(90 days)
No
The device description and performance studies focus on the mechanical and material properties of the needle and its ability to obtain tissue samples, with no mention of AI or ML for image analysis, guidance, or any other function.
No
The device is used for diagnostic purposes (obtaining tissue samples for examination), not for treating a disease or condition.
No
Explanation: This device is a biopsy needle used to obtain tissue samples, not to diagnose a condition. The collected samples are then sent for separate pathological examination.
No
The device description clearly outlines physical components (handle, sheath, needle, stylet) and mechanical actions (insertion, advancement, locking, suction), indicating it is a hardware medical device.
Based on the provided information, the ViziShot 2 FLEX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for obtaining tissue samples (FNA and FNB) from the tracheobronchial tree using ultrasound guidance. The device itself is used to collect the sample, not to perform a diagnostic test on the sample.
- Device Description: The description details a mechanical device for aspiration and biopsy. It facilitates the collection of tissue.
- Function: The device's function is to physically access and retrieve tissue. The diagnostic testing happens after the sample is collected, typically in a laboratory setting using other methods (cytopathological or microbiological examination).
- Performance Studies: The performance studies focus on the mechanical and physical properties of the device (insertion force, durability, echogenicity, sample quality metrics like weight and length), not on the diagnostic accuracy of the device itself in analyzing a sample.
An IVD device is typically used to perform tests on samples taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. The ViziShot 2 FLEX is a tool for obtaining the sample, which is then used with other IVD devices or methods for diagnosis.
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) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.
Product codes
KTI
Device Description
The subject device, ViziShot 2 FLEX is a single use aspiration needle to be used in conjunction with compatible ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.
The subject 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. The device is a single-use sterile device.
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
submucosal and extramural lesions of the 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
Bench Performance Testing:
- 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
A GLP Comparison of the ViziShot 2 FLEX to the Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle was performed to evaluate if the ViziShot 2 FLEX 19G needle obtains sufficient tissue samples for histologic and core sample analysis and provides similar quality of samples as the predicate. The performance testing in this study included observations on ease of needle passage through the tissue, and tissue sampling metrics to include weight, length, number of segments and quality of the tissues obtained for microscopic evaluation.
Animal Study: No animal study was performed.
Clinical Study: No clinical study was performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 18, 2020
Olympus Surgical Technologies America Mary Patella Senior Specialist, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772-2104
Re: K193517
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: December 18, 2019 Received: December 19, 2019
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. 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. 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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) and fine needle biopsy (FNB) 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) |
|---|---|
| ------------------------------------------------------------------------------------- | ----------------------------------------------- |
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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 18, 2019 |
| Device Description | |
| Classification Name:
CFR Citation Number:
Product Code:
Classification:
Review Panel
Trade Name:
Generic/Common Name: | Bronchoscope (flexible or rigid) and
accessories
21 CFR 874.4680
KTI
Class II
Ear Nose & Throat
Gyrus ACMI ViziShot 2 FLEX
Aspiration Needle |
| Predicate Device | |
| Cook Ireland, Ltd Echotip Procore
Endobronchial High Definition
Ultrasound Biopsy Needle | K160229 |
| Reference Device | |
| Gyrus ACMI ViziShot 2 FLEX | K163469 |
4
Product Description
The subject device, ViziShot 2 FLEX is a single use aspiration needle to be used in conjunction with compatible ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree.
The subject 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. The device is a single-use sterile device.
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) and fine needle biopsy (FNB) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.
Comparison of Proposed and Predicate DeviceThe proposed addition of "fine needle biopsy (FNB)" to the Indications for Use is the same as the primary predicate Cook Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle cleared via K160229.
The ViziShot 2 FLEX has the same technological characteristics and design as the as the reference predicate ViziShot 2 FLEX cleared under K163469. The subject and predicate device operate in the same manner to obtain a tissue biopsy using an ultrasound endoscope. Please refer to the following Substantial Equivalence Table.
