Search Results

The Galt Medical Corp Elite HV Radial is indicated to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Galt Medical Corp Elite HV product has been on the market since February of 2005, and was cleared under 510(k) K043525. The clearance included sizes from 4-9FR, and lengths from 5-110 cm with the following indication for use: The Sheath Introducer system is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature. The purpose of this 510(k) is to expand that indication for use for the Elite HV products to include radial placement. There were no design changes required as the current Galt offering included sizes which are appropriate for radial placement. The only limitation of the Radial placement claim is that the range of sizes is more limited due to the target anatomy. The Elite HV and Elite HV Radial consists of an introducer (valved sheath with sidearm and stopcock and dilator), which are packaged together with a guide wire. The Elite HV product is configured with a silicone valve or a TPE valve cleared under 510(k) K152528. Some product configurations also include an entry needle, guide wire inserter and a flushing syringe. The Elite HV Radial is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain barium sulfate, making these devices visible under fluoroscopy.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Galt Medical Corp. Elite HV Radial device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria for each test. Instead, it describes what types of tests were performed to establish substantial equivalence. It implies that the results of these tests demonstrated substantial equivalence to the predicate device, which is the primary "acceptance criterion" for a 510(k) submission.

Therefore, the table will reflect the types of tests performed and the conclusion reached regarding substantial equivalence.

• Particulate Test
• Mechanical Properties Test
• Lubricity Test
• Durability of coating
• Dimensional comparison test
  Accelerated aging to an equivalent age of 4 years was also performed, and the functional testing was repeated, with the implication that results remained acceptable. The submission concludes: "The technological differences between the subject device and predicate device have been evaluated through bench and biocompatibility tests to provide evidence of substantial equivalence." |
  | Biocompatibility: Device materials are safe for human contact. | Biocompatibility Testing Results: Performed in accordance with ISO 10993-1, including:
• Cytotoxicity (MEM Elution)
• Sensitization (Magnusson - Kligman)
• Irritation (Intracutaneous injection)
• Systemic Toxicity (Systemic injection)
• Hemolysis (Direct Contact)
• Hemocompatibility (Complement Activation)
• In-Vitro Hemocompatibility (Dog Thrombogenicity)
• Systemic Toxicity (Materials Mediated Pyrogen)
• EO Residuals (EO, ECH, & EG)
  This was done "to update the biocompatibility testing to current standards" and the conclusion of substantial equivalence implies these tests were met. |
  | Sterilization Efficacy: Device is effectively sterilized. | Sterilization Efficacy: The subject device was "adopted into the existing ethylene oxide sterilization cycle for the Galt product cleared under K043525 & K152528." This implies the cycle is validated and effective for the new device. |
  | Shelf-Life Stability: Device maintains integrity over shelf life. | Shelf-Life Stability: "Current packaging shelf life testing was provided in the predicate submission." This indicates reliance on previous validation, implying stability for the Elite HV Radial in its unchanged packaging. |
  | Safety and Effectiveness: No new questions regarding safety and effectiveness are raised by the differences to predicate devices. | Conclusion: "It will be shown in this 510(k) submission that the differences between the Galt Elite HV Radial and the predicate devices do not raise any new questions regarding safety and effectiveness. The Galt Elite HV Radial as designed and manufactured is determined to be substantially equivalent to the current marketed predicate device." |

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing and biocompatibility testing. It does not specify a "test set" in terms of patient data.

• Sample Size for Functional/Biocompatibility Tests: The document does not provide specific sample sizes (e.g., number of devices tested for particulate, mechanical properties, etc.). It only mentions that testing was conducted "according to protocols based on international standards and Galt Medical requirements."
• Data Provenance: The data provenance is from bench laboratory testing and in vitro biocompatibility studies, not human patient data. There is no mention of country of origin for the data as it's not clinical data. It is inherently retrospective in the sense that the testing was performed, and then the results were compiled for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This question is not applicable to this submission. The "ground truth" for this type of device (a medical introducer) in a 510(k) context is established through compliance with recognized standards (e.g., ISO for biocompatibility, internal engineering specifications for functional tests). There isn't a "ground truth" established by human experts in the same way an AI diagnostic device would have radiologists establishing ground truth for images. The "experts" involved would be the engineers, toxicologists, and quality assurance personnel who designed the tests, conducted them, and interpreted the results against established standards.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. For bench testing and biocompatibility, the results are typically quantitative or qualitative (pass/fail) based on pre-defined criteria in the test protocols and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers. The Elite HV Radial is a physical medical device (catheter introducer) and does not involve AI or human interpretation in its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, a standalone performance study was not done. This term also applies to AI algorithms. The Elite HV Radial is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance in the context of the 510(k) submission is derived from:

• Compliance with International Standards: e.g., ISO 10993-1 for biocompatibility.
• Internal Engineering Specifications/Requirements: Derived from design control processes and the intended function of the device, often benchmarked against predicate device performance.
• Predicate Device Performance: The underlying assumption of the 510(k) pathway is that the predicate device is safe and effective when used as labeled. By demonstrating "substantial equivalence," the new device inherits this established "ground truth" of safety and effectiveness.

8. The Sample Size for the Training Set

• This question is not applicable as there is no "training set" in the context of a physical medical device. This term is used for machine learning models.

9. How the Ground Truth for the Training Set was Established

• This question is not applicable as there is no "training set" for this device.

Ask a specific question about this device