The SPIWay®Endonasal Access Guide is a temporary working channel sheath for use in endoscopic sphenoid sinus and transsphenoidal surgery. The device consists of a single piece of thermoplastic polymer with a low friction coating, which creates a working channel sheath in the natural orifice of the nose to facilitate visualization of the surgical site and smooth manipulation of introduced instruments during transnasal endoscopic surgery.

The shape of the SPIWay Endonasal Access Guide contains a flared portion at the proximal end of the device which remains outside the nasal passage and a conical body that sits within the nasal cavity. The flared proximal end and conical body act to anchor the device, preventing migration once inserted and allow simple removal. The device has an elliptical shape, and the major axis of the ellipse is oriented vertically with the nostril.

The device is supplied in several lengths that are selected based upon the surgeon's needs. It is provided sterile and for single use in a pack of two, one for each nostril. A pair of devices is sealed in a Tyvek pouch and 5 pouches are placed into a labeled carton.

AI/ML Overview

The provided document is a 510(k) summary for the SPIWay Endonasal Access Guide, which is a Class I medical device. For devices in this class, the regulatory requirements for demonstrating safety and effectiveness are generally less stringent than for higher-risk devices and often rely on substantial equivalence to a predicate device rather than extensive clinical studies.

The document does not contain the detailed information required to fill out all aspects of your request regarding acceptance criteria and performance studies, specifically for an AI/ML-based device or a device involving human readers/ground truth experts. This is because the SPIWay device is a physical, non-AI surgical accessory, and its evaluation focuses on materials, functionality, and biocompatibility, not diagnostic performance or human-AI interaction.

However, I can extract what is available and explain why other sections cannot be completed based on this document.

Acceptance Criteria and Device Performance (Based on available information for a physical medical device)

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SPIWay Endonasal Access Guide, K153686) after modifications were made (coating, material, and size range). The "acceptance criteria" for such a device are typically met through various bench testing and design validation activities to ensure physical and functional requirements are met, rather than a statistical performance study against clinical metrics.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria (Inferred from testing types)	Reported Device Performance (from "Performance Data" section)
Physical and Functional Requirements	"[Design verification] bench testing was performed for the SPIWay Endonasal Access Guide to demonstrate that physical and functional requirements were met."
Effectiveness for Intended Use	"[Design validation] cadaver testing was performed for the SPIWay Endonasal Access Guide to demonstrate effectiveness for its intended use."
Material Biocompatibility	"The SPIWay Endonasal Access Guide complies with the biocompatibility requirements for its intended use." (Specific tests listed: Cytotoxicity, Intracutaneous Irritation, Acute Systemic Toxicity, Sensitization, all in accordance with ISO 10993 standards)
Meeting Design Specifications	"Performance testing showed the device meets design specifications and performed as intended."

Information NOT Available in the Document (and why it's not applicable/expected for this device type):

The following points pertain to AI/ML or diagnostic performance studies, which are not relevant to this physical surgical guide. Therefore, the document does not contain this information.

2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/ML diagnostic. Testing involved bench and cadaver studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device, not an AI/ML diagnostic or image reader.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a diagnostic test with subjective interpretation.

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 device does not involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This device does not have an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Performance was likely assessed against engineering specifications and functional success in cadaver models.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary regarding the study proving device meets acceptance criteria:

For the SPIWay Endonasal Access Guide, acceptance was proven through:

Design verification bench testing: To ensure physical and functional requirements were met.
Design validation cadaver testing: To demonstrate effectiveness for its intended use.
Biocompatibility testing (per ISO 10993): To ensure material safety.

The primary "study" proving acceptance was the successful completion of these non-clinical tests, affirming that the modified device performed equivalently to its predicate and met safety standards for a Class I intranasal splint.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 16, 2018

SPIWay, LLC Mary Lou Mooney Regulatory Consultant 3600 Corte Castillo Carlsbad, CA 92009

Re: K180141

Trade/Device Name: SPIWay Endonasal Access Guide Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: January 17, 2018 Received: January 18, 2018

Dear Mary Lou Mooney:

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. Iisting 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

Srinivas Nandkumar -S

for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180141

Device Name SPIWay Endonasal Access Guide

Indications for Use (Describe)

The SPIWay® Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.

