(102 days)
Not Found
No
The description focuses on the mechanical and physical aspects of a steerable sheath for bronchoscopy, with no mention of AI or ML capabilities.
No.
The device is described as a guide for endotherapy accessories, not as providing therapy itself. Its function is to facilitate access for other tools.
No
Explanation: The device description and intended use clearly state that the Recon Steerable Sheath is an extended working channel designed to guide endotherapy accessories to a target area. It acts as an access tool for other procedures (endotherapy) and does not perform any diagnostic function itself.
No
The device description clearly outlines a physical, sterile, single-use transbronchial sheath with a steerable distal tip, handle, stylet, and adapters. It is a hardware device used to guide endotherapy accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "extended working channel intended to be used with a compatible bronchoscope to guide endotherapy accessories to the target area within the respiratory system." This describes a device used within the body for guiding tools, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a physical device with a steerable tip, designed to be inserted into the respiratory system and used with a bronchoscope. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other components typically associated with in vitro diagnostics.
Therefore, the Recon Steerable Sheath is a medical device used for interventional procedures within the respiratory system, not an IVD.
N/A
Intended Use / Indications for Use
The Recon Steerable Sheath is an extended working channel intended to be used with a compatible bronchoscope to guide endotherapy accessories to the target area within the respiratory system.
Product codes
EOQ
Device Description
The Recon Steerable Sheath is a sterile, single use transbronchial sheath with a unidirectional, steerable distal tip that provides access to the intrapulmonary regions. It is designed to guide endotherapy tools with an outer diameter of up to 1.9 mm and minimum length of 1100 mm to the target tissue.
The Recon Steerable Sheath (Model RSS1000) includes the Steerable Sheath, Stylet, Bronchoscope Adapter and Pentax Adapter.
The Recon Steerable Sheath is compatible with Olympus® 190 or Pentax® bronchoscopes that have a 2.8mm working channel and 600 mm working length. It is coupled to the selected bronchoscope using an adapter(s).
The handle provides the user with control of device rotation, extension, retraction, and distal tip articulation of 90° minimum within a plane with the stylet inserted. A Luer connector on the proximal end of the device provides the connection for the stylet.
The Recon Steerable Sheath with stylet is inserted and coupled to a bronchoscope via a clip on the handle. The telescope advances the device beyond the bronchoscope into the lung. Depressing the plunger articulates the distal end of the sheath by tensioning an internal pull wire. Once in the desired location, the Stylet is removed from the Steerable Sheath and the tool of choice can be inserted for access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
respiratory system, Lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians trained in bronchoscopy devices, accessories, and procedures
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)
Bench Testing:
All testing was performed pre and post aging.
- Visual ●
- Dimensional ●
- Insertion force ●
- Articulation angle, length, curve profile, curve stability, and planarity ●
- Coupling Tensile ●
- Tensile for all bonds/joints ●
- Bronchoscope Adapter Pneumostasis / Adapter Vacuum,
- Simulated Use / Device robustness
- Plunger force
- Bending, Buckling
- Torque Transmission and Integrity ●
- Lumen Patency ●
All tests met the predefined acceptance criteria. The test results demonstrated that differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness.
Packaging Testing:
Packaging was subjected to Environmental, Distribution Simulation and Aging with testing performed pre and post aging
- Distribution per ASTM D4169:2016 ●
- Environmental Conditioning per ISTA 3A:2011 ●
- Aging per ASTM F1980:2016,
- . Packaging per ISO 11607-1:2006
- Visual per ASTM F1886-16/F1886M-16 o
- Bubble Leak per ASTM F2096-11:2019 o
- Seal Strength per ASTM F88/F88M-15 o
Packages met the specifications pre and post aging.
Validation testing:
Validation testing was performed demonstrating the Recon Steerable Sheath user needs and intended use were met. Testing under simulated use conditions was performed in accordance with the Instructions for Use. The Recon Steerable Sheath met the performance requirements and was found to be clinically acceptable by all evaluators.
Usability:
Formative and summative validation studies were conducted to identify and minimize use errors related to the use of the Recon Steerable Sheath. Studies were conducted by intended user groups in a simulated bronchoscopy suite and involved preoperative preparation and simulated procedures. The Instructions for Use and Reference Guide were assessed in the usability study. No new use errors were identified. The Recon Steerable Sheath has been assessed and found to be safe and effective for its intended use, by the intended users, in its intended use environment.
Biocompatibility:
Testing demonstrated that all endpoints were met.
