(133 days)
No
The summary describes a mechanical luer access device and its performance testing, with no mention of AI or ML capabilities.
No
The device is a valve intended for administering fluids and blood, not for treating a disease or condition.
No
This device is a Luer access device, used for the administration of fluids and blood, and for power injection. It facilitates the delivery of substances to the body rather than collecting information about the body's condition.
No
The device description clearly states it consists of physical components (body, piston, spike/nut, male luer lock cover) and is a sterile, single-use disposable device, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector." This describes a device used for administering or withdrawing substances from a patient's vascular system, which is a therapeutic or procedural function, not a diagnostic one.
- Device Description: The description reinforces its function as a "neutral displacement needleless connector intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood." Again, this is about access and administration, not about performing a diagnostic test on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing information for diagnosis. The device facilitates the movement of fluids, not the analysis of them.
- Performance Studies: The performance studies focus on functional aspects like flow rate, seal integrity, durability, power injection compatibility, and biocompatibility. These are relevant to a device used for fluid administration, not for diagnostic accuracy.
In summary, the device's purpose is to provide a safe and convenient way to connect to IV lines for administering fluids or withdrawing blood, which falls under the category of medical devices used for patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Microvolume Luer Access Device is a valve intended for the aspiration, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Microvolume Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec.
Product codes
FPA
Device Description
The Microvolume Luer Access Device (LAD) consists of a body, piston, spike/nut, and a male luer lock cover. The Microvolume LAD is a neutral displacement needleless connector intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The Microvolume LAD may be used with a power injector. The Microvolume LAD is individually packaged and supplied as a sterile, nonpyrogenic, single use disposable device.
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
This is a general use device that may be used for any patient population with consideration given to the adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional performance bench testing was conducted to demonstrate that the Microvolume Luer Access Device performs as intended. No clinical was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. The following nonclinical performance tests were conducted in support of the substantial equivalence determination:
- ISO 8536-4:2019: Flow Rate & Capacity Attributes Seal and Snap Tests Seal Test Seal Tests - Post Durability Particulate Contamination Associate Male ID Testing Tensile Testing
- ISO 8536-8:2015: Seal and Snap Tests Seal Test Seal Tests - Post Durability Associate Male ID Testing Tensile Testing
- ISO 8536-9:2015: Tensile Testing
- ISO 8536-10:2015: Seal and Snap Tests Seal Test Seal Tests - Post Durability Associate Male ID Testing Tensile Testing
- ISO 10993-4:2017: Mechanical Hemolysis
- ISO 10993-12:2021: Not specified.
- ISO 80369-7:2021: Dimensional requirements for Luer connectors Fluid leakage Sub-atmospheric pressure air leakage Stress cracking Resistance to separation from axial load Resistance to separation from unscrewing Resistance to overriding
- ISO 11607-1:2020, ASTM F1980-16, ASTM F1886M-16, ASTM D4169-16, ASTM D4332-14, ASTM F88/F88M-15, ASTM F1929-15, ASTM F2096-11, ASTM F2638-18: Sterile Barrier System Validation
- USP , ANSI/AAMI ST72:2019: Pyrogen
- ISO 11135:2014/AMD 1:2018: Sterilization Validation
- ISO 10993-7:2008/AMD 1:2019: EO Residuals
- B. Braun Medical Inc. device performance test methods: Durability Microbial Ingress Displacement Volume Power Injection 7 Day IPA & CHG Compatibility IPA Exposure, Infusate Compatibility Duration & Connector Removal Disinfection Cap 7-Day Compatibility with Swab Cap, Curos Jet, and CareCap. Disinfection Cap Valve Activation Cap Assessment after Ship Test Flushability
- **USP **: Particulate Contamination
Biocompatibility Testing: The Microvolume Luer Access Device was evaluated according to ISO 10993-1:2018.
