OLYMPUS NA-10J-KB ASPIRATION NEEDLE

K991672 · Olympus America, Inc. · FCG · Nov 3, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991672
• Device Name: OLYMPUS NA-10J-KB ASPIRATION NEEDLE
• Applicant: Olympus America, Inc.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Nov 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Indications for Use

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

Device Story

Aspiration needle for use with ultrasonic endoscopes; facilitates fine needle aspiration (FNA) of GI tract lesions (pancreatic, mediastinal, perirectal masses, lymph nodes). Device comprises handle and sheath sections; used with separate needle section (MAJ-363). Handle connects to endoscope channel; allows manual advancement of sheath/needle. Features spring mechanism for rapid needle projection to puncture indurated lesions; projection length is adjustable. Clinician observes ultrasonic image to determine spring-loaded projection length. Used in clinical settings by physicians to obtain tissue samples for diagnostic purposes.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual aspiration needle instrument. Components: handle, sheath, and needle section (MAJ-363). Features spring-loaded mechanism for rapid needle projection with adjustable length. Designed for use with ultrasonic endoscopes.

Indications for Use

Indicated for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural gastrointestinal tract lesions, including pancreatic, mediastinal, and perirectal masses, and lymph nodes.

Regulatory Classification

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.

Predicate Devices

• Olympus NA-10J-1 Aspiration Needle (K973128)

Submission Summary (Full Text)

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# A. Submitter's Name, Address, Phone and Fax Numbers

### 1. Manufacturer of the subject devices

| Name & Address of manufacturer: | Olympus Optical Co., Ltd.<br>2-3-1 Shinjyuku Monolis Nishi-Shinjuku<br>Shinjyuku-ku Tokyo, Tokyo 163-0914<br>Japan |
|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 8010047 |
| Address, Phone and Fax Numbers:<br>of R&D Department,<br>Endoscope Division | 2951 Ishikawa-Cho,<br>Hachioji-shi, Tokyo 192-8507<br>Japan<br>TEL [phone] |

### B. Name of Contact Person

Name: Address, Phone and Fax Numbers:

Ms. Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157 TEL: [phone] FAX: [phone]

FAX [phone]

## C. Device Name, Common Name, Classification Name and Predicate Devices

| Trade Name:<br>Common Name: | Olympus NA-10J-KB Aspiration Needle<br>Aspiration Needle |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Classification: | Gastroenterology-urology biopsy instrument<br>21 CFR 876.1075<br>Endoscope and accessories<br>21 CFR 876.1500 |
| Predicate Device: | Olympus NA-10J-1 Aspiration Needle K973128 |

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### D. Description of the Device(s)

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

The NA-10J-KB consists of a handle section and a sheath section. This instrument is designed to be used with the needle section, MAJ-363.

The handle section is connected to the endoscope channel opening.

The handle section facilitates to advance the sheath section and the needle section manually. And the handle section projects the needle section rapidly by its spring mechanism. This spring mechanism is equipped to facilitate puncturing of indurated lesions. The projection length by the spring mechanism is adjustable.

The setting for projection length by spring-loaded needle is determined by observing the ultrasonic image.

### E. Intended Use of the Device(s)

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

### F. Summary including Conclusions drawn from Non-clinical Tests

When compared to the predicate device, the Olympus NA-10J-KB Aspiration Needle does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 1999

Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747-3157

Re: K991672 Olympus NA-10J-KB Aspiration Needle Dated: August 10, 1999 Received: November 1, 1999 Requlatory Class: II 21 CFR §876.1075/Procode: 78 FCG

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K991672

Device Name: Olympus NA-10J-KB Aspiration Needle

Indications for Use:

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

(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 CFR 801.109)

OR

Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number. K991672/5⁰⁰¹

(Optional Format 1-2-96)