(99 days)
No
The description focuses on the mechanical function of a disposable tubing set used with a peristaltic pump and does not mention any AI/ML components or capabilities.
No
Explanation: The device is used for compounding and transferring fluids for drug preparation, not for direct diagnosis, treatment, or prevention of disease in a patient. It is explicitly stated that the device "is not intended to be used for direct patient contact."
No
The device is described as a "fluid transfer tubing set" used for "the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration." Its purpose is to accurately and fast transfer sterile fluids for drug compounding and administration, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "disposable sterile, single-use fluid transfer tubing set medical device" comprised of "medical grade silicone tubing" and connectors. This indicates a physical hardware device, not software.
Based on the provided information, the KIRO Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the transfer of fluids for the reconstitution and preparation of intravenous drugs. This is a process related to drug preparation and administration, not the diagnosis of a disease or condition.
- Device Description: The device is a fluid transfer tubing set used with a compounding device. It handles sterile fluids and drugs. There is no mention of it being used to analyze samples from the human body (like blood, urine, or tissue) for diagnostic purposes.
- Lack of Diagnostic Function: The device's function is purely mechanical - transferring fluids accurately. It does not perform any tests or analyses on biological samples to provide diagnostic information.
- Performance Studies: The performance studies focus on aspects like biocompatibility, sterility (media fill), physical properties (leakage, tensile strength), and accuracy of fluid delivery. These are relevant to a device used for drug preparation and administration, not for diagnostic testing.
- Key Metrics: The key metrics are related to the accuracy of fluid delivery, which is crucial for drug compounding, not for diagnostic test performance (like sensitivity, specificity, etc.).
In summary, the KIRO Set is a medical device used in the preparation of medications, not for diagnosing diseases.
N/A
Intended Use / 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.
Product codes
LHI, NEP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained health-care personnel in the hospital pharmacy environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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: Conducted in accordance with 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. The battery of testing included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity, Hemocompatibility (Hemolysis Indirect and Hemolysis Direct), and Pyrogen testing.
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. Samples were incubated for 7 days at 22°C with an additional 7 days at 35°C and visually inspected for turbidity for up to 14 days. None of the media fill simulation vials or reservoirs filled using the KIRO Set showed any turbidity, indicating no microbial growth.
Performance Testing: Included 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, and Distribution Testing.
Key Results: The performance testing conducted demonstrates that the KIRO Set performs substantially equivalent to the predicate device. 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.
Key Metrics
Accuracy of Delivered Doses:
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 ml
Doses into reservoirs:
50 ml to 200 ml: ±10%
10 ml to 49.99 ml: ±2 ml
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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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.
1
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
2
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: +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 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
(K050339)
Predicate Device | Baxa Tubing Sets (for
Pharmacy Pump)
(K872743)
Reference Device |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The KIRO Set is a sterile,
single-use disposable
ancillary device used with
the peristaltic pump in
the KIRO Oncology
pharmacy compounding
device for the transfer of
fluids into sterile powder
drug vials or into sterile
medication containers for
intravenous drug
administration.
The device is for
prescription use only. | SETS GRI-FILL 3.0 1
WAY and 2 WAY fluid
transfer sets are
ancillary devices used in
conjunction with the
GRI-FILL 3.0 pharmacy
compounder in the
hospital pharmacy to
provide a fluid pathway
through which one or
two substances are
delivered into a final IV
container or syringe.
SETS GRI-FILL 3.0
MULTIPLE fluid transfer
sets are ancillary
devices used as fluid
pathways in conjunction
with the GRI-FILL 3.0
pharmacy compounder
and associated 1 WAY
or 2 WAY transfer sets
through which the same
substance from up to 6
source containers may
be delivered into a final | The Repeater Pump
tube set is part of the
Repeater Pump device.
This device provides
peristaltic pump driven
fluid transfer that
facilitates repeatable
drug dosage distribution
and reconstitution in
hospital pharmacies.
The Repeater Pump
tube set provides the
fluid pathway and
pumping mechanism for
the pump system. The
device is for use with IV
bags, syringes,
elastomeric infusers,
and other drug
administration
containers. Some sets
are sold sterile and
others are not based on
the end use of the set. |
| | | IV container.
The device should not
be used with lipids.
The device is intended
to be used by trained
health-care personnel.
It is restricted to sale by
or on the order of a
physician. | |
| Intended Use | This product would be
used for fluid transfer in
the preparation final
medication containers
and the reconstitution of
drug vials in hospital
pharmacies when used
with the KIRO Oncology
pharmacy compounding
device. | This product would be
used for fluid transfer in
the preparation of final
medication containers
or syringes, and the
reconstitution of drug
vials in hospital
pharmacies when used
with the GRI-FILL 3.0
pharmacy compounding
device. | This product would be
used for fluid transfer in
hospital pharmacies
when used with the
Repeater Pump for the
filling of oral dispensers,
luer syringes, vials,
elastomeric infusers,
minibags, cassettes and
the reconstitution of
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
use | Prescription Use | Prescription Use | Prescription Use |
| Pharmacy
Compounding Device
Specified | KIRO Oncology | GRI-FILL 3.0 | Repeater Pump (The
Repeater Pump is a
classified as a Piston
Syringe (880.5860) and
not a pharmacy
compounding device |
| Intended for Direct
Connection to Patient | NO | NO | NO |
| Use environment | Hospital pharmacy inside
the KIRO Oncology PCD
ISO 5 environment. | Hospital pharmacy both
outside and inside of
flow hoods | Hospital pharmacy both
outside and inside of
flow hoods. |
| Target users | Trained health-care
personnel | Trained health-care
personnel | Trained health-care
personnel |
| Sterility | Sterile; Non-pyrogenic
fluid pathway | Sterile; Non-pyrogenic
fluid pathway | Sterile |
| Sterilization | Gamma Radiation | Ethylene Oxide | Ethylene Oxide |
| Biocompatibility | Per ISO 10993-1:2010
for prolonged duration,
indirect blood path | Not known | Not known |
| | contacting device | | |
| SUBSTANTIAL EQUIVALENCE BASED UPON TECHNOLOGICAL CHARACTERISTICS | | | |
| Acceptable Fluids | 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 | Not to be used with
lipids | No limitations provided
for acceptable fluids |
| Biocompatibility | Per ISO 10993-1:2010
for prolonged duration,
indirect blood path
contacting device | Not known | Not known |
| Acceptable Fluids | 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 | Not to be used with
lipids | No limitations provided
for acceptable fluids |
| Primary Fluid Contact
Material - Tubing | Medical Grade Silicone | PVC with DEHP | Medical Grade PVC
Resin with Medical
Grade Silicone section
in contact with peristaltic
pump |
| Fluid Transfer
Mechanism | External Peristaltic Pump
- Double Channel | Integrated Syringe -
Single Channel | External Peristaltic
Pump - Single Channel |
| Closed system (fluid
not in contact with
any reusable part of
the compounding
device) | YES | YES | YES |
| Dose Range | 0.5 ml to 200 ml | 2.0 ml to 3000 ml | Minimum dispensing
volume 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 ml
Doses into reservoirs:
50 ml to 200 ml: ±10%
10 ml to 49.99 ml: ±2 ml | Doses from 2.0 ml to
25.0 ml: