BIOSUC

• K Number: K013108
• Device Name: BIOSUC
• Manufacturer: HAKKO MEDICAL CO., LTD.
• Date Cleared: 2002-04-04 ( 199 days)
• Product Code: KNW
• Regulation Number: 876.1075
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: K943651 , K831392 , K974575
• Predicate For: N/A

Intended Use

The BioSuc Fine Aspiration Cytology Needle is indicated for the biopsy of tumors in the Thyroid, Breast or Lymph node.

Device Description

Needle size: 20G: 50mm to 100mm, 21G: 50mm, 22G: 50mm Needle tip: Bayonet point (Lancet point) Suction syringe: 7 ml Plunger slide: 35 mm Side Hole 20G: φ 0.35 to φ 0.5 n=0 to 3; 21G: φ 0.35 to φ 0.5 n=0 to 3; 22G: φ 0.35 n=0 to 2

AI/ML Overview

This submission (K013108) is for the BioSuc Fine Aspiration Cytology Needle. The provided documents focus on establishing substantial equivalence to predicate devices and do not contain detailed information about performance studies or acceptance criteria beyond stating the device's intended use and physical characteristics.

Therefore, I cannot provide a complete answer to your request regarding acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a 510(k) premarket notification for a medical device, which primarily establishes substantial equivalence to predicate devices rather than providing detailed performance study results in the way a clinical trial report might.

However, I can extract the information that is present and explain why other sections are not available in this document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., success rate of aspiration, tissue yield). The acceptance criteria for this type of submission generally revolve around demonstrating that the device is as safe and effective as its predicate devices. This is typically done by comparing technological characteristics and intended use.
• Reported Device Performance: Not reported in terms of quantitative performance metrics from a study. The document lists physical specifications of the needle (size, tip, syringe, side holes) which are inherent to the device design rather than performance outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not available in the provided 510(k) submission. A 510(k) generally focuses on demonstrating substantial equivalence to existing devices through comparison of design, materials, and intended use, rather than requiring extensive new clinical trial data for devices like this aspiration needle. If any testing was done, it would likely be non-clinical (e.g., mechanical testing, biocompatibility) but details are not provided here.

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 information is not available. Ground truth establishment and expert review are typically part of clinical performance studies, which are not detailed in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not available.

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

• This question is not applicable to this device. The BioSuc Fine Aspiration Cytology Needle is a physical biopsy instrument, not an AI-assisted diagnostic tool or imaging device that would involve human readers or MRMC studies.

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

• This question is not applicable to this device. It is a physical medical instrument, not an algorithm.

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

• As no clinical performance study data is provided, the type of ground truth used is not applicable/not available. For a device like this, ground truth in a clinical study would typically involve pathological confirmation of biopsies.

8. The sample size for the training set

• This information is not applicable/not available as there is no mention of a training set, usually associated with machine learning or AI models, which this device is not.

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

• This information is not applicable/not available.

Summary of available information related to "acceptance criteria" and "study":

The core "study" proving the device meets "acceptance criteria" in a 510(k) for a device like this is the demonstration of substantial equivalence to predicate devices. The "acceptance criteria" for such a submission are met if the FDA agrees that the new device is as safe and effective as a legally marketed predicate device.

The provided document states:

• "The BioSuc Fine Aspiration Cytology Needle is substantially equivalent to the referenced predicated devices in that it is similar with respect to technological characteristics and intended use."

The FDA's letter further confirms:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined that the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Therefore, the "study" is the 510(k) review process itself, which concluded that based on comparison of intended use and technological characteristics (listed in the tables for needle size, tip, syringe, side holes), the BioSuc needle is substantially equivalent to existing, legally marketed predicate devices (Manan Medical Products, Inc. Westcott Aspiration Needle K943651; Allegiance Aspiration Needle K831392; Travenol Lab. Daum Aspiration Biopsy Needle K974575). The "acceptance criteria" were met by successfully demonstrating this substantial equivalence to the FDA.

Regulation Number and Section

§ 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.