The KIRO Set is a sterile, single-use disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy compounding device for the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration.

Device Description

The KIRO Set is a disposable sterile, single-use fluid transfer tubing set medical device that when placed in one of the double channel peristaltic pumps integrated in the KIRO Oncology pharmacy compounding device, the KIRO Set allows the accurate and fast transfer of sterile fluids from a large source container into a drug vial for the reconstitution of lyophilized drugs (powder), or into a final medication container from which an intravenous medication will be administered. Sterile fluids delivered can be saline (0.9% sodium chloride), 5% alucose, Water for Injection (WFI) or any aqueous diluent which is adequate for the dilution of drugs into the right concentration for intravenous administration.

The KIRO Set is comprised of medical grade silicone tubing with a central double tubing channel pathway for use in the KIRO Oncology peristaltic pump. The KIRO Set includes a filtered vented bag spike for connection to source containers on one end and a male luer lock connector on the outlet end for connection to a dosing spike to allow for dosing into vials for reconstitution or direct connection to final medication containers such as infusion bags, cassettes or elastomeric pump reservoirs.

The device is intended to be used inside the KIRO Oncology compounding area, which is an ISO5 environment for the compounding of sterile medications.

The device is provided sterile and is intended for single-use.

The KIRO Set is not intended to be used for direct patient contact.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the "KIRO Set." It evaluates the substantial equivalence of the KIRO Set to a legally marketed predicate device (Sets Gri-Fill 3.0, K050339) and a reference device (Baxa Tubing Set, K872743).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria (from Predicate/Reference)	Reported Device Performance (KIRO Set)
Intended Use	Fluid transfer in preparation of final medication containers or syringes, and reconstitution of drug vials in hospital pharmacies when used with the GRI-FILL 3.0/Repeater Pump pharmacy compounding devices.	Fluid transfer in the preparation of final medication containers and the reconstitution of drug vials in hospital pharmacies when used with the KIRO Oncology pharmacy compounding device. (This is presented as being substantially equivalent, implying it meets the same functional intention.)
Use	Single Use	Single Use
Sterility	Sterile; Non-pyrogenic fluid pathway	Sterile; Non-pyrogenic fluid pathway
Biocompatibility	Not known (for predicate/reference)	Per ISO 10993-1:2010 for prolonged duration, indirect blood path contacting device. Testing results: Passed Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity, Hemocompatibility (Hemolysis Indirect and Hemolysis Direct), Pyrogen testing.
Acceptable Fluids	Not to be used with lipids (predicate); No limitations (reference)	Saline (0.9% sodium chloride), 5% glucose, WFI or any aqueous diluent which is adequate for the dilution of drugs into the right concentration for intravenous administration.
Closed system (fluid not in contact with any reusable part of the compounding device)	YES	YES
Dose Range	2.0 ml to 3000 ml (predicate); Minimum dispensing volume of 0.2 ml (reference)	0.5 ml to 200 ml
Accuracy (Doses into vials)	<±0.5 ml for 2.0-25.0 ml; <±2% for 25.0-3000 ml (predicate); +/-10% @ 0.2 ml, +/-5% @ 0.4 ml, +/-2% @ 1.0 ml (reference)	5.0 ml to 100 ml: ±5% 1.0 ml to 4.99 ml: ±10% 0.5 ml to 0.99 ml: ±0.1 ml
Accuracy (Doses into reservoirs)	(Not explicitly stated for predicate in direct comparison, generally covered by overall accuracy for final containers)	50 ml to 200 ml: ±10% 10 ml to 49.99 ml: ±2 ml
Microbial Ingress (Worst-case use conditions)	(Implied standard for sterile medical devices)	No turbidity in media fill simulation vials or reservoirs, indicating no growth of microorganisms.
Physical and Chemical Testing	(Implied standard for ISO 8536-4)	Met criteria per ISO 8536-4 (including Leakage/Tensile Strength Testing).
Physical Testing of Luer Locks	(Implied standard for ISO 594-2)	Met criteria per ISO 594-2.
Stability in Peristaltic Pump	(Implied standard for device function)	Stability testing conducted. (No specific numerical results provided in this summary, but implies positive outcome).
Distribution Testing	(Implied standard for device function)	Distribution testing conducted. (No specific numerical results provided in this summary, but implies positive outcome).

