This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

Device Description

The PeriView FLEX needle is a single use tissue biopsy device that consists of five parts: Handle, Stopper, Sheath, Needle, and, Stylet. The sheath and needle (together termed the insertion section) are attached to the handle. The Stopper is removable and is attached between the Handle and the Needle Slider. The removable Stylet runs the full length of the device and is located within the inner lumen of the needle.

AI/ML Overview

The provided text describes the Olympus Surgical Technologies America PeriView FLEX device, which is a single-use tissue biopsy device intended for use through a bronchoscope for collecting intrapulmonary tissue. This is a Special 510(k) Notification, meaning the modified device is compared to its own predicate device (also named PeriView FLEX) and the primary change is the addition of a removable stopper.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a summary of performance testing with specifications/objectives.

Description	Specification/Objective	Reported Device Performance
Stopper Width	Meet width specification	All performance testing passed or met prescribed acceptance criteria
Removal Force	Meet specification	All performance testing passed or met prescribed acceptance criteria
Bubble Leak	ASTM F2096-11	All performance testing passed or met prescribed acceptance criteria
Accelerated Aging	ASTM F1980-16	All performance testing passed or met prescribed acceptance criteria

Note: The specific numerical values for the specifications are not provided in the document, only that they "met specification" or conformed to the ASTM standards.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "All performance testing passed or met prescribed acceptance criteria." However, it does not provide details on the sample size used for the various tests (Stopper Width, Removal Force, Bubble Leak, Accelerated Aging).

The data provenance is from bench testing ("Summary of All Performance Testing (no clinical testing was conducted)"). The country of origin is not explicitly stated for the testing, but the manufacturer is Olympus Surgical Technologies America, located in Southborough, Massachusetts, USA. The testing appears to be retrospective relative to the submission date of the 510(k).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as there was "no clinical testing conducted." The ground truth for the engineering performance tests (stopper width, removal force, etc.) would be established by measuring the device's physical attributes against pre-defined engineering specifications, not by expert interpretation.

4. Adjudication Method for the Test Set

This section is not applicable as there was "no clinical testing conducted" and thus no human interpretation of results requiring adjudication. The performance tests are objective engineering measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case comparative effectiveness study was not done. The document explicitly states "no clinical testing was conducted." Therefore, there is no effect size reported for human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study was not conducted in the context of an algorithm or AI. This device is a mechanical tissue biopsy device, not an AI-powered diagnostic or assistive tool. The performance evaluation focuses on its mechanical and material properties.

7. Type of Ground Truth Used

The ground truth used for the performance testing cited (Stopper Width, Removal Force, Bubble Leak, Accelerated Aging) would be engineering specifications and established ASTM standards. For example, for "Stopper Width," the ground truth would be the specific design dimension it was intended to meet. For "Bubble Leak," the ground truth is defined by the passing criteria of ASTM F2096-11.

8. Sample Size for the Training Set

This refers to a training set for an AI/algorithm, which is not applicable to this device as it is a mechanical device with no AI component mentioned.

9. How the Ground Truth for the Training Set Was Established

This refers to an AI/algorithm, which is not applicable to this device.

Summary

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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 & 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.

July 3, 2018

Olympus Surgical Technologies America Mary Anne Patella Senior Specialist, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104

Re: K181193

Trade/Device Name: PeriView FLEX Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: June 1, 2018 Received: June 4, 2018

Dear Ms. 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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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,

James J. Lee -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181193

Device Name PeriView FLEX

Indications for Use (Describe)

This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

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)

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K181193 510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. PeriView FLEX

General Information

Manufacturer:	Olympus Surgical TechnologiesAmericaGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104Phone: 508-804-2600Fax: 508-804-2624
Establishment Registration Number:	3003790304
Contact Person:	Mary Anne PatellaSenior Specialist, Regulatory Affairs508-804-2771Maryanne.patella@olympus-osta.com
Date Prepared:	May 3, 2018
Device Description
Classification Name:	Bronchoscope (flexible or rigid) andaccessories
CFR Citation Number:	21 CFR 874.4680
Product Code:	KTI
Classification:	Class II
Review Panel:	Ear Nose & Throat
Trade Name:	PeriView FLEX
Generic/Common Name:	Aspiration Needle
Predicate Device
K171232	Gyrus ACMI, Inc. PeriView FLEX

Comparison to Predicate Device:

The PeriView FLEX has been compared to the predicate PeriView FLEX with respect to intended use, design and fundamental scientific technology. The comparisons and summary of testing results presented in this Special 510(k)

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Notification show this device to be substantially equivalent to the predicate PeriView FLEX and raises no new concerns of safety or effectiveness.

