KIRO Set

K152441 · Kiro Robotics S.L. · LHI · Dec 4, 2015 · General Hospital

Device Facts

• Record ID: K152441
• Device Name: KIRO Set
• Applicant: Kiro Robotics S.L.
• Product Code: LHI · General Hospital
• Decision Date: Dec 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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 Story

The KIRO Set is a sterile, single-use tubing set designed for use within the KIRO Oncology pharmacy compounding device (PCD). It consists of medical-grade silicone tubing with a filtered vented bag spike for source containers and a male luer lock for connection to dosing spikes or final medication containers (infusion bags, cassettes, elastomeric pumps). The device is placed into the PCD's double-channel peristaltic pump, which drives fluid transfer from source containers to vials or final reservoirs. Used in ISO 5 pharmacy environments by trained personnel, the system operates as a closed fluid pathway, preventing contact between the fluid and the compounding device's reusable components. By automating the reconstitution and transfer process, the device aims to improve accuracy and speed in pharmacy compounding while maintaining sterility. Healthcare providers use the output—reconstituted drugs or filled medication containers—for subsequent patient administration. The device is not intended for direct patient connection.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included biocompatibility (ISO 10993-1), media fill studies (ISO 13408-1, USP Chapter 71) to confirm no microbial ingress, physical/chemical testing (ISO 8536-4), luer lock testing (ISO 594-2), dose accuracy, and pump stability testing.

Technological Characteristics

Medical grade silicone tubing; double-channel pathway. Components include filtered vented bag spike and male luer lock. Energy source: external peristaltic pump. Sterilization: Gamma radiation. Biocompatibility: ISO 10993-1 compliant. Closed system design.

Indications for Use

Indicated for use by trained healthcare personnel in hospital pharmacy environments for the transfer of sterile fluids (saline, 5% glucose, WFI, or aqueous diluents) into drug vials for reconstitution or into medication containers for IV administration. Not for direct patient contact.

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

• Sets Gri-Fill 3.0 (K050339)

Reference Devices

• Baxa Tubing Set (for Pharmacy Pump) (K872743)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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

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.

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: [phone] 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: [phone] 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 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.

#### V. INDICATIONS FOR USE

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.

