SONOPSY

• K Number: K013109
• Device Name: SONOPSY
• Manufacturer: HAKKO MEDICAL CO., LTD.
• Date Cleared: 2002-03-12 ( 176 days)
• Product Code: FCG
• Regulation Number: 876.1075
• Type: Traditional
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: K981166 , K882601 , K974575
• Predicate For: N/A

Intended Use

The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.

Device Description

Needle size: 14G to 21G, 80 to 200mm Needle tip: Biopsy point Inner needle tip: pencil point or trocar point Suction syringe: 7 ml Plunger slide: 35 mm Guide needle size: L=50 to 80 mm or without Guide needle tip: Lancet point or blunt end Filter paper: size 20x35mm, 3 pieces

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "Sonopsy Aspiration Biopsy Needle." This type of submission establishes substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical study in the way a novel AI or diagnostic device might.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not applicable to this type of regulatory submission.

Here's why:

• 510(k) for Substantial Equivalence: A 510(k) premarket notification demonstrates that a new device is "substantially equivalent" to a predicate device already legally marketed. This process primarily focuses on comparing the new device's technological characteristics and intended use to the predicate, rather than conducting new clinical trials to establish performance against pre-defined clinical acceptance criteria.
• Device Type: The Sonopsy Aspiration Biopsy Needle is a Class II gastroenterology-urology biopsy instrument. These are typically mechanical devices where performance is assessed through bench testing (e.g., needle sharpness, strength, material compatibility) and comparison of specifications to predicate devices. Clinical studies with human subjects to determine performance metrics like sensitivity, specificity, or accuracy (as would be relevant for an AI diagnostic tool) are generally not required for this type of device to obtain 510(k) clearance.

The key takeaway from the provided text is that the device was deemed substantially equivalent to the predicate devices listed (INRAD/MANAM Accucore Biopsy Needle, E-Z-EM, INC. Lufkin Aspiration Needle, DAUM Corp. DAUM Aspiration Needle) based on its technological characteristics and intended use, which is sufficient for 510(k) clearance.

If this were an AI-powered diagnostic device, a much more comprehensive study section detailing the points you've listed would be present.

Summary

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510(K) SUMMARY

• HAKKO SHOJI CO., LTD 1. 7-9 Kamimeguro 1-Chome, Meguro-ku Tokyo 153 Japan 81-(3)-464-8500 Fax [phone]
  Contact person: M. Moruyama

• 2. DEVICE NAME SONOPSY Proprietary Name(s): Aspiration biopsy needle Common Name(s):
     Classification: Aspiration biopsy needle (gastroenterology-urology biopsy instrument). 21CFR 876.1075 Class II Product Code: FCG

STATEMENT OF SUBSTANTIAL EQUIVALENCE: 3.

Predicate Device:

INRAD/MANAM	Accucore Biopsy Needle	K981166
E-Z-EM, INC.	Lufkin Aspiration Needle	K882601
DAUM Corp.	DAUM AspirationNeedle	K974575

The Sonopsy Aspiration Biopsy Needle is substantially equivalent to the referenced predicated devices in that it is similar with respect to technological characteristics and intended use.

DESCRIPTION OF THE DEVICE(S): 4.

Needle size: 14G to 21G, 80 to 200mm Needle tip: Biopsy point Inner needle tip: pencil point or trocar point Suction syringe: 7 ml Plunger slide: 35 mm Guide needle size: L=50 to 80 mm or without Guide needle tip: Lancet point or blunt end Filter paper: size 20x35mm, 3 pieces

ProductCode No.	Needle size	Needletip	Innerneedletip	Syringe	Guideneedle size	Guide needletip	Filterpaper
22032170	21Gx170mm	Biopsypoint	Pencilpoint	7 ml	18Gx70mm	Lancet point	20x353 pieces
22032180	21Gx180mm	Biopsypoint	Pencilpoint	7 ml	18Gx70mm	Lancet point	20x353 pieces

న. STATEMENT OF INDENDED USE

The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2002

Mr. Shiro Kitagawa Director, Marketing Division Hakko Shoji Co., Ltd. 7-9 Kamimeguro 1-Chome, Meguro-ku, Tokyo 153 JAPAN

Re: K013109 Trade/Device Name: HAKKO Sonopsy Biopsy Needle Set Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 FCG Dated: December 21, 2001 Received: December 26, 2001

Dear Mr. Kitagawa

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Other or Compilance w ( rotification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOT 370

510(k)NUMBER (IF KNOWN) K013109

DEVICE NAME: Aspiration Biopsy Needle

INDICATION FOR USE:

The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.

David C. Byrom

(Division Sign-Om
4
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KOB109

(please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFE 801.109) OR

Over-The-Counter-Use (Options Format 1-2-9

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.