DISPOSABLE ASPIRATION NEEDLE NA-200H

K023272 · The Olympus Optical Co. · FCG · Dec 23, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K023272
• Device Name: DISPOSABLE ASPIRATION NEEDLE NA-200H
• Applicant: The Olympus Optical Co.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

This instrument has been designed to be used with the ultrasound endoscope for ultrasonically quided 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 Story

Disposable aspiration needle NA-200H used with ultrasound endoscope for fine needle aspiration (FNA) of GI tract lesions; includes pre-assembled sterile needle, VACLOK syringe, and stopcock. Device facilitates tissue sampling of submucosal and extramural masses (pancreatic, mediastinal, perirectal, lymph nodes). Operated by clinicians during endoscopic procedures. Syringe/stopcock assembly allows for controlled aspiration. Pre-assembled, single-use design improves procedural convenience and sterility compared to previous reusable or non-pre-assembled models. Output is tissue sample for diagnostic evaluation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on non-clinical testing and design comparison to predicate devices.

Technological Characteristics

Disposable aspiration needle; includes VACLOK syringe and stopcock. Sterile, single-use, pre-assembled. Mechanical biopsy instrument. No software or electronic components.

Indications for Use

Indicated for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract, 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

• ASPIRATION NEEDLE NA-10J-1 (K973128)
• VACLOK Syringe (K994253)
• STOPCOCK (One-port manifold) (K934123)

Submission Summary (Full Text)

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DEC 2 3 2002

K023272
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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 Section 807.92.

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

| 1. Applicant: | Olympus Optical Co., Ltd.<br>2-3-1 Shinjuku Monolis Nishi-shinjuku<br>Shinjuku-ku, Tokyo, Japan, 163-0914 |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration No. | 8010047 |
| Address, Phone and Fax<br>Numbers of R&D<br>Department Endoscope<br>Division: | 2951 Ishikawa-Cho,<br>Hachioji-shi, Tokyo 192-8507 Japan<br>Tel. [phone]<br>Fax [phone] |
| 2. Initial Importer | Olympus America Inc.<br>Two Corporate Center Drive<br>Melville, NY 11747-3157 |
| Registration No. | 2429304 |
| 3. Contact Person | Laura Storms-Tyler<br>Director, Regulatory Affairs<br>Olympus America Inc.<br>Two Corporate Center Drive<br>Melville, NY 11747-3157<br>Tel [phone]<br>Fax [phone] |

#### B. Device Name, Common Name

- Trade/Proprietary Name and Common Name 1. Trade Name: DISPOSABLE ASPIRATION NEEDLE NA-200H ASPIRATION NEEDLE Common Name:
- 2. Class, Classification Number and Classification Name

| Classification Number | Classification Name | Class |
|-----------------------|--------------------------------------------|-------|
| 21 CFR 876.1075 | Gastroenterology-urology biopsy instrument | II |

# 3. Identification of Legally Marketed Devices Which We Claim Substantial Equivalence

| Description | Model No | Manufacturer | #K |
|-----------------------------|----------|---------------------------|---------|
| ASPIRATION NEEDLE | NA-10J-1 | Olympus Optical Co., Ltd. | K973128 |
| VACLOK Syringe | - | Merit Medical System Inc. | K994253 |
| STOPCOCK(One-port manifold) | - | Merit Medical System Inc. | K934123 |

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## C. Description of the Device(s)

#### NA-200H

DISPOSABLE ASPIRATION NEEDLE NA-200H is a modified version of NA-10J-1 Aspiration Needle, which was cleared #K973128. When compared with the predicate device, the following modifications have been made to the NA-10J-1 needle:

- 1. The NA-200H is provided pre-assembled, sterile single use disposable.
- 2. The NA-200H includes a sterile single use disposable syringe for aspiration.

The comparison table provided shows all other similarities and differences to the legally marketed device. Please refer to Attachment 5 for details.

#### VACLOK Syringe/ STOPCOCK

The K12-MS2666 Syringe (VACLOK Syringe and Stopcock) is attached to the aspiration port on the handle section of the NA-200H. These devices will be provided sterile single use. We are offering these devices together to improve convenience to the customer. The syringe to be included in the package has been cleared by FDA as a cardiologist or radiologist during angiographic or radiologic, it is intended to be used for aspiration in this submission.

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

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

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

When compared to the predicate device, Disposable Aspiration Needle NA-200H, VackLock Syringe and Stopcock 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus.

#### Public Health Service

Food and Drug Administratio 200 Corporate Boulevard Rockville MD 20850

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

#### Re: K023272

Trade/Device Name: Disposable Aspiration Needle NA-200H Regulation Number: 21 CFR §876.1076 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 FCG Dated: September 30, 2002 Received: October 1, 2002

Dear Ms. Storms-Tyler:

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 by reference to premarket notification" (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 Chogden

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

Enclosure

Page 2

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510(k) Number(if known):

02.327.2

Device Name: DISPOSABLE ASPIRATION NEEDLE NA-200H

Indications for Use:

This instrument has been designed to be used with the 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).

(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

(Optional Format 1-2-96)

David G. Ingram

(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number