These instruments have been designed to be used with an Olympus 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).

Device Description

The Single Use Aspiration Needle NA U201H are single use aspiration needles to be used in conjunction with an Olympus 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).

The Single Use Aspiration Needle NA U201H consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G will be available. The Single Use Aspiration Needle NA U201H are sterilized and packaged in a sterilization package. The Syringe (VACLOK Syringe and Stopcock), which is supplied by Merit Medical System and packaged in an individual sterilization package, is bundled. The Single Use Aspiration Needle NA U201H and the Syringe are put in one carton. When users use the device, the syringe is attached to the aspiration port on the handle section of the subject devices.

AI/ML Overview

The provided document is a 510(k) summary for the Olympus Single Use Aspiration Needle NA-U201H. The key takeaway from this document is that no clinical studies or multi-reader multi-case (MRMC) comparative effectiveness studies were conducted involving human readers or AI. The submission relies on performance data from bench and animal testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions that "Risk analysis for the Single Use Aspiration Needle NA-U201H 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 analysis assessment." However, the specific quantitative acceptance criteria and detailed performance results for each test (e.g., insertion force, aspiration volume, etc.) are not explicitly provided in the summary. It only lists the categories of tests performed.

Test Category	Acceptance Criteria (Not explicitly detailed in document)	Reported Device Performance (Not explicitly detailed in document)
Sterilization/Shelf life testing	Compliance with FDA Guidance and ASTM F1980-16	Accelerated aging test conducted; real-time aging ongoing
Biocompatibility testing	Compliance with ISO 10993-1	Testing conducted
Insertion and withdrawal performance	Established in-house criteria	Testing performed
Visibility by using diagnostic ultrasound systems	Established in-house criteria	Testing performed
Aspiration performance	Established in-house criteria	Testing performed
Needle durability and package integrated test	Established in-house criteria	Testing performed

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on sample sizes for the bench or animal testing. It also does not specify the provenance of any data (e.g., country of origin, retrospective or prospective), as the tests are described as internal performance evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as there were no clinical studies, and therefore no a ground truth established by medical experts for a test set. The performance evaluation was based on bench and animal testing, which would involve technical personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there were no clinical studies involving human interpretation or adjudication.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "This premarket notification does not rely on clinical study data to demonstrate substantial equivalence." Furthermore, this device is an aspiration needle and does not involve AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone performance study was not done, as this device is a physical medical instrument and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench and animal testing, the "ground truth" would be defined by the measurement standards and specifications for each test (e.g., a specific force for insertion, a certain volume for aspiration, image quality metrics for visibility, etc.). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as there were no clinical studies.

8. The sample size for the training set

This information is not applicable as there were no machine learning algorithms or AI components involved in this device, and thus no training set.

9. How the ground truth for the training set was established

This information is not applicable as there was no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 31, 2018

Olympus Medical Systems Corp. % Mary Anne Patella Senior Specialist, Regulatory Affairs Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772

Re: K181994

Trade/Device Name: Single Use Aspiration Needle NA-U201H Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: October 3, 2018 Received: October 4, 2018

Dear Mary Anne Patella:

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 medical devices and radiation-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,

Image /page/1/Picture/7 description: The image shows the logo of the Food and Drug Administration (FDA). The logo is in white and consists of the letters "FDA" in a stylized font. The letters are connected and have a modern, clean design. The logo is simple and recognizable, representing the FDA's role in regulating and overseeing food and drug products.

Jeffrey W. Cooper -2018.10.31 16:45:48 -04'00

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) K181994

Device Name Single Use Aspiration Needle NA-U201H

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 slightly rounded and have a glossy appearance. The word is set against a white background, and there is a subtle yellow gradient below the word.

July 23, 2018

Section 5 510(k) Summary

5.1 GENERAL INFORMATION

■ 510(k) Submitter:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
■ Contact Person:	Mary Anne PatellaOlympus Surgical Technologies America136 Turnpike RoadSouthborough, MA 01772, USAPhone: 508-804-2771Fax: 508-804-2624Email: Maryanne.patella@olympus-osta.com

5.2 DEVICE IDENTIFICATION

■ Device Name	Single Use Aspiration Needle NA-U201H
■ 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 and Urology

