The Pulmo Via Working Channel is intended to be used as an access channel through which a bronchoscope and other endoscopic tools may be introduced to treat targeted tissue of the airways. The Pulmo Via Working Chamel can also provide means for bronchoalveolar lavage. The PulmoVia Working Channel is indicated for adult patients.

Device Description

The PulmoVia Working Channel is a single-use disposable, terminally-sterilized device for transtracheal access to bronchi of the lungs, and consists of a hollow tube with an angled flexible tip to assist in anatomical navigation. A radiopaque marker is located 4 mm from the distal tip to aid in localization under fluoroscopy/CT. Printed markings are positioned at 370 mm from the distal tip, and every 50 mm proximally from that point. The distal tip of the device has a pliable leading edge. The device also contains a disposable Tuohy-Borst adaptor to allow use of third-party devices such as ultrathin bronchoscopes. The full assembly will be packaged in a polyethylene and Tyvek pouch, sterilized via ethylene oxide (EO).

AI/ML Overview

The provided text is a 510(k) Summary for the Sanovas, Inc. PulmoVia Working Channel. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or effectiveness through clinical trials in the same way a PMA would require. Therefore, the information provided reflects this context.

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 explicitly list "acceptance criteria" in the traditional sense of performance metrics for a diagnostic or therapeutic device (e.g., sensitivity, specificity, accuracy for an AI device). Instead, it establishes substantial equivalence through a comparison of technological characteristics and non-clinical performance testing against predicate devices. The "acceptance criteria" here are implicitly meeting the performance and safety as demonstrated by the predicate devices and general medical device standards.

Acceptance Criteria (Implicitly Derived)	Reported Device Performance (PulmoVia Working Channel)	Comparative Performance with Predicate Devices
Biocompatibility	Meets ISO 10993-1:2009 for nature and duration of contact.	Similar polymeric materials to predicate devices.
- Cytotoxicity	Passes ISO 10993-5:2009	-
- Irritation/Intracutaneous	Passes ISO 10993-10:2010	-
- Sensitization	Passes ISO 10993-10:2010	-
- Acute Systemic Toxicity	Passes ISO 10993-11:2006	-
- Pyrogenicity	Passes ISO 10993-11:2006	-
Mechanical Performance	Met all mechanical design and safety requirements.	Side-by-side testing confirms equivalent physical and mechanical characteristics to identified predicates.
- Pull test	Passed	Equivalent to predicates
- Torque test	Passed	Equivalent to predicates
- Kink test	Passed	Equivalent to predicates
- Bend test	Passed	Equivalent to predicates
- Leak test	Passed	Equivalent to predicates
- Vacuum test	Passed	Equivalent to predicates
- Operating temp/humidity	Passed	Equivalent to predicates
- Radiopaque	Confirmed	Similar to LungPoint and Olympus Guide Sheath
- Gravity fed hydrostatic flow	Passed	Equivalent to predicates
Sterility	Confirmed sterile (Ethylene Oxide).	Similar to predicate devices (E-beam, unspecified sterile methods).
Shelf-Life & Packaging Integrity	Validated shelf life; packaging adequate to maintain sterility and withstand transportation.	-
Usability/Human Factors	Users can operate the device safely and effectively.	-
Intended Use	Access channel for bronchoscope and other endoscopic tools to treat targeted airway tissue; bronchoalveolar lavage; adult patients.	Substantially similar to LungPoint Sheath (working channel for endoscopic tools to targeted tissue) and BAL Cath (bronchoalveolar lavage) and Olympus Guide Sheath (for use with bronchoscopes/accessories to targeted area).
Design Characteristics	Single use; 485mm working length; 5.25mm ID; 6.0mm max OD; compatible with max 4.0mm OD bronchoscope; angled, flexible distal tip; radiopaque marker; TUohy-Borst adaptor; no stylet.	Compared item-by-item against predicate and reference devices, demonstrating similar principles of operation and design.

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

The document does not describe a clinical "test set" in the context of an AI device. The evaluations were non-clinical (bench testing, biocompatibility).

Non-clinical testing (mechanical tests): The document does not specify a quantitative sample size (N-number of devices tested) for the mechanical tests. It only states "side by side testing" was performed.
Biocompatibility testing: Standardized ISO documents are cited, implying compliance with typical sample size requirements for such tests, but no specific numbers are given.
Usability assessments: Conducted in a "simulated use environment," but no sample size for users or cases is provided.
Data Provenance: All testing appears to be internal (laboratory/bench testing) for the device manufacturer or contracted labs working for the manufacturer. There is no mention of country of origin for data or whether it was retrospective or prospective in the clinical sense, as no clinical data was used.

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 no clinical test set requiring expert ground truth was performed for this 510(k) submission. The evaluation was non-clinical.

