This instrument has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

Device Description

The NA-201SX-4022 Single Use Aspiration Needle consists of a handle section, needle section, rne NN20 North section. The handle section is connected to the endoscopes instrument channel port via the single use adapter biopsy valve (MAJ-1414). The handle section facilitates the advancement of the needle section during puncture of the targeted site. The syringe (VACLOK Syringe and Stopcock) is attached to the aspiration port on the handle section of the NA-201SX-4022. The syringe is used to aspirate the specimen that was punctured with the needle. The syringe has a lock function which can lock the piston (plunger) is pulled. When the stopcock is closed and the piston (plunger) keeps it evacuated. For aspiration, the syringe should be connected with the needle and the stopcock should be opened just before aspiration. The lock Connected with the need for the operator to keep pulling the piston during the procedure thus improving usability. The position to lock the piston (plunger) is selected from 4 levels. Accordingly, the operator can select the specimen size required.

AI/ML Overview

The provided text is a 510(k) summary for the Olympus Single Use Aspiration Needle NA-201SX-4022. It explicitly states in section F that no clinical data was required to establish substantial equivalence for this device. Therefore, a study proving device acceptance criteria was not performed or reported in this document. The decision was based on the device not incorporating any significant change that impacts safety and effectiveness compared to predicate devices, thus obviating the need for clinical data.

Reason for Not Requiring Clinical Data (as stated in the document):

"When compared to the predicate device, the Single Use Aspiration Needle NA-201SX-4022, WAJ-1414 and Syringe does not incorporate any significant change that impacts safety and Mro-1414 and Dynings acos not history drive. Therefore, clinical data is not necessary to establish the subject device."

Given this, the following sections cannot be answered based on the provided document:

A table of acceptance criteria and the reported device performance: This would be generated from a clinical study, which was not performed.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set for a clinical study was used.
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): No ground truth for a clinical study was established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set required adjudication.
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: Not applicable, as this is a medical device, not an AI-assisted diagnostic tool, and no clinical study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI-driven algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth established for a clinical study.
The sample size for the training set: No training set for a clinical study was used.
How the ground truth for the training set was established: No ground truth for a training set was established.

The document focuses on the substantial equivalence of the new device to existing predicate devices based on design and intended use, rather than presenting clinical performance data from a specific study.

Summary

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K050503

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SMDA 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with The requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

A. GENERAL INFORMATION

1. Applicant
  Name & Address:

Registration Number:

2. Initial Importer

Name & Address:

Registration Number:

3. Submission Correspondence

Name, Address, Tel & Fax:

Aomori Olympus Co., Ltd. 2-248-1 Okkonoki Kuroishi-shi, Aomori-ken, Japan 036-0357 9614641

Olvmpus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058 2429304

Laura Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058 TEL 631-844-5688 FAX 631-844-5554 2429304

Registration Number:

B. DEVICE IDENTIFICATION

1. Common/Usual Name Aspiration Needle

2. Device Name Single Use Aspiration Needle NA-201SX-4022

1. Class, Classification Number, and Classification Name Class II, 21CFR 876.1075, Set, Biopsy needle, Gastro-urology
  1

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C. PREDICATE DEVICES

Device Name	510(k) #	Manufacturer	Class	ProductCode
EVIS EXERA UltrasonicBronchofibervideoscopeOlympus BF Type UC160F-OL8,OLYMPUS EU-C60 EUSEXERA Compact EndoscopicUltrasound Center	#K042140	Olympus Corporation	II	KOG
VACLOK Syringe	#K994253	Merit Medical System Inc.	II	FMF
STOPCOCK(One-port manifold)	#K934123	Merit Medical System Inc.	II	DTL
Disposable Aspiration NeedleNA-200H	#K023272	Olympus Corporation	II	FCG

D. DESCRIPTION OF THE DEVICE

E. INTENDED USE OF THE DEVICE

F. REASON FOR NOT REQUIRING CLINICAL DATA

When compared to the predicate device, the Single Use Aspiration Needle NA-201SX-4022, WAJ-1414 and Syringe does not incorporate any significant change that impacts safety and Mro-1414 and Dynings acos not history drive. Therefore, clinical data is not necessary to establish the subject device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular fashion around the eagle symbol. The text is also in black, creating a monochrome design.

MAY 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Medical Systems Corporation C/O Ms. Larua Storms-Tyler Director, Regulatory Affairs and Quality Assurance Olympus America, Incorporated Two Corporate Center Drive, USA Melville, New York 11747-9058

Re: K050503

Trade/Device Name: Single Use Aspiration Needle NA-201SX-4022 Regulation Number: 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: February 18, 2005 Received: February 28, 2005

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, of to arrowns act (Act) that do not require approval of a premarket the rederal 1 6 car, 2 only may, therefore, market the device, subject to the general approval upprisions of the Act. The general controls provisions of the Act include controls provided by 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 such additional controls. Existing major regulations affecting (1 writ), it may be badyer to and Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can oe roundsh further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Storms-Tyler

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 modified in that industry and regulations administered by other Federal agencies. or the Act of all , I outs all the Act's requirements, including, but not limited to: registration r od intest compry was a 807); labeling (21 CFR Part 801); good manufacturing practice alle libing (22 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis reter with as a substantial equivalence of your device of your device to a premarket notified.com - 11 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), If you desire specific at no of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj obtain of Small Manufacturers, 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/industry/support/index.html.

Sincerely yours,

Carls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050503.
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Indications for Use

510(k) Number(if known):

Device Name: Single Use Aspiration Needle NA-201SX-4022

Indications for Use:

. J

Do not use this instrument for any purpose other than its intended use.

Prescription Use_ (21 CFR 801 Subpan D)

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Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Chinta Varma

10(%) Number:_KySussy3

்புision Sign-Off) ിനടിംന വിട്ടുണ്ട്. General Hospital, Intection Control, Dental Devices

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.