(352 days)
Not Found
No
The document describes a standard medical device (extension set with needle-free connector) and its performance testing, with no mention of AI or ML capabilities.
No.
The device is used for the administration or aspiration of drugs, blood, and fluids, not for therapeutic purposes.
No
The device is described as an "extension set with needle-free connector(s)" used for administration or aspiration of drugs, blood, and fluids. Its function is to facilitate the delivery or removal of substances from the body, not to diagnose a condition.
No
The device description clearly indicates it is a physical medical device (extension set with needle-free connectors) used for administering fluids, not a software-only device.
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 or aspiration of drugs, blood, and fluids directly into or from the bloodstream (intravascular). This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description confirms it's an intravascular extension set for administering or aspirating substances.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health. IVDs are designed to perform tests on biological samples.
- Performance Studies: The performance studies focus on the physical and functional integrity of the device for its intended use (leakage, flow, strength, etc.), not on the accuracy or reliability of diagnostic results.
In summary, the MaxZero™ extension set is a medical device used for delivering or withdrawing substances from the body, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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:
MaxZero Needle-free Connector: Needle-free connector used for the delivery or aspiration of drugs, 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
Trifurcated adapter: Connects 3 legs of tubing to a single male luer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatrics
Intended User / Care Setting
hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Testing was performed according to FDA recognized/voluntary consensus standards and guidelines, including ISO 594-1:1986, ISO 594-2:1998, ISO 8536-4:2010, ISO 8536-8:2015, ISO 8536-9:2015, ISO 8536-10:2015, ISO 8536-11:2015, ISO 14971:2016, Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submission [510(k)], July 11,2008, and USP . Tests conducted included: Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking, Particulate Contamination, Tensile Strength, Tubing (air/water interface only), Fluid Filter, Male Conical Fitting, Protective Caps, Chemical Requirements, Biological Requirements.
Biocompatibility: Biocompatibility assessments were conducted in accordance with ISO-10993-1:2009. Testing was performed according to ISO 10993-2:2006, ISO 10993-4:2002, ISO 10993-5: 2009, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012.
Sterilization and Shelf life: The device is radiation sterilized and has a shelf life of 1 year. Testing was completed according to ISO 11137-1:2006, ISO 11137-2:2006, ISO 11607-1:2006, ASTM F1980-07: 2002, ASTM F1140: 2000, ASTM D4169: 1998, ASTM-F1929-98(04): 1998.
Additional performance testing conducted: UV Light Resistant, Flow Testing, Clamps (Internal Excess Pressure and Tubing Open Fluid Path Testing), Peak Pressure testing, Priming volume testing, Harsh Infusates testing, Air Water Interface Visibility (Clear Tubing), Microbial Ingress.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
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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
1
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
2
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 Blvd | |
| Brea, 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-free | |
| Connector | Needle-free connector used for the delivery or aspiration of |
| drugs, 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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Traditional 510(k) Premarket Notification MaxZero™ Extension Sets with Needle-Free Connector(s)
Proposed MaxZero Extension Sets
| Model
| Number | Description | Tubing | ID | OD |
|---|---|---|---|---|
| MZ9303 | Microbore amber extension set, IV | |||
| connector (70") | Microbore Amber | 0.023" | 0.079" | |
| MZ9321 | Microbore amber extension set, IV | |||
| connector, 0.2 micron filter (81") | Microbore Amber | 0.023" | 0.079" | |
| MZ9299 | Microbore quad-fuse extension set, 4 IV | |||
| connectors, 1 amber | ||||
| tubing lead, 3 clear tubing leads (7") | Microbore Amber | 0.023" | 0.079" | |
| Microbore Clear | 0.020" | 0.079" | ||
| MZ9328 | Minibore amber extension set, IV | |||
| connector, 1.2 micron filter (81") | Minibore Amber | 0.042" | 0.079" |
Substantial Equivalence Table
| | MaxZero™ Extension
Sets with Needle-free
Connector(s)
(Subject Device) | CareFusion MaxZero™
Extension Sets with
Needleless Connector
(K140831) | Equivalence |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Reg.
Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| FDA Regulation
Name | Intravascular
Administration Set | Intravascular
Administration Set | Same |
| FDA Class | Class II | Class II | Same |
| FDA Product
Code | FPA | FPA | Same |
| Product
Description | MaxZero™ Extension Sets
with Needle-free
Connector(s) and the
predicate devices are
sterile, single patient use,
including pediatrics and
immunocompromised
patients for direct inject,
intermittent infusion,
continuous infusion or
aspiration of drugs, blood
and fluids | MaxZero™ Extension Sets
with Needleless Connector
and the predicate devices
are sterile, single patient
use, including pediatrics
and immunocompromised
patients for direct inject,
intermittent infusion,
continuous infusion or
aspiration of drugs, blood
and fluids | Same |
| Intended Use | The MaxZero™ Extension
Set with Needle-free
Connector(s) is a sterile
single patient use device
intended to be used for
the delivery or aspiration | The MaxZero™ Extension
Sets with Needleless
Connector is a sterile single
patient use device intended
to be used for the delivery | Equivalent
Clarified delivery or
aspiration of drugs,
bloods and fluids.
