MED-RX EXTENSION SET WITH T-CONNECTOR

K112799 · Benlan, Inc. · FPA · Dec 23, 2011 · General Hospital

Device Facts

• Record ID: K112799
• Device Name: MED-RX EXTENSION SET WITH T-CONNECTOR
• Applicant: Benlan, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Intravascular administration set; used for fluid administration or withdrawal in neonatal patients. Device consists of tubing (4" or 38" length), proximal T-connector with injection port and rotating male luer lock, and distal female luer lock fitting. Includes slide clamp. Operated by clinicians in hospital settings. Connects to standard luer fittings. Facilitates fluid delivery/access; single-use; sterile.

Clinical Evidence

Bench testing only. Performance verified per ISO 8536-4:2007, including tensile strength, leakage under pressure, liquid leakage, and particulate contamination. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity) and ASTM F-756-00 (hemolysis). Sterilization validated to SAL 10^-6 per ISO 11135-1:2007. No clinical data.

Technological Characteristics

Tubing: Polyvinyl Chloride (PVC). Connectors: Medical grade plastic. Dimensions: 0.040" ID, 0.095" OD; 4" or 38" length. Features: T-connector, injection site, rotating male luer lock, female luer lock, slide clamp. Sterilization: Ethylene Oxide (EO). Standards: ISO 8536-4:2007, ISO 10993, ISO 11135-1:2007.

Indications for Use

Indicated for administration or withdrawal of fluids to or from neonatal patients as directed by a physician.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Baxter Interlink T-Connector Extension Set (K060074)

Submission Summary (Full Text)

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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 [phone] | |
| Oakville, ON L6H 5T4 | Fax [phone] | |
| 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
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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 –<br>MED-RX Extension Set with T-<br>Connector | PREDICATE DEVICE –<br>Baxter Interlink T-Connector Extension<br>Set (K060074) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| General Indications | | |
| Indications for Use | For administration or withdrawal of<br>fluids to or from a neonatal patient as<br>directed by a physician | Same |
| Type of Placement | Intravascular | Same |
| Intended for single<br>patient use | Yes | Yes |
| Prescription | Yes | Yes |
| Intended Population | Neonatal | Same |
| Intended Environment of<br>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<br>rotating male luer lock | T-connector with injection site and male<br>luer slip adaptor or rotating male luer<br>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<br>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.

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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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K112799

# n Set with T-Connector

| Test | Standard | Results |
|------------------------------|-------------------------------------|-------------------------------------------------|
| Chemical Requirements | ISO 8536-4:2007 per<br>Clause 5 & 7 | Pass |
| Natural Rubber Latex Content | Modified Lowry Method | Device does not contain<br>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<br>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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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<br>Mouse Fibroblast Cells<br>(Cytotoxicity) | ISO 10993-5: 2009 | Product code 10-1053XLU is considered<br>non-toxic. |
| ISO Guinea Pig Maximization<br>Sensitization Test (Method<br>of Biomaterial Extracts) | ISO 10993-10:2002 | Product code 10-1053XLU did not elicit a<br>sensitization response. |
| ISO Intracutaneous<br>Reactivity Test | ISO 10993-10:2002 | Product code 10-1053XLU would be<br>considered a non-irritant. |
| ISO Acute Systemic Injection<br>Test | ISO 10993-11: 2006 | The findings indicate that the<br>requirements of the ISO Acute Systemic<br>Injection Test have been met. |
| ASTM Hemolysis Assay -<br>Extract Method | ASTM F-756-00 | Product code 10-1053XLU is considered<br>non-hemolytic and passes the test. |
| Materials Mediated Rabbit<br>Pyrogen Test | USP 32: 2009 <151> | Product code 10-1053XLU is determined<br>to 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 [phone] or [phone] 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: | <span style="text-align: center;">✓</span> |
|-----------------------------|--------------------------------------------|
| (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

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510(k) Number: K112799