Sterilization:
Testing demonstrated that all endpoints were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 15, 2022
Serpex Medical, Inc. % Laurie Lewandowski Vice President Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, Minnesota 55123
Re: K221302
Trade/Device Name: Recon Steerable Sheath Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: July 14, 2022 Received: July 15, 2022
Dear Laurie Lewandowski:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221302
Device Name Recon Steerable Sheath
Indications for Use (Describe)
The Recon Steerable Sheath is an extended working channel intended to be used with a compatible bronchoscope to guide endotherapy accessories to the target area within the respiratory system.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
1. SUBMITTER INFORMATION
Submitter: Serpex Medical, Inc. Sasha Schrode 3350 Scott Blvd, Suite 37B Santa Clara, CA 95054 sschrode(@serpexmedical.com Email:
Primary Contact: Laurie Lewandowski Consultant, Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan, MN 55123 Telephone: 612-770-4038 (cell) llewandowski(@serpexmedical.com Email:
DATE PREPARED:
May 4, 2022
2. DEVICE INFORMATION
Recon Steerable Sheath
Proprietary Name: Classification Name: Common/Usual Name: Regulatory Class: Product Code: Regulation Number:
Bronchoscope (flexible or rigid) and accessories Guide Catheter Class II EOQ 21 CFR 874.4680
3. PREDICATE DEVICE INFORMATION
Proprietary Name: Common/Usual Name: Classification Name: Regulatory Class: Product Code: Regulation Number: 510K Number:
Lung Vision Tool Guide Catheter Bronchoscope (flexible or rigid) and accessories Class II EOQ 21 CFR 874.4680 K172955
4. DEVICE DESCRIPTION
The Recon Steerable Sheath is a sterile, single use transbronchial sheath with a unidirectional, steerable distal tip that provides access to the intrapulmonary regions. It is
4
designed to guide endotherapy tools with an outer diameter of up to 1.9 mm and minimum length of 1100 mm to the target tissue.
The Recon Steerable Sheath (Model RSS1000) includes the Steerable Sheath, Stylet, Bronchoscope Adapter and Pentax Adapter.
The Recon Steerable Sheath is compatible with Olympus® 190 or Pentax® bronchoscopes that have a 2.8mm working channel and 600 mm working length. It is coupled to the selected bronchoscope using an adapter(s).
The handle provides the user with control of device rotation, extension, retraction, and distal tip articulation of 90° minimum within a plane with the stylet inserted. A Luer connector on the proximal end of the device provides the connection for the stylet.
The Recon Steerable Sheath with stylet is inserted and coupled to a bronchoscope via a clip on the handle. The telescope advances the device beyond the bronchoscope into the lung. Depressing the plunger articulates the distal end of the sheath by tensioning an internal pull wire. Once in the desired location, the Stylet is removed from the Steerable Sheath and the tool of choice can be inserted for access.
5. INTENDED USE/INDICATION FOR USE
The Recon Steerable Sheath is an extended working channel intended to be used with a compatible bronchoscope to guide endotherapy accessories to the target area within the respiratory system.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Recon Steerable Sheaths have the same technological characteristics as the predicate, Lung Vision Tool, cleared under K172955. The subject and predicate device both provide a path for endotherapy tools to reach target tissue.
A comparison of the Recon Steerable Sheath and the Lung Vision Tool is in the following table.
| Attribute | Proposed Device
Recon Steerable Sheath | Body Vision
Lung Vision Tool
K172955
Predicate | Difference and Impact
on Substantial
Equivalence |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To guide endoscopic tools
to target tissue | Identical | Identical to predicate |
| Attribute | Proposed Device
Recon Steerable Sheath | Body Vision
Lung Vision Tool
K172955
Predicate | Difference and Impact
on Substantial
Equivalence |
| Indications for
use | The Recon Steerable
Sheath is an extended
working channel intended
to be used with a
compatible bronchoscope
to guide endotherapy
accessories to the target
area within the respiratory
system. | 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. | Similar to predicate;
minor wording
differences including the
use of an ultrasound
probe for guiding for the
predicate |
| Users | Clinicians trained in
bronchoscopy devices,
accessories, and
procedures | Identical | Identical to predicate |
| Anatomic Site | Lung | Identical | Identical to predicate |
| Method of
Introduction | Delivered through a
flexible bronchoscope | Identical | Identical to predicate |
| Recommended
Channel Size | 2.8 mm | Identical | Identical to predicate |
| Components | Handle,
Shaft,
Stylet,
Adapters | Handle,
Sheath,
Stylet,
Adapters | Identical to predicate |
| Compatible
Bronchoscope
Size | 2.8 mm | Identical | Identical to predicate |
| Articulation /
Curve | Manual articulation
(depress plunger) to
articulate the distal tip a
minimum of 90° | Preformed curve
shapes of 90° and 210° | Similar
Subject device
articulates to 90°, the
same articulation as one
of the preformed curves. |
| Extension | Yes
140mm | Yes
Not listed | Identical to predicate |
| Extension
beyond scope
with device
retracted | ≤ 10 mm | 17 mm | Similar |
| Attribute | Proposed Device
Recon Steerable Sheath | Body Vision
Lung Vision Tool
K172955
Predicate | Difference and Impact
on Substantial
Equivalence |
| Outer
Diameter | $ \u2264 $ 2.73mm | $ \u2264 $ 2.72mm | Similar
Both are intended to fit
within a 2.8 mm
bronchoscope |
| Inner
Diameter | $ \u2265 $ 1.93mm | $ \u2265 $ 2.08mm | Similar – accommodates
endotherapy tools up to
1.90mm |
| Total Length | 1095 mm ± 5 mm | 1000mm | Similar |
| Stylet OD | 1.83 mm ± 0.05 mm | Not listed | Sized to fit sheath |
| Radiopaque | Yes | Yes | Identical to predicate |
| Life/Sterility | Single Use, EO sterilized | Identical | Identical to predicate |
| Biocompatible | Yes | Yes | Identical to predicate |
5
6
The Recon Steerable Sheath has the same intended use, similar indications for use with the ability to articulate distal tip 90° minimum unidirectionally to reach target tissue. The angle of articulation is identical to one of the preformed curve shapes of the predicate device. The clinician manually articulates the subject device and manually manipulates the predicate device to reach target tissue.