- Cytotoxicity Study Using the ISO Elution Method: ISO 10993-5:2009
- Guinea Pig Maximization Sensitization Test: ISO 10993-10:2010
- Intracutaneous Study in Rabbits: ISO 10993-10:2010
- Acute Systemic Toxicity Study in Mice: ISO 10993-11:2017
- Subacute Toxicity Study in Rats: ISO 10993-11:2017
- Hemocompatibility - Hemolysis: ISO 10993-4:2017
- Partial Thromboplastin Time (PTT) Assay: ISO 10993-4:2017
- Heparinized Blood Platelet and Leukocyte Count Assay: ISO 10993-4:2017
- Complement Activation Assay: ISO 10993-4:2017
- Material Mediated Pyrogenicity in Rabbits: ISO 10993-11:2017
- FTIR - Confirmation of Materials: ASTM E1252
- Section 8; Annex B - Chemical Requirements: ISO 8536-4:2020
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 18, 2021
B. Braun Medical Inc. Kimberly Smith Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109-9341
Re: K212842
Trade/Device Name: Microvolume Luer Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: December 15, 2021 Received: December 17, 2021
Dear Kimberly Smith:
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gang Peng For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212842
Device Name Microvolume Luer Access Device
Indications for Use (Describe)
The Microvolume Luer Access Device is a valve intended for the aspiration, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Microvolume Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec.
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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3
510(k) Summary K212842
I. Submitter Information
| Name: | B. Braun Medical Inc. |
|---|---|
| Address: | 901 Marcon Boulevard |
| Allentown, PA 18109-9341 | |
| Contact Person: | Kimberly Smith |
| Sr. Regulatory Affairs Specialist | |
| Telephone Number: | (610) 596-2326 |
| Fax Number: | (610) 266-4962 |
| kim.smith@bbraunusa.com | |
| Date Prepared: | January 13, 2022 |
II. Device Name and Classification
| Device Trade Name: | Microvolume Luer Access Device |
|---|---|
| Common Name: | Luer Access Device, Needleless Connector; Needle-free |
| Injection Site; Needle-free Luer Access Device; Needle-free | |
| connector; Valve | |
| Classification Name: | Intravascular administration set; §21 CFR 880.5440 |
| Regulatory Class | Class II |
| Product Code: | FPA |
III. Predicate Device
| Device Trade Name: | Caresite Luer Access Device |
|---|---|
| Common Name: | Needleless Connector; Needle-free Injection Site; Needle-free Luer Access Device |
| Classification Name: | Intravascular administration set; §21 CFR 880.5440 |
| Regulatory Class | Class II |
| Product Code: | FPA |
| 510(k) Number: | K140311, B. Braun Medical Inc. |
| Reference Device Trade Name: | Clave Connector |
| Classification Name: | Intravascular administration set; §21 CFR 880.5440 |
| 510(k) Number: | K970855, ICU Medical, Inc. |
4
IV. Device Description
The Microvolume Luer Access Device (LAD) consists of a body, piston, spike/nut, and a male luer lock cover. The Microvolume LAD is a neutral displacement needleless connector intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The Microvolume LAD may be used with a power injector. The Microvolume LAD is individually packaged and supplied as a sterile, nonpyrogenic, single use disposable device.
V. Indications for Use / Intended Use
Indications for Use
The Microvolume Luer Access Device is a valve intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Microvolume Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec.
Intended Use
The intended use of the Microvolume Luer Access Device is to provide a sterile needle-free fluid pathway for the administration or aspiration of blood, IV therapy, or medications as prescribed by the physician. Fluids are administered to the patient through a catheter or cannula. The device can be utilized as a conduit between two devices, in addition to being used to deliver contrast media via power injection. This is a general use device that may be used for any patient population with consideration given to the adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
5
VI. Comparison of Technological Characteristics with the Predicate Device
The similarities and differences of the technological characteristics between the predicate and the subject device are summarized below.
Similarities:
- · The subject Microvolume Luer Access Device and the predicate device are identical in their intended use.
- · Mode of fluid delivery is the same for both the predicate and subject devices. Both devices are used for gravity/pump administration.
- · Conditions of use are the same for both the predicate and subject devices. Both devices are used by the same type of healthcare professionals under the same conditions of use.
- · Sterilization method, SAL Level and sterilization cycle are the same for both the predicate and subject devices.
- · Interfaces are similar between the subject device and predicate device. Both devices contain threaded female and male ports intended for use with associated luers.
