(87 days)
The MED-RX Extension Set with T-Connector is intended to be used for administration or withdrawal of fluids to or from a neonatal patient as directed by a physician.
The MED-RX Extension Set with T-Connector is offered in two configurations, identical except for the tubing length. The proximal end of the MED-RX Extension Set with T-Connector features a T-Connector with an injection port and an integral rotating male luer lock. The distal end has a female luer lock fitting. The inner and outer diameter of both devices is consistent at 0.040" and 0.095" respectively, while the lengths available are either 4" or 38". Each of the luer fittings (distal female luer lock and proximal rotating male luer lock) are provided with protective caps. The MED-RX Extension Set with T-Connector is provided sterile and is single use.
This document describes the premarket notification for the "MED-RX Extension Set with T-Connector." The provided text focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or algorithms, human readers, or image analysis. Therefore, many of the requested categories related to AI performance are not applicable.
Here's an analysis of the provided information based on the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description | Standard | Acceptance Criteria (Implied by "Pass") | Reported Device Performance |
|---|---|---|---|
| Tensile Strength - Tubing/T-Connector | ISO 8536-4:2007 | Pass | Pass |
| Tensile Strength - Tubing/Female Luer Lock | ISO 8536-4:2007 | Pass | Pass |
| Leakage under Pressure | ISO 8536-4:2007 | Pass | Pass |
| Liquid Leakage | ISO 8536-4:2007 | Pass | Pass |
| Particulate Contamination | ISO 8536-4:2007 | Samples meet contamination index limit | Samples met contamination index limit |
| Chemical Requirements | ISO 8536-4:2007 (Clauses 5 & 7) | Pass | Pass |
| Natural Rubber Latex Content | Modified Lowry Method | Device does not contain natural rubber latex | Device does not contain natural rubber latex |
| Sterilization Method of Validation | ANSI/AMMI/ISO 11135-1: 2007 | Validated to a Sterility Assurance Level of 1 x 10^-6 | Validated to a Sterility Assurance Level of 1 x 10^-6 |
| EO Sterilization Residuals | ISO 10993-7: 2008 | Pass | Pass |
| Bacterial Endotoxins | ANSI/AAMI ST72: 2002 | Pass | Pass |
| ISO MEM Elution with L-929 Mouse Fibroblast Cells (Cytotoxicity) | ISO 10993-5: 2009 | Considered non-toxic | Product code 10-1053XLU is considered non-toxic. |
| ISO Guinea Pig Maximization Sensitization Test | ISO 10993-10:2002 | Did not elicit a sensitization response | Product code 10-1053XLU did not elicit a sensitization response. |
| ISO Intracutaneous Reactivity Test | ISO 10993-10:2002 | Considered a non-irritant | Product code 10-1053XLU would be considered a non-irritant. |
| ISO Acute Systemic Injection Test | ISO 10993-11: 2006 | Requirements of the test met | The findings indicate that the requirements of the ISO Acute Systemic Injection Test have been met. |
| ASTM Hemolysis Assay - Extract Method | ASTM F-756-00 | Considered non-hemolytic and passes | Product code 10-1053XLU is considered non-hemolytic and passes the test. |
| Materials Mediated Rabbit Pyrogen Test | USP 32: 2009 <151> | Determined to be non-pyrogenic | Product code 10-1053XLU is determined to be non-pyrogenic. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units) used for each non-clinical test. The data provenance is internal testing performed by Benlan Inc., as part of their 510(k) submission to the FDA. This is likely retrospective testing for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device in vitro testing, not an AI or diagnostic tool requiring expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation or AI output that would require adjudication.
5. 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
Not applicable. This is a medical device (extension set) that does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (extension set) and does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests is established by the specified ISO, ANSI/AAMI, ASTM, and USP standards. These standards define the acceptable physical, chemical, and biological properties of the device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/machine learning model, no ground truth was established for it.