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 OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92

SUBMITTER INFORMATION 1.

a. Company Name:	SPIWay, LLC
b. Company Address:	SPIWay, LLC3600 Corte CastilloCarlsbad, CA 92009
c. Telephone:	(844)-565-1226
Fax:	614-737-4760
d. Contact Person:	Mary Lou MooneyRegulatory Consultant
e. Date Summary Prepared:	January 17, 2018

DEVICE IDENTIFICATION

a. Trade/Proprietary Name:	SPIWay Endonasal Access Guide
b. Common Name:	Nasal splint
c. Classification Name:	Intranasal splint, 874.4780

3. IDENTIFICATION OF PREDICATE DEVICES

SPIWay Endonasal Access Guide (K153686).

4. DESCRIPTION OF THE DEVICE

Product code LYA

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natural orifice of the nose to facilitate visualization of the surgical site and smooth manipulation of introduced instruments during transnasal endoscopic surgery.

The modifications made to the subject device are summarized below:

Replaced the hydrophilic coating with a silicone coating.
Changed the material from a thermoplastic elastomer to a thermoplastic polymer. ●
Supply the device in three lengths rather than one length and one aperture size rather ● than three.

ട്. INDICATIONS FOR USE

The SPIWay Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.

TECHNOLOGICAL CHARACTERISTICS 6.

The SPIWay Endonasal Access Guide and the predicate SPIWay device are a cylindricallyshaped, flexible thermoplastic elastomer placed within the nasal cavity. Both devices are supplied sterile (gamma radiation). Both devices are placed prior to transnasal surgery and held in position by the proximal flare and conical distal body. The subject device has the same indications for use and same technological characteristics (i.e., principle of operation, basic design, function, basic materials, biocompatibility, packaging and sterilization) as the predicate device.

Table 1 – SPIWay Endonasal Access Guide Substantial Equivalence
Characteristic	Predicate Device (SPIWay Endonasal Access Guide, K153686)	Modified Device
Intended Use	To facilitate visualization of the surgical site and smooth manipulation of introduced instruments during transnasal endoscopic surgery	Same
Characteristic	Predicate Device(SPIWay Endonasal AccessGuide, K153686)	Modified Device
Indications forUse	For use endoscopic sphenoidsinus and transsphenoidalsurgery.	Same
SterilizationMethod	Gamma radiation	Same
Packaging	A pair of devices aremounted on a high densitypolyethylene (HDPE) insertcard and placed into alabeled, Tyvek pouch.Pouches are placed into alabeled carton.	Same
Single Use	Yes	Same
Sizes	Length :Nominal total length= 8.8cm;Nominal inf. length =7.5 cm;device trimmable by MD todesired working lengthHeight and width (3 sizes):9.3 x 4.9mm, 11.2 x 6.5 mmand 13.6 x 9.5mm	Length (3 sizes):Nominal total lengths of 5.6,6.5 and 7.6 cm;Nominal inf. lengths of 4.0,5.0 and 6.0 cmHeight and width:12.5 x 8.5 mm
Material	Thermoplastic elastomerwith hydrophilic coating	Thermoplastic polymer (PET)with silicone coating
Mechanism ofAction	Positioned in nostril to createa working channel sheath inthe natural orifice of the noseto facilitate visualization ofthe surgical site and smoothmanipulation of introducedinstruments during transnasalendoscopic surgery	Same
Method ofinsertion intonasal cavity	Forceps	Same
Duration of use	Removed at conclusion ofsurgical procedure	Same

Table 1 - SPIWay Endonasal Access Guide Substantial Equivalence

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7. PERFORMANCE DATA

Design verification bench testing was performed for the SPIWay Endonasal Access Guide to demonstrate that physical and functional requirements were met. Design validation cadaver

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testing was performed for the SPIWay Endonasal Access Guide to demonstrate effectiveness for its intended use. Performance testing showed the device meets design specifications and performed as intended.

BIOCOMPATIBILITY 8.

Biocompatibility testing was performed in accordance with ISO 10993-Biological Evaluation of Medical Devices. Specific tests are listed below:

Cytotoxicity (in accordance with ISO 10993-5:2009) ●
Intracutaneous Irritation (in accordance with ISO 10993-10:2010)
Acute Systemic Toxicity (in accordance with ISO 10993-11:2006) ●
Sensitization (in accordance with 10993-10:2010) ●

The SPIWay Endonasal Access Guide complies with the biocompatibility requirements for its intended use.

9. CONCLUSION

Through the data and information presented, SPIWay, LLC, considers the SPIWay Endonasal Access Guide substantially equivalent to the predicate device in terms of indications for use, technological characteristics, design and functional performance and that it presents no new concerns about safety or effectiveness.

Regulation Number and Section

§ 874.4780 Intranasal splint.

(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.