The MED-RX Transfer Set is offered in four (4) different models: 10-1227TS, 10-1300TS, 10-1305TS, and 10-1306TS. The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe. The MED-RX Transfer Sets each consist of a spike, tubing, and either a valve (swabbable or dual check) or 3-way stopcock. All sets but the 10-1306TS also have a pinch clamp. The tube is made of polyvinyl chloride (PVC) and is available in lengths from 18″ – 44″. The MED-RX Transfer Sets are provided sterile and are not to be resterilized.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (MED-RX Transfer Set), not an AI/ML device. Therefore, the requested information about acceptance criteria and study details related to AI/ML device performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC study, standalone performance, training set size, ground truth for training set) is not applicable and not available in the provided document.

The document describes the acceptance criteria and study results for the physical and functional performance of the MED-RX Transfer Set, which is an intravascular administration set. The study aims to demonstrate substantial equivalence to predicate devices (Medrad Transfer Set K022431 and Medrad Swabbable Valve Transfer Set K031808), not to prove AI/ML performance.

Here's a breakdown of the acceptance criteria and study results based on the provided text, modified to fit the context of a medical device (not AI/ML):

1. Table of Acceptance Criteria and Reported Device Performance

Test Description	Standard	Acceptance Criteria	Reported Device Performance
Particulate Contamination	ISO 8536-4:2007	Met contamination index limit.	Samples met contamination index limit.
Leakage under Pressure	ISO 8536-4:2007	Pass	Pass
Liquid Leakage	ISO 8536-4:2007	Pass	Pass
Tensile Strength — Tubing/Spike	ISO 8536-4:2007	Withstand 15 N for 15 Seconds	Withstand 15 N for 15 Seconds = Pass
Tensile Strength — Tubing/Valve	ISO 8536-4:2007	Withstand 15 N for 15 Seconds	Withstand 15 N for 15 Seconds = Pass
Withstand designated test force without damage or separation	ISO 8536-4:2007	Pass	Pass
Efficiency of the Air Filter	ISO 8536-4:2007	Pass	Pass
Flow Rate Test	ISO 8536-4:2007	Pass	Pass
Chemical Requirements	ISO 8536-4:2007 PER Clause 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 Assurance Level	ANSI/AMMI/ISO 11135:1994	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
Hemolysis Assay – Extract Method	ASTM F-756-00	Non-hemolytic	Considered non-hemolytic and passes the test.
Acute Systemic Injection Test	ISO 10993-11	Requirements met	The findings indicate that the requirements have been met.
Materials Mediated Rabbit Pyrogen Test	USP 32:2009 <151>	Non-pyrogenic	Determined to be non-pyrogenic.
Intracutaneous Reactivity Test	ISO 10993-10:2002	Non-irritant	Would be considered a non-irritant.
Guinea Pig Maximization Sensitization Test	ISO 10993-10:2002	No sensitization response	Did not elicit a sensitization response.
Cytotoxicity (ISO MEM Elution with L-929 Mouse Fibroblast Cells)	ISO 10993-5:2009	Non-toxic	Considered non-toxic.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact sample sizes (N value) for each individual non-clinical performance and biocompatibility test. It generally states that "samples met" or "product code X was determined," implying that sufficient samples were tested to meet the respective standards.
Data Provenance: Not explicitly stated, but the testing would have been conducted by Benlan Inc. (located in Oakville, ON, Canada) or its designated testing facilities, following international (ISO, ASTM, USP) and national (ANSI/AAMI) standards. The nature of these tests is prospective: samples of the MED-RX Transfer Set are deliberately subjected to these tests to evaluate their performance against established criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" for a medical device like a transfer set is established by objective, standardized laboratory testing procedures as defined by the international and national standards listed (e.g., ISO, ASTM, USP, ANSI/AAMI). It does not involve expert interpretation or consensus in the way an AI/ML diagnostic algorithm's output would. The results are quantitative (e.g., force applied, levels of contamination, presence/absence of hemolysis) or qualitative (pass/fail) based on predefined thresholds in the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As described above, the tests are objective, standardized laboratory assessments, not subjective evaluations requiring expert 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 not an AI/ML device; it is a physical medical device. MRMC studies are used for evaluating diagnostic performance, often involving human readers and AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is derived from objective, standardized test methods and criteria defined by established international and national standards (e.g., ISO 8536-4 for infusion equipment, ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135 for sterilization). These standards specify the test conditions, measurement methods, and acceptable limits or outcomes for various performance parameters (e.g., leakage, tensile strength, sterility, biocompatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this physical medical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Benlan MED-RX Transfer Sets. The logo consists of a stylized water drop symbol on the left, followed by the word "Benlan" in bold, sans-serif font. Below the word "Benlan" is the text "MED-RX Transfer Sets", with the "RX" having a registered trademark symbol.