Note: The document focuses on demonstrating substantial equivalence to predicate devices. Therefore, the "acceptance criteria" are implicitly derived from the performance and safety characteristics of the predicate and reference devices, as well as relevant performance standards. The "reported device performance" is the outcome of the KIRO Set's testing, which aims to show it meets or is comparable to these implicit criteria. Specific numerical acceptance criteria were only provided for "Accuracy."

2. Sample size used for the test set and the data provenance:

Biocompatibility Testing: The document does not specify the sample size for each biocompatibility test. It mentions that "Biocompatibility testing as required for External Communicating Devices, Blood Path, Indirect Contact, Prolonged Duration was conducted in accordance with cited guidances and standards." This implies the sample sizes would have been determined by those standards (e.g., ISO 10993-1).
Media Fill Testing: The document states that "Media fill cycles of drug vials and reservoirs filled using the KIRO Set... were designed to represent the worst-case use conditions." It does not provide a specific number for the sample size (number of vials/reservoirs or cycles).
Performance Testing (Physical, Chemical, Luer Locks, Accuracy, Stability, Distribution): The document does not specify the sample sizes for these tests.
Data Provenance: The studies were conducted by KIRO Robotics S.L. to support their 510(k) submission to the FDA. The data provenance is from internal testing designed to meet FDA and international standards (e.g., ISO 10993, ISO 13408-1, USP Chapter 71, ISO 8536-4, ISO 594-2). This would be prospective data generated specifically for regulatory submission. The country of origin of the testing is not explicitly stated but would likely be Spain, where KIRO Robotics S.L. is based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the studies described are for a physical medical device (fluid transfer tubing set) and involve engineering/scientific performance testing, not diagnostic/interpretive studies requiring expert consensus for ground truth. The "ground truth" for these tests are objective measurements against established physical, chemical, and biological standards and protocols.

4. Adjudication method for the test set:

Not applicable for the same reasons as #3. The testing involves objective measurements rather than qualitative assessment requiring 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-assisted diagnostic device, but a physical medical device for fluid transfer.

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

Not applicable. This is not an algorithm. The "standalone" performance here refers to the device's functional characteristics (e.g., accuracy, sterility) when used as intended within the KIRO Oncology pharmacy compounding device, without further human subjective interpretation for its core function.

7. The type of ground truth used:

Biocompatibility: Established scientific standards (ISO 10993-1) for biological response, chemical exposure assessment for material safety.
Media Fill Testing: Absence of microbial growth (turbidity) in a culture medium, with positive and negative controls. This is an objective biological outcome based on incubation and visual inspection. The methods are based on ISO 13408-1:2008 and Chapter 71 of the USP.
Performance Testing (Physical, Chemical, Luer Locks, Accuracy, Stability, Distribution): Objective measurements against established engineering and performance standards (e.g., ISO 8536-4, ISO 594-2) and the stated accuracy specifications.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning algorithm, 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 this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

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

December 4, 2015

KIRO Robotics S.L. c/o Ms. Korina Akhondzadeh KARA & Associates 6965 El Camino Real, Suite 105-428 Carlsbad, CA 92009

Re: K152441

Trade/Device Name: KIRO Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI, NEP Dated: October 30, 2015 Received: November 2, 2015

Dear Ms. Akhondzadeh:

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. Korina Akhondzadeh

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 devicerelated 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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152441

Device Name KIRO Set

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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Image /page/3/Picture/0 description: The image is a logo for KIRO oncology. The logo consists of a circle that is half teal and half gray, followed by the word "KIRO" in teal. Below the word "KIRO" is the word "oncology" in a smaller font, also in teal.

510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

l. SUBMITTER

KIRO Robotics S.L. Polo de Innovación Garaia Goiru Kalea 1, Edificio B, Planta 2 C.P. 20500 Mondragon Gipuzkoa SPAIN

Phone: +34 943-252-249 Contact at KIRO Robotics: Naiara Telleria

Official Correspondent

Korina A. Akhondzadeh KARA & Associates - Regulatory Consultant to KIRO Robotics 6965 El Camino Real, Suite 105-428 Carlsbad. CA 92009 Phone: 760-798-9642 760-798-9643 Fax:

Date Prepared: August 25, 2015

ll. DEVICE

Device Name: KIRO Set Common/Usual Name: Set, I.V. Fluid Transfer Classification Name: Intravascular administration set (21 CFR 880.5440) Product Code: LHI Secondary Product Code: NEP Class: ll

lll. PREDICATE DEVICE

Predicate Device Sets Gri-Fill 3.0, K050339

This predicate device has not been subject to a recall.

