The ViziShot FLEX has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose of the than its intended use.

Device Description

The ViziShot FLEX is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use.

The device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although the device has a component called a needle, the device is often referred to as a needle as well.

Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve. The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing.

The ViziShot FLEX is available in one model only (NA-U402SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Olympus Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot FLEX.

AI/ML Overview

This document is a 510(k) premarket notification for the ViziShot FLEX, a device designed for ultrasound-guided fine needle aspiration (FNA) of tracheobronchial lesions. This submission focuses on demonstrating substantial equivalence to a predicate device, the Flexible 19G EBUS Needle (K142909), primarily through bench testing to confirm its performance and technological characteristics.

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 submission does not present a formal table of "acceptance criteria" with quantitative performance metrics for device performance in a diagnostic sense (e.g., sensitivity, specificity for disease detection). Instead, the acceptance criteria are generally qualitative and relate to the device's functional integrity, safety, and operational capabilities in a simulated clinical setting. The "reported device performance" refers to the successful completion of these tests.

Acceptance Criteria (Functional/Safety)	Reported Device Performance
Bench Testing
Sheath and Needle Insertion and Withdrawal Force	Met pre-determined acceptance criteria
Stylet Insertion and Withdrawal Force	Met pre-determined acceptance criteria
Bronchoscope Angulation Activation Force	Met pre-determined acceptance criteria
Plastic Deformation Angle	Met pre-determined acceptance criteria
Penetration Force	Met pre-determined acceptance criteria
Transmission Force	Met pre-determined acceptance criteria
Durability	Met pre-determined acceptance criteria
Vacuum Leak Test	Met pre-determined acceptance criteria
Bronchoscope Adapter Sliding Force	Met pre-determined acceptance criteria
Handle Durability	Met pre-determined acceptance criteria
Sheath to Handle Joint Strength	Met pre-determined acceptance criteria
Echogenicity	Met pre-determined acceptance criteria
Simulated Use - Ex Vivo (Bovine Lung)
Able to connect to endoscope using supplied adapter biopsy valve	Confirmed
Remains functional after exposure to saline, water, and water-based lubricants	Confirmed
Single operator able to collect a tissue sample	Confirmed
Able to aspirate and expulse tissue	Confirmed
Sterilization Validation
Achieves a 10⁻⁶ SAL (Sterility Assurance Level)	Cycle validated in accordance with EN ISO 11135:2014
EO residual below limits dictated by ISO 10993-7	Met acceptance criteria
Endotoxin test results below 20 EU/device	Met acceptance criteria
Biocompatibility
Cytotoxicity	Passed (for ViziShot FLEX)
Sensitization	Passed (for predicate)
Irritation	Passed (for predicate)
Hemocompatibility	Passed (for predicate)
Systemic Toxicity	Passed (for predicate)

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

The document does not explicitly state the specific sample sizes (e.g., number of devices, number of trials) for each individual bench test. It broadly states: "Device performance of the ViziShot FLEX was verified through in vitro (bench) and ex vivo testing. Testing was designed to mimic stresses encountered in a clinical setting. All testing met the pre-determined acceptance criteria as outlined in the test protocols." The provenance of the data is from in vitro (bench) and ex vivo (bovine lung) testing, implying controlled laboratory conditions rather than human clinical data. The country of origin for the data is not specified but is implicitly associated with the manufacturer, Spiration, Inc., based in Redmond, Washington, USA. The data is thus prospective, as it was generated specifically for this 510(k) submission.

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

This type of information is generally not applicable to bench and ex vivo testing studies focused on device functionality and safety. Ground truth in this context would be defined by engineering specifications and objective measurements (e.g., force transducers, calibrated measurement tools, visual inspection against design specifications). There were no human experts establishing a "ground truth" for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" involves objective bench and ex vivo measurements against engineering specifications, not expert interpretation requiring adjudication.

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

No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence based on engineering and performance characteristics of the device itself, not on the effectiveness of human readers using the device for diagnostic purposes. Therefore, there is no effect size reported for human readers improving with or without AI assistance, as AI is not part of this device.

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

Not applicable. The ViziShot FLEX is a mechanical medical device (an aspiration needle), not an AI algorithm. Its performance is intrinsically linked to human operation by a clinician.

7. Type of Ground Truth Used

For the bench and ex vivo testing, the "ground truth" was established by pre-defined engineering specifications, material properties, and functional requirements (e.g., specific force thresholds, dimensional tolerances, successful aspiration of tissue, maintenance of sterility). For biocompatibility, the ground truth was adherence to established ISO standards (ISO 10993-1, ISO 10993-7).

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the machine learning sense. The "training" for the device's design implicitly comes from prior engineering knowledge and the design of the predicate device.

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

Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the design and development of the device (if one were to stretch the analogy) would be established through established biomedical engineering principles, clinical needs, safety standards, and lessons learned from the predicate device.

Summary

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

February 19, 2016

Spiration, Inc. Ms. Cyndy J. Adams Senior Manager Regulatory 6675 185th Ave NE Redmond. Washington, 98052

Re: K152922

Trade/Device Name: ViziShot FLEX Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories. Regulatory Class: II Product Code: KTI Dated: January 19, 2016 Received: January 21, 2016

Dear Ms. Adams:

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.

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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-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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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)

Device Name ViziShot FLEX

Indications for Use (Describe)

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

Registration Use (Part 21 CFR 201 Subpart D)	☒
OTC Complaint Use (21 CFR 201 Subpart C)	☐

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary 1

Submitter Information

Date of 510(k) Summary Preparation:	February 19, 2016
Name and Address of Manufacturer:	Spiration, Inc.6675 185th Avenue NeRedmond, WA 98052
Contact Person:	Cyndy AdamsSenior Regulatory Affairs ManagerPhone: (425) 636.5450Fax: (425) 497.8802

Subject Device

Device Trade Name: Common Name:

ViziShot FLEX Aspiration Needle

Bronchoscope (flexible or rigid) and accessories Classification: Regulation : 21 CFR 874.4680 Product Code: KTI ENT Review Panel:

Predicate Device

Trade Name: 510(k) Number: Manufacturer:

Flexible 19G EBUS Needle K142909, cleared 4/24/2015 Spiration, Inc.