This is equivalent to |
| | | Traditional 510(k) Premarket Notification
MaxZero™ Extension Sets with Needle-Free Connector(s) | |
| | | CareFusion MaxZero™
Extension Sets with
Needleless Connector
(K140831) | Equivalence |
| Indication for
use | | | |
| | MaxZero™ Extension
Sets with Needle-free
Connector(s)
(Subject Device) | | |
| | of drugs, blood and fluids
to/from an IV catheter. | or aspiration of fluids
to/from an IV catheter. | the device
description of the
predicate device. |
| Indication for
use | 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. | Pressure Rated: The
MaxZero™ multi fuse
extension set with
needleless connector(s) is
for single use only. The
extension set may be used
for direct injection,
intermittent infusion,
continuous infusion or
aspiration. This set may be
used with power injector
procedures to a maximum
pressure of 325 psi at a
flow rate of 10mL per
second.
Non-Pressure Rated:
The MaxZero™ multi fuse
extension set with
needleless connector(s) is
for single use only. The
extension set may be used
for direct injection,
intermittent infusion,
continuous infusion or
aspiration. | Equivalent to non-
pressure rated sets
The subject device is
not indicated for
power injection. All
subject devices are
non-pressure rated
sets.
Clarified delivery
and/or aspiration of
drugs, bloods and
fluids. This is
equivalent to the
device description of
the predicate device. |
| Device Length | MZ9303
Microbore amber
extension set, IV
connector (70"
Total Length) MZ9321
Microbore amber
extension set, IV
connector, filter
(81" Total
Length) MZ9299
Microbore quad-
fuse extension
set, 4 IV
connectors, 1
amber tubing
lead (7" Total
Length) | MZ5301 Pressure
rated extension
set, MaxZero
connector, slide
clamp, spin male
luer lock (7" Total
Length) MZ5301 Pressure
rated extension
set, MaxZero
connector, slide
clamp, spin male
luer lock (7" Total
Length) MZ5304 Pressure
rated extension
set, MaxZero
connector, slide
clamp spin male | Different
New lengths added -
subject device has
the same intended
use as the predicate
device. Length
differences were
tested according to
applicable consensus
standards (same as
the predicate
device). |
| 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 | |
| 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 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 |
| Fluid Contacting
Material
Composition | Needle-free Connector:
Polycarbonate, silicone
rubber
Tubing: Non DEHP PVC
Bi-F Connector: Rigid
PVC
Tri-F Connector: Acrylic
Male Luer (Spinlock):
ABS
Amber Tubing: Non
DEHP PVC
Filters: Acrylic, Filter
Media | Needle-free Connector:
Polycarbonate, silicone
rubber
Tubing: Non DEHP PVC
Bi-F Connector: Rigid PVC
Back Check Valve: ABS,
silicon rubber
Male Luer Adapter: ABS
Male Spinlock: ABS
Female Luer: Copolyester | Different
New Materials
included in subject
device:
Acrylic, Filter Media.
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 |
| Configurations | MaxZero Needle-free
Connector, PVC tubing
with various length and
ID/OD, clear tubing,
amber tubing, in-line
filters of various sizes,
slide clamps, male luer
(spin lock), female luer
(female wing adapter),
bifurcated connectors (Y-
connectors) and
trifurcated adapter | MaxZero Needleless
Connector, tubing of
various length and ID/OD,
back check valve, slide
clamps, pinch clamps, Y
connectors, male spin lock
and female wing adapter
depending on configuration | Different
New Components
included in subject
device:
Amber tubing,
filters, trifurcated
adaptor. 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 |
| Physical
Specification | Up to quad-fuse extension
set. Lengths from 6" to
81" | Up to 2-piece extension set.
Average length 7" | Different
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 |
| 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 Filter
1.2 Micron Filter | NA | proposed device do not raise different questions of safety and effectiveness
Different
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 |
| Tubing Bore | Micro Bore = .023 ID X .079 OD
Mini Bore = .042 ID X .079 OD | Standard Bore = .060 ID X 0.144 OD
Micro Bore = .023 ID X .079 OD | Different
New tubing added: Mini bore tubing
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 |
| NON-DEHP tubing | Yes | Yes | Same |
| Bonding agent | Cyclohexanone, Methylene Chloride, and Methyl Ethyl Ketone | Cyclohexanone | Different Bonding Agents used
Design Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different |
| MaxZero™ Extension
Sets with Needle-free
Connector(s)
(Subject Device) | MaxZero™ Extension Sets with Needle-Free Connector(s)
CareFusion MaxZero™
Extension Sets with
Needleless Connector
(K140831) | Equivalence | |
| No natural
rubber latex | Yes | Yes | questions of safety
and effectiveness |
| Sterilization
Method | E-Beam | E-Beam | Same |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Usable Life | Up to 7 days 200
activation | 7 days 200 activation | Equivalent
Clarification added
for up to 7 days |
| Disinfect with
70% Isopropyl
Alcohol | Disinfect with 70%
Isopropyl Alcohol | Disinfect with 70%
Isopropyl Alcohol | Same |
| Performance | | | |
| Priming Volume | $0.7mL – 2.0mL$ | Avg. $0.66 mL – 0.99 mL$ | Different
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 |
| Vacuum
Integrity | -2.9 psi vacuum | -3.0 psi vacuum | Different
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 |
| Maximum
Pressure | 30 psi non-pressure rated
sets | 45 psi non-pressure rated
sets | Different
Subject device
requirement has |
| | 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 |
| | | | ISO 8536 which
specifies 30 psi (200
kPa) |
| Shelf Life | 1 Year | 3 Years | Equivalent |
| Tubing
Transparency
(Clear Tubing) | Pass | Pass | Same |
| Light Resistance
(Amber Tubing) | Blocks a minimum of 90%
of UV light at any
wavelength between 250-
450 nm | N/A | Different
New component
added:
Amber tubing
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 |
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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
"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.