The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic sphenoid sinus or transsphenoidal surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.

AI/ML Overview

The provided text is a 510(k) summary for the SPIWay Endonasal Access Guide, a Class I medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed AI algorithm study. Therefore, most of the requested information about acceptance criteria, detailed study design, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.

However, based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document mentions "design verification bench testing" and "design validation cadaver testing" were performed. It states: "Performance testing showed the device meets design specifications and performed as intended." However, specific quantitative acceptance criteria or detailed performance metrics are not provided in this summary for direct comparison in a table.

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

Test Set Sample Size: Not explicitly stated. The document mentions "cadaver testing," implying a set of cadavers were used, but the number is not specified.
Data Provenance: "Cadaver testing" implies the data would be from human cadavers. The country of origin is not mentioned. It would be considered prospective for the specific tests conducted.

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

This information is not provided in the document. For a physical device like this, the "ground truth" would likely be the successful physical manipulation and visualization during the cadaveric procedures, observed by the study conductor(s), rather than an expert consensus on interpretative outputs.

4. Adjudication method for the test set:

This information is not provided. Given it's a physical device validation, formal adjudication methods like "2+1" typically used for interpretation tasks (e.g., image reading) are unlikely to apply. The assessment would likely be direct observation by the study conductor(s) or surgeon(s) performing the cadaveric tests.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretive devices. The SPIWay Endonasal Access Guide is a physical surgical guide.
Effect Size: Not applicable as no such study was conducted.

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

No, a standalone algorithm-only performance study was not done. This device is not an AI algorithm. It's a physical guide intended for human-in-the-loop use during surgery.

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

The document implies the "ground truth" for the cadaveric testing was the successful physical functionality and visualization during the procedures. This would likely be assessed by the surgical team performing the testing, confirming the device "performed as intended" and "demonstrate[d] effectiveness for its intended use." It's not expert consensus on an interpretation, pathology, or outcomes data in the usual sense for diagnostic AI.

8. The sample size for the training set:

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure, possibly representing an eagle or other bird of prey. The image is in black and white.

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

January 28, 2016

SPIWay LLC Ms. Mary Lou Mooney Regulatory Consultant 1120 Calle Cordillera, #102 San Clemente, CA 92673

Re: K153686

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: December 17, 2015 Received: December 23, 2015

Dear Ms. 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, 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 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

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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.

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,

Kesia Y. Alexander -A

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

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Indications for Use

510(k) Number (if known) K153686

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

1. SUBMITTER INFORMATION

a. Company Name:	SPIWay, LLC
b. Company Address:	SPIWay, LLC1120 Calle Cordillera ste 102San Clemente, CA 92673
c. Telephone:Fax:	(844)-565-1226(814)-295-1226
d. Contact Person:	Mary Lou MooneyRegulatory Consultant
e. Date Summary Prepared:	December 16, 2015
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 (K132721)

4. DESCRIPTION OF THE DEVICE

Product code LY A

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5. INDICATIONS FOR USE

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

6. TECHNOLOGICAL CHARACTERISTICS

The SPIWay Endonasal Access Guide and the predicate SPIWay device are a cylindrically-