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510(k) Data Aggregation
(90 days)
The Single Use Injector NM-400/401 Series is intended to be used to perform endoscopic vascular or submucosal injection in the digestive tract with an endoscope.
The Olympus Single-Use Injector NM-400/NM-401 is a sterile, disposable injection needle designed for use with Olympus endoscopes to perform endoscopic vascular or submucosal injections in the digestive tract. The device comprises a handle section, needle section, and sheath section, and operates via a slider mechanism that extends and retracts the needle. The needle is connected to an injection port through which fluids can be delivered to targeted tissue. The NM-400/NM-401 series includes various models with needle gauges ranging from 21G to 25G and working lengths from 1650 mm to 2700 mm, accommodating different clinical needs and endoscope compatibilities. The device is constructed from biocompatible materials including stainless steel (SUS304), polypropylene (PP), and perfluoroalkoxy (PFA), and is sterilized using ethylene oxide (EtO). It is intended for single use only.
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(88 days)
The indication for use of the PhaSeal system and included components are reconstitution and transfer of drug solutions from one container to another while minimizing exposure to potentially hazardous drugs aerosols and spills that can occur during the reconstitution, administration and disposal process.
The Injector and Connector is a sterile device for single-use within the PhaSeal® closed system drug transfer device for preparation and administration of parenteral drugs.
The provided document describes the 510(k) summary for the Carmel Pharma ab's Injector N34, N35, N35C and Connector C35, C45, which are components of the PhaSeal® - A Closed System Drug Transfer Device for Preparation and Administration of Parenteral Drugs. The device relies on demonstrating substantial equivalence to previously cleared predicate devices rather than meeting specific quantitative acceptance criteria through a clinical study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This submission is a 510(k) for substantial equivalence, not a performance study with quantitative acceptance criteria against specific metrics. The "acceptance criteria" here are qualitative, focusing on whether the new devices are "substantially equivalent" to predicate devices. The performance is demonstrated by comparing technological characteristics and intended use.
| Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Device's purpose is the same as the predicate. | Injector N34, N35, N35C: Intended use (injecting/withdrawing fluids from drug vials, then into IV sets/containers) is identical to predicate N30 (K972527) and N31 (K001368). Connector C35, C45: Intended use (connecting PhaSeal Injector to IV administration set parts, minimizing drug spillage) is identical to predicate C40 (K972527). |
| Technological Characteristics: Key features are similar or present acceptable differences. | Injector N34 vs. Predicate N30: Cannula (pencil point vs. cut), Needle safety lock (ErgoMotion™ vs. latch), Fitting connection (Luer rotation vs. no rotation), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. Injector N35/N35C vs. Predicate N31: Cannula (pencil point vs. cut), Needle safety lock (ErgoMotion™ vs. latch), Fitting connection (Luer Lock rotation vs. no rotation), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. Connector C35 vs. Predicate C40: Bayonet fitting (reduced notches - no click vs. notches - with a "click"), Length (26 mm vs. 26 mm), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. Connector C45 vs. Predicate C40: Bayonet fitting (reduced notches - no click vs. notches - with a "click"), Length (34 mm for CLAVE connection vs. 26 mm), Sterilization method (EtO vs. EtO). All deemed "Yes" for equivalence. |
| Safety and Effectiveness: Do not raise new questions of safety or effectiveness. | The submission concludes that "Based on comparison to the predicate device, we come to the conclusion that the Injectors N34, N35, N35C and Connectors C35, C45 included in the PhaSeal System, are substantially equivalent to previously cleared predicate devices and present no new concerns about safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" in the context of a performance study with a sample size of clinical cases or data points. This is a submission for substantial equivalence based on bench testing and comparison of technical specifications to predicate devices. Therefore:
- Sample size for the test set: Not applicable, as there's no clinical "test set" described. The testing mentioned is "performance testing" which likely refers to engineering/bench tests rather than clinical data.
- Data provenance: Not applicable. There is no clinical data (e.g., country of origin, retrospective/prospective) used to prove performance in the context of this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a technical comparison for substantial equivalence, not a study involving expert-established ground truth for a test set of medical conditions.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study, nor does it quantify an effect size of human readers improving with or without AI assistance. The device is a physical medical device (injectors and connectors), not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
No. The document does not describe any standalone algorithm performance study. The device is a physical medical device.
