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510(k) Data Aggregation
(76 days)
SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.
· Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.
· Route of administration: intravenous.
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.
· Routes of administration: intravenous and intra-arterial.
The SMARTeZ™ Elastomeric Infusion Pump (SMARTeZ™ Pump) is a sterile, single-use, mechanical (non-electric, non-electronic) infusion pump that consists of an elastomeric fluid reservoir as an energy source and an administration line. The constriction of the elastomeric fluid reservoir drives the fluid through the administration tubing and eventually through a flow restrictor, into the patient connection.
The SMARTeZ™ Pump is intended to administer infusion therapies only, and not for fluid storage.
This Special 510(k) Submission is to inform FDA of the addition to the thirty-nine (39) existing SMARTeZ™ Pump offerings, four (4) new models of different nominal volumes, flow rates and time: 498111: 100 ml, 0.5 ml/h, 200 h; 498121: 100 ml, 1 ml/h, 100 h: 498131: 50 ml, 0.5 ml/h, 100 h: 498141: 50 ml. 1 ml/h, 50 h. with KVO (Keep Vein Open) infusion pump labeling.
This document describes the FDA clearance for the SMARTeZ™ Elastomeric Infusion Pump (K242152), which identifies it as substantially equivalent to a previously cleared device (K151650). This submission is a "Special 510(k)" for the addition of new models with different nominal volumes, flow rates, and infusion times, along with a change to a detachable administration tube.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to recognized international standards. The document doesn't provide a direct "table" of acceptance criteria values alongside specific performance metrics for each, but rather states that tests were performed in conformance with these standards.
| Acceptance Criteria (Standard & Subclause) | Reported Device Performance |
|---|---|
| ISO 28620:2020, Medical devices – Non-electrically driven portable infusion devices (General) | Bench performance verifications and validations performed on the Subject device (pump and administration tubing connected) and referred-to existing devices (K151650). |
| ISO 28620:2020, Subclause 6.2 & 6.6 (Flow rate test conditions) | Flow rate tests performed under nominal conditions (on Subject device), various ambient temperatures, various solution viscosities, after resistance to pressure (on Subject device), after resistance to traction test (on Subject device), after refrigeration, under non-ambient pressure (simulating influences of routes of administration). These tests were performed for both K151650 and the Subject device where indicated. |
| ISO 28620:2020, Subclause 6.3, 6.4, 6.5 & 6.6 (Leak-proof test conditions) | Leak-proof tests performed under conditions of resistance to pressure (on Subject device), after drop test, after resistance to traction test (on Subject device), after refrigeration. These tests were performed for both K151650 and the Subject device where indicated. |
| ISO 80369-7:2021 (Luer lock connection tests) | Luer lock connection tests on the new Luer lock connectors, including: positive pressure fluid leakage, sub-atmospheric pressure air leakage, stress cracking, resistance to separation from axial load, resistance to separation from unscrewing, and resistance to overriding. These tests were performed on the Subject device. |
| ISO 10993-5 (Cytotoxicity) | Performed under K151650 and conducted on the Subject device. |
| ISO 10993-10 (Sensitization, Intracutaneous Reactivity) | Performed under K151650 and conducted on the Subject device. |
| ISO 10993-11 (Acute Systemic Toxicity) | Performed under K151650 and conducted on the Subject device. |
| ISO 10993-4 (In-vitro Hemolysis Assessment) | Performed under K151650 and conducted on the Subject device. |
| ISO 10993-18 and ISO 10993-17 (Chemical Characterization and Toxicological Risk Assessment) | Performed under K151650 and conducted on the Subject device. |
| ISO 11135:2014 (Sterilization) | Complies with sterilization requirements, performed under K151650. |
| Package Integrity Tests (ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009) | Performed on the proposed device, including seal strength, dye penetration, and heat/self-sealable pouches. |
| Pyrogen Tests (ANSI/AAMI ST72/2019, USP 40 , USP-NF , USP-NF ) | Performed under K151650. |
| Shelf-life Validation (ASTM 1980-21) | 3 years (36 months) validated using the FDA recognized standard. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size for each specific test in the "test set". It mentions "bench performance verifications and validations performed on the Subject device (pump and administration tubing connected) and referred-to existing devices (K151650)". The provenance of the data is not specified in terms of country of origin. The studies are described as "bench performance verifications and validations," indicating controlled laboratory testing, and would be considered prospective for the specific tests performed on the Subject device to support this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The document describes bench testing and compliance with standards for a medical device. Ground truth, in the context of expert review, is not applicable here as these are performance tests and biocompatibility assessments, not diagnostic or interpretive tasks.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes objective performance testing and compliance with standards, not a case-based review where expert adjudication would be needed.
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 an elastomeric infusion pump, a hardware device for fluid delivery, not a software device or an AI application that assists human readers.
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, an elastomeric infusion pump, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The ground truth for this device's performance is objective measurements against established engineering and biocompatibility standards (e.g., flow rate accuracy within specifications, confirmation of sterility, absence of cytotoxicity).
8. The Sample Size for the Training Set
This information is not applicable. This document describes the clearance of a physical medical device (an elastomeric infusion pump) based on engineering performance and biocompatibility testing, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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