(212 days)
No
The device description and performance studies focus on the mechanical and material properties of a working channel tool for bronchoscopy, with no mention of software, algorithms, image processing, or AI/ML terms.
No
The device is described as an instrument to guide other endotherapy accessories or ultrasound probes, rather than performing a therapeutic function itself.
No
The Lung Vision Tool is described as an instrument that acts as a working channel to guide other accessories (endotherapy accessories or ultrasound probes) to a target area within the respiratory system. Its "Intended Use" states it is "to guide the endotherapy accessories or ultrasound probe to the target area," not to make a diagnosis itself. It is a tool for accessing and guiding, not for direct diagnostic output.
No
The device description explicitly details physical components like a working channel, handle, bronchoscope adaptor, and sheath, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Lung Vision Tool is described as an instrument designed as a working channel to guide other devices (endotherapy accessories and ultrasound probes) within the respiratory system. It is a tool used during a procedure within the body, not for analyzing samples outside the body.
- Intended Use: The intended use is to guide other instruments to a target area within the respiratory system, not to perform diagnostic tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic assays, which are hallmarks of IVD devices.
The Lung Vision Tool is a medical device used for procedural guidance within the body, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
LungVision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area, specifically within the respiratory system.
Product codes
EOQ
Device Description
Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system.
LungVision tool is designed to be used by pulmonologists or thoracic surgeons during pulmonary procedures.
The LungVision Tool is designed to be connected to a standard Bronchoscope Instrument Port.
The Lung Vision Bronchoscope Adaptor is used to connect the LungVision Handle to the Bronchoscope instrument port / working channel entrance, and to allow the physician to release the tool from the bronchoscope. The current adaptor is for the Olympus Bronchoscope Model BF-1T160.
More types of Bronchoscope Adaptors for other bronchoscopy brands and models.
Lung Vision Tool Sheath can accommodate endo-therapy accessories and ultrasound probes with an outer diameter up to 1.9 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Respiratrory organs
Indicated Patient Age Range
Not specified but for patients undergoing endoscopic procedures.
Intended User / Care Setting
pulmonologists or thoracic surgeons during pulmonary procedures.
Anywhere a patient may undergo a bronchoscopy procedure, e.g., hospital, sub-acute care or physician office settings.
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)
Nonclinical / Bench studies were performed. The Lung Vision Tool met all requirements specifications.
- Bronchoscope Compatibility Test
- Simulated Use
- Fluoroscopy
- Tensile Test for Sheath and Wire
- Tensile Test for Wire Distal End
- Repeatability Use
- Sheath Insertion/Withdrawal
- Twisting Test
- Drop Test
- Accelerated Aging Verification Test
Biocompatibility testing included:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity (no claim of non-pyrogenic)
The test results supported the materials as non-cytotoxic, non-sensitizers, and non-irritants.
Sterilization and Packaging validation were performed:
- Bioburden
- Bioburden Validation
- Fractional Cycle – BI show no growth
- Fractional Cycle - Sterility Test
- Sterility Validation
- Full Cycle – BI show no growth
- Full Cycle - ETO Residual
- Bacterial Endotoxin test as per LAL method
- Package integrity Test
- Package Stability Test
The results confirm that the single lot Ethylene Oxide sterilization process capability has achieved SAL of at least 10-6.
No animal testing was performed.
No clinical testing was performed.
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.
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.
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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
April 26, 2018
Body Vision Medical Ltd. % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704
Re: K172955
Trade/Device Name: LungVision Tool Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: March 22, 2018 Received: March 23, 2018
Dear Paul Dryden:
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.
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.
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 yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172955
Device Name LungVision Tool
Indications for Use (Describe)
Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area, specifically within the respiratory system.
| 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
| Official Contact: | Dorian Averbuch
Body Vision Medical Ltd.
34 Sokolov St.
Ramat Hasharon Israel
Tel: 646- 863-7848 (US) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 19, 2018 |
| Proprietary or Trade Name: | LungVision Tool |
| Common/Usual Name: | Bronchoscope (flexible or rigid) and accessories |
| Classification Name: | Bronchoscope (flexible or rigid) and accessories
EOQ, Class II, CFR 874.4680 |
| Predicate Device:
Reference Device: | K060243 - Olympus Sheath Guide
K151315 - Boston Scientific Expect™ Pulmonary Endobronchial
Ultrasound Transbronchial Aspiration Needle ("EPEUTAN") |
Device Description:
Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system.
LungVision tool is designed to be used by pulmonologists or thoracic surgeons during pulmonary procedures.
The LungVision Tool is designed to be connected to a standard Bronchoscope Instrument Port.
The Lung Vision Bronchoscope Adaptor is used to connect the LungVision Handle to the Bronchoscope instrument port / working channel entrance, and to allow the physician to release the tool from the bronchoscope. The current adaptor is for the Olympus Bronchoscope Model BF-1T160.
