(88 days)
The SonoTip II 25-gauge Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.
The Medi-Globe SonoTip II 25-gauge Ultrasound Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only.
The provided text describes a 510(k) premarket notification for the Medi-Globe SonoTip II 25-gauge Ultrasound Needle System. This submission is for a new device claiming substantial equivalence to previously cleared predicate devices. Therefore, the acceptance criteria and the study that proves the device meets the acceptance criteria are based on equivalence to predicate devices rather than a standalone performance study with specific metrics.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
This 510(k) summary does not present specific quantitative acceptance criteria or detailed performance metrics against those criteria in the manner one might expect for a new performance claim. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, meaning the new device has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "Design verification data has demonstrated that the proposed Medi-Globe SonoTip II 25-gauge Ultrasound Needle System meets the same performance requirements and is as safe and effective as its predicate device. The 25-gauge SonoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, and intended range of descriptive features as the predicate Medi-Globe SonoTip II Ultrasound Needle System (K070129)." This statement confirms the device fulfills the criteria of having comparable performance, safety, and effectiveness to its predicate, based on design verification. |
| Intended Use Equivalence | The intended use for the SonoTip II 25-gauge is identical to its predicate: "for ultrasonically guided, fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes)." |
| Technological Characteristics Equivalence | The device "utilizes endoscopic ultrasound technology which, when used with an ultrasound endoscope, allows the user to ultrasonically guide the biopsy needle to its intended target." This characteristic is consistent with the described predicate devices. |
| Material/Design Characteristics (Implicit) | The submission implies that any material or design differences (e.g., the 25-gauge size) do not alter the fundamental safety or effectiveness profile as compared to the predicate. No new questions of safety or effectiveness are raised. |
Study Proving Acceptance Criteria
The study described is a design verification as part of a 510(k) submission for substantial equivalence.
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Sample size used for the test set and the data provenance:
- The document states "Design verification data has demonstrated..." but does not specify a sample size for any test set nor the data provenance (e.g., country of origin, retrospective/prospective). Design verification in this context likely refers to internal testing (e.g., mechanical testing, materials testing, functional testing) to ensure the device meets its design specifications and performs comparably to the predicate. It is not presented as a clinical study with human subjects.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was not a study involving expert assessment of diagnostic accuracy against a ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is mentioned.
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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 for fine needle aspiration, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical ground truth. The "performance requirements" mentioned likely refer to engineering and functional specifications (e.g., needle integrity, fluid aspiration capability, compatibility with ultrasound endoscopes) which would be verified against design specifications, not clinical pathology or outcomes directly in a human cohort during this 510(k) process.
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The sample size for the training set:
- Not applicable. The submission does not refer to a training set for a machine learning algorithm.
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
In summary, the K083802 submission for the Medi-Globe SonoTip II 25-gauge Ultrasound Needle System relies on demonstrating substantial equivalence to an existing, legally marketed predicate device (K070129) through design verification data. This approach means that a comprehensive clinical study with detailed performance metrics, ground truth establishment, or human reader assessments was not required or provided in the 510(k) summary, as the device's fundamental safety and effectiveness are established by its similarity to already approved devices.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.