Reference Device Baxa Tubing Set (for Pharmacy Pump), K872743

This reference device has not been subject to a recall.

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Image /page/4/Picture/0 description: The image shows the logo for KIRO oncology. The logo consists of the letter O, which is half teal and half gray, followed by the word KIRO in teal. Below the word KIRO is the word oncology, also in teal.

IV. DEVICE DESCRIPTION

The device is intended to be used inside the KIRO Oncology compounding area, which is an ISO5 environment for the compounding of sterile medications.

The device is provided sterile and is intended for single-use.

The KIRO Set is not intended to be used for direct patient contact.

V. INDICATIONS FOR USE

The device is for prescription use only.

The KIRO Set and its predicate device are intended to be used with their respective pharmacy compounding devices by trained health-care personnel in the hospital pharmacy environment for the transfer of solutions for pharmaceutical preparations. Both devices are not intended to be connected directly to patients.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the KIRO Set and the predicate device are tubing sets with similar inlets and outlets for connection to source containers and vials or final medication containers. Both the subject and predicate devices are based upon the same technological elements:

. Tubing Set - Both are based upon medical grade tubing

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Image /page/5/Picture/0 description: The image shows the logo for KIRO oncology. The logo consists of a circle that is half teal and half gray, followed by the text "KIRO" in teal. Below the text "KIRO" is the word "oncology" in a smaller teal font.

. Source Connections – Both have filtered vented bag spike connected by luer lock to the tubing
Final Connections Both have male luer lock connections available at the outlet end . allowing for connection to dosing spikes for vials and to reservoirs such as infusion bags, cassettes and elastomeric pumps
. Both are closed systems not having any contact of the fluid pathway with any reusable part of the pharmacy compounding device

The following technological differences exist between the KIRO Set and predicate devices:

. Use in a peristaltic pump for fluid transfer for the KIRO Set as compared to an integrated syringe for the predicate
. KIRO Set uses silicone tubing as compared to PVC tubing in the predicate
. The KIRO Set uses the external waste container of the KIRO Oncology device to contain the priming waste as compared to the integrated waste container for the predicate device.