- · Mechanical and Performance Specifications are similar between the subject device and predicate device. The predicate device performance testing and referenced standards were utilized as a guide to establish the testing for the subject device. The subject device meets all the standards that were met by the predicate. Additional standards were considered for performance testing of the subject device.
Differences:
- · Principle of operation is different but achieves the same intended use. The difference does not raise different questions of safety and effectiveness and is evaluated by design verification testing.
- · Physical characteristics and dimensions are different but do not impact the intended use. The differences do not raise different questions on safety and effectiveness and is evaluated by performance testing.
- · Displacement Volume is different but does not impact the intended use. The difference does not raise different questions on safety and effectiveness and is evaluated by performance testing.
6
| Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|
| Microvolume Luer Access | (K140311) | ||
| Device | Caresite Luer Access Device | ||
| Manufacturer | B. Braun Medical Inc. | B. Braun Medical Inc. | Same |
| Intended Use | The intended use of the | The intended use of the | Same |
| Microvolume Luer Access | Caresite Luer Access Device is | ||
| Device is to provide a sterile | to provide a sterile needle-free | ||
| needle-free fluid pathway for | fluid pathway for the | ||
| the administration or | administration or aspiration of | ||
| aspiration of blood, IV | blood, IV therapy, or | ||
| therapy, or medications as | medications as prescribed by | ||
| prescribed by the physician. | the physician. Fluids are | ||
| Fluids are administered to the | administered to the patient | ||
| patient through a catheter or | through a catheter or cannula. | ||
| cannula. The device can be | The device can be utilized as a | ||
| utilized as a conduit between | conduit between two devices, in | ||
| two devices, in addition to | addition to being used to | ||
| being used to deliver contrast | deliver contrast media via | ||
| media via power injection. | power injection. This device | ||
| This device may be used for | may be used for any patient | ||
| any patient population with | population with consideration | ||
| consideration given to the | given to the adequacy of | ||
| adequacy of vascular | vascular anatomy and | ||
| anatomy and appropriateness | appropriateness for the solution | ||
| for the solution being infused | being infused and duration of | ||
| and duration of therapy. | therapy. | ||
| Indications for Use | The Microvolume Luer | The Caresite Luer Access | Different |
| Access Device is a valve | Device is a valve intended for | Difference in | |
| intended for the aspiration, | the aspiration, injection, or | power injector | |
| injection, or gravity/pump | gravity/pump flow of IV fluids | maximum flow rate | |
| flow of IV fluids and blood | and blood upon insertion of a | falls within the | |
| upon insertion of a male luer | male luer connector. The | indications for use | |
| connector. The Microvolume | Caresite Luer Access Device | of the predicate | |
| Luer Access Device may be | may be used with power | device, therefore; | |
| used with power injectors at a | injectors at a maximum | the two devices | |
| maximum pressure of 400 psi | |||
| and a maximum flow rate of | pressure of 400 psi and a | ||
| maximum flow rate of | have equivalent | ||
| indications for use. | |||
| 10ml/sec. | 15ml/sec. | ||
| Mode of Fluid Delivery | Gravity/Pump Administration | Gravity/Pump Administration | Same |
| Components of Device | 3-piece assembly containing: | 3-piece assembly containing: | Same |
| 1. Body | 1. Body | ||
| 2. Piston | 2. Piston | ||
| 3. Luer Nut | 3. Luer Nut | ||
| 4. Male luer lock vented | 4. Male luer lock vented cover | ||
| cover | |||
| Summary of nonclinical | |||
| tests for determination | |||
| of substantial | |||
| equivalence | • Flow Rate & Capacity | ||
| Attributes | |||
| • Seal and Snap Tests | |||
| • Durability Testing | |||
| • Seal Tests - Post | |||
| Durability | |||
| • Power Injection | |||
| • 7 Day IPA & CHG | |||
