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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Recon Steerable Sheath. While it mentions performance data, it primarily focuses on bench testing, packaging, validation, usability, biocompatibility, and sterilization to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria related to diagnostic performance, such as sensitivity, specificity, or accuracy. Therefore, I cannot generate the table and answer the requested questions in the format initially outlined.

The document indicates that "All tests met the predefined acceptance criteria" for bench testing and packaging, and that "The Recon Steerable Sheath met the performance requirements and was found to be clinically acceptable by all evaluators" during validation testing. However, the exact quantitative acceptance criteria and the numerical results for these specific tests are not detailed in this public summary.

If a study involving diagnostic performance (e.g., how well the device guides tools to a target) was conducted with metrics like accuracy or success rates, that information is not present here.

Therefore, I will provide the available information regarding "acceptance criteria" and "study" based on the provided text, but it will not fully match the structure you requested for a device with measurable diagnostic performance metrics.

Available Information from the Document:

The document describes various tests performed to demonstrate the safety and effectiveness of the Recon Steerable Sheath, primarily focusing on its physical and functional integrity, biocompatibility, and sterilization, rather than a diagnostic performance study.

Here's an overview of the "acceptance criteria" and "studies" mentioned, as much as can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance (Based on available information for engineering performance):

Acceptance Criterion Category	Specific Test/Evaluation	Acceptance Criteria (General Description)	Reported Device Performance (General Description)
Bench Testing	Visual	Not specified	Met specifications pre and post aging
	Dimensional	Not specified	Met specifications pre and post aging
	Insertion force	Not specified	Met specifications pre and post aging
	Articulation angle, length, curve profile, curve stability, planarity	Minimum 90° articulation for the device (specific quantitative criteria for other aspects not provided)	Articulation to 90° (specific quantitative results for other aspects not provided)
	Coupling Tensile	Not specified	Met specifications pre and post aging
	Tensile for all bonds/joints	Not specified	Met specifications pre and post aging
	Bronchoscope Adapter Pneumostasis / Adapter Vacuum	Not specified	Met specifications pre and post aging
	Simulated Use / Device robustness	Not specified	Met specifications pre and post aging
	Plunger force	Not specified	Met specifications pre and post aging
	Bending, Buckling	Not specified	Met specifications pre and post aging
	Torque Transmission and Integrity	Not specified	Met specifications pre and post aging
	Lumen Patency	Not specified	Met specifications pre and post aging
Packaging	Environmental, Distribution Simulation, Aging (per ASTM D4169, ISTA 3A, ASTM F1980, ISO 11607-1)	Not specified	Packages met specifications pre and post aging
	Visual (per ASTM F1886)	Not specified	Packages met specifications pre and post aging
	Bubble Leak (per ASTM F2096)	Not specified	Packages met specifications pre and post aging
	Seal Strength (per ASTM F88)	Not specified	Packages met specifications pre and post aging
Validation Testing	Simulated Use Conditions with Instructions for Use	User needs and intended use met, performance requirements met, clinically acceptable	Met performance requirements and was found to be clinically acceptable by all evaluators
Usability	Formative and Summative Validation Studies	No new use errors identified	No new use errors were identified
Biocompatibility	Cytotoxicity, Sensitization, Irritation, Toxicity (Acute Systemic, Rabbit Pyrogen), Bacterial Endotoxin	Endpoints met (e.g., non-cytotoxic, non-sensitizing, non-irritating)	All endpoints were met
Sterilization	EO Sterilization and Packaging Validation	Endpoints met (e.g., sterility assurance level)	All endpoints were met

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated for any of the individual tests. The document refers to "evaluators" for validation and "intended user groups" for usability studies, but no numbers are provided.
Data Provenance: The studies were conducted by Serpex Medical, Inc. (the device manufacturer) in accordance with various FDA guidances and international standards. This is prospective testing performed for regulatory submission. Country of origin for data is not specified beyond being generated by the submitting company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable in the context of the studies described. The "ground truth" here relates to engineering specifications, safety standards, and user-reported clinical acceptability, rather than expert-established diagnostic ground truth on a dataset. For "Validation testing", it states the device "was found to be clinically acceptable by all evaluators," but the number and qualifications of these evaluators are not specified. For "Usability," "intended user groups" were involved, but details are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The tests described are primarily objective engineering and biological tests, or user evaluations, not diagnostic performance assessments requiring adjudication of interpretations.

