Single Use Aspiration Needle NA-U401SX

K160098 · Olympus Medical Systems Corp. · FCG · Mar 22, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160098
• Device Name: Single Use Aspiration Needle NA-U401SX
• Applicant: Olympus Medical Systems Corp.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Mar 22, 2016
• 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 ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

Device Story

Single-use aspiration needle (ViziShot 2) used with ultrasound endoscopes for fine needle aspiration (FNA) of submucosal/extramural lesions in tracheobronchial tree and GI tract. Device comprises handle, insertion section (sheath, needle, stylet), and aspiration port. Operator (physician) inserts device into endoscope channel; needle slider on handle extends needle from sheath to puncture target tissue; syringe attached to aspiration port collects specimen. Needle features dimpled surface for echo enhancement and oval proximal section for improved angulation. Used in clinical settings; provides tissue samples for diagnostic evaluation; benefits patient by enabling minimally invasive biopsy of deep-seated lesions.

Clinical Evidence

Bench testing only. Performance testing evaluated insertion, flexibility, piercing, ultrasound visibility, needle extraction/retraction, aspiration, withdrawal, handle locking force, and needle depth limitation. Biocompatibility testing performed per ISO 10993-1, -5, -10, -11. Sterilization validated per ISO 11135. Accelerated aging per ASTM F-1980-07.

Technological Characteristics

Single-use aspiration needle; stainless steel/polymer construction; dimpled needle for echo enhancement; oval proximal needle tube; manual actuation via handle slider; ethylene oxide sterilization (ISO 11135); biocompatibility per ISO 10993; shelf-life testing per ASTM F-1980-07.

Indications for Use

Indicated for patients requiring ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions within the tracheobronchial tree and gastrointestinal tract.

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

• Single Use Aspiration Needle NA-201SX-4022 (K050503)

Reference Devices

• Olympus Aspiration Biopsy Needle (K904667)

Submission Summary (Full Text)

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

March 22, 2016

Olympus Medical Systems Corp. % Sheri Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkwav, Po Box 610 Center Valley, PA 18034-0610

Re: K160098

> Trade/Device Name: Single Use Aspiration Needle NA-U401SX Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: FCG Dated: January 15, 2016 Received: January 19, 2016

Dear Sheri Musgnung,

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related 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 [phone] or [phone] 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 [phone] or [phone] 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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## Indications for Use

510(k) Number (if known)

K160098

Device Name Single Use Aspiration Needle NA-U401SX

Indications for Use (Describe)

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

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

| <span style="font-family: sans-serif;"> <svg height="10" width="10"> <rect fill="lightgray" height="10" width="10" x="0" y="0"></rect> <path d="M1,1 L9,9 M9,1 L1,9" stroke="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span style="font-family: sans-serif;"> <svg height="10" width="10"> <rect fill="lightgray" height="10" width="10" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY Single Use Aspiration Needle NA-U401SX

January 15, 2016

## 5.1 General Information

| ■ Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,<br>Japan<br>Establishment Registration No: 8010047 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent: | Sheri L. Musgnung<br>Manager, Regulatory Affairs<br>Olympus Corporation of the Americas<br>3500 Corporate Parkway PO Box 610<br>Center Valley, PA 18034-0610, USA<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| ■ Manufacturer: | Aomori Olympus Co., Ltd.<br>2-248-1 Okkonoki, Kuroishi-shi, Aomori, 036-0357,<br>Japan<br>Establishment Registration No.: 9614691 |
| 5.2 Device Identification | |
| ■ Device Trade Name: | Single Use Aspiration Needle NA-U401SX |

- 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

Section 5 510(k) Summary Page 2 of 5

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#### 5.3 Predicate Device Information

| ■ Device Name: | Single Use Aspiration Needle NA-201SX-4022 |
|----------------|--------------------------------------------|
| ■ Common Name: | Aspiration Needle |
| ■ Applicant | Olympus Medical Systems Corp. |
| ■ 510(k) No. | K050503 |

#### 5.4 Device Description

The single use aspiration needle NA-U401SX (aka ViziShot 2) is intended to be used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). It consists of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle, and stylet. The needle is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen that was punctured with the needle. The needle is dimpled for echo enhancement and also consists of an oval portion for better angulation.

The subject device will be sold with or without medallion syringe manufactured by Merit Medical, which consists of VACLOK Syringe and Stopcock.

#### ર્સ્ડ Indications for Use

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

#### 5.6 Comparison of Technological Characteristics

Compared to the predicate device, the proposed subject device; Single Use Aspiration Needle NA-U401SX, has similar technological characteristics except for the following differences.

- Needle tube shape on proximal side
- Sheath composition
- Materials

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The needle tube of the subject device has a part of oval portion on its proximal side whereas the predicate device consisted of a round shape. The sheath design is similar to another 510(k) cleared device, Olympus Aspiration Biopsy Needle (#K904667). The subject device utilizes new patient contact materials compared to PD.

Validation testing demonstrated that these technological features do not affect the safety or effectiveness of the subject devices.

#### 5.7 Summary of non-clinical testing

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

- inserting into endoscope
- Flexibility of the insertion portion
- Piercing
- Ultrasound visibility
- Needle extraction and retraction
- Aspiration
- Withdrawal from endoscope
- Locking force of handle portion
- Limitation of needle depth

· 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-U401SX.

. ISO 10993-1 ·ISO 10993-5 · ISO 10993-10 · ISO 10993-11 ·ISO 11135 · ISO 14971 · ASTM F-1980-07

#### 5.8 Conclusion

When compared to the predicate device, the Single Use Aspiration Needle NA-U401SX

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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.