(352 days)
The MaxZero™ extension set with needle-free connector(s) is for single use only. The MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.
The MaxZero™ Extension Sets with Needle-Free Connector(s) are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. The MaxZero™ Extension Sets with Needle-Free Connector(s) are sterile single patient devices that can be used for up to seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.
The provided text describes a 510(k) premarket notification for a medical device, the MaxZero™ Extension Sets with Needle-Free Connector(s). This type of submission relies on demonstrating "substantial equivalence" to a predicate device, rather than proving independent effectiveness through clinical trials in the same way a new drug or novel medical device might.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance tests performed to demonstrate that the new device (subject device) is as safe and effective as the previously cleared predicate device, despite some differences.
Here's an analysis of the provided information within the framework of your request:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative table with corresponding numerical results in the provided document. Instead, the document discusses various performance tests conducted according to established ISO standards and FDA guidance, with a general statement that "All test results met their acceptance criteria." The table provided on pages 5-6 outlines various characteristics of the subject device and compares them to the predicate device, indicating "Equivalence" or "Different" with explanations.
Based on the information, the acceptance criteria are implicitly derived from the relevant ISO standards and FDA guidance documents, which define the expected performance metrics for intravascular administration sets. The "reported device performance" refers to the fact that the device passed these tests.
Implied Acceptance Criteria and Reported Performance (extracted from comparison and performance discussion):
| Performance Characteristic | Implied Acceptance Criteria (based on predicate/standards) | Reported Device Performance (as stated in document) |
|---|---|---|
| Regulation Number | 21 CFR 880.5440 | Met (Same as predicate) |
| Regulation Name | Intravascular Administration Set | Met (Same as predicate) |
| Class | Class II | Met (Same as predicate) |
| Product Code | FPA | Met (Same as predicate) |
| Sterility | Must be sterile (E-Beam) | Met (Sterilization by E-Beam) |
| Purity | Non-Pyrogenic | Met (Non-pyrogenic) |
| Material Safety | Not made with DEHP, Not natural latex rubber | Met (Not made with DEHP, not natural latex rubber) |
| Usable Life | Up to 7 days, 200 activations | Met (Up to 7 days, 200 activations) |
| Disinfection | Disinfectable with 70% Isopropyl Alcohol | Met |
| Biocompatibility | ISO 10993-1 compliant | Met (Conducted per ISO 10993 series) |
| Leakage | Must not leak (per ISO 594-1/2) | Met acceptance criteria |
| Separation Force | Must meet spec (per ISO 594-1/2) | Met acceptance criteria |
| Unscrewing Torque | Must meet spec (per ISO 594-1/2) | Met acceptance criteria |
| Ease of Assembly | Must meet spec | Met acceptance criteria |
| Resistance to Overriding | Must meet spec | Met acceptance criteria |
| Stress Cracking | Must meet spec | Met acceptance criteria |
| Particulate Contamination | Must meet USP <788> | Met acceptance criteria |
| Tensile Strength | Must meet spec | Met acceptance criteria |
| Male Conical Fitting | Must meet spec | Met acceptance criteria |
| Protective Caps | Must meet spec | Met acceptance criteria |
| Chemical Requirements | Must meet spec | Met acceptance criteria |
| Biological Requirements | Must meet spec | Met acceptance criteria |
| Fluid Filter Performance | Must perform as intended (for filtered models) | Met acceptance criteria |
| UV Light Resistance | Blocks minimum 90% of UV light (250-450 nm) | Met (Proposed new component performance) |
| Flow Testing | Must meet spec (microbore/minibore) | Met acceptance criteria |
| Clamps | Must meet spec (internal excess pressure, fluid path) | Met acceptance criteria |
| Peak Pressure Testing | Must meet spec | Met acceptance criteria |
| Priming Volume | Varies (range from 0.7mL – 2.0mL reported) | Met (Different from predicate, but acceptable) |
| Vacuum Integrity | -2.9 psi vacuum reported | Met (Different from predicate, but acceptable) |
| Maximum Pressure | 30 psi (non-pressure rated sets per ISO 8536) | Met (Different from predicate, but acceptable) |
| Shelf Life | 1 Year (subject device) vs 3 Years (predicate) | Met (Acceptable for substantial equivalence) |
| Air Water Interface Visibility | Pass (Clear Tubing) | Met acceptance criteria |
| Microbial Ingress | Must not permit microbial ingress | Met acceptance criteria |
Note: The document explicitly states "Design Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different questions of safety and effectiveness" for the characteristics where the subject device differs from the predicate (e.g., device length, materials, configurations, physical specifications, filter size, tubing bore, bonding agent, priming volume, vacuum integrity, maximum pressure, shelf life, light resistance of amber tubing). This indicates that the differences were evaluated and found to be acceptable for substantial equivalence.