5
| | Proposed Device | Predicate
Device
(K160229) | Reference Device
(K163469) | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Device Name/
Characteristics | Gyrus ACMI
ViziShot 2
FLEX | Cook Echotip
Procore
Endobronchial
High Definition
Ultrasound
Biopsy Needle | Gyrus ACMI
ViziShot
FLEX | Comment |
| Indications for
Use | The ViziShot 2
FLEX has been
designed to be
used with
ultrasound
endoscopes for
ultrasound
guided fine
needle
aspiration
(FNA) and fine
needle biopsy
(FNB) of
submucosal and
extramural
lesions of the
tracheobronchial
tree. Do not use
this device for
any purpose
other than its
intended use. | Echotip
Procore®
Endobronchial
High Definition
Ultrasound
Biopsy Needle
for use with
Olympus EBUS
scopes: This
device is used
with an
ultrasound
endoscope for
fine needle
biopsy, (FNB),
of submucosal
and extramural
lesions within or
adjacent to the
tracheobronchial
tree or
gastrointestinal
tract. | 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. | Similar to
the Cook
Predicate. |
| Use Conditions | Surgical suite,
endoscopy or
bronchoscopy
suite, used with a
bronchoscope | Surgical suite,
endoscopy or
bronchoscopy
suite, used with
a bronchoscope | Surgical suite,
endoscopy or
bronchoscopy
suite, used with a
bronchoscope | Identical |
| Mechanics of
Action | Manual | Manual | Manual | Identical |
| Mode of Action | Single/multiple
puncture and
aspirate | Single/multiple
puncture and
aspirate | Single/multiple
puncture and
aspirate | Identical |
| General design | Handle, Sheath,
Needle, Stylet | Handle, Sheath,
Needle, Stylet | Handle, Sheath,
Needle, Stylet | Identical |
| Patient
Contacting
Materials | Stainless Steel,
PTFE, PEBAX,
Nitinol | Unknown | Stainless Steel,
PTFE, PEBAX,
Nitinol | Identical
to
reference
ViziShot 2
FLEX |
| Biocompatible | Yes | Yes | Yes | Identical |
| Single Use
Only | Yes | Yes | Yes | Identical |
| Working OD
(mm) | 2.08 | Unknown | 2.08 | Identical
to
reference
ViziShot 2
FLEX |
| Catheter Length
(cm) | 70 | Unknown | 70 | Identical
to
reference
ViziShot 2
FLEX |
| Needle Gauge | 19G | 22G, 25G | 19G | Identical
to |
| Table 5.1 Comparison of Proposed and Predicate Device | ||
|---|---|---|
6
| | Proposed Device | Predicate
Device
(K160229) | Reference Device
(K163469) | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Device Name/
Characteristics | Gyrus ACMI
ViziShot 2
FLEX | Cook Echotip
Procore
Endobronchial
High Definition
Ultrasound
Biopsy Needle | Gyrus ACMI
ViziShot
FLEX | Comment |
| | | | | reference
ViziShot 2
FLEX |
| Typical Needle
Length (mm) | 20 | Unknown | 20 | Identical
to
reference
ViziShot 2
FLEX |
| Max Needle
Length (mm) | 40 | Unknown | 40 | Identical
to
reference
ViziShot 2
FLEX |
| Stylet OD (in) | 0.0204 | Unknown | 0.0204 | Identical
to
reference
ViziShot 2
FLEX |
| Stylet Surface
Finish | Polished | Unknown | Polished | Identical
to
reference
ViziShot 2
FLEX |
| Accessories | Syringe with
stopcock and
Adapter biopsy
valve are
provided with
device | Syringe with
stopcock and
Device adapter/
biopsy valve are
provided with
device | Syringe with
stopcock and
Adapter biopsy
valve are
provided with
device | Identical |
| Packaging | Needle
assembly,
syringe, adapter
placed in tray
with snap
downs and
Tyvek lid. Tray
placed in shelf
box prior to
sterilization. | Needle
assembly,
syringe, adapter
placed in tray
with snap
downs and lid. | Needle
assembly,
syringe, adapter
placed in tray
with snap
downs and
Tyvek lid. Tray
placed in shelf
box prior to
sterilization. | Identical |
| Sterilization | EO | EO | EO | Identical |
| Shelf Life | 3 Year at launch | Unknown | 1 Year at launch | Reference
device
subsequent
to launch
achieved 3
Year Shelf
Life |
Summary of Perfomance Testing
The proposed ViziShot 2 FLEX in its final finished form is identical to the reference ViziShot 2 FLEX (previously marketed device) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
7
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
Biocompatibility testing on all patient contacting surfaces has been performed in Accordance with the FDA Guidance Document "Use of International Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". 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
- United States Pharmacopeia 39, National Formulary 34, 2016 Pyrogen ● Test
- United States Pharmacopeia 39, National Formulary 34, 2016 Bacterial ● Endotoxins Test
ViziShot 2 FLEX is external communicating, blood path, indirect, and limited duration (