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The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.

The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 4 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The stainless steel cannula is 300 to 500 mm long with an 18-23 gauge tip (10 - 15 mm in length) and a metal luer lock connector; the needle also has a protective polyethylene sheath.

The provided text describes a 510(k) premarket notification for the Uroplasty Rigid Endoscopic Needle, asserting its substantial equivalence to a previously cleared predicate device. However, it does not contain information about specific acceptance criteria or a dedicated study that proves the device meets such criteria in terms of quantitative performance metrics.

The submission focuses on demonstrating technological equivalence to the predicate device, not on presenting novel performance data from human or animal studies.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

A table of acceptance criteria and reported device performance is not available in the provided text. The submission states: "The new and predicate devices are technologically the same; they are both rigid endoscopic needles intended to be accessories for standard endoscopes for the use of administering injectable materials. Both devices have similar intended uses and principles of action; they are both supplied sterile and are for single use only. In the few instances where the devices differ, no concerns about safety or effectiveness are raised."

The "Performance" section merely states: "The Uroplasty Rigid Endoscopic Needle allows delivery of injectable materials into tissues during an endoscopic procedure, thereby achieving its intended use." This is a description of its intended function, not a quantification of its performance against specific criteria.

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

Not applicable. No test set or clinical study data is presented. The submission relies on demonstrating substantial equivalence to a predicate device.

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

Not applicable. No test set or ground truth establishment by experts is mentioned.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No. An MRMC comparative effectiveness study was not conducted or reported in this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical instrument, not an algorithm, so standalone performance in this context is irrelevant.

7. The Type of Ground Truth Used:

Not applicable. No ground truth data is presented. The basis for clearance is substantial equivalence to a predicate device, meaning the new device is considered as safe and effective as the legally marketed predicate.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware device submission, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the Study (Implied by the 510(k) process):

The "study" in this context is essentially the comparison to the predicate device (K051905). The submission is a regulatory filing arguing that the new device is sufficiently similar to an already cleared device that it does not raise new questions of safety or effectiveness.

• Acceptance Criteria (Implied): The implied acceptance criteria for this 510(k) would be that the new device's technological characteristics, intended use, and principles of operation are substantially equivalent to the predicate device, and any differences do not negatively impact safety or effectiveness.
• Proof: The "proof" is the written argument provided in the "Technological Characteristics" section, stating that the new and predicate devices are "technologically the same" and that "In the few instances where the devices differ, no concerns about safety or effectiveness are raised." This is a qualitative assessment presented to the FDA. The FDA's letter confirms their agreement with this assessment by stating the device is "substantially equivalent."

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The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.

The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 5 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The 5 French stainless steel cannula is 380 to 500 mm long with an 18-gauge tip (10 mm in length) and a metal luer lock connector; the needle also has a protective polyethylene sheath.

Here's a breakdown of the acceptance criteria and study information for the Uroplasty Rigid Endoscopic Needle, based on the provided document:

This document is a marketing submission (510(k)) for a medical device. These submissions generally aim to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those for novel high-risk devices.

Based on the provided information, the "study" described is a declaration of substantial equivalence to a predicate device rather than a performance study with acceptance criteria in the typical sense of a diagnostic or therapeutic accuracy study.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission relies on substantial equivalence to a predicate device, not on a new performance study with a test set.

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

Not applicable.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a comparative effectiveness study involving human readers and AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used

Not applicable. The "ground truth" here is the established performance and safety profile of the predicate device, K982890, as determined by its prior clearance. The submission argues that the new device shares those characteristics.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.

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

Not applicable.

Summary of the Device's "Acceptance Criteria" Met by the "Study":

The acceptance criteria for the Uroplasty Rigid Endoscopic Needle, within the context of this 510(k) submission, is to demonstrate Substantial Equivalence to a legally marketed predicate device (Advanced UroScience Injection Needle, K982890).

The "study" that proves the device meets this acceptance criteria is the comparison provided in Section 8: 510(k) Summary under "Technological Characteristics" and "Performance."

• Technological Characteristics: The submission explicitly states, "The new and predicate devices are technologically the same; they are both rigid endoscopic needles intended to be accessories for standard endoscopes for the use of administering injectable materials. Both devices have similar intended uses and principles of action; they are both supplied sterile and are for single use only." It further notes, "In the few instances where the devices differ, no concerns about safety or effectiveness are raised."
• Performance: The document states, "The Uroplasty Rigid Endoscopic Needle allows delivery of injectable materials into tissues during an endoscopic procedure, thereby achieving its intended use." This implies its performance is aligned with its intended use, which is consistent with the predicate device.
• Conclusion: The submission explicitly concludes, "The subject device, the Uroplasty Rigid Endoscopic Needle, is substantially equivalent to the previously cleared endoscopic needle by Advance UroScience (K982890)."

The FDA's decision letter (K051905) confirms that the FDA reviewed the submission and "determined the device is substantially equivalent...". This FDA determination is the ultimate "proof" in the regulatory sense that the "acceptance criteria" of substantial equivalence were met.

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