The different technological characteristics of the new device do not raise different questions of safety and effectiveness.
7. PERFORMANCE DATA
Bench Testing
All testing was performed pre and post aging.
- Visual ●
- Dimensional ●
- Insertion force ●
- Articulation angle, length, curve profile, curve stability, and planarity ●
- Coupling Tensile ●
- Tensile for all bonds/joints ●
- Bronchoscope Adapter Pneumostasis / Adapter Vacuum,
- Simulated Use / Device robustness
- Plunger force
- Bending, Buckling
- Torque Transmission and Integrity ●
- Lumen Patency ●
Packaging
Packaging was subjected to Environmental, Distribution Simulation and Aging with testing performed pre and post aging
Serpex Medical, Inc. Recon Steerable Sheath
7
Distribution, Environmental and Aging of Packages
- Distribution per ASTM D4169:2016 ●
- Environmental Conditioning per ISTA 3A:2011 ●
- Aging per ASTM F1980:2016,
- . Packaging per ISO 11607-1:2006
- Visual per ASTM F1886-16/F1886M-16 o
- Bubble Leak per ASTM F2096-11:2019 o
- Seal Strength per ASTM F88/F88M-15 o
Packages met the specifications pre and post aging.
All tests met the predefined acceptance criteria. The test results demonstrated that differences in device characteristics between the subject device and predicate device do not raise any new questions of safety or effectiveness.
Validation testing
Validation testing was performed demonstrating the Recon Steerable Sheath user needs and intended use were met. Testing under simulated use conditions was performed in accordance with the Instructions for Use. The Recon Steerable Sheath met the performance requirements and was found to be clinically acceptable by all evaluators.
Usability
A human factors (HF) engineering process was followed in accordance with the following:
- ANSI/AAMI/IEC 62366-1:2015, Medical devices Application of usability . engineering to medical devices
- . FDA Guidance: "Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff." 2016
Formative and summative validation studies were conducted to identify and minimize use errors related to the use of the Recon Steerable Sheath. Studies were conducted by intended user groups in a simulated bronchoscopy suite and involved preoperative preparation and simulated procedures. The Instructions for Use and Reference Guide were assessed in the usability study. No new use errors were identified. The Recon Steerable Sheath has been assessed and found to be safe and effective for its intended use, by the intended users, in its intended use environment.
Biocompatibility
Biocompatibility testing was performed in accordance with:
- ISO 10993-1:2018 for a limited ( .
- . Bacterial Endotoxin Testing per USP 39
Sterilization:
Sterilization (ethylene oxide) and packaging of the Recon Steerable Sheaths were validated using the following standards:
- ANSI/AAMI/ISO 11607-1:2019 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
- FDA Guidance: Submission and Review of Sterility Information in Pre-Market ● Notification 510(k) Submissions for Device Labeled as Sterile (January 21, 2016)
- AAMI ST72:2011/(R)2016 Bacterial Endotoxins Test Methods, Routine ● Monitoring,
- ISO 10993-7:2008 Amendment 1:2019 Biological evaluation of medical devices -● Part 7: Ethylene oxide sterilization residuals
Testing demonstrated that all endpoints were met.
8. CONCLUSION
The Recon Steerable Sheath is substantially equivalent in terms of the indications for use, technological characteristics, performance testing and comparison to the cited predicate, and does not present any new questions of safety and effectiveness.