Study Details (as applicable to a 510(k) for a Class II device)
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided abstract for each specific test. However, typical non-clinical performance testing for medical devices involved in 510(k) submissions would use a predetermined number of samples for each test type (e.g., n=3, n=5, n=10, or more, depending on the test and statistical rationale).
- Data Provenance: The data is from non-clinical bench testing ("CareFusion performed design verification performance testing"). There is no mention of country of origin for the testing itself, but given it's an FDA submission, the testing would be expected to adhere to international and potentially US-specific standards. The nature of the testing is prospective as it's part of design verification for a new device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. This is a non-clinical, engineering/performance study assessing a physical medical device's functional characteristics (e.g., leakage, tensile strength, flow rate, material compatibility). "Ground truth" established by human experts (like radiologists for image analysis) is not relevant to this type of device and study. The "ground truth" here is the pass/fail criteria defined by the recognized consensus standards (e.g., ISO, ASTM, USP) and the device's design specifications.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. The test results are quantitative physical measurements or qualitative pass/fail outcomes against pre-defined engineering and material standards.
4. 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:
- No. This is a medical device (intravascular administration set), not an AI/imaging device. Therefore, MRMC studies are not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated, this is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" (or more accurately, the acceptance criteria) for this type of device performance study is based on recognized consensus standards (like various ISO standards for medical devices, ASTM standards, USP for particulate matter) and the predicate device's established performance and safety profile. The testing verifies that the subject device meets these established engineering, material, and functional benchmarks.
7. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this traditional 510(k) submission for a physical medical device. This is not an AI/machine learning product. The design and manufacturing process are subject to Quality System (QS) Regulation (21 CFR Part 820), which involves process validation and quality control, but not a "training set" in the computational sense.
8. How the ground truth for the training set was established:
- Not applicable. (See point 7).
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Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
October 23, 2020
Carefusion, Inc. Nesli Karakaya Sr. Manager, Regulatory Affairs 120 S State College Blvd, Suite 100 Brea, California 92821
Re: K193088
Trade/Device Name: MaxZero™ Extension Sets with Needle-Free Connector(s) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: September 22, 2020 Received: September 23, 2020
Dear Nesli Karakaya:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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 Paval 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
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Indications for Use
510(k) Number (if known) K193088
Device Name
MaxZero™ Extension Sets with Needle-Free Connector(s)
Indications for Use (Describe)
The MaxZero™ extension set with needle-free connector(s) is for single use only. The
MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.
| 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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Image /page/3/Picture/0 description: The image contains the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a yellow accent on the top right corner. The text is to the right of the circle.
