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510(k) Data Aggregation
(99 days)
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 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.
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.
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