SECTION 5 - 510(K) SUMMARY

K102073

NOV - 8

Image /page/0/Picture/4 description: The image shows a close-up of a curved surface covered in small, circular shapes. The shapes appear to be raised or textured, creating a bumpy surface. The lighting in the image is uneven, with the top portion appearing darker and more shadowed than the bottom portion. The overall impression is that of a detailed, textured surface with varying degrees of light and shadow.

Date of Summary: September 22, 2010

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 Transfer Set
Common Name:	Intravascular Administration Set
Classification Name:	Intravascular Administration Set, 880.5440 Intravascular Administration Set.
Class:	Class II
Product Code:	FPA
Predicate Device:	Medrad Transfer Set (K022431)
	Medrad Swabbable Valve Transfer Set (K031808)

Device Description

Indications for Use

The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe.

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 Transfer Sets are substantially equivalent to the predicate Medrad Transfer Set (K022431) and Medrad Swabbable Valve Transfer Set (K031808). All devices have the same intended use to deliver contrast media or saline from a spikeable container into a syringe. All devices allow multiple filling from one reservoir up to a 6 hour time limit.

A comparison of features and principles of operation between the proposed device and predicate device is provided in Table 1 below.

05 829 5004 F 905 829 5006 € benlon@benlan.com 2760 Brighton Rd. Oakville ON L6H 5T4 www.benlon.com

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K-102073

MED-RX® Transfer Sets

Table 1: Comparison between MED-RX Transfer Set, Medrad Transfer Set (K022431), and Medrad Swabbable Valves Transfer Set (K031808)

ATTRIBUTE	PROPOSED DEVICEMED-RX Transfer Set	PREDICATE DEVICEMedrad Transfer Set(K022431)	PREDICATE DEVICEMedrad SwabbableValve Transfer Set(K031808)
General Indications
Indications for Use	Delivery of contrastmedia or saline from aspikeable container into asyringe	Same	Same
System Configuration	1 Part System – multi-fillspike system	Same	Same
Time Limit	6 hours maximum	Same	Same
Multi - fill	Yes, until reservoir isempty or time limitreached	Yes	Yes
Shelf Container	For use with onecontainer of media only	Same	Same
Prescription	Yes	Yes	Yes
Intended Environment of Use	Hospital	Same	Same
Material Composition
Tubing	Polyvinyl Chloride - DEHPfree	PVC - medical grade	PVC - medical grade
Adhesive	Cyclohexanone and 3921Light Cure Adhesive	Cyclohexanone and 3321Light Cure Adhesive	Cyclohexanone and 3321Light Cure Adhesive
Packaging and Sterilization
Sterile	Yes	Yes	Yes
Sterilization Method	Ethylene Oxide (EO)	Same	Same
Packaging Configuration	Medical grade peelablepaper/ poly pouch	Same	Same
	DIFFERENCES
Physical Specifications
Tubing outer diameter (OD)	0.158" - 0.168"	0.160"	0.160"
Tubing inner diameter (ID)	0.095" - 0.111"	0.110"	0.120"
Tubing length	18", 20", 31", 44"	20"	23"
Design Features
Distal Configuration	Dual check valve OR 3-way stopcock ORswabbable luer valve	One-way stopcock	Swabbable threadedvalve
Proximal Configuration	Universal spike ORVented spike	Hyperal vented spike	Hyperal vented spike
Clamp	Pinch clamp(except for 10-1306)	Pinch clamp	None
Caps	Luer caps (except for 10-1306)	Luer caps	None

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Summary of Differences

There are no significant differences between the proposed MED-RX Transfer Sets and the predicate devices, Medrad Transfer Set (K022431) and Medrad Swabbable Valve Transfer Set (K031808). Similarities between the proposed device and the predicate devices include identical indications for use and duration of use. The MED-RX Transfer Sets and the Medrad Transfer Set and Medrad Swabbable Valve Transfer Set are sterile, disposable devices, packaged in peelable paper/poly pouches and sterilized using ethylene oxide.

The proposed MED-RX Transfer Sets to be offered utilize either a dual-check valve, a stopcock, or a luer compatible swabbable valve on the distal end of the set. The predicate Medrad Transfer Set has a stopcock while the predicate Medrad Swabbable Valve Transfer Set has a luer threaded swabbable valve. The dual-check valve used on the MED-RX Transfer Set is not offered on either of the predicate devices, but is a very similar component to the stopcock utilized, both of which are luer compatible, with two user-accessible ports.

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 Transfer Sets. 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 Transfer Sets has been performed as per ISO 8536-4: 2007. The MED-RX Transfer Sets were subject to numerous performance tests including tensile strength, resistance to leakage under pressure and also for resistance to liquid leakage, particulate contamination, and for chemical requirements. The MED-RX Transfer Sets have successfully completed all required performance testing following the applicable guidelines of ISO 8536-4: 2007 and were tested for natural rubber latex content. Please refer to Table 2.