Traditional 510(k) Premarket Notification MaxZero™ Extension Sets with Needle-Free Connector(s)
510(k) Summary K193088
Submitter Information
Submitter:
CareFusion, Inc.
| Contact Person: | Nesli Karakaya |
|---|---|
| Phone: | +41 21 556 3192 |
| Email: | Nesli.Karakaya@bd.com |
| Date Prepared: | October 20, 2020 |
| 120 S State College BlvdBrea, CA 92821, USA |
Subject Device Identification
| Trade Name: | MaxZero™ Extension Sets with Needle-Free Connector(s) |
|---|---|
| Common Name: | Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set |
| Classification Panel: | General Hospital |
| Regulation Number: | 21 CFR 880.5440 |
| Regulatory Class: | Class II |
| Product Code: | FPA |
Predicate Device Identification
| Trade Name: | MaxZero™ Extension Sets with Needleless Connector | ||
|---|---|---|---|
| Common Name: | Intravascular Administration Set | ||
| Classification Name: | Intravascular Administration Set | ||
| Classification Panel: | General Hospital | ||
| Regulation Number: | 21 CFR 880.5440 | ||
| Regulatory Class: | Class II | ||
| Product Code: | FPA | ||
| Manufacturer: | Carefusion, Inc. | ||
| 510k Number: | K140831 | ||
| 510K Clearance Date: | April 15, 2014 |
Reason for Submission
The objective of this submission is to introduce new components such as amber tubing that is resistant to UV light, trifurcated adaptors that connects 3 legs of tubing to a single male luer and filters that help prevent particles from flowing through the IV fluid line to the MaxZero™ Extension Sets with Needleless Connector(s).
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Image /page/4/Picture/0 description: The image shows the logo for CareFusion. The logo consists of an orange circle with a white shield inside. The shield has a yellow arrow pointing to the upper right. To the right of the logo is the word "CareFusion" in gray.
Device Description
The MaxZero™ Extension Sets with Needle-Free Connector(s) are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. The MaxZero™ Extension Sets with Needle-Free Connector(s) are sterile single patient devices that can be used for up to seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.
| Components | Description |
|---|---|
| MaxZero Needle-freeConnector | Needle-free connector used for the delivery or aspiration ofdrugs, blood and fluids to/from an IV catheter |
| Amber tubing | Delivers fluid to/from patient while blocking UV light |
| Filters | Filters out particulate |
| Slide Clamp | To close fluid path along tubing |
| Male Luer (spin lock) | Connects distal end of set to female luer |
| Bifurcated connectors(Y-connectors) | Merges two legs of tubing into single leg |
The following table lists the components that the device is comprised of.
Indication for Use
Trifurcated adapter
The MaxZero™ extension set with needle-free connector(s) is for single use only. The MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.
Connects 3 legs of tubing to a single male luer
Technological Characteristics
The information provided in this premarket notification demonstrates that the subject MaxZero™ Extension Sets with Needle-Free Connector(s) is substantially equivalent to the leqally marketed predicated device. The subject device and the predicate device are intended to be used for the delivery or aspiration of drugs, blood and fluids to/from an IV catheter in a hospital environment. The subject and predicate devices are similar in physical properties, materials, and configuration. Each device includes connectors that allow for needle-free access to the IV line during IV therapy eliminating the risk of needlestick injury. The subject device incorporates the MaxZero™ Needle-Free Connector attached to IV tubing. Components of the subject devices are made of materials that are substantially equivalent to those of the predicate device.
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Image /page/5/Picture/0 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white shield-like shape inside, with a small portion of the shield colored yellow. To the right of the circle is the text "CareFusion" in a dark gray, sans-serif font.