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Set with T-Connector
DEC 2 3 2011
SECTION 5 - 510(K) SUMMARY
Date of Summary: September 23, 2011
| Benlan Inc | ||
|---|---|---|
| 2760 Brighton Road | Tel (905) 829-5004 | |
| Oakville, ON L6H 5T4 | Fax (905) 829-5006 | |
| Official Contact: | Cheryl Brown - QA / RA Manager | |
| Proprietary Name: | MED-RX Extension Set with T-Connector | |
| Common Name: | Intravascular Administration Set | |
| Classification Name: | Intravascular Administration Set, 880.5440 Intravascular Administration | |
| Set. | ||
| Class: | Class II | |
| Product Code: | FPA | |
| Predicate Device: | Baxter Interlink T-Connector Extension Set (K060074) |
Device Description
The MED-RX Extension Set with T-Connector is offered in two configurations, identical except for the tubing length. The proximal end of the MED-RX Extension Set with T-Connector features a T-Connector with an injection port and an integral rotating male luer lock. The distal end has a female luer lock fitting. The inner and outer diameter of both devices is consistent at 0.040" and 0.095" respectively, while the lengths available are either 4" or 38". Each of the luer fittings (distal female luer lock and proximal rotating male luer lock) are provided with protective caps. The MED-RX Extension Set with T-Connector is provided sterile and is single use.
Indications for Use
The MED-RX Extension Set with T-Connector is intended to be used for administration or withdrawal of fluids to or from a neonatal patient as directed by a physician.
Substantial Equivalence
The information provided in the premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed MED-RX Extension Set with T-Connector is substantially equivalent to the predicate Baxter Interlink T-Connector Extension Set (K060074). Both devices have the same intended use for intravascular administration or withdrawal of fluids to or from a neonatal patient as directed by a physician. Both devices are provided sterile and are single use.
A comparison of features and principles of operation between the proposed device and predicate device is provided in Table 1 below.
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K112799
page 2 of 5
n Set with T-Connector
Table 1: Comparison between MED-RX Extension Set with T-Connector and Baxter Interlink T-Connector Extension Set (K060074)
| ATTRIBUTE | PROPOSED DEVICE –MED-RX Extension Set with T-Connector | PREDICATE DEVICE –Baxter Interlink T-Connector ExtensionSet (K060074) |
|---|---|---|
| General Indications | ||
| Indications for Use | For administration or withdrawal offluids to or from a neonatal patient asdirected by a physician | Same |
| Type of Placement | Intravascular | Same |
| Intended for singlepatient use | Yes | Yes |
| Prescription | Yes | Yes |
| Intended Population | Neonatal | Same |
| Intended Environment ofUse | Hospital | Same |
| Non Pyrogenic | Yes | Yes |
| Physical Specifications | ||
| Tubing outer diameter | 0.095" | 0.090" |
| Tubing inner diameter | 0.040" | 0.040" |
| Approximate length | 4" or 38" | 6" |
| Design Features | ||
| Distal Configuration | Female luer lock fitting | Same |
| Proximal Configuration | T-Connector with injection site androtating male luer lock | T-connector with injection site and maleluer slip adaptor or rotating male luerlock adaptor |
| Clamp | Slide clamp | Same |
| Caps | Protective luer caps as necessary | Same |
| Compatibility | Compatible with standard luer fittings | Same |
| Material Composition | ||
| Tubing | Polyvinyl Chloride | Same |
| Connectors | Medical grade plastic | Medical grade plastic |
| Packaging and Sterilization | ||
| Sterile | Yes | Yes |
| Sterilization Method | Ethylene Oxide (EO) | Gamma Radiation |
| Packaging Configuration | Medical grade peelable paper/ polypouch | Polypropylene pouch |
Summary of Differences
There are no significant differences between the proposed MED-RX Extension Set with T-Connector and the predicate device Baxter Interlink T-Connector Extension Set (K060074). Similarities between the proposed device and the predicate devices include identical indications for use and duration of use. The MED-RX Extension Set with T-Connector and the Baxter Interlink T-Connector Extension Set are sterile, single use devices, packaged in peelable pouches.
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sion Set with T-Connector
page 3 of 5
The proposed MED-RX Extension Set with T-Connector is to be offered in two different lengths: 4″ and 38″, whereas the predicate device is only available in a 6″ length. The additional lengths of extension sets to be offered for the proposed device can be considered to have no impact on safety or effectiveness as the additional length is merely intended to increase the amount of accessible tubing for use. The proposed device has a slightly larger tubing outer diameter than the predicate device but the dimensions are effectively equivalent. Both devices feature luer connectors with protective caps as required and slide clamps are placed on each set. The design features of both the proposed device and the predicate device can be also considered equivalent as the configuration of the devices are identical.
Therefore, any minor differences between the proposed device and the predicate have been evaluated to have no impact on safety or effectiveness of the MED-RX Extension Set with T-Connector. Therefore the proposed device can be considered substantially equivalent to legally market devices.