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Device Description

Indications for Use

The ViziShot FLEX 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. Do not use this device for any purpose other than its intended use.

Technological Characteristics

The technological characteristics of the ViziShot FLEX are the same as those of the predicate Flexible 19G EBUS Needle. That is they have substantially the same design, material, and energy source. They are both designed to obtain a sample from lung tissue or lymph node tissue under ultrasound visualization. Both devices have the following technological characteristics:

Needle length adjustable and lockable ●
. Sheath length adiustable and lockable
Secure attachment to scope with controlled device orientation ●
Manual needle movement through bronchoscope to target site .
Flexible needle
Stylet resistant to kinking ●
. Echogenic needle tip visible with ultrasound
. Sharp needle tip
Aspiration capability ●

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Comparison to Predicate

The ViziShot FLEX has the same technological characteristics as the predicate Flexible 19G EBUS Needle cleared under K142909. The subject and predicate device operate in the same manner to obtain a tissue biopsy using an ultrasound endoscope. The indications for use of the ViziShot FLEX is the same as that of the predicate.

The ViziShot FLEX has a slightly less flexible distal tip and a slightly larger stylet relative to the predicate device and the required accessories are packaged with the device. A detailed comparison of the ViziShot FLEX Needle and the Flexible 19G EBUS Needle is provided in the following table.

	Predicate Device (K142909)	Modified Device
Device Name→	Flexible 19G EBUS Needle	ViziShot FLEX
Device Characteristics↓
Indications for Use	The Flexible 19G EBUS Needle 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. Do not use this device for any purpose other than its intended use.	The ViziShot FLEX 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. Do not use this device for any purpose other than its intended use.
Use Conditions	Surgical suite, endoscopy or bronchoscopy suite, used with a bronchoscope	Identical
Mechanics of Action	Manual	Identical
Mode of Action	Single/multiple puncture and aspirate	Identical
General Design	Handle, Sheath, Needle, Stylet	Identical
Patient Contacting Material	Stainless Steel, PTFE, PEBAX, Nitinol	Identical
Biocompatible	Yes	Identical
Product Specifications and Properties	Engineering bench testing confirms that the modified 19G Needle meets its product specifications, which are equivalent to those of the predicate 19G Needle	Identical
Sterilization	EO	Identical
Single Use Only	Yes	Identical

Comparison of Key Characteristics

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	Predicate Device (K142909)	Modified Device
Device Name→	Flexible 19G EBUS Needle	ViziShot FLEX
Device Characteristics↓
Working OD (mm)	1.9	2.08
Catheter Length (cm)	70	Identical
Needle Gauge	19G	Identical
Typical Needle Length (mm)	20	Identical
Max Needle Length (mm)	40	Identical
Stylet OD (in)	0.0177	0.0205
Stylet Surface Finish	Not polished	Polished
Accessories	User acquires	Identical accessories provided withdevice

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Bench Testing

Device performance of the ViziShot FLEX was verified through in vitro (bench) and ex vivo testing. Testing was designed to mimic stresses encountered in a clinical setting. All testing met the pre-determined acceptance criteria as outlined in the test protocols.

Sheath and Needle Insertion and Withdrawal Force Stylet Insertion and Withdrawal Force Bronchoscope Angulation Activation Force Plastic Deformation Angle Penetration Force Transmission Force Durability Vacuum Leak Test Bronchoscope Adapter Sliding Force Handle Durability Sheath to Handle Joint Strength Echogenicity Simulated use - ex vivo (bovine lung) bench testing In simulated use testing, the following aspects of device use were evaluated:

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Able to connect to endoscope using supplied adapter biopsy valve ●
Remains functional after exposure to saline, water, and water-based lubricants ●
Single operator is able to collect a tissue sample .
Able to aspirate and expulse tissue .

Sterilization Validation

The ViziShot FLEX is EO sterilized with a cycle that has been validated in accordance with EN ISO 11135:2014. This cycle is validated to assure the ViziShot FLEX achieves a 10 °SAL. EO residual and Endotoxin test results also met acceptance criteria with results below the limits dictated by ISO 10993-7 for residuals and below the endotoxin limits of 20 EU/device.

Biocompatibility

Spiration considered ISO 10993-1, the ODE Blue Book Memorandum #G95-1 (1995), Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and the FDA draft guidance "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing (4/23/13)" in determining the applicable tests and test methods for biocompatibility testing. As an external communicating device with a limited blood path indirect exposure (<24 hours), the ViziShot FLEX the following battery of tests is required:

Cytotoxicity ●
Sensitization .
Irritation ●
Hemocompatibilty ●
Systemic Toxicity ●

The full battery of tests was conducted on the patient contacting/fluid path portion of the predicate Flexible 19G EBUS Needle; all testing passed. Because the only material change in the ViziShot FLEX Needle, is a supplier change in a non-patient contacting, non-fluid path component, only cytotoxicity was conducted on the ViziShot FLEX; this testing passed.

The results from this testing demonstrate that the performance and technological characteristics of the ViziShot FLEX meet defined design requirements and that the device performs equivalently to the predicate Flexible 19G EBUS Needle.

Conclusion

The data and information presented within this 510(k) Premarket Notification support the substantial equivalence of the ViziShot FLEX to the cleared Flexible 19G EBUS Needle.

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.