Traditional 510(k) Premarket Notification MaxZero™ Extension Sets with Needle-Free Connector(s)
Proposed MaxZero Extension Sets
| ModelNumber | Description | Tubing | ID | OD |
|---|---|---|---|---|
| MZ9303 | Microbore amber extension set, IVconnector (70") | Microbore Amber | 0.023" | 0.079" |
| MZ9321 | Microbore amber extension set, IVconnector, 0.2 micron filter (81") | Microbore Amber | 0.023" | 0.079" |
| MZ9299 | Microbore quad-fuse extension set, 4 IVconnectors, 1 ambertubing lead, 3 clear tubing leads (7") | Microbore Amber | 0.023" | 0.079" |
| Microbore Clear | 0.020" | 0.079" | ||
| MZ9328 | Minibore amber extension set, IVconnector, 1.2 micron filter (81") | Minibore Amber | 0.042" | 0.079" |
Substantial Equivalence Table
| MaxZero™ ExtensionSets with Needle-freeConnector(s)(Subject Device) | CareFusion MaxZero™Extension Sets withNeedleless Connector(K140831) | Equivalence | |
|---|---|---|---|
| FDA Reg.Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| FDA RegulationName | IntravascularAdministration Set | IntravascularAdministration Set | Same |
| FDA Class | Class II | Class II | Same |
| FDA ProductCode | FPA | FPA | Same |
| ProductDescription | MaxZero™ Extension Setswith Needle-freeConnector(s) and thepredicate devices aresterile, single patient use,including pediatrics andimmunocompromisedpatients for direct inject,intermittent infusion,continuous infusion oraspiration of drugs, bloodand fluids | MaxZero™ Extension Setswith Needleless Connectorand the predicate devicesare sterile, single patientuse, including pediatricsand immunocompromisedpatients for direct inject,intermittent infusion,continuous infusion oraspiration of drugs, bloodand fluids | Same |
| Intended Use | The MaxZero™ ExtensionSet with Needle-freeConnector(s) is a sterilesingle patient use deviceintended to be used forthe delivery or aspiration | The MaxZero™ ExtensionSets with NeedlelessConnector is a sterile singlepatient use device intendedto be used for the delivery | EquivalentClarified delivery oraspiration of drugs,bloods and fluids.This is equivalent to |
| Traditional 510(k) Premarket NotificationMaxZero™ Extension Sets with Needle-Free Connector(s) | |||
| CareFusion MaxZero™Extension Sets withNeedleless Connector(K140831) | Equivalence | ||
| Indication foruse | |||
| MaxZero™ ExtensionSets with Needle-freeConnector(s)(Subject Device) | |||
| of drugs, blood and fluidsto/from an IV catheter. | or aspiration of fluidsto/from an IV catheter. | the devicedescription of thepredicate device. | |
| Indication foruse | The MaxZero™ extensionset with needle-freeconnector(s) is for singleuse only. The MaxZero™extension set with needle-free connector(s) may beused for direct injection,intermittent infusion,continuous infusion oraspiration of drugs, bloodand fluids. | Pressure Rated: TheMaxZero™ multi fuseextension set withneedleless connector(s) isfor single use only. Theextension set may be usedfor direct injection,intermittent infusion,continuous infusion oraspiration. This set may beused with power injectorprocedures to a maximumpressure of 325 psi at aflow rate of 10mL persecond.Non-Pressure Rated:The MaxZero™ multi fuseextension set withneedleless connector(s) isfor single use only. Theextension set may be usedfor direct injection,intermittent infusion,continuous infusion oraspiration. | Equivalent to non-pressure rated setsThe subject device isnot indicated forpower injection. Allsubject devices arenon-pressure ratedsets.Clarified deliveryand/or aspiration ofdrugs, bloods andfluids. This isequivalent to thedevice description ofthe predicate device. |