Characteristics	KIRO Set	Sets Gri-Fill 3.0(K050339)Predicate Device	Baxa Tubing Sets (forPharmacy Pump)(K872743)Reference Device
Indications for Use	The KIRO Set is a sterile,single-use disposableancillary device used withthe peristaltic pump inthe KIRO Oncologypharmacy compoundingdevice for the transfer offluids into sterile powderdrug vials or into sterilemedication containers forintravenous drugadministration.The device is forprescription use only.	SETS GRI-FILL 3.0 1WAY and 2 WAY fluidtransfer sets areancillary devices used inconjunction with theGRI-FILL 3.0 pharmacycompounder in thehospital pharmacy toprovide a fluid pathwaythrough which one ortwo substances aredelivered into a final IVcontainer or syringe.SETS GRI-FILL 3.0MULTIPLE fluid transfersets are ancillarydevices used as fluidpathways in conjunctionwith the GRI-FILL 3.0pharmacy compounderand associated 1 WAYor 2 WAY transfer setsthrough which the samesubstance from up to 6source containers maybe delivered into a final	The Repeater Pumptube set is part of theRepeater Pump device.This device providesperistaltic pump drivenfluid transfer thatfacilitates repeatabledrug dosage distributionand reconstitution inhospital pharmacies.The Repeater Pumptube set provides thefluid pathway andpumping mechanism forthe pump system. Thedevice is for use with IVbags, syringes,elastomeric infusers,and other drugadministrationcontainers. Some setsare sold sterile andothers are not based onthe end use of the set.
		IV container.The device should notbe used with lipids.The device is intendedto be used by trainedhealth-care personnel.It is restricted to sale byor on the order of aphysician.
Intended Use	This product would beused for fluid transfer inthe preparation finalmedication containersand the reconstitution ofdrug vials in hospitalpharmacies when usedwith the KIRO Oncologypharmacy compoundingdevice.	This product would beused for fluid transfer inthe preparation of finalmedication containersor syringes, and thereconstitution of drugvials in hospitalpharmacies when usedwith the GRI-FILL 3.0pharmacy compoundingdevice.	This product would beused for fluid transfer inhospital pharmacieswhen used with theRepeater Pump for thefilling of oral dispensers,luer syringes, vials,elastomeric infusers,minibags, cassettes andthe reconstitution ofdrug vials.
Product Code	LHI	LHI	FMF
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	21 CFR 880.5860
Classification	Class II	Class II	Class II
	SUBSTANTIAL EQUIVALENCE BASED UPON INTENDED USE
Use	Single Use	Single Use	Single Use
Prescription / OTCuse	Prescription Use	Prescription Use	Prescription Use
PharmacyCompounding DeviceSpecified	KIRO Oncology	GRI-FILL 3.0	Repeater Pump (TheRepeater Pump is aclassified as a PistonSyringe (880.5860) andnot a pharmacycompounding device
Intended for DirectConnection to Patient	NO	NO	NO
Use environment	Hospital pharmacy insidethe KIRO Oncology PCDISO 5 environment.	Hospital pharmacy bothoutside and inside offlow hoods	Hospital pharmacy bothoutside and inside offlow hoods.
Target users	Trained health-carepersonnel	Trained health-carepersonnel	Trained health-carepersonnel
Sterility	Sterile; Non-pyrogenicfluid pathway	Sterile; Non-pyrogenicfluid pathway	Sterile
Sterilization	Gamma Radiation	Ethylene Oxide	Ethylene Oxide
Biocompatibility	Per ISO 10993-1:2010for prolonged duration,indirect blood path	Not known	Not known
	contacting device
SUBSTANTIAL EQUIVALENCE BASED UPON TECHNOLOGICAL CHARACTERISTICS
Acceptable Fluids	Saline (0.9% sodiumchloride), 5% glucose,WFI or any aqueousdiluent which is adequatefor the dilution of drugsinto the rightconcentration forintravenousadministration	Not to be used withlipids	No limitations providedfor acceptable fluids
Biocompatibility	Per ISO 10993-1:2010for prolonged duration,indirect blood pathcontacting device	Not known	Not known
Acceptable Fluids	Saline (0.9% sodiumchloride), 5% glucose,WFI or any aqueousdiluent which is adequatefor the dilution of drugsinto the rightconcentration forintravenousadministration	Not to be used withlipids	No limitations providedfor acceptable fluids
Primary Fluid ContactMaterial - Tubing	Medical Grade Silicone	PVC with DEHP	Medical Grade PVCResin with MedicalGrade Silicone sectionin contact with peristalticpump
Fluid TransferMechanism	External Peristaltic Pump- Double Channel	Integrated Syringe -Single Channel	External PeristalticPump - Single Channel
Closed system (fluidnot in contact withany reusable part ofthe compoundingdevice)	YES	YES	YES
Dose Range	0.5 ml to 200 ml	2.0 ml to 3000 ml	Minimum dispensingvolume of 0.2 ml
Accuracy	Doses into vials:5.0 ml to 100 ml: ±5%1.0 ml to 4.99 ml: ±10%0.5 ml to 0.99 ml: ±0.1 mlDoses into reservoirs:50 ml to 200 ml: ±10%10 ml to 49.99 ml: ±2 ml	Doses from 2.0 ml to25.0 ml: <±0.5 mlDoses from 25.0 ml to3000 ml: <± 2%	Volume accuracy:+/-10% @ 0.2 ml+/-5% @ 0.4 ml+/-2% @ 1.0 ml
Number ofdiluent/source	One	One container with 1	One
containers
		WAY setTwo containers with 2WAY setUp to 6 containers withMULTIPLE set
Integrated WasteContainer	NO	YES	NO
Connections toSource Containers	Vented bag spike or maleluer	Vented bag spike ormale luer	Vented bag spike
Connections to FinalContainers	Male Luer Connector	Male Luer ConnectorAlso supplied withfemale to female luer toallow for female to maleluer connection	Male Luer Connector
Final Containers	Vials, Infusion Bags,Cassettes, Elastomericpumps	Vials, Syringes,Elastomeric pumps, Gri-bag, Gri-flex	Oral dispensers,Syringes, Vials,Elastomeric pumps,minibags, cassettes

Substantial Equivalence Comparison Table - KIRO Set, Predicate Device Sets Gri-Fill 3.0 and Reference Device

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Image /page/6/Picture/0 description: The image is a logo for Kiro Oncology. The logo features a circle that is partially filled in with a teal color on the left side and gray on the right side. The text "KIRO" is written in teal, with the word "oncology" written in a smaller font size below the "RO".

