K Number
K163469
Device Name
ViziShot 2 FLEX
Date Cleared
2017-04-06

(115 days)

Product Code
Regulation Number
874.4680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ViziShot 2 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.
Device Description
The ViziShot 2 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 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.
More Information

Not Found

No
The description focuses on the mechanical components and function of a needle aspiration device used with ultrasound guidance. There is no mention of AI or ML in the intended use, device description, or performance studies.

No.
The device is used for diagnostic purposes (fine needle aspiration for examination and testing) rather than for treating a disease or condition.

No

This device is a needle used for tissue sampling (biopsy) and does not interpret or diagnose conditions, even though it's used with an imaging modality. The obtained tissue samples are subsequently sent for cytopathological or microbiological examination, which is where the diagnostic process occurs.

No

The device description clearly outlines physical components such as a handle, sheath, needle, and stylet, and describes their mechanical function and interaction with other hardware (ultrasound endoscope, bronchoscope). The performance studies also focus on bench testing of these physical components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
  • ViziShot 2 FLEX Function: The ViziShot 2 FLEX is a tool used within the body (in vivo) to obtain a tissue sample (biopsy) from the tracheobronchial tree. It facilitates the collection of the sample, but it does not perform any diagnostic testing on the sample itself.
  • Subsequent Testing: The description explicitly states that the removed tissue is then "prepared for cytopathological or microbiological examination and testing." This indicates that the diagnostic testing happens after the sample is collected using the ViziShot 2 FLEX, and likely involves separate IVD devices or laboratory procedures.

The ViziShot 2 FLEX is a surgical/procedural device used for tissue acquisition, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

The ViziShot 2 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.

Product codes (comma separated list FDA assigned to the subject device)

KTI

Device Description

The ViziShot 2 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 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

tracheobronchial tree

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgical suite, endoscopy or bronchoscopy suite

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing performed:
Biocompatibility: Testing on all patient contacting surfaces in compliance with ISO-10993, including ISO 10993-4 (interactions with blood), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and sensitization), and ISO 10993-11 (systemic toxicity).
Sterilization: Validation of ethylene oxide sterilization and packaging according to ANSI/AAMI/ISO 11607-1:2006 and ANSI/AAMI/ISO 11135-1:2014. Packaging integrity and performance testing on devices that had undergone accelerated aging support a labeled one-year shelf life.
Bench testing conducted during design verification: Sheath and Needle Insertion and Withdrawal Force, Stylet Insertion and Withdrawal Force, Bronchoscope Angulation, Activation Force, Plastic Deformation Angle, Penetration Force, Transmission Force, Device Durability/Handle Durability, Bronchoscope Adapter Sliding Force, Handle Durability, Sheath to Handle Joint Strength, Echogenicity.
Key results: Engineering bench testing confirms that the modified ViziShot 2 FLEX meets its critical product specifications, which are substantially equivalent to those of the predicate ViziShot FLEX.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152922

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

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

April 6, 2017

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

Re: K163469

Trade/Device Name: Vizishot 2 Flex Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: March 9, 2017 Received: March 10, 2017

Dear Mary 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.

1

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

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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

2

Indications for Use

510(k) Number (if known)

Device Name ViziShot 2 FLEX

Indications for Use (Describe)

The ViziShot 2 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.

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.

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3

510(k) Summary Gyrus ACMI ViziShot 2 FLEX

General Information

| Manufacturer: | Olympus Surgical Technologies
America
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104
Phone: 508-804-2600
Fax: 508-804-2624 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Mary Anne Patella
Senior Specialist, Regulatory Affairs
508-804-2771
Maryanne.patella@olympus-osta.com |
| Date Prepared: | December 16, 2016 |

Device Description

| Classification Name: | Bronchoscope (flexible or rigid) and
accessories |
|----------------------|-----------------------------------------------------|
| CFR Citation Number: | 21 CFR 874.4680 |
| Product Code: | KTI |
| Classification: | Class II |
| Review Panel | Ear Nose & Throat |
| Trade Name: | ViziShot 2 FLEX |
| Generic/Common Name: | Aspiration Needle |

Predicate Devices

Spiration, Inc. ViziShot FLEXK152922
----------------------------------------

4

Product Description

The ViziShot 2 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 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.

Intended Use

The ViziShot 2 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.

The Intended Use is identical to that of the predicate device.