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<br>(K050339)<br>Predicate Device | Baxa Tubing Sets (for<br>Pharmacy Pump)<br>(K872743)<br>Reference Device |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The KIRO Set is a sterile,<br>single-use disposable<br>ancillary device used with<br>the peristaltic pump in<br>the KIRO Oncology<br>pharmacy compounding<br>device for the transfer of<br>fluids into sterile powder<br>drug vials or into sterile<br>medication containers for<br>intravenous drug<br>administration.<br>The device is for<br>prescription use only. | SETS GRI-FILL 3.0 1<br>WAY and 2 WAY fluid<br>transfer sets are<br>ancillary devices used in<br>conjunction with the<br>GRI-FILL 3.0 pharmacy<br>compounder in the<br>hospital pharmacy to<br>provide a fluid pathway<br>through which one or<br>two substances are<br>delivered into a final IV<br>container or syringe.<br>SETS GRI-FILL 3.0<br>MULTIPLE fluid transfer<br>sets are ancillary<br>devices used as fluid<br>pathways in conjunction<br>with the GRI-FILL 3.0<br>pharmacy compounder<br>and associated 1 WAY<br>or 2 WAY transfer sets<br>through which the same<br>substance from up to 6<br>source containers may<br>be delivered into a final | The Repeater Pump<br>tube set is part of the<br>Repeater Pump device.<br>This device provides<br>peristaltic pump driven<br>fluid transfer that<br>facilitates repeatable<br>drug dosage distribution<br>and reconstitution in<br>hospital pharmacies.<br>The Repeater Pump<br>tube set provides the<br>fluid pathway and<br>pumping mechanism for<br>the pump system. The<br>device is for use with IV<br>bags, syringes,<br>elastomeric infusers,<br>and other drug<br>administration<br>containers. Some sets<br>are sold sterile and<br>others are not based on<br>the end use of the set. |
| | | IV container.<br>The device should not<br>be used with lipids.<br>The device is intended<br>to be used by trained<br>health-care personnel.<br>It is restricted to sale by<br>or on the order of a<br>physician. | |
| Intended Use | This product would be<br>used for fluid transfer in<br>the preparation final<br>medication containers<br>and the reconstitution of<br>drug vials in hospital<br>pharmacies when used<br>with the KIRO Oncology<br>pharmacy compounding<br>device. | This product would be<br>used for fluid transfer in<br>the preparation of final<br>medication containers<br>or syringes, and the<br>reconstitution of drug<br>vials in hospital<br>pharmacies when used<br>with the GRI-FILL 3.0<br>pharmacy compounding<br>device. | This product would be<br>used for fluid transfer in<br>hospital pharmacies<br>when used with the<br>Repeater Pump for the<br>filling of oral dispensers,<br>luer syringes, vials,<br>elastomeric infusers,<br>minibags, cassettes and<br>the reconstitution of<br>drug 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 / OTC<br>use | Prescription Use | Prescription Use | Prescription Use |
| Pharmacy<br>Compounding Device<br>Specified | KIRO Oncology | GRI-FILL 3.0 | Repeater Pump (The<br>Repeater Pump is a<br>classified as a Piston<br>Syringe (880.5860) and<br>not a pharmacy<br>compounding device |
| Intended for Direct<br>Connection to Patient | NO | NO | NO |
| Use environment | Hospital pharmacy inside<br>the KIRO Oncology PCD<br>ISO 5 environment. | Hospital pharmacy both<br>outside and inside of<br>flow hoods | Hospital pharmacy both<br>outside and inside of<br>flow hoods. |
| Target users | Trained health-care<br>personnel | Trained health-care<br>personnel | Trained health-care<br>personnel |
| Sterility | Sterile; Non-pyrogenic<br>fluid pathway | Sterile; Non-pyrogenic<br>fluid pathway | Sterile |
| Sterilization | Gamma Radiation | Ethylene Oxide | Ethylene Oxide |
| Biocompatibility | Per ISO 10993-1:2010<br>for prolonged duration,<br>indirect blood path | Not known | Not known |
| | contacting device | | |
| SUBSTANTIAL EQUIVALENCE BASED UPON TECHNOLOGICAL CHARACTERISTICS | | | |
| Acceptable Fluids | Saline (0.9% sodium<br>chloride), 5% glucose,<br>WFI or any aqueous<br>diluent which is adequate<br>for the dilution of drugs<br>into the right<br>concentration for<br>intravenous<br>administration | Not to be used with<br>lipids | No limitations provided<br>for acceptable fluids |
| Biocompatibility | Per ISO 10993-1:2010<br>for prolonged duration,<br>indirect blood path<br>contacting device | Not known | Not known |
| Acceptable Fluids | Saline (0.9% sodium<br>chloride), 5% glucose,<br>WFI or any aqueous<br>diluent which is adequate<br>for the dilution of drugs<br>into the right<br>concentration for<br>intravenous<br>administration | Not to be used with<br>lipids | No limitations provided<br>for acceptable fluids |
| Primary Fluid Contact<br>Material - Tubing | Medical Grade Silicone | PVC with DEHP | Medical Grade PVC<br>Resin with Medical<br>Grade Silicone section<br>in contact with peristaltic<br>pump |
| Fluid Transfer<br>Mechanism | External Peristaltic Pump<br>- Double Channel | Integrated Syringe -<br>Single Channel | External Peristaltic<br>Pump - Single Channel |
| Closed system (fluid<br>not in contact with<br>any reusable part of<br>the compounding<br>device) | YES | YES | YES |
| Dose Range | 0.5 ml to 200 ml | 2.0 ml to 3000 ml | Minimum dispensing<br>volume of 0.2 ml |
| Accuracy | Doses into vials:<br>5.0 ml to 100 ml: ±5%<br>1.0 ml to 4.99 ml: ±10%<br>0.5 ml to 0.99 ml: ±0.1 ml<br>Doses into reservoirs:<br>50 ml to 200 ml: ±10%<br>10 ml to 49.99 ml: ±2 ml | Doses from 2.0 ml to<br>25.0 ml: <±0.5 ml<br>Doses from 25.0 ml to<br>3000 ml: <± 2% | Volume accuracy:<br>+/-10% @ 0.2 ml<br>+/-5% @ 0.4 ml<br>+/-2% @ 1.0 ml |
| Number of<br>diluent/source | One | One container with 1 | One |
| containers | | | |
| | | WAY set<br>Two containers with 2<br>WAY set<br>Up to 6 containers with<br>MULTIPLE set | |
| Integrated Waste<br>Container | NO | YES | NO |
| Connections to<br>Source Containers | Vented bag spike or male<br>luer | Vented bag spike or<br>male luer | Vented bag spike |
| Connections to Final<br>Containers | Male Luer Connector | Male Luer Connector<br>Also supplied with<br>female to female luer to<br>allow for female to male<br>luer connection | Male Luer Connector |
| Final Containers | Vials, Infusion Bags,<br>Cassettes, Elastomeric<br>pumps | Vials, Syringes,<br>Elastomeric pumps, Gri-<br>bag, Gri-flex | Oral dispensers,<br>Syringes, Vials,<br>Elastomeric pumps,<br>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.