Like the predicate PeriView FLEX. the modified PeriView FLEX is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions.

Product Description

Technological Characteristics

PeriView FLEX, with the Stopper, is identical in design to its predicate, PeriView FLEX, except for the added Stopper. They both operate similarly to obtain a tissue sample by inserting the insertion section (sheath and needle) of the device into a bronchoscope's working channel or guide sheath. It is then pushed forward to position the device to the tissue target. The Needle is thenadvanced out of the sheath and into the tissue by pushing the Needle Slider forward while holding the handle. When the Needle Slider is pushed forward (distally), the Needle can be deployed up to 20 mm from the sheath's distal tip. With the Stopper attached between the Handle and the Needle Slider, it blocks the forward movement of the Needle Slider, reducing needle deployment by 10mm. The Stopper is removable/replaceable by the user as desired.

Material

No changes were made to patient contacting material or packaging to the modified PeriView FLEX since the predicate system was cleared in K171232.

Intended Uses

The intended use of the modified device, as described in its labeling, has not changed as a result of the addition of the stopper.

This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.

Summary of Sterilization and Shelf Life Discussion

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Like the predicate PeriView FLEX, (K171232), the modified PeriView FLEX will be distributed in a sterile state and is intended for single patient use only. The sterilization method used continues to be ethylene oxide.

Summary of All Performance Testing (no clinical testing was conducted)

Description	Specification/objective
Stopper Width	Meet width specification
Removal Force	Meet specification
Bubble Leak	ASTM F2096-11
Accelerated Aging	ASTM F1980-16

All performance testing passed or met prescribed acceptance criteria

Substantial Equivalence

The modified PeriView FLEX has the same intended use, scientific technology and similar design as its predicate PeriView FLEX device. The predicate and modified PeriView FLEX devices are both bronchial aspiration needles consisting of a handle, sheath, needle, and stylet. The predicate and modified devices were shown to perform substantially equivalent in bench testing. There were no new issues of safety or effectiveness with the proposed device. Please see the following substantial equivalence comparison table.

	Predicate Device(K171232)	Proposed Device
Device Name/Characteristics	PeriView FLEX	PeriView FLEX
Indications for Use	This device is intended to be usedthrough a compatible bronchoscope forthe collection of tissue from theintrapulmonary regions. Do not use forany purpose other than its intended use.	This device is intended to be used througha compatible bronchoscope for thecollection of tissue from theintrapulmonary regions. Do not use forany purpose other than its intended use.
Anatomical Site	Lung	Identical
Use Conditions	Surgical suite, endoscopy orbronchoscopy suite, used with abronchoscope	Identical
Intended User	By or under the supervision of aphysician	Identical
Mechanics of Action	Manual	Identical
Mode of Action	Single/multiple puncture and aspirate	Identical
General design	Handle, Sheath, Needle, Stylet	SimilarA Stopper will be added to the shaft on thepiston of the needle assembly.
Patient Contacting	Stainless Steel, PTFE, PeBax ™, Nitinol	Identical

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	Predicate Device(K171232)	Proposed Device
Device Name/Characteristics	PeriView FLEX	PeriView FLEX
Materials
Biocompatible	Yes	Yes
Sterilization	Ethylene Oxide	Identical
Single Use Only	Yes	Identical
Maximum WorkingOD (mm)	1.5	Identical
Catheter Length(cm)	115	Identical
Needle Gauge	21G	Identical
Maximum NeedleExtended Length(mm)	20	Identical
Stylet OD (mm)	0.47	Identical

Conclusion:

In summary, the PeriView FLEX is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.