Non-Clinical Test Summary
Verification of functional performance of the MED-RX Extension Set with T-Connector has been performed as per ISO 8536-4: 2007. The MED-RX Extension Set with T-Connector has successfully completed all required performance testing following the applicable guidelines of ISO 8536-4: 2007 including tensile strength, resistance to leakage under pressure, resistance to liquid leakage, particulate contamination, and chemical requirements. The MED-RX Extension Set with T-Connector was also tested for natural rubber latex content. Please refer to Table 2.
| Test | Standard | Results |
|---|---|---|
| Tensile Strength -Tubing/T-Connector | ISO 8536-4:2007 | Pass |
| Tensile Strength - Tubing/Female Luer Lock | ISO 8536-4:2007 | Pass |
| Leakage under Pressure | ISO 8536-4:2007 | Pass |
| Liquid Leakage | ISO 8536-4:2007 | Pass |
| Particulate Contamination | ISO 8536-4:2007 | Samples met contamination index limit. |
Table 2: Non-Clinical Test Summary
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n Set with T-Connector
| Test | Standard | Results |
|---|---|---|
| Chemical Requirements | ISO 8536-4:2007 perClause 5 & 7 | Pass |
| Natural Rubber Latex Content | Modified Lowry Method | Device does not containnatural rubber latex |
Summary of Sterilization
Each MED-RX Extension Set with T-Connector is individually packaged using a medical grade peelable synthetic polymer reinforced paper with a film backing, and sterilized using ethylene oxide. Please see Table 3 for a summary.
Table 3: Sterilization Summary
| Test Description | Standard | Results |
|---|---|---|
| Method of Validation | ANSI/AMMI/ISO 11135-1: 2007 | Validated to a Sterility AssuranceLevel of 1 x 10-6 |
| EO Sterilization Residuals | ISO 10993-7: 2008 | Pass |
| Bacterial Endotoxins | ANSI/AAMI ST72: 2002 | Pass |
Summary of Biocompatibility Tests
Biocompatibility testing was successfully completed on sterile finished devices. The MED-RX Extension Set with T-Connector is classified as a prolonged duration, indirect blood path contacting device. A summary of the testing completed and the relevant standards are listed in Table 4.
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Benlan™
MED-RX® Extension Set with T-Connector
K1127991
page ్ర 50
Table 4: Biocompatibility Test Summary
| Test Description | Standard | Results |
|---|---|---|
| ISO MEM Elution with L-929Mouse Fibroblast Cells(Cytotoxicity) | ISO 10993-5: 2009 | Product code 10-1053XLU is considerednon-toxic. |
| ISO Guinea Pig MaximizationSensitization Test (Methodof Biomaterial Extracts) | ISO 10993-10:2002 | Product code 10-1053XLU did not elicit asensitization response. |
| ISO IntracutaneousReactivity Test | ISO 10993-10:2002 | Product code 10-1053XLU would beconsidered a non-irritant. |
| ISO Acute Systemic InjectionTest | ISO 10993-11: 2006 | The findings indicate that therequirements of the ISO Acute SystemicInjection Test have been met. |
| ASTM Hemolysis Assay -Extract Method | ASTM F-756-00 | Product code 10-1053XLU is considerednon-hemolytic and passes the test. |
| Materials Mediated RabbitPyrogen Test | USP 32: 2009 <151> | Product code 10-1053XLU is determinedto be non-pyrogenic. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 3 2011
Ms. Cheryl Brown Quality Assurance / Regulatory Affairs Manager Benlan Incorporated 2760 Brighton Road Oakville, Ontario CANADA L6H 5T4
Re: K112799
Trade/Device Name: MED-RX Extension Set with T-Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 23, 2011 Received: September 27, 2011
Dear Ms. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Brown
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety /ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov /MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D.m
Anthony D. Watson, B.S., M.S., M.P.
nthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KII2799
SECTION 4 - INDICATIONS FOR USE
510(K) Number (If Known): Not Known.
Device Name: MED-RX Extension Set with T-Connector
Indications For Use:
The MED-RX Extension Set with T-Connector is intended to be used for administration or withdrawal of fluids to or from a neonatal patient as directed by a physician.
| Prescription Use: | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-the-Counter Use | |
| (21 CFR 801 Subpart C) | |
| N/A |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Richard Chapman Dec 21, 2016
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number: K112799
§ 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.