| Device Length | MZ9303Microbore amberextension set, IVconnector (70"Total Length) MZ9321Microbore amberextension set, IVconnector, filter(81" TotalLength) MZ9299Microbore quad-fuse extensionset, 4 IVconnectors, 1amber tubinglead (7" TotalLength) | MZ5301 Pressurerated extensionset, MaxZeroconnector, slideclamp, spin maleluer lock (7" TotalLength) MZ5301 Pressurerated extensionset, MaxZeroconnector, slideclamp, spin maleluer lock (7" TotalLength) MZ5304 Pressurerated extensionset, MaxZeroconnector, slideclamp spin male | DifferentNew lengths added -subject device hasthe same intendeduse as the predicatedevice. Lengthdifferences weretested according toapplicable consensusstandards (same asthe predicatedevice). |
| Traditional 510(k) Premarket NotificationMaxZero™ Extension Sets with Needle-Free Connector(s) | |||
| MaxZero™ Extension Sets with Needle-free Connector(s) (Subject Device) | CareFusion MaxZero™ Extension Sets with Needleless Connector (K140831) | Equivalence | |
| MZ9328 Minibore amber extension set, IV connector, filter (81" Total Length) | luer lock (7" Total Length) MZ5305 Pressure rated extension set, MaxZero connector, spin make luer lock (7" Total Length) MZ5306 Pressure rated extension set, minibore tubing, MaxZero connector, spin make luer lock (7" Total Length) MZ5307 Bi-fuse pressure rated extension set, minibore tubing, (2) MaxZero connectors, (2) side clamps, spin male luer lock. (7" Total Length) MZ3508 Bi-fuse pressure rated extension set, minibore tubing, (2) MaxZero connectors, (2) slide clamps, spin make luer lock. (6" Total Length) MZ9284 Bi-fuse pressure rated extension set, minibore tubing, (2) MaxZero connectors, (2) check valves (2) slide clamps, spin make luer lock (7" Total Length) MZ9285 Bi-fuse pressure rated extension set, minibore tubing, (2) MaxZero connectors | ||
| Traditional 510(k) Premarket NotificationMaxZero™ Extension Sets with Needle-Free Connector(s) | |||
| MaxZero™ ExtensionSets with Needle-freeConnector(s)(Subject Device) | CareFusion MaxZero™Extension Sets withNeedleless Connector(K140831) | Equivalence | |
| Fluid ContactingMaterialComposition | Needle-free Connector:Polycarbonate, siliconerubberTubing: Non DEHP PVCBi-F Connector: RigidPVCTri-F Connector: AcrylicMale Luer (Spinlock):ABSAmber Tubing: NonDEHP PVCFilters: Acrylic, FilterMedia | Needle-free Connector:Polycarbonate, siliconerubberTubing: Non DEHP PVCBi-F Connector: Rigid PVCBack Check Valve: ABS,silicon rubberMale Luer Adapter: ABSMale Spinlock: ABSFemale Luer: Copolyester | DifferentNew Materialsincluded in subjectdevice:Acrylic, Filter Media.Design Controlactivities have beenconducted and haveconfirmed thedifferenttechnologicalcharacteristics of theproposed device donot raise differentquestions of safetyand effectiveness |
| Configurations | MaxZero Needle-freeConnector, PVC tubingwith various length andID/OD, clear tubing,amber tubing, in-linefilters of various sizes,slide clamps, male luer(spin lock), female luer(female wing adapter),bifurcated connectors (Y-connectors) andtrifurcated adapter | MaxZero NeedlelessConnector, tubing ofvarious length and ID/OD,back check valve, slideclamps, pinch clamps, Yconnectors, male spin lockand female wing adapterdepending on configuration | DifferentNew Componentsincluded in subjectdevice:Amber tubing,filters, trifurcatedadaptor. DesignControl activitieshave been conductedand have confirmedthe differenttechnologicalcharacteristics of theproposed device donot raise differentquestions of safetyand effectiveness |
| PhysicalSpecification | Up to quad-fuse extensionset. Lengths from 6" to81" | Up to 2-piece extension set.Average length 7" | DifferentDesign Controlactivities have beenconducted and haveconfirmed thedifferenttechnologicalcharacteristics of theproposed device donot raise differentquestions of safetyand effectiveness |
| Traditional 510(k) Premarket Notification MaxZero™ Extension Sets with Needle-Free Connector(s) | |||
| MaxZero™ Extension Sets with Needle-free Connector(s) (Subject Device) | CareFusion MaxZero™ Extension Sets with Needleless Connector (K140831) | Equivalence | |
| Filter Size | 0.2 Micron Filter1.2 Micron Filter | NA | proposed device do not raise different questions of safety and effectivenessDifferentDesign Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different questions of safety and effectiveness |