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:

Not applicable. This document does not describe an MRMC study or any AI component. The device is a physical medical instrument (steerable sheath), not a diagnostic algorithm.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the various tests described refers to:

Predefined engineering specifications and performance benchmarks (for bench testing).
Compliance with international standards (for packaging, biocompatibility, sterilization).
User satisfaction and ability to perform intended tasks without (new) errors (for validation and usability).

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. This is a physical device, not an AI algorithm.

Summary

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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

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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

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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)

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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

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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 DeviceRecon Steerable Sheath	Body VisionLung Vision ToolK172955Predicate	Difference and Impacton SubstantialEquivalence
Intended Use	To guide endoscopic toolsto target tissue	Identical	Identical to predicate
Attribute	Proposed DeviceRecon Steerable Sheath	Body VisionLung Vision ToolK172955Predicate	Difference and Impacton SubstantialEquivalence
Indications foruse	The Recon SteerableSheath is an extendedworking channel intendedto be used with acompatible bronchoscopeto guide endotherapyaccessories to the targetarea within the respiratorysystem.	LungVision Tool is aninstrument designed asa working channelintended to be usedwith standardbronchoscopes,endotherapyaccessories andultrasound probe toguide the endotherapyaccessories orultrasound probe tothe target area,specifically within therespiratory system.	Similar to predicate;minor wordingdifferences including theuse of an ultrasoundprobe for guiding for thepredicate
Users	Clinicians trained inbronchoscopy devices,accessories, andprocedures	Identical	Identical to predicate
Anatomic Site	Lung	Identical	Identical to predicate
Method ofIntroduction	Delivered through aflexible bronchoscope	Identical	Identical to predicate
RecommendedChannel Size	2.8 mm	Identical	Identical to predicate
Components	Handle,Shaft,Stylet,Adapters	Handle,Sheath,Stylet,Adapters	Identical to predicate
CompatibleBronchoscopeSize	2.8 mm	Identical	Identical to predicate
Articulation /Curve	Manual articulation(depress plunger) toarticulate the distal tip aminimum of 90°	Preformed curveshapes of 90° and 210°	SimilarSubject devicearticulates to 90°, thesame articulation as oneof the preformed curves.
Extension	Yes140mm	YesNot listed	Identical to predicate
Extensionbeyond scopewith deviceretracted	≤ 10 mm	17 mm	Similar
Attribute	Proposed DeviceRecon Steerable Sheath	Body VisionLung Vision ToolK172955Predicate	Difference and Impacton SubstantialEquivalence
OuterDiameter	$ \u2264 $ 2.73mm	$ \u2264 $ 2.72mm	SimilarBoth are intended to fitwithin a 2.8 mmbronchoscope
InnerDiameter	$ \u2265 $ 1.93mm	$ \u2265 $ 2.08mm	Similar – accommodatesendotherapy tools up to1.90mm
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

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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

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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 (<24 hour) tissue contacting device and .
FDA Guidance: "Use of International Standard ISO-10993, "Biological Evaluation of . Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," June 2016

The following testing was performed:

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Cytotoxicity: MEM Extraction Cytotoxicity Assay per ISO 10993-5:2009/ (R) 2014 ●
Sensitization: Guinea Pig Maximization Test per ISO 10993-10:2010 / (R) 2014 .
Irritation: Intracutaneous Reactivity Test, per ISO10993- 23:2021 .
. Toxicity: Acute Systemic Toxicity per ISO 10993-11:2017
Toxicity: Materials Medicated Rabbit Pyrogen Test ISO 10993-11:2017 ●
Pyrogen testing per USP 39 <151> .
. Bacterial Endotoxin Testing per USP 39 <85>

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.

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.