Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 15, 2018 Olympus Medical Systems Corp. % Sheri L. Musgnung Manager, Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034-0610 Re: K180668 > Trade/Device Name: Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: October 11, 2018 Received: October 15, 2018 Dear Sheri L. 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Glenn B. Bell -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180668 Device Name Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N Indications for Use (Describe) 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 gastrointestinal tract. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are thick and sans-serif, giving the word a strong and modern appearance. A thin yellow line is visible beneath the word, adding a subtle accent to the logo. October 10, 2018 # 5. 510(k) Summary # 5.1 GENERAL INFORMATION - 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 - Sheri L. Musgnung ■ Contact Person: Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung(@olympus.com # 5.2 DEVICE IDENTIFICATION | ■ Device Name | Single Use Aspiration Needle | |------------------------|--------------------------------------------| | ■ Model Name | NA-U401SX-4025, NA-U401SX-4025N | | ■ Common Name | Aspiration Needle | | ■ Regulation Number | 21 CFR 876.1075 | | ■ Regulation Name | Gastroenterology-urology biopsy instrument | | ■ Regulatory Class | II | | ■ Product Code | FCG | | ■ Classification Panel | Gastroenterology/Urology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The word is positioned above a thick, horizontal, yellow line. The font is sans-serif and the letters are closely spaced, giving the word a strong, unified appearance. The overall design is simple and clean, with a focus on the brand name. K180668 # 5.3 PREDICATE DEVICE #### 1) Predicate device Table 12-1 Primary predicate device for NA-U401SX-4025/NA-U401SX-4025N | Device name | 510(k) Submitter | 510(k) No. | |---------------------------------------------------------------|----------------------------------|------------| | NA-U401SX-4022<br>(Single Use Aspiration Needle<br>NA-U401SX) | OLYMPUS MEDICAL<br>SYSTEMS CORP. | K160098 | #### 2) Reference device #### Table 12-2 Reference device for NA-U401SX-4025/NA-U401SX-4025N | Device name | 510(k) Submitter | 510(k) No. | |------------------------------------------------------------------------------------------------|-------------------|------------| | ECHO-HD-25-EBUS-O<br>(Echotip Ultra Endobronchial High<br>Definition Ultrasound Biopsy Needle) | Cook Ireland Ltd. | K160229 | #### 5.4 DEVICE DESCRIPTION #### 1) General Description of the subject device The Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N (aka ViziShot 2) is used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). The subject devices consist 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 tube 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. The needle is dimpled for echo enhancement. The subject devices will be sold with or without medallion syringe manufactured by Merit Medical, which consists of VACLOK Syringe and Stopcock. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. There is a yellow line underneath the word. The registered trademark symbol is located to the right of the letter "S". # 2) Principle of Operation Ultrasound emitted by ultrasound transducer of ultrasound endoscope diffusely reflects at dimples on the echo-enhanced region of needle tube. The ultrasound transducer detects the part of ultrasound which diffusely reflects and the echo-enhanced region is indicated on ultrasound image. The needle tube and stylet are extracted from the sheath by moving the needle slider to distal side and is drawn into the sheath by moving the needle slider in the counter direction. The subject devices are used with specified ultrasound endoscopes for aspirating tissue or cells by piercing the target area in ultrasound image and attaching the medallion syringe to the aspiration port on the handle section. # 5.5 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 gastrointestinal tract. # 5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE The Single Use Aspiration Needles, NA-U401SX-4025/NA-U401SX-4025N have the same technological characteristics and design as the predicate device except for the following new features: - Needle width - Needle shape - Needle tip shape - Sheath composition - New colored sheath (NA-U401SX-4025 only) All other technological characteristics of both the subject and predicate devices are identical. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The letters are closely spaced and fill most of the upper portion of the image. Below the word "OLYMPUS" is a horizontal bar in a gradient of yellow and gold. The bar is positioned directly beneath the text, providing a visual base for the logo. K180668 # 5.7 PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. #### 1) Sterilization/Shelf life testing Sterilization/shelf life life testing for Single Use Aspiration Needle. NA-U401SX-4025/NA-U401SX-4025N was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Accelerated aging test for the NA-U401SX-4025/NA-U401SX-4025N was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three-years will be performed to demonstrate longer stability and support the results of the accelerated aging test. #### 2) Biocompatibility testing Biocompatibility testing for the the Single Use Aspiration Needle, NA-U401SX-4025/NA-U401SX-4025N were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1:2009, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process''. #### 3) Performance testing - Bench Bench testing for the Single Use Aspiration Needle, NA-U401SX-4025/NA-U401SX-4025N as listed below was conducted to ensure that the subject devices perform as intended and meet design specifications. - 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 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are a sans-serif font and are evenly spaced. There is a yellow line underneath the word. The registered trademark symbol is in the upper right corner of the image. # 4) Risk analysis Risk analysis for the Single Use Aspiration Needle, NA-U401SX-4025/NA-U401SX-4025N was conducted 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 analvsis assessment. The following standards have been applied to the Single Use Aspiration Needle, NA-U401SX-4025/NA-U401SX-4025N. - ISO 10993-1: 2009 - AAMI/ANSI/ISO 10993-5: 2009 - ISO 10993-10: 2010 - ISO 10993-11: 2006 - ISO 11135: 2014 - ISO 10993-7: 2008+Cor1 - ISO 11607-1: 2006+A1 - ISO 11607-2: 2006+A1 - ASTM F1980-16 - ISO 14971: 2007 # 5.8 CONCLUSIONS Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the NA-U401SX-4025/ NA-U401SX-4025N raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, efficacy and performance.