductedand have confirmed that thedifferent technologicalcharacteristics of the proposeddevices do not raise differentquestions of safety andeffectiveness. |
| Male LuerLock | AcrylonitrileButadiene Styrene(2N8374) | Same(2N3358, 2N3380,2N3354, 2N3382,2N3357, 2N3355,2N3356, 2N3359,2N3360, 2N3361,2N3362, 2N3386) | N/A |
| Male LuerCap | Polypropylene(2N8374) | High DensityPolyethylene (Cap)Hydrophobic Filter,Acrylic (W/Non-WovenNylon Substrate) (FilterMembrane)(2N3358, 2N3380,2N3354, 2N3382,2N3357, 2N3355,2N3356, 2N3359,2N3360, 2N3361,2N3362, 2N3386) | The predicate device does nothave the same type of material.Design control activities havebeen conducted and haveconfirmed that the differenttechnological characteristics ofthe proposed devices do not raisedifferent questions of safety andeffectiveness. |
Table 4. Device Comparison
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be slightly italicized. The word is the main focus of the image and is positioned horizontally.
Table 4. Device Comparison
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement.
Table 4. Device Comparison
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly blurred, giving it a sense of depth. The font is sans-serif and appears to be a company logo.
Table 4. Device Comparison
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly blurred, suggesting that the image may have been taken from a distance or with a slightly out-of-focus lens. The background is white.
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.
Performance Data:
The following bench tests (Table 5) were conducted to evaluate the functional performance of the proposed devices:
| Test | Acceptance Criteria |
|---|---|
| ISO 80369-7 Luer Tests on male Luer Lock Connector | BS EN ISO 80369-7:2016, Clause 6.1.2,BS EN ISO 80369-7:2016, Clause 6.1.3,ISO 80369-7:2016, Clause 6.2,ISO 80369-7:2016, Clause 6.3,ISO 80369-20:2015 AnnexE,ISO 80369-7:2016, Clause 6.1.2,ISO 80369-7:2016, Clause 6.1.3,ISO 80369-7:2016, Clause 6.4,ISO 80369-7:2016, Clause 6.5,ISO 80369-7:2016, Clause 6.6,ISO 80369-7: 2016, Clause 5,ISO 594-1:1986, Clause 3,ISO 594-2:1998, Clause 3 (as applicable) |
| ISO 80369-7 Luer Tests on female Luer LockConnector | BS EN ISO 80369-7:2016, Clause 6.1.2,BS EN ISO 80369-7:2016, Clause 6.1.3,ISO 80369-7:2016, Clause 6.2,ISO 80369-7:2016 Clause 6.3,ISO 80369-20:2015 AnnexE,ISO 80369-7:2016, Clause 6.1.2,ISO 80369- 7:2016, Clause 6.1.3,ISO 80369-7:2016, Clause 6.4,ISO 803697:2016, Clause 6.5.ISO 80369-7:2016, Clause 6.6,ISO 80369-7:2016, Clause 5 (as applicable),ISO 594-1:1986, Clause 3,ISO 594-2:1998, Clause 3 |
| Tensile Strength Test | BS EN ISO 8536-9, Clause 5.3,BS EN ISO 8536-10, Clause 4.3,BS EN ISO 8536-11, Clause 5.3,BS EN ISO 8536-12, Clause 6.2, |
| Leak Test | BS EN ISO 8536-9: 2015, Section A.4,BS EN ISO 8536-11:2015, Section A.4,ISO 8536-10: 2015, section A.4 |
| Counter Flow Test | ISO 8536-12:2007+A1:2013, Clause A.4. |
Table 5. Performance Data
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement. The background is plain white, which makes the blue text stand out.
| Test | Acceptance Criteria |
|---|---|
| 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 |
| Notch Clamp Activation Force Test | Per Baxter Test Method |
| Notch Clamp Shut-Off Test | ISO 8536-14:2015 |
| Filter Tests | EN ISO 8536-11, Clause 5.1and per Baxter Test Method |
| Non-DEHP Claim Verification (<0.1% DEHP) | Per Baxter Test Method (as tested inK161808) |
Table 5. 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 duration, external communicating device, indirect blood path and FDA-2013-D-0350 Guidance for Industry & FDA Staff, Use of ISO 10993-1, "Biological evaluation and medical devices - Part 1: Evaluation and testing within a risk management process, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing",as recommended in the Intravascular Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]". Biocompatibility assessments were conducted on a worst case/representative final, finished device for all materials of the proposed devices. The following tests were conducted as part of the biocompatibility testing for the proposed devices' fluid path:
- Cytotoxicity ISO 10993-5
- Sensitization ISO 10993-10
- Intracutaneous (Irritation) Reactivity ISO 10993-10
- Systemic Toxicity (acute dose) ISO 10993-11
- Toxicological Assessment of Extractable Profile ISO 10993-17
- Materials Mediated Pyrogen ISO 10993-11
- Hemolysis ISO 10993-4
- Extractable Assessment ISO 10993-18
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly italicized, giving it a sense of movement. The background is plain white, which makes the blue text stand out.
- . 14 Day Systemic Repeat Dose Toxicity Study ISO 10993-11
Based upon the results of this prolonged duration, external communicating, indirect blood path testing, the proposed devices have been shown to be biocompatible and appropriate for their intended use.
Sterility:
The proposed devices are sterilized with gamma radiation. The products are in the bioburden (sub) category "General Sets Labeled "Sterile" and "General Small Devices 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 presteriilzation bioburden testing is performed for each (sub) category.
Shelf-Life :
Baxter has performed aging testing to support a shelf-life claim of 3 (three) years.
Microbial Ingress Testing:
Baxter has conducted testing on all potential points of microbial entry into the sterile fluid pathway of the proposed devices subject to this premarket notification. The Luer Connector Sites were tested following Baxter's test method. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.
Particulate Matter Testing
Baxter has performed particulate matter testing per <USP 788> on the proposed devices subject to this premarket notification. All test results meet 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.
§ 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.