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.

Summary

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K013108 1/:

HAKKO SHOJI CO., LTD 1. 7-9 Kamimeguro 1-Chome, Meguro-ku Tokyo 153 Japan 81-(3)-464-8500 Fax 81-(3)-464-8539

APR 0 4 2002

Contact person: M. Moruyama

DEVICE NAME

Proprietary Name(s): BioSuc Common Name(s): Fine Aspiration Cytology Needle

Device Class: Class II 21CFR 876.1075 Aspiration biopsy needle (gastroenterology-urology biopsy instrument). Product Code: KNW

3. STATEMENT OF SUBSTANTIAL EQUIVALENCE:

Predicate Devices: Manan Medical Products, Inc. Westcott Aspiration Needle K943651 Allegiance Aspiration Needle K831392 Travenol Lab. Daum Aspiration Biopsy Needle K974575 Daum GMBH

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.

4. DESCRIPTION OF THE DEVICE(S)

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: 0 0.35 to 0 0.5 n=0 to 3

21G: φ 0.35 to φ 0.5 n=0 to 3

22G: ф 0.35 n=0 to 2

Product Code No.	Needle size	Side Hole	Syringe
22030500	20Gx50mm	$\phi$ 0.5 1 hole	7 ml
22030510	20Gx100mm	$\phi$ 0.5 1 hole	7 ml
22030520	21Gx50mm	$\phi$ 0.5 1 hole	7 ml
22030540	22Gx50mm	$\phi$ 0.35 1 hole	7 ml

STATEMENT OF INTENDED USE:

Biopsy of tumors in the Thyroid, Breast or Lymph Node, etc., and adjacent to the body surface.

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K013108 2/2

DESCRIPTION OF DEVICE(s): E. DESORIE: 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

Product Code No.	Needle size	Side Hole	Syringe
22030500	20Gx50mm	φ 0.5 1 hole	7 ml
22030510	20Gx100mm	φ 0.5 1 hole	7 ml
22030520	21Gx50mm	φ 0.5 1 hole	7 ml
22030540	22Gx50mm	φ 0.35 1 hole	7 ml

PROPOSED LABELING: F. See attached (Page 46) Each Product Label will have the following information:
Complete product description

Manufactured by: Hakko Medical Co., Ltd.

Distributed by: Havel's Incorporated 3726 Lonsdale Street Cincinnati, Oh 45227 (513) 271-2117 Made in Japan

SINGLE USE ONLY STERILE

CAUTION: Do not use if package has been opened or damaged. Store in a cool, dry place. Federal law restricts this device to sale by or on the order of a physician.

Sterile unless opened or damaged

STATEMENT OF INTENDED USE: G. Biopsy of tumors in the Thyroid, Breast or Lymph Node, etc., and adjacent to the body surface.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hakko Medical Company, Ltd. c/o Mr. Shiro Kitagawa Director, Marketing Division Hakko Shoji Co., Ltd. 7-9 Kamimeguro 1-Chome Meguro-Ku, Tokyo, Japan 153

APR 0 4 2002

Re: K013108

Trade/Device Name: BioSuc Fine Aspiration Cytology Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: December 14, 2001 Received: March 21, 2002

Dear Mr. Kitagawa:

We have reviewed your Section 510(k) premarket notification of intent to market the device in indication we have reviewed your Section 510(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regary many of the Medical Device American by the debecal Brush Brush commerce provided in accordance with the provisions of the Federal Food, Drug, devices that have bech recadssince in acce approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvise the general controls provisions of the Act. The You may, ulciclore, market the act include requirements for annual registration, listing of general controls provisions of the recess, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classince (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FRA this be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out of I cases oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualles or wouldwice complies with other requirements of the Act that IDA has made a acterimations administered by other Federal agencies. You must or any if ederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, me. and 801); good manufacturing practice requirements as set CFN Fatt 807), labeling (21 CFR Part 820), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Shiro Kitagawa

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w Jourse FDA finding of substantial equivalence of your device to a legally premative notification "The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire by of CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Furt 0071 or questions on the promotion and advertising of Comphance at (301) 594-1697 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisolanany responsibilities under the Act may be obtained from the Outer general information of you International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KO(3108

Device Name Big Suc Firme Aspination Cutology Needle

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrente of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

Poplional Formar 1-2-96)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013108

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.