This instrument has been designed to be used with an Olympus ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

Device Description

The subject device is a Single Use Aspiration Needle NA-U200H to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The subject device consists of a handle section, needle section, and sheath section. When users use the device, the syringe needs to be attached to the subject device. The subject device is used to obtain an acceptable specimen. The lesion is punctured by the Needle equipped at the distal end of the subject device and aspirated by the syringe. Subsequently, the tissue of the lesion in the needle is taken out by feeding air from the syringe or pushing the tissue with the stylet for sampling.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter and a 510(k) summary for the "Single Use Aspiration Needle NA-U200H".

While it states that "Performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended," and that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007," it does not provide specific details on:

A table of acceptance criteria and reported device performance (with specific metrics and values).
Sample sizes used for test sets or data provenance.
Number and qualifications of experts for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
Type of ground truth used.
Sample size for the training set (again, not applicable to a physical device in the context of AI).
How ground truth for the training set was established.

This document focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices, rather than detailed performance study results with specific acceptance criteria that would be typical for an AI/software device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2015

Olympus Medical Systems Corp. % Daphney Germain-Kolawole Project Manager, Regulatory Affairs Olympus Corporation of The Americas 3500 Corporate Parkway Po Box 610 Center Valley, PA 18034-0610

Re: K151738

Trade/Device Name: Single Use Aspiration Needle NA-U200H Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: FCG Dated: October 19, 2015 Received: October 20, 2015

Dear Daphney Germain-Kolawole,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151738

Device Name

Single Use Aspiration Needle NA-U200H

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Single Use Aspiration Needle NA-U200H

June 25, 2015

5.1 General Information

■ Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan192-8507Establishment Registration No: 8010047
■ Official Correspondent:	Daphney Germain-KolawoleOlympus Corporation of the Americas, Inc.3500 Corporate ParkwayPO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-5691FAX: 484-896-7128Email: daphney.germain-kolawole@olympus.com
■ Manufacturer:	Aomori Olympus Co., Ltd.248-1 Okkonoki 2-chome Kuroishi-shi,Aomori, Japan 036-0357Establishment Registration No .: 9614641

5.2 Device Identification

■ Device Trade Name:	Single Use Aspiration Needle NA-U200H
■ Common Name:	Aspiration Needle
■ Regulation Number:	876.1075
■ Regulation Name:	Gastroenterology-urology biopsy instrument
■ Regulatory Class:	II
■ Classification Panel:	Gastroenterology and urology
■ Product Code:	FCG

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Image /page/4/Picture/0 description: The image shows the logo for Olympus. The word "OLYMPUS" is written in large, bold, blue letters. Below the word is a thin, gold line. Underneath the line, the words "Your Vision, Our Future" are written in a smaller font.

Predicate Device Information 5.3

Device TradeName	Common Name	Applicant	510(k) No.
DisposableAspirationNeedleNA-200H	AspirationNeedle	OLYMPUS OPTICAL Co.,Ltd.	K023272
OlympusNA-10J-1AspirationNeedle	BiopsyInstruments	OLYMPUS AMERICA, INC.	K973128
ExpectTMEndoscopicAspirationNeedle	-	BOSTON SCIENTIFICCORPORATION	K112198

5.4 Device Description

Indications for Use 5.5

This instrument has been designed to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal

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Image /page/5/Picture/0 description: The image displays the logo for OLYMPUS. The word "OLYMPUS" is written in large, bold, dark blue letters. A thin, horizontal, golden line is underneath the company name. Below the line, the text "Your Vision, Our Future" is written in a smaller, dark font.

masses and lymph nodes).

5.6 Comparison of Technological Characteristics

Compared to the predicate device, the proposed subject device, Single Use Aspiration Needle NA-U200H, has similar technological characteristics. There is no significant difference that affects the safety or effectiveness of the subject device.

5.7 Summary of non-clinical testing

· Performance testing was conducted to demonstrate the basic performance of the subject device and confirmed that the subject device performs as intended.

· Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

· Biocompatibility testing is performed in accordance with the FDA Guidance," Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, Blue Book Memo, G95-1".

The following standards have been applied to the Single Use Aspiration Needle NA-U200H.

· ISO 10993-1 ·ISO 10993-5 · ISO 10993-10 · ISO 10993-11 ·ISO 11135 · ISO 14971 · ASTM F1980-07

5.8 Conclusion

When compared to the predicate device, the Single Use Aspiration Needle NA-U200H does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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.