Particulate Contamination	ISO 8536-4: 2007	Samples met contaminationindex limit.
Leakage under Pressure	ISO 8536-4:2007	Pass
Liquid Leakage	ISO 8536-4:2007	Pass
Tensile Strength —Tubing/Spike	ISO 8536-4:2007	Withstand 15 N for 15Seconds = Pass

Table 2: Non-Clinical Test Summary

5-3 R1

905 829 5004 F 905 829 5006 € benlan@benlon.com

2760 Brighton Rd. Oakville ON L6H 5T4 www.benlan.com

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Test	Standard	Results
Tensile Strength – Tubing/Valve	ISO 8536-4:2007	Withstand 15 N for 15Seconds = Pass
Demonstrate MED-RX TransferSets are capable of withstandingthe designated test force withoutdamage or separation.	ISO 8536-4:2007	Pass
Efficiency of the Air Filter	ISO 8536-4:2007	Pass
Flow Rate Test	ISO 8536-4:2007	Pass
Chemical Requirements	ISO 8536-4:2007 PERClause5 & 7	Pass
Natural Rubber Latex Content	Modified Lowry Method	Device does not containnatural rubber latex

Summary of Sterilization

Each MED-RX Transfer Set 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 11135:1994	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

Image /page/3/Picture/11 description: The image shows the logo for Benlan. The logo consists of a stylized letter "O" on the left and the word "Benlan" on the right. The letter "O" is not a complete circle, but rather an open shape that resembles a crescent moon or a horseshoe.

x 2760 Brighton Rd. Oakville ON L6H ST4 www.benlan.com ·

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Image /page/4/Picture/2 description: The image shows a microscopic view of a biological sample. The sample appears to be a tubular structure, possibly a vessel or duct, filled with numerous small, circular or oval-shaped objects. These objects are densely packed in some areas and more sparsely distributed in others, suggesting varying concentrations within the structure.

Summary of Biocompatibility Tests

Biocompatibility testing was successfully completed on sterile finished devices. The MED-RX Transfer Sets are classified as external communicating devices with limited indirect blood path contact. A summary of the testing completed and the relevant standards are listed in Table 4.

Table 4: Biocompatibility Test Summary

Test Description	Standard	Results
Hemolysis Assay – ExtractMethod	ASTM F-756-00	Product code 10-1300, 10-1305, 10-1306 and10-1227 is considered non-hemolytic and passesthe test.
Acute Systemic InjectionTest	ISO 10993-11	The findings indicate that the requirements ofthe ISO Acute Systemic Injection Test have beenmet.
Materials Mediated RabbitPyrogen Test	USP 32:2009 <151>	Product code 10-1300, 10-1305, 10-1306 and10-1227 was determined to be non-pyrogenic.
Intracutaneous ReactivityTest	ISO 10993-10:2002	Product code 10-1300, 10-1305, 10-1306 and10-1227 would be considered a non-irritant.
Guinea Pig MaximizationSensitization Test (Methodof Biomaterial Extracts)	ISO 10993-10:2002	Product code 10-1300, 10-1305, 10-1306 and10-1227 did not elicit a sensitization response.
ISO MEM Elution withL-929 Mouse FibroblastCells (Cytotoxicity)	ISO 10993-5: 2009	Product code 10-1300, 10-1305, 10-1306 and10-1227 are considered non-toxic.

Image /page/4/Picture/9 description: The image shows the logo for Benlan, with the company name in bold black letters next to a circular graphic. Below the logo are the company's phone and fax numbers, as well as their email address. The phone number is 905-829-5004, the fax number is 905-829-5006, and the email address is benlan@benlan.com.

ג 2760 Brighton Rd. Oakville ON L6H 5T4 ששוש.benlan.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Benlan, Incorporated C/O Mr. E.J. Smith Smiths Associates P.O.Box 4341 Crofton, Maryland 21114

NOV - 8 2010

Re: K102073

Trade/Device Name: MED-RX Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 27, 2010 Received: October 28, 2010

Dear Mr. 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. 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- Mr. Smith

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/ucm] 15809.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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

th for

Anthony 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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Image /page/7/Picture/0 description: The image shows the logo for Benlan MED-RX Transfer Sets. The logo consists of a stylized letter O with a drop-like shape inside, followed by the word "Benlan" in bold, sans-serif font. Below "Benlan" is the text "MED-RX Transfer Sets", with the "RX" having a registered trademark symbol.

K102073

SECTION 4 - INDICATIONS FOR USE

NOV - 8 2010

510(K) Number (If Known): K102073

Device Name: MED-RX Transfer Set

Indications For Use:

The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe.

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)

Rhad C. Chaym 11/5/2010
Page 1 of 1

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthesionogy !
Infection Control, Dental Devices

510(k) Number: _ . .

Regulation Number and Section

§ 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.