4. Adjudication Method for the Test Set

This section is Not Applicable as no clinical test set requiring expert adjudication was performed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This section is Not Applicable. The device is a physical medical instrument (a working channel for bronchoscopes), not an AI-powered diagnostic or therapeutic tool for which an MRMC study would be relevant. No AI component is described.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This section is Not Applicable. The device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" was established by:

Industry Standards: Compliance with ISO 10993 series for biocompatibility.
Engineering Specifications: The device's design requirements and specifications for mechanical properties (e.g., pull strength, kink resistance, leak proofing).
Predicate Device Characteristics: Comparison of physical and technological characteristics against established predicate devices.
User Feedback: (Implicitly) "Usability assessments were conducted in a simulated use environment to optimize the safety of the device design and validate the usability of the device."

8. The Sample Size for the Training Set

This section is Not Applicable as the device is not an AI algorithm requiring a training set.

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

This section is Not Applicable as the device is not an AI algorithm requiring a training set.

Summary

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

June 11, 2015

Sanovas, Inc. c/o Cynthia Nolte, Ph.D., RAC Senior Director of Regulatory Affairs ICON Clinical Research LLC 62 Forest Street, Suite 300 Marlborough, MA 01752

Re: K150280

Trade/Device Name: PulmoVia Working Channel Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) Regulatory Class: Class II Product Code: EOO Dated: April 22, 2015 Received: April 22, 2015

Dear Dr. Nolte:

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 devicerelated 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/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 yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150280

Device Name

PulmoVia Working Channel

Indications for Use (Describe)

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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FORM FDA 3881 (8/14)

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ട്. 510(K) SUMMARY

Sanovas, Inc. PulmoVia Working Channel

(per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

1. SUBMITTER/510(K) HOLDER

Sanovas, Inc.
2597 Kerner Blvd
San Rafael, CA 94901
Phone: 415-729-9391
Contact: Roy Morgan, VP of Research and Development
Contact's Phone: 415-729-9391
Contact's Email: regulatory@sanovas.com
Date Prepared: June 10, 2015

2. DEVICE NAME

Trade Name:	PulmoVia Working Channel
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Classification Panel:	Ear, Nose, and Throat Devices Panel
Classification Regulation:	21 CFR 874.4680
Device Classification:	Class II
Product Code:	EOQ

3. PREDICATE DEVICES

LungPoint™ Tools (LungPoint Sheath and LungPoint Dilation Balloon), K131234 ●
KimVent BAL Cath Bronchial Aspirate Sampling Catheter, K112562 ●
Olympus Guide Sheath, K060243 ●

DEVICE DESCRIPTION 4.

The device also contains a disposable Tuohy-Borst adaptor to allow use of third-party devices such as ultrathin bronchoscopes. The full assembly will be packaged in a polyethylene and Tyvek pouch, sterilized via ethylene oxide (EO).

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5. INDICATION FOR USE/INTENDED USE

The PulmoVia Working Channel is intended to be used as an access channel through which a bronchoscope and other endoscopic tools may be introduced to treat targeted tissue of the airways. The PulmoVia Working Channel can also provide means for bronchoalyeolar lavage. The PulmoVia Working Channel is indicated for adult patients.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6. DEVICES

Both the proposed PulmoVia Working Channel and the predicate Lung Point Sheath are catheters designed for use with a bronchoscope to reach a targeted area of the bronchial tree. The working length of the PulmoVia Working Channel (485 mm) is less than that of the predicate Lung Point Sheath and reference devices. The inner diameter of the catheter (5.25 mm) is greater than that of the Lung Point and Olympus Guide Sheath. The inner diameter was established in order to be compatible with bronchoscopes with an OD of 4.0 mm.

The predicate Lung Point Sheath is supplied with a stylet. Neither the proposed PulmoVia Working Channel nor the reference device Olympus Guide Sheath are supplied with a stylet.

The proposed PulmoVia Working Channel has an angled, flexible tip to aid in navigation of the PulmoVia Working Channel within the lung. The BAL Cath tip is also designed with a flexible tip.

The materials used for the proposed device are provided in the side-by-side comparison table. Like the predicate devices, the PulmoVia Working Channel sheath and connector are composed of polymers. As will be discussed in Section 7, the PulmoVia Working Channel meets the biocompatibility requirements of ISO 10993-1:2009 for the nature and duration of contact.

SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL 7. EQUIVALENCE

Non-clinical performance testing consisted of sterility, shelf-life, packaging validation, transport, biocompatibility and mechanical bench testing which demonstrated that the device met all mechanical design and safety requirements.

