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510(k) Data Aggregation
(437 days)
KIRO Set, K152441
Gri-Fill Peristaltic Set fluid transfer set is an ancillary device used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one solution source is delivered into a final IV container. This device is not intended to be directly connected to the patient.
Gri-fill Peristaltic Set is a disposable fluid transfer set for connection to a source container and to Gri-fill sets for use with the Gri-Fill Pharmacy Compounder. lt consists of a silicone tube linking a male luer-lock connector and a spike (with a 1.2 um hydrophobic air filter) for connecting to the source container, and a female luer-lock connection, for connecting to the Gri-fill set. The silicone tube allows the set to be used with a peristaltic pump. The Gri-fill Peristaltic Set is intended to be used by trained health-care personnel. The product is presented sterile (SAL = 1 x 10-6) in peel-pack pouches each containing 1 unit. Sterility is achieved using a validated ethylene oxide sterilization process. Gri-fill Peristaltic Set is not intended to be used for direct patient contact.
The provided document describes the 510(k) premarket notification for the Gri-fill Peristaltic Set, a fluid transfer set used in hospital pharmacies. It claims substantial equivalence to a predicate device, the KIRO Set (K152441).
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against which a device's performance is measured in a quantitative manner as typically seen in clinical performance studies of AI/diagnostic devices. Instead, the "acceptance criteria" are implied by the various performance tests conducted to demonstrate substantial equivalence to the predicate device and adherence to relevant standards. The "reported device performance" is described qualitatively as "All tests yielded correct results."
However, the closest equivalent to quantitative acceptance criteria and performance data are those related to Dose Range and Accuracy, which are compared between the subject device and the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate Device) | Gri-fill Peristaltic Set Performance (Claimed) | Comparison |
|---|---|---|---|
| Dose Range | 0.5 ml to 200 ml | 2 ml to 3000 ml | Different dose range as programmed through the respective pharmacy compounding devices. |
| Accuracy (Predicate's) | 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 10 ml: ±0.2 ml | ||
| Doses from 10 ml to 25 ml: ±0.5 ml | |||
| Doses from 25 ml to 3000 ml: ±2 % | Different accuracy claims as achieved with the respective pharmacy compounding devices. | ||
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 | Identical to predicate device |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Identical to predicate device. Same biological tests performed. |
| Closed system (fluid not in contact with any reusable part of the compounding device) | YES | YES | Identical to predicate device |
| Shelf life | 5 years | 5 years | Identical to predicate device |
Note: For most other performance tests (e.g., leakage, tensile strength, functionality, residuals, endotoxins), the document states "All tests yielded correct results," implying they met their respective standard-defined acceptance criteria, but these criteria are not numerically specified in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (e.g., number of devices tested) for the performance tests conducted. It only mentions that "Performance testing was conducted in accordance with 'FDA Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]' dated July 11, 2008."
The data provenance is implied to be from laboratory bench testing performed by the manufacturer, Laboratorios Grifols, S.A. (SPAIN). All studies were prospective bench tests rather than retrospective or prospective human data clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is a physical medical device (fluid transfer set) and not an AI or diagnostic tool requiring ground truth established by human experts for interpretation of images or patient data. The "ground truth" for its performance is derived from physical and chemical measurements against established standards.
4. Adjudication Method for the Test Set
This information is not applicable as there are no human interpretations or classifications of data that would require an adjudication method. Performance is assessed through objective physical and chemical testing.
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
This information is not applicable. The device is a physical medical device (fluid transfer set), not an AI or diagnostic tool, and therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical device. It does not involve algorithms or AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective measurements against established engineering and safety standards, such as:
- ISO 11607-1 for individual packaging validation.
- ISO 11135:2014 for ethylene oxide sterilization process validation.
- ISO 10993-7:2008 for residuals of ethylene oxide sterilization.
- ANSI/AAMI ST72:2002 and FDA Guidance for Industry for bacterial endotoxin testing.
- ISO 8536-4 for chemical, physical, and functional performance (leakage, tensile strength).
- ISO 22413 for chemical, physical, and functional performance.
- ISO 594-1 and ISO 594-2 for physical testing of luer-locks.
- ISO 10993-1 for biocompatibility (hemocompatibility, cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity).
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device. It does not involve AI or machine learning models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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