| Compatibility | |||
| • IPA Exposure, Infusate | |||
| Compatibility | |||
| • Duration & Connector | |||
| Removal | |||
| • ISO 80369-7 Compliance | |||
| Testing | |||
| • Associate Male ID Testing | |||
| • 7 Day Disinfection Cap | |||
| Compatibility with Swab | |||
| Cap, Curos Jet, and | |||
| CareCap. Disinfection Cap | |||
| Valve Activation | |||
| • Particulate Contamination | |||
| • Cap Assessment after Ship | |||
| Test | |||
| • Mechanical Hemolysis | |||
| • Microbial Ingress Testing | |||
| • Tensile Testing | |||
| • Real-Time Aging | |||
| • Displacement Volume | |||
| • Flushability | |||
| • Ship Testing | • Flow Rate & Capacity | ||
| Attributes | |||
| • Seal and Weld Tests | |||
| • Durability Testing | |||
| • Seal Tests - Post Durability | |||
| • Power Injection | |||
| • 4 Day IPA & CHG | |||
| Compatibility | |||
| • IPA Exposure, Infusate | |||
| Compatibility | |||
| • Duration | |||
| • ISO 594 Compliance Testing | |||
| • Associate Device Testing | |||
| • Mechanical Hemolysis | |||
| • Microbial Ingress Testing | |||
| • Flushability | |||
| • Ship Testing | Different | ||
| The additional | |||
| nonclinical tests do | |||
| not raise different | |||
| questions on safety | |||
| and effectiveness, | |||
| as demonstrated by | |||
| performance | |||
| testing. | |||
| Physical Characteristics | Male Luer ID = 0.0673 in. | ||
| Male Luer OD = 0.1565in. | |||
| w/0.060 in/in taper | |||
| Female ID = 0.1669in. | |||
| Priming Volume = 0.0345 mL, | |||
| average | |||
| Residual Volume = 0.052 mL, | |||
| average | Male Luer ID = 0.080 in. | ||
| Male Luer OD = 0.1565 in. | |||
| w/0.060 in/in taper | |||
| Female ID = 0.1669 in. | |||
| Priming Volume = 0.22 mL, | |||
| average | |||
| Residual Volume = 0.20 mL, | |||
| average | Different | ||
| The physical | |||
| characteristics do | |||
| not raise different | |||
| questions on safety | |||
| and effectiveness, as | |||
| demonstrated by | |||
| performance testing. | |||
| Materials | • Body - Copolyester | ||
| • Piston - Silicone Elastomer, | |||
| Self-lubricating | |||
| • Luer Nut - ABS | |||
| • Male Luer Lock Vented | |||
| Cover - Polyethylene | • Body - Polycarbonate | ||
| • Piston - Silicone Elastomer, | |||
| Self-lubricating | |||
| • Luer Nut - Polycarbonate | |||
| • Male Luer Lock Vented Cover |
- Polyethylene | Different
The difference in
materials do not
raise different
questions on safety
and effectiveness as
demonstrated by
performance testing
and
biocompatibility. |
| Patient Contact
category/duration | Externally Communicating,
Blood Path Indirect
prolonged exposure | Externally Communicating,
Blood Path Indirect
prolonged exposure | Same |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Same |
7
8
Performance Data VII.
Performance Testing Bench
Functional performance bench testing was conducted to demonstrate that the Microvolume Luer Access Device performs as intended. No clinical was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. The following nonclinical performance tests were conducted in support of the substantial equivalence determination:
| Standard | Test Performed |
|---|---|
| ISO 8536-4:2019 | Flow Rate & Capacity Attributes Seal and Snap Tests Seal Test Seal Tests - Post Durability Particulate Contamination Associate Male ID Testing Tensile Testing |
| ISO 8536-8:2015 | Seal and Snap Tests Seal Test Seal Tests - Post Durability Associate Male ID Testing Tensile Testing |
| ISO 8536-9:2015 | Tensile Testing |
| ISO 8536-10:2015 | Seal and Snap Tests Seal Test Seal Tests - Post Durability Associate Male ID Testing Tensile Testing |
| ISO 10993-4:2017 | Mechanical Hemolysis |
| ISO 10993-12:2021 | |
| ISO 80369-7:2021 | Dimensional requirements for Luer connectors Fluid leakage Sub-atmospheric pressure air leakage Stress cracking Resistance to separation from axial load Resistance to separation from unscrewing Resistance to overriding |
| ISO 11607-1:2020 | |
| ASTM F1980-16 | |
| ASTM F1886M-16 | |
| ASTM D4169-16 | |
| ASTM D4332-14 | |
| ASTM F88/F88M-15 | |
| ASTM F1929-15 | |
| ASTM F2096-11 | |
| ASTM F2638-18 | Sterile Barrier System Validation |
9
B. Braun Medical Inc. Microvolume Luer Access Device Traditional 510(k) Premarket Notification
| USP