The biocompatibility testing included:

. Cytotoxicity (ISO 10993-5:2009, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)

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Irritation/ Intracutaneous (ISO 10993-10:2010, Biological Evaluation Of Medical ● Devices - Part 10: Tests For Irritation And Skin Sensitization)
Sensitization (ISO 10993-10:2010, Biological Evaluation Of Medical Devices Part . 10: Tests For Irritation And Skin Sensitization)
Acute systemic toxicity (ISO 10993-11:2006, Biological Evaluation Of Medical . Devices - Part 11: Tests For Systemic Toxicity)
. Pyrogenicity (ISO 10993-11:2006 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity)

The mechanical testing included: (Side by side testing indicated by an asterisk *)

. Pull test*
Torque test*
Kink test* ●
. Bend test*
. Leak test*
Vacuum test*
Operating temperature/humidity test* ●
Radiopaque test ●
Gravity fed hydrostatic flow test* ●

SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE 8.

No clinical studies were performed using the PulmoVia Working Channel. Usability assessments were conducted in a simulated use environment to optimize the safety of the device design and validate the usability of the device. The results demonstrated that users can operate the PulmoVia Working Channel safely and effectively.

SUMMARY OF OTHER INFORMATION 9.

No other information is available.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Non-clinical testing confirms that the PulmoVia Working Channel is sterile, has a packaging system adequate to maintain sterility and transportation hazards, and a validated shelf life. The PulmoVia Working Channel is biocompatible and side by side testing confirms that the proposed device has equivalent physical and mechanical characteristics to the identified predicates. Human factors testing confirms that users can operate the PulmoVia Working Channel safely and effectively.

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The similarities in intended use, operational characteristics, functional technological characteristics and conclusions drawn from nonclinical testing between the proposed PulmoVia Working Channel and the predicate LungPoint Sheath and KimVent BAL Cath lead to a conclusion of substantial equivalence between the proposed and predicate devices. A side-by-side comparison of the predicate devices and the proposed device is provided in the table at the end of this section.

	PulmoVia™	LungPoint™ Tools	Olympus GuideSheath	BAL Cath*
Feature	Working Channel(Proposed)	K131234(Predicate)	K060243(Reference)	K112562(Reference)
Indication for Use	The PulmoViaWorking Channel isintended to be usedas an access channelthrough which abronchoscope andother endoscopictools may beintroduced to treattargeted tissue ofthe airways. ThePulmoVia WorkingChannel can alsoprovide means forbronchoalveolarlavage. ThePulmoVia WorkingChannel is indicatedfor adult patients.	The LungPointSheath is intendedto be used as aworking channelthrough whichendoscopic toolsmay be introducedto targeted tissue.Not for pediatricuse.	The instrument hasbeen designed to beused with Olympusbronchoscopes,endo-therapyaccessories orultrasound probe tothe targeted areawithin therespiratory organs.	The BAL Cath isused in thediagnosis of diffuselung disease byallowing collectionof bronchoalveolarlavage (BAL)specimens fromdeep within thelung. The use of abronchoscope is notnecessary. Thiscatheter is used inadult intubatedpatients.
Single Use	Single use	Single use	Single use	Single use
Sterile	Yes (Ethyleneoxide)	Yes (E-beam)	Yes	Yes
Catheter WorkingLength	485 mm	900 mm	1050 mm	Not known
Catheter InternalDiameter (ID)	5.25 mm	2.0 mm	2.1 mm	4 mm
Maximum CatheterOuter Diameter(OD)	6.0 mm	2.65 mm	2.7 mm	5.2 mm
BronchoscopeCompatibility	Max OD: 4.0 mmMin WorkingLength: 600 mm	Not known	Not known	Not used with abronchoscope
Catheter Length	495 mm	975 mm	900 mm	Not known
Tuohy-BorstAdaptor	Yes	No	Not known	Not known
Stylet	No	Yes	No	No
Distal Tip	Angled, flexible	Not known	Not pliable	Flexible, directional
Radiopaque	Yes	Yes	Yes	Yes
FeatureMarkers	PulmoViaTMWorking Channel(Proposed)	LungPointTM ToolsK131234(Predicate)	Olympus GuideSheathK060243(Reference)	BAL Cath*K112562(Reference)
Materials	Extrusion:Tecothane andPebaxMarker Band:Platinum-IridiumHub: PolycarbonateTuohy BorstConnector:Polycarbonate withsilicone gasket	Extrusion: Notknown^Marker band: Notknown^	Extrusion:Polymer^Marker band:Radio-opaque metalAccessory Port:Polymer^Tri-ChannelConnector:Polymer^	Extrusion:Polymer^Marker band: Notknown^Collar: Polymer^

Side-by-Side Comparison of the PulmoVia™ Working Channel with the LungPoint™ Tools and Reference Devices

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*BAL Cath: Kimberly-Clark KimVent BAL Cath Bronchial Aspirate Sampling Catheter ^Material composition is not known

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.