Technological Characteristics

The technological characteristics of the ViziShot 2 FLEX are the same as those of the predicate ViziShot FLEX. That is they have substantially the same design, material, and energy source. They are both designed to obtain a sample from lung tissue or

5

lymph node tissue under ultrasound visualization. Both devices have the following technological characteristics:

  • Needle length adjustable and lockable ●
  • Sheath length adjustable 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 ●

Comparison of Technological Characteristics

The ViziShot 2 FLEX has the same basic technological characteristics as the predicate ViziShot FLEX cleared under K152922. 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 2 FLEX are the same as that of the predicate.

The ViziShot 2 FLEX handle profile design has been changed from the predicate device to improve ergonomics; as well as to utilize Design for Manufacturing principles to make the manufacturing assembly more efficient. The resulting device functionality, look, and interaction with the physician are equivalent to those of the predicate device ViziShot FLEX. A detailed comparison of the ViziShot 2 FLEX and the ViziShot FLEX is provided in the following table.

Predicate Device (K152922)Modified Device
Device Name/
CharacteristicsViziShot FLEXViziShot 2 FLEX
Indications for UseThe 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.The ViziShot 2 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 ConditionsSurgical suite, endoscopy or
bronchoscopy suite, used with
a bronchoscopeIdentical
Predicate Device (K152922)Modified Device
Device Name/
CharacteristicsViziShot FLEXViziShot 2 FLEX
Mechanics of ActionManualIdentical
Mode of ActionSingle/multiple puncture and
aspirateIdentical
General designHandle, Sheath, Needle,
StyletSimilar
The handle profile design has
been changed to improve
ergonomics and utilize Design
for Manufacturing principles.
Changes include:
• Handle shape and added
rubber finger grip
• Sheath adjuster rotates
• Snap bonds instead of
screw and glue
Patient Contacting
MaterialsStainless Steel, PTFE,
PEBAX, NitinolStainless Steel, PTFE, PEBAX,
Nitinol
BiocompatibleYesYes
Product Specification
and PropertiesEngineering bench testing confirms that the modified ViziShot 2
FLEX meets its critical product specifications, which are
substantially equivalent to those of the predicate ViziShot
FLEX.
SterilizationEOEO
Single Use OnlyYesIdentical
Working OD (mm)2.08Identical
Catheter Length (cm)70Identical
Needle Gauge19GIdentical
Typical Needle Length
(mm)20Identical
Max Needle Length
(mm)40Identical
Stylet OD (in)0.0205Equivalent
0.0204
Stylet Surface FinishPolishedIdentical
AccessoriesSyringe with stopcock
Adapter biopsy valve
Devices provided with deviceIdentical
PackagingNeedle assembly in tray withNeedle assembly, syringe,
Predicate Device (K152922)Modified Device
Device Name/
CharacteristicsViziShot FLEXViziShot 2 FLEX
snap downs. Tray placed in
pouch. Pouch placed in shelf
box (dust cover) for sterilization.
After sterilization, the sterile
pouched syringe and sterile
pouched adapter will be added
to the dust cover.adapter placed in tray with
snap downs and tyvek lid.
Tray placed in shelf box
prior to sterilization.

6

.

7

Summary of Non-Clinical Testing

Biocompatibility:

Biocompatibility testing on all patient contacting surfaces has been performed in compliance to relevant requirements of ISO-10993. Biocompatibility testing included the following tests:

  • ISO 10993-4: 2002 Biological evaluation of medical devices Part 4: ● Selection of tests for interactions with blood
  • ISO 10993-5: 2009 Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity
  • ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for ● irritation and sensitization
  • . ISO 10993-11:2006. Biological evaluation of medical devices. Tests for systemic toxicity

Sterilization:

The ViziShot 2 FLEX will be delivered in a sterile state and is intended for single patient use only. Sterilization (ethylene oxide) and packaging of the device was validated using the following standards:

  • . ANSI/AAMI/ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • . ANSI/AAMI/ISO 11135-1:2014 Sterilization of health-care products ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

Packaging integrity and performance testing on devices that had undergone accelerated aging support a labeled one year shelf life.

8

Bench testing:

During design verification, the output of the design process was evaluated against the physical and performance specifications. The following performance tests were conducted:

  • Sheath and Needle Insertion and Withdrawal Force
  • Stylet Insertion and Withdrawal Force ●
  • Bronchoscope Angulation ●
  • Activation Force
  • Plastic Deformation Angle
  • Penetration Force
  • Transmission Force
  • Device Durability/Handle Durability
  • Bronchoscope Adapter Sliding Force
  • Handle Durability
  • Sheath to Handle Joint Strength ●
  • . Echogenicity

Conclusion:

In summary, the ViziShot 2 FLEX is substantially equivalent to the predicate device and presents no new questions of safety or efficacy.