| ANSI/AAMI ST72:2019 | ● Pyrogen |
|---|---|
| ISO 11135:2014/AMD 1:2018 | ● Sterilization Validation |
| ISO 10993-7:2008/AMD 1:2019 | ● EO Residuals |
| B. Braun Medical Inc. device | |
| performance test methods | ● Durability |
| ● Microbial Ingress | |
| ● Displacement Volume | |
| ● Power Injection | |
| ● 7 Day IPA & CHG Compatibility | |
| ● IPA Exposure, Infusate Compatibility | |
| ● Duration & Connector Removal | |
| ● Disinfection Cap 7-Day Compatibility with Swab Cap, Curos Jet, and CareCap. Disinfection Cap Valve Activation | |
| ● Cap Assessment after Ship Test | |
| ● Flushability | |
| USP | ● Particulate Contamination |
Biocompatibility Testing
The Microvolume Luer Access Device was evaluated according to ISO 10993-1:2018. The following biocompatibility testing was performed with the reference standard utilized:
| Test Performed | Standard |
|---|---|
| Cytotoxicity Study Using the ISO Elution Method | ISO 10993-5:2009 |
| Guinea Pig Maximization Sensitization Test | ISO 10993-10:2010 |
| Intracutaneous Study in Rabbits | ISO 10993-10:2010 |
| Acute Systemic Toxicity Study in Mice | ISO 10993-11:2017 |
| Subacute Toxicity Study in Rats | ISO 10993-11:2017 |
| Hemocompatibility - Hemolysis | ISO 10993-4:2017 |
| Partial Thromboplastin Time (PTT) Assay | ISO 10993-4:2017 |
| Heparinized Blood Platelet and Leukocyte Count Assay | ISO 10993-4:2017 |
| Complement Activation Assay | ISO 10993-4:2017 |
| Material Mediated Pyrogenicity in Rabbits | ISO 10993-11:2017 |
| FTIR - Confirmation of Materials | ASTM E1252 |
| Section 8; Annex B - Chemical Requirements | ISO 8536-4:2020 |
10
VIII. Substantial Equivalence
Intended Use/Indications for Use - Discussion of differences and similarities
The intended use of the proposed and the predicate device are identical. The indications for use of the proposed and the predicate device are equivalent and do not create a new intended use:
- · Both devices are valves intended for the administration of blood. IV therapy, or medications as prescribed by the physician.
- Both devices can be utilized as a conduit between two devices, in addition to being used to deliver contrast media via power injection.
- · Both devices are general used device and may be used for any patient population with consideration given to the adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
- · The indications for use of the proposed device fall within the intended use of the predicate device and, therefore, the two devices have the same intended use.
The differences in the Indications for Use do not affect safety and effectiveness and do not alter the intended use of the proposed device:
- · The Indications for Use of the proposed device allows for use with a power injector at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec and the predicate allows for use with a power injector at a maximum pressure of 400 psi and a maximum flow rate of 15ml/sec.
- · Both devices are used by the same type of healthcare professionals under the same conditions of use.
- · Both devices have the same fundamental scientific technology.
Technological Characteristics - Discussion of Differences
Based on the performance data, the Microvolume Luer Access Device was found to have a safety and effectiveness profile similar to the predicate device. The technological characteristics of the proposed device are substantially equivalent to the predicate device as compared in sections VI and VII above.
Conclusion on Substantial Equivalence
The proposed Microvolume Luer Access Device has the same intended use and equivalent Indications for Use as the predicate device. The proposed device has the same mode of fluid delivery as the predicate. The proposed device has similar technological characteristics to the predicate, meets the same relevant performance specifications as the predicate, and the descriptive and performance information provided within this premarket notification demonstrates that:
- any differences do not raise different questions of safety and effectiveness than that of the . predicate device; and
- the proposed device is as safe and effective as the legally marketed predicate device. .
The Microvolume Luer Access Device is substantially equivalent to the predicate device.