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Image /page/7/Picture/0 description: The image is a logo for KIRO oncology. The logo consists of a circle that is half teal and half gray, followed by the text "KIRO" in teal. Below the "KIRO" text is the word "oncology" in a smaller font, also in teal.

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Image /page/8/Picture/0 description: The image shows the logo for KIRO oncology. The logo consists of a circle that is half teal and half gray, followed by the text "KIRO" in teal. Below the text "KIRO" is the word "oncology" in a smaller teal font.

VII. PERFORMANCE DATA

Performance testing was conducted in accordance with FDA Guidance for Industry and FDA Staff - "Intravascular Administration Sets Premarket Notification Submissions [510(k)], " July 11, 2008 and to address any technological differences with the predicate device.

Biocompatibility Testing

The biocompatibility evaluation for the KIRO Set device was conducted in accordance with the FDA Blue Book Memorandum #G95-1"Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995; ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA; and FDA Guidance for Industry and FDA Staff - "Intravascular Administration Sets Premarket Notification Submissions [510(k)]," July 11, 2008. Biocompatibility testing as required for External Communicating Devices, Blood Path, Indirect Contact, Prolonged Duration was conducted in accordance with cited guidances and standards.

The battery of testing included the following tests:

Cytotoxicity .
. Sensitization
. Intracutaneous reactivity
. Acute systemic toxicity
Material-mediated pyrogenicity
Hemocompatibility - Hemolysis Indirect and Hemolysis Direct
. Pyrogen testing

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Image /page/9/Picture/0 description: The image shows the logo for Kiro Oncology. The logo consists of a circle that is half teal and half gray, followed by the word "KIRO" in teal. Below the word "KIRO" is the word "oncology" in a smaller teal font.

Media Fill Testing

A media fill study was conducted to demonstrate that the KIRO Set does not allow for microbial ingress into the internal fluid pathway during its use under worst-case use conditions in the KIRO Oncology pharmacy compounding device (PCD). The study design considered the test method described in ISO 13408-1:2008, Aseptic processing of health care products – Part 1: General requirements and Chapter 71 of the USP for Sterility Testing of Compounded Sterile Preparations (CSPs).

Media fill cycles of drug vials and reservoirs filled using the KIRO Set in the KIRO Oncology PCD reconstitution station using soybean casein digest broth (TSB) as the source diluent were designed to represent the worst-case use conditions which have the maximal potential for allowing microbial contamination of the KIRO Set internal fluid pathway. These simulations included conditions for the maximum number of connections to be expected in an 8-hour use session with simulated interruptions due to user errors.

The TSB filled vials and reservoirs and corresponding negative and positive controls were placed in incubation at the end of each working session for 7 days at 22°C with an additional 7 days at 35 C. The samples were visually inspected for turbidity indicating growth of microorganisms in the TSB culture medium for up to 14 days after incubation. Positive controls were found to be turbid after a minimum of 3 days of incubation at 22°C.

None of the media fill simulation vials or reservoirs filled using the KIRO Set showed any turbidity, thereby indicating that no growth of microorganisms occurred. The media fill study conducted demonstrates that the use of the KIRO Set does not present a risk for microbial ingress into the internal fluid path.

Performance Testing

Physical and Chemical Testing per ISO 8536-4 including Leakage/Tensile Strength . Testing
. Physical Testing of Luer Locks per ISO 594-2
. Accuracy of Delivered Doses
Stability of the KIRO Set in the KIRO Oncology Peristaltic Pump ●
. Distribution Testing

VIII. CONCLUSIONS

The performance testing conducted demonstrates that the KIRO Set performs substantially equivalent to the predicate device. Both the KIRO Set and the predicate device have the same intended use. The KIRO Set performance testing supports that any technological differences with the predicate device do not raise any different questions of performance for the device when compared to the predicate device.

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.