(87 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a fluid administration set, with no mention of AI or ML capabilities.
No.
The device is an extension set used for administering or withdrawing fluids, not for providing therapy directly.
No
The device is an extension set used for administration or withdrawal of fluids, not for diagnosing medical conditions.
No
The device description clearly outlines a physical medical device (tubing, connectors, luer locks, caps) intended for fluid administration, not a software application. The performance studies focus on physical properties and standards (ISO 8536-4).
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 withdrawal of fluids to or from a neonatal patient." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a set of tubing and connectors designed to connect to a patient's vascular system (indicated by "Intravascular" anatomical site). This is consistent with a device used for fluid delivery or withdrawal from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living organism) to provide information for diagnostic, monitoring, or compatibility purposes. The description of the MED-RX Extension Set with T-Connector does not mention any such function or interaction with patient specimens outside the body.
- Performance Studies: The performance studies mentioned (tensile strength, resistance to leakage, etc.) are related to the physical integrity and functionality of the device for its intended use in fluid administration/withdrawal, not for analyzing biological specimens.
Therefore, the MED-RX Extension Set with T-Connector is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended 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.
Product codes
FPA
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.
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
neonatal patient
Intended User / Care Setting
physician / Hospital
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 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.
Key results:
- Tensile Strength -Tubing/T-Connector: Pass
- Tensile Strength - Tubing/Female Luer Lock: Pass
- Leakage under Pressure: Pass
- Liquid Leakage: Pass
- Particulate Contamination: Samples met contamination index limit.
- Chemical Requirements: Pass
- Natural Rubber Latex Content: Device does not contain natural 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.
Key results:
- Method of Validation (ANSI/AMMI/ISO 11135-1: 2007): Validated to a Sterility Assurance Level 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.
Key results:
- ISO MEM Elution with L-929 Mouse Fibroblast Cells (Cytotoxicity) (ISO 10993-5: 2009): Product code 10-1053XLU is considered non-toxic.
- ISO Guinea Pig Maximization Sensitization Test (Method of Biomaterial Extracts) (ISO 10993-10:2002): Product code 10-1053XLU did not elicit a sensitization response.
- ISO Intracutaneous Reactivity Test (ISO 10993-10:2002): Product code 10-1053XLU would be considered a non-irritant.
- ISO Acute Systemic Injection Test (ISO 10993-11: 2006): 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): Product code 10-1053XLU is considered non-hemolytic and passes the test.
- Materials Mediated Rabbit Pyrogen Test (USP 32: 2009 ): Product code 10-1053XLU is determined to be non-pyrogenic.
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
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.
1
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 Extension
Set (K060074) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| General Indications | | |
| Indications for Use | For administration or withdrawal of
fluids to or from a neonatal patient as
directed by a physician | Same |
| Type of Placement | Intravascular | Same |
| Intended for single
patient use | Yes | Yes |
| Prescription | Yes | Yes |
| Intended Population | Neonatal | Same |
| Intended Environment of
Use | 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 and
rotating male luer lock | T-connector with injection site and male
luer slip adaptor or rotating male luer
lock 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/ poly
pouch | 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.
2
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
3
n Set with T-Connector
| Test | Standard | Results |
|---|---|---|
| Chemical Requirements | ISO 8536-4:2007 per | |
| Clause 5 & 7 | Pass | |
| Natural Rubber Latex Content | Modified Lowry Method | Device does not contain |
| natural 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 Assurance |
| Level 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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4
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-929 | ||
| Mouse Fibroblast Cells | ||
| (Cytotoxicity) | ISO 10993-5: 2009 | Product code 10-1053XLU is considered |
| non-toxic. | ||
| ISO Guinea Pig Maximization | ||
| Sensitization Test (Method | ||
| of Biomaterial Extracts) | ISO 10993-10:2002 | Product code 10-1053XLU did not elicit a |
| sensitization response. | ||
| ISO Intracutaneous | ||
| Reactivity Test | ISO 10993-10:2002 | Product code 10-1053XLU would be |
| considered a non-irritant. | ||
| ISO Acute Systemic Injection | ||
| Test | ISO 10993-11: 2006 | 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 | Product code 10-1053XLU is considered |
| non-hemolytic and passes the test. | ||
| Materials Mediated Rabbit | ||
| Pyrogen Test | USP 32: 2009 | Product code 10-1053XLU is determined |
| to be non-pyrogenic. |
5
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.
6
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
7
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