| Tubing Bore | Micro Bore = .023 ID X .079 ODMini Bore = .042 ID X .079 OD | Standard Bore = .060 ID X 0.144 ODMicro Bore = .023 ID X .079 OD | DifferentNew tubing added: Mini bore tubingDesign Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different questions of safety and effectiveness |
| NON-DEHP tubing | Yes | Yes | Same |
| Bonding agent | Cyclohexanone, Methylene Chloride, and Methyl Ethyl Ketone | Cyclohexanone | Different Bonding Agents usedDesign Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different |
| MaxZero™ ExtensionSets with Needle-freeConnector(s)(Subject Device) | MaxZero™ Extension Sets with Needle-Free Connector(s)CareFusion MaxZero™Extension Sets withNeedleless Connector(K140831) | Equivalence | |
| No naturalrubber latex | Yes | Yes | questions of safetyand effectiveness |
| SterilizationMethod | E-Beam | E-Beam | Same |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Usable Life | Up to 7 days 200activation | 7 days 200 activation | EquivalentClarification addedfor up to 7 days |
| Disinfect with70% IsopropylAlcohol | Disinfect with 70%Isopropyl Alcohol | Disinfect with 70%Isopropyl Alcohol | Same |
| Performance | |||
| Priming Volume | $0.7mL – 2.0mL$ | Avg. $0.66 mL – 0.99 mL$ | DifferentDesign Controlactivities have beenconducted and haveconfirmed thedifferenttechnologicalcharacteristics of theproposed device donot raise differentquestions of safetyand effectiveness |
| VacuumIntegrity | -2.9 psi vacuum | -3.0 psi vacuum | DifferentDesign Controlactivities have beenconducted and haveconfirmed thedifferenttechnologicalcharacteristics of theproposed device donot raise differentquestions of safetyand effectiveness |
| MaximumPressure | 30 psi non-pressure ratedsets | 45 psi non-pressure ratedsets | DifferentSubject devicerequirement has |
| MaxZero™ Extension Sets with Needle-Free Connector(s) | |||
| MaxZero™ ExtensionSets with Needle-freeConnector(s)(Subject Device) | CareFusion MaxZero™Extension Sets withNeedleless Connector(K140831) | Equivalence | |
| ISO 8536 whichspecifies 30 psi (200kPa) | |||
| Shelf Life | 1 Year | 3 Years | Equivalent |
| TubingTransparency(Clear Tubing) | Pass | Pass | Same |
| Light Resistance(Amber Tubing) | Blocks a minimum of 90%of UV light at anywavelength between 250-450 nm | N/A | DifferentNew componentadded:Amber tubingDesign Controlactivities have beenconducted and haveconfirmed thedifferenttechnologicalcharacteristics of theproposed device donot raise differentquestions of safetyand effectiveness |
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Image /page/6/Picture/0 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white shield containing a yellow arrow pointing to the upper right. To the right of the logo is the text "CareFusion" in a dark gray sans-serif font.
Traditional 510(k) Premarket Notification
<tension Sets with Needle-Free Connector(s)
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Image /page/7/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. The shield has a small orange arrow pointing downwards.
Traditional 510(k) Premarket Notification
<tension Sets with Needle-Free Connector(s)
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Image /page/8/Picture/0 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white shield-like shape inside, and the text "CareFusion" is written in a gray sans-serif font to the right of the circle. The shield shape has a small orange arrow pointing downwards.
Traditional 510(k) Premarket Notification
<tension Sets with Needle-Free Connector(s)
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Image /page/9/Picture/0 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in a dark gray sans-serif font to the right of the circle. The shield has a small orange section in the upper right corner.
