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The Unger Quad Injector is intended to be used as the needle infusion set component of a tissue expander fill kit for breast tissue expanders designed to be filled with sterile saline using 21-gauge needles. Specifically, the Unger Quad Injector is indicated for assisting the clinician in delivery of sterile saline into the surgically-placed, sub-dermal, temporary, removable tissue expander.

The Unger Quad Injector is a 'needle infusion set' component to a breast tissue expander fill kit. The device is comprised of four 21 gauge hypodermic lumen needles, which are connected to a needle hub, a luer adapter and tubing.

This document is a 510(k) premarket notification for the Unger Quad Injector, indicating it is a device intended for assisting in the delivery of sterile saline into breast tissue expanders. However, the provided text does not contain acceptance criteria or a study that evaluates the device against specific performance metrics for the purpose of demonstrating clinical accuracy or diagnostic performance, which is typically found in documentation for diagnostic or AI-enabled devices.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and non-clinical bench testing. The "acceptance criteria" discussed here are primarily related to conforming to established standards and matching the performance of predicate devices in specific non-clinical tests.

Here's a breakdown of the information that can be extracted or inferred from the provided text, adjusted to the context of this device:

Acceptance Criteria and Device Performance (Non-Clinical Bench Testing)

Since this is a non-AI, non-diagnostic device, the "acceptance criteria" are related to manufacturing standards, material properties, and functional performance compared to predicate devices, rather than accuracy metrics like sensitivity or specificity.

1. A table of acceptance criteria and the reported device performance:
See table above. The "reported device performance" indicates whether the device met the stated standard or showed comparability to the predicate/reference device, as described in the "Non Clinical Tests performed" section and the "Summary of the Technological Characteristics" table.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for each non-clinical bench test. The studies were non-clinical bench tests, not involving human subjects or real-world data provenance in the sense of patient data. The tests were conducted to verify equivalence.

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):
This is not applicable as this device is not an AI/diagnostic device that requires expert-established ground truth for a test set. The evaluation is based on engineering and material standards and comparison to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The tests are bench tests against established standards or direct comparisons, not requiring expert 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 device is not an AI-enabled diagnostic or assistance tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device does not involve an algorithm. The "standalone" performance here refers to the device's functional characteristics in isolation, which were assessed through the bench tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this type of device is defined by:

• Established Industry Standards: Such as ISO 7864, ISO 9626, ISO 6009, ANSI/AAMI/ISO 11135.
• Performance of Legally Marketed Predicate Devices: The McGhan Tissue Expander Fill System (K870754) and other reference devices served as comparators for technological characteristics, materials, and functional performance.

8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.

Summary of the Study:

The document describes a series of non-clinical bench tests rather than a clinical study. These tests were performed to demonstrate that the Unger Quad Injector is substantially equivalent to legally marketed predicate devices, primarily the McGhan Tissue Expander Fill System (K870754).

The specific non-clinical tests conducted include:

• Pre-clinical Investigational Evaluation of Tissue Expander Inter-operative Filling Device
• Quad Injector Flow Rate Comparison
• Unger Quad Injector Bioburden Test
• Unger Quad Injector Endotoxin Test
• Unger Quad Injector Bioburden Validation Test
• Shelf Life / Expiration Dating – Aging Testing
• ISO 7864 Hub Needle Bond Strength
• ISO 7864 and ISO 9626 Conformance

Purpose of the Studies: The main purpose was to verify the equivalence of the Unger Quad Injector's performance, safety, and specifications with the predicate devices, and to ensure conformance with relevant ISO standards.

Conclusion from the Studies: The data from these tests "supports a finding of substantial equivalence because the data demonstrates that the Unger Quad Injector is safely and effectively indicated for use as the 'needle infusion set' component... Testing results demonstrate the filling, sealing capability and leakage prevention as compared to lawfully marketed predicate devices. Performance testing results also demonstrate safety and efficacy in terms of biocompatibility, sterilization, shelf life, and general device performance."

No clinical tests were conducted. The device's safety and effectiveness were established through comparison of its technological characteristics and performance in bench tests to those of existing, legally marketed devices.

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The Terumo SurGuard®3 Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

The Terumo SurGuard®3 Safety Hypodermic Needle [hereinafter referred to as "SurGuard 3 (Short Sheath 2)"] consists of a hypodermic needle with a hinged safety sheath attached to the connector hub which can be attached to either a luer slip or luer lock syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheathcollar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation, using the finger, thumb, or surface activation.

The document describes the Terumo SurGuard®3 Safety Hypodermic Needle and its modifications. However, the provided text does not contain detailed information about acceptance criteria and a study that comprehensively proves the device meets those criteria in the format requested.

Specifically, the document states:

• "No deviations from recognized consensus ISO standards were identified, except where the design of the device resulted in a modified method or acceptance criterion." (page 10)
• "The device complies with the acceptance criteria established based on the predicate, as shown in the table below: Table 5.6: Performance Testing per Internal Standards" (page 10)
• "Performance testing demonstrates that the new Terumo SurGuard®3 Safety Hypodermic Needle conforms to the recognized consensus ISO standards (ISO 7864 and ISO 23908) and meets internal standards acceptance criteria." (page 10)

This indicates that acceptance criteria were established and met, but the specific numerical criteria for each test and the detailed results demonstrating conformance are not provided. The results are summarized as "Meets acceptance criteria" or "Meets standard."

Additionally, the document explicitly states:

• "This 510(k) does not include data from clinical tests." (page 11)

Therefore, much of the requested information regarding study details (sample size, data provenance, ground truth establishment, expert involvement, MRMC studies) is not available in the provided text.

Here's a summary of what can be extracted or inferred:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for any of the performance tests.
• Data Provenance: Not specified, but generally, such performance testing is conducted by the manufacturer (Terumo (Philippines) Corporation). The nature of the tests (mechanical, sterilization, biocompatibility) suggests laboratory testing rather than human subject data. Retrospective/Prospective is not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as the testing involves physical/mechanical performance and adherence to ISO standards and internal criteria, not expert interpretation of outputs.

4. Adjudication method for the test set

• Not applicable as the testing involves physical/mechanical performance and adherence to ISO standards and internal criteria.

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

• No. This is a medical device (hypodermic needle) and not an AI/imaging device. The document explicitly states: "This 510(k) does not include data from clinical tests." (page 11)

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

• No. This is a medical device (hypodermic needle) and not an AI/imaging device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the physical and mechanical performance tests, the "ground truth" would be the established specifications, engineering tolerances, and requirements set forth by ISO standards (ISO 7864, ISO 23908, ISO 11137-1, ISO 14971) and the manufacturer's internal standards.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable as this is not an AI/machine learning device.

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