{4}------------------------------------------------

K181994 Page 2 of 5

5.3 PREDICATE DEVICE

1) Primary predicate device

Table 12-1 Primary predicate device on Single Use Aspiration Needle NA-U201H

Device name	510(k) Submitter	510(k) No.
Single Use Aspiration NeedleNA-U200H	OLYMPUS MEDICALSYSTEMS CORP.	K151738

2) Reference device

Table 12-2 Reference device on Single Use Aspiration Needle NA-U201H

Device name	510(k) Submitter	510(k) No.
DISPOSABLE ASPIRATIONNEEDLE NA-200H	OLYMPUS MEDICALSYSTEMS CORP.	K023272
EXPECT ENDOSCOPICULTRASOUND ASPIRATIONNEEDLE	BOSTON SCIENTIFIC CORP.	K110030

5.4 DEVICE DESCRIPTION

{5}------------------------------------------------

K181994 Page 3 of 5

5.5 INDICATIONS FOR USE

5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The Single Use Aspiration Needle NA-U201H has the same technological characteristics and design as the predicate device except for following features:

Needle width (addition of 25G needle) .
Maximum insertion portion diameter (smaller diameter)
. Patient-contacting material (sheath, needle, silicone oil)
Stylet diameter (smaller diameter for 25G needle) •
Tip shape of needle (Backcut, Lancet shape) .
. Sheath type

A side by side comparison of the subject device and the predicate device is provided below.

Table 12-3 A side by side comparison of the subject device and the predicate device
Item	Subject Device	Predicate Device
	Single Use Aspiration NeedleNA-U201H	Single Use Aspiration NeedleNA-U200H (K151738)
Indications for use	These instruments have beendesigned to be used with anOlympus ultrasound endoscopefor ultrasonically guided fineneedle aspiration (FNA) ofsubmucosal and extramurallesions within thegastrointestinal tract (i.e.pancreatic masses, mediastinalmasses, perirectal masses andlymph nodes).	This instrument has beendesigned to be used with anOlympus ultrasound endoscopefor ultrasonically guided fineneedle aspiration (FNA) ofsubmucosal and extramurallesions within thegastrointestinal tract (i.e.pancreatic masses, mediastinalmasses, perirectal masses andlymph nodes).
Common name	Aspiration Needle	Aspiration Needle
ra	876.1075	876.1075

		Table 12-3 A side by side comparison of the subject device and the predicate device

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, dark blue letters. The font is sans-serif and the letters are closely spaced together. A small registration mark is present to the right of the letter "S".

Item	Subject Device	Predicate Device
	Single Use Aspiration NeedleNA-U201H	Single Use Aspiration NeedleNA-U200H (K151738)
Regulation name	Gastroenterology-UrologyBiopsy Instrument	Gastroenterology-UrologyBiopsy Instrument
Regulatory class	II	II
Classification panel	Gastroenterology and Urology	Gastroenterology and Urology
Product code	FCG	FCG
Environment of use	Healthcare facility/hospital	Healthcare facility/hospital
Single/repeat use	Single-Use	Single-Use
Sterile/non-sterile	Marketed as a sterile device	Marketed as a sterile device
Sterilization method	ETO sterile	ETO sterile
Patient-contactmaterials	Sheath: PEEKNeedle: Stainless steelStylet: NitinolSilicone oil: MethylphenylPolysiloxane	Sheath: Stainless steelNeedle: Nitinol and StainlesssteelStylet: NitinolSilicone oil: Not equipped

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 testing for the Single Use Aspiration Needle NA-U201H were 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 demonstrating stability of the Single Use Aspiration Needle NA-U201H 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 Single Use Aspiration Needle NA-U201H were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. A registered trademark symbol is located to the right of the word.

K181994 Page 5 of 5

evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

3) Performance testing - Bench

Bench testing has been performed on the proposed Single Use Aspiration Needle NA-U201H.Bench Testing includes:

Insertion and withdrawal performance
Visibility by using diagnostic ultrasound systems
Aspiration performance
Needle durability and package integrated test

4) Performance testing - Animal

This premarket notification does not rely on Animal study data to demonstrate substantial equivalence.

5) Performance testing - Clinical

This premarket notification does not rely on clinical study data to demonstrate substantial equivalence.

6) Risk analysis

Risk analysis for the Single Use Aspiration Needle NA-U201H 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 analysis assessment.

5.8 CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the Single Use Aspiration Needle NA-U201H raises no new issues of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, effectiveness and performance.

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.