7. Type of Ground Truth Used
Not applicable. Since there is no clinical "test set" and outcome evaluation in the traditional sense, there is no ground truth (e.g., pathology, outcomes data) as would be used in a diagnostic study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which the new devices are compared.
8. Sample Size for the Training Set
Not applicable. This is a submission for a physical medical device, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply.
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(86 days)
The dual lumen Injector Needle Share is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using direct visualization, through a flexible endoscope, prior to electrosurgical excision and for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes.
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The provided text is an FDA 510(k) clearance letter for an "Endoscopic Injection Needle/Snare." This document does not contain information about specific acceptance criteria or a study that proves the device meets such criteria.
FDA 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on meeting new, specific performance acceptance criteria from a study described in the submission itself. The letter primarily confirms that the device is substantially equivalent for its stated indications for use.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Number of experts and their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training set was established.
This information would typically be found in the 510(k) submission itself (which this document is a letter in response to), or in a separate clinical study report, but it is not present in the provided FDA clearance letter. The letter only broadly states the "Indications for Use" for which the device was cleared as substantially equivalent.
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(249 days)
The Royale® AE 9045 injector is intended as a reusable instrument to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. It is designed to incorporate Alcon cartridges Type C for foldable intraocular lenses. The cartridge is loaded into the injector body and by pushing the piston. The lens will be removed out of the cartridge and delivered to the desired position.
The injector is an autoclavable, reusable titanium hand piece which is used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens.
The provided text is a 510(k) summary for the "Injector" device, a reusable titanium handpiece for delivering folded intraocular lenses (IOLs) during cataract surgery. To provide the requested information about acceptance criteria and study details, I need to extract this from the provided text.
Based on the provided document, here's an analysis of the acceptance criteria and study information:
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials with precise acceptance criteria and performance metrics in the same way a PMA (Pre-Market Approval) submission would.
Here's what can be inferred and what is not explicitly stated in the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Deliver IOL cartridges (Type C Cartridges with corresponding ACYSOF® Lens Models) without adversely affecting the overall power, shape resolution, or cosmetic attributes of the lenses. (From Section 5: "The performance tests for the injector will show that it can be used to deliver IOL cartridges... without adversely affecting the overall power, shape resolution or cosmetic attributes of the lenses.") | "The results of the non clinical performance testing will be subject to particular passing criteria that will support claim of substantial equivalence." (From Section 6: Summary of the Performance Data). The specific numerical results or how these 'passing criteria' were met are not detailed in this summary. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided 510(k) summary. The document mentions "performance tests" but does not detail the number of IOLs, cartridges, or test runs conducted.
- Data Provenance: Not specified. The manufacturer is Anton Meyer & Co. Ltd. in Nidau, Switzerland, suggesting the testing could have occurred there, but this is not explicitly stated.
- Retrospective or Prospective: Unclear, but typically, performance tests for a 510(k) submission are conducted prospectively as part of the device development and validation process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable and not specified. The "performance tests" described focus on the physical delivery of the IOL and its integrity, not on subjective expert assessment of an outcome which would require ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not specified. Adjudication methods are typically used when there's an ambiguity in interpretation (e.g., image analysis, clinical outcome assessment). The described performance tests are likely objective measurements of physical attributes.
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. The device is a mechanical injector for IOLs, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device itself is a mechanical "standalone" instrument. There is no algorithm being evaluated in this context. The performance tests would be of the device's mechanical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the acceptance criteria would be based on objective physical measurements and visual inspection to ensure the IOL's "overall power, shape resolution or cosmetic attributes" are not adversely affected. This would likely involve:
- Dimensional measurements to verify shape resolution and overall power (if measurable after delivery).
- Optical inspection (e.g., microscopy) for cosmetic attributes (scratches, deformations).
- Functional tests to confirm the lens is delivered smoothly and correctly.
The document doesn't detail the specific methods for these measurements.
8. The sample size for the training set
Not applicable. The "Injector" is a mechanical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an AI model.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
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