Traditional 510(k) Premarket Notification
xtension Sets with Needle-Free Connector(s)
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Image /page/10/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in a sans-serif font. The shield has an orange outline and a white interior, and it is tilted slightly to the right. The text "CareFusion" is in a dark gray color.
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Image /page/11/Picture/0 description: The image contains the CareFusion logo. The logo consists of an orange circle with a white shield inside. The shield has an orange outline and a white arrow pointing downwards. To the right of the circle is the text "CareFusion" in a gray, sans-serif font.
Traditional 510(k) Premarket Notification
Explanation of Similarities and Differences technological Characteristics compared to Predicate Device
The Subject MaxZero™ Extension Sets with Needle-Free Connector(s) have the following similarities to the predicate devices:
- Same Intended Use and Indication for Use ●
- Principle of operation .
- Device Design .
- Zero Reflux Needleless Connector ●
- Needle-free connector can be disinfected with 3 sec scrub with 70% IPA ●
- Maximum clinical use of up to 7 days 200 activations for the ● needleless connector (single patient use)
- . Non-hemolytic and Non-pyrogenic
- Not made with DEHP and not made with natural latex rubber ●
- Sets tested to be used with harsh infusates
The following are technical characteristics differences between the subject and predicate devices:
- The subject device includes amber tubing that is resistant to UV light o
510(K) Summary
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Image /page/12/Picture/0 description: The image shows the logo for CareFusion. The logo consists of an orange circle with a white shield inside. The shield has a small orange triangle in the upper right corner. To the right of the circle is the word "CareFusion" in gray sans-serif font.
Traditional 510(k) Premarket Notification
- MaxZero™ Extension Sets with Needle-Free Connector(s) 0 The subject device includes filters that help prevent particles from flowing through the IV fluid line
- The subject device has new materials
- The subject device includes trifurcated adaptor that provides multi-fuse set with both o amber and clear tubing
- The subject device includes mini bore tubing and different bonding agent
- o The subject device includes different in priming volume, Vacuum Integrity, Maximum pressure and Shelf life
- 0 The subject device offers new lengths
Design Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different questions of safety and effectiveness.
Discussion of Performance Data:
Non-Clinical Data
CareFusion performed design verification performance testing to verify, demonstrate and support the claim of substantial equivalence to the predicate devices. All test results met their acceptance criteria and support that the MaxZero™ Extension Sets with Needle-free Connector are appropriately designed for their intended use.
Carefusion performed design verformance testing according to the FDA recognized/voluntary consensus standards and quidelines.
- . ISO 594-1:1986 Conical fittings with a 6% (luer) taper of syringes, needles, and certain other medical equipment - Part 1: General requirements"
- . ISO 594-2:1998 Conical fittings with 6%(luer) taper for syringes, needles, and certain other medical equipment – Part 2 Lockingfittings
- . ISO 8536-4:2010 "Infusion equipment for medical use- Part 4: Infusion set for single use, gravity feed"
- . ISO 8536-8:2015 "Infusion equipment for medical use – Part 8: Infusion equipment for medical use. Infusion equipment for use with pressure infusion apparatus"
- . ISO 8536-9:2015 "Infusion equipment for medical use – Part 9: Fluid lines for single use with pressure infusion equipment"
- . ISO 8536-10:2015 "Infusion equipment for medical use – Part 10: Accessories for Fluid lines for single use with pressure infusion equipment"
- o ISO 8536-11:2015 "Infusion equipment for medical use – Part 11 Infusion filters for use with pressure infusion equipment"
- . ISO 14971:2016 "Medical devices- Application of risk management to medical devices"
- . Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submission [510(k)], July 11,2008
- . USP <788> "Particulate Matter in Injections"
The following tests were conducted according to the above standards:
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Image /page/13/Picture/0 description: The image shows the logo for CareFusion. The logo consists of an orange circle with a white shield inside. The shield has a small orange accent in the upper right corner. To the right of the circle is the word "CareFusion" in a dark gray sans-serif font.