More types of Bronchoscope Adaptors for other bronchoscopy brands and models.
Lung Vision Tool Sheath can accommodate endo-therapy accessories and ultrasound probes with an outer diameter up to 1.9 mm.
Indications for Use:
Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area, specifically within the respiratory system.
Patient Population
Patients undergoing endoscopic procedures.
Contraindications
Contraindications are limited to those of the use of a bronchoscope of the endotherapy instruments that the clinician may desire to use.
4
Environments of use
Anywhere a patient may undergo a bronchoscopy procedure, e.g., hospital, sub-acute care or physician office settings.
Device Comparison
The following tables compare the subject device to the predicate and reference devices.
| Feature | Predicate
K060243
Olympus Guide Sheath | Reference
K151315
Boston EPEUTAN | Subject device
K172955
LungVision Tool |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To be used with
bronchoscopes and endo-
therapy accessories | To be used with
bronchoscopes and endo-
therapy accessories | To be used with
bronchoscopes and endo-
therapy accessories |
| Anatomical location | Respiratory organs | Respiratory organs | Respiratory organs |
| Components | | | |
| Handle | Handle-like | Yes | Yes |
| Connector / Adaptor to
attach to working channel | Stopper | Yes | Yes |
| Sheath | Yes | Yes | Yes |
| Wire / stylet to stiffen or
protect the sheath | No | Yes | Yes |
| Works with endo-therapy
instruments | Yes | Yes | Yes |
| Feature | Predicate
K060243
Olympus Guide Sheath | Reference
K151315
Boston EPEUTAN | Subject Device
K172955
LungVision Tool |
| Indications for Use | This instrument has been designed to be used
with Olympus bronchoscopes, endo-therapy
accessories and ultrasound probe to guide
the endo-therapy accessories or ultrasound
probe to the target area within the respiratory
organs. | The Expect™ Pulmonary Endobronchial
Ultrasound Transbronchial Aspiration Needle
is designed to be used with endobronchial
ultrasound endoscopes for ultrasound guided
fine needle aspiration (FNA) of the
submucosal and extramural lesions of the
tracheobronchial tree. Do not use this
instrument for any purpose other than its
intended use. | LungVision Tool is an instrument designed
as a working channel intended to be used
with standard bronchoscopes, endotherapy
accessories and ultrasound probe to guide
the endotherapy accessories or ultrasound
probe to the target area, specifically within
the respiratory system. |
| Classification | Bronchoscope (flexible or rigid) and
accessories.
21CFR 874.4680
Procut Code: EOQ | Bronchoscope (flexible or rigid) and
accessories.
21CFR 874.4680
Procut Code: EOQ | Bronchoscope (flexible or rigid) and
accessories.
21CFR 874.4680
Procut Code: EOQ |
| Target anatomy | Respiratory Organs | Respiratory Organs | Respiratory Organs |
| Anatomy access | Bronchial airways | Bronchial airways | Bronchial airways |
| Patient Population | Not specified but for patients undergoing
endoscopic procedures | Not specified but for patients undergoing
endoscopic procedures | Patients undergoing endoscopic procedures |
| Environment of use | Not specified but where endoscopic
procedures are performed: hospitals, sub-
acute and physician office settings | Not specified but where endoscopic procedures
are performed: hospitals, sub-acute and
physician office settings | Not specified but where endoscopic
procedures are performed: hospitals, sub-
acute and physician office settings |
| Single Use | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Mechanism of action | Manual attachment | Manual attachment | Manual attachment |
| Number of device
passes during a
procedure | Multiple passes | Multiple passes | Multiple passes |
| Echogenic | No | Yes | No |
| X-ray detection | Yes | No | Yes |
| Components | Handle-like
Stopper (Connector)
Sheath | Handle
Adaptor / Connector
Sheath
Wire / Stylet | Handle
Adaptor / Connector
Sheath
Wire |
| Sheath Max Outer
Diameter | 2.7 mm | N/A | 2.72 mm |
| Sheath Min Inner
Diameter | 2.1 mm | N/A | 2.08 mm |
| Feature | Predicate
K060243
Olympus Guide Sheath | Reference
K151315
Boston EPEUTAN | Subject Device
K172955
LungVision Tool |
| Working Length | 900 mm | N/A | 1000 mm |
| Length extended
beyond the scope | 27.5 mm | N/A | 17 mm |
| Sheath length
adjustable | Yes | Yes | Yes |
| Recommended
Channel Size | 2.8 mm | 2.0 mm (this device is inserted into a sheath | 2.8mm |
| Curved distal tip | No, but endotherapy instruments do | N/A | Yes |
| Performance - Non-clinical | | | |
| Biocompatibility | Surface Contact
Skin and Breached
Limited duration (