Traditional 510(k) Premarket Notification MaxZero™ Extension Sets with Needle-Free Connector(s)
- Leakage .
- Separation Force .
- . Unscrewing Torque
- Ease of Assembly ●
- . Resistance to Overriding
- . Stress Cracking
- . Particulate Contamination
- Tensile Strength ●
- . Tubing: air/water interface only, not applicable to sets with light blocking tubing
- Fluid Filter
- Male Conical Fitting
- Protective Caps
- . Chemical Requirements
- . Biological Requirements
Biocompatibility
Biocompatibility assessments were conducted in accordance with ISO-10993-1:2009, "Biological evaluation of medical devices – part 1: Evaluation and testing within a risk manaqement process," Carefusion performed the biocompatibility testing of the components and finish product according to the following parts of the ISO 10993 standard.
- . ISO 10993-2:2006: "Biological evaluation of medical devices – part 2: Animal welfare requirements"
- . ISO 10993-4:2002: "Biological evaluation of medical devices - part 4: Selection of tests for interactions with blood"
- ISO 10993-5: 2009: "Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity"
- ISO 10993-10:2010: "Biological evaluation of medical devices part 10: Tests for ● irritation and delayed-type hypersensitivity"
- o ISO 10993-11:2006: "Biological evaluation of medical devices – part 11: Test for systemic Toxicity"
- ISO 10993-12:2012: "Biological evaluation of medical devices - part 12: Sample preparation and reference materials"
Sterilization and Shelf life
The subject MaxZero™ Extension Sets with Needle-Free Connector(s) device is radiation sterilized and the shelf life data supports a shelf life claim of 1 year. Sterilization and shelf life testing were completed according to the following FDA recognized standards:
- ISO 11137-1:2006 "Sterilization of health care products - Radiation- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices"
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Image /page/14/Picture/0 description: The image contains the logo for CareFusion. The logo consists of an orange circle with a white arrow pointing downwards and to the left, partially surrounded by an orange arc. To the right of the circle is the word "CareFusion" in a gray, sans-serif font. The logo is simple and modern, with a focus on the company name.
Traditional 510(k) Premarket Notification
- MaxZero™ Extension Sets with Needle-Free Connector(s)
- ISO 11137-2:2006 "Sterilization of health care products Radiation Part 2 . Establishing the sterilization dose"
- . ISO 11607-1:2006 "Packaging for terminally sterilized medicaldevices – Part 1: Requirements for materials, sterile barrier systems, and packaging systems"
- . ASTM F1980-07: 2002 "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"
- ASTM F1140: 2000 "Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization within Restraining Plates"
- . ASTM D4169: 1998 "Standard Practice for Performance Testing of Shipping Containers and Systems"
- ASTM-F1929-98(04): 1998 "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"
In addition to the above testing performed according to the ISO standards, the following performance testing was also conducted:
- UV Light Resistant: Test for light resistant ability of tube ●
- Flow Testing: Testing for flow of microbore and minibore tubing ●
- Clamps: Internal Excess Pressure and Tubing Open Fluid Path Testing
- Peak Pressure testing: Internal fluid peak pressure testing
- o Priming volume testing: Priming volume is measured to have an approximate average of priming volume.
- Harsh Infusates testing: Device tests for multiple days with worst case infusates
- . Air Water Interface Visibility (Clear Tubing)
- Microbial Ingress
Clinical Data
There are no clinical data included in this submission.
Conclusion
The subject MaxZero™ Extension Sets with Needle-Free Connector(s) met all predetermined acceptance criteria for functional, microbial ingress, sterility, biocompatibility, and other performance testing. Results of this testing demonstrate that the subject device is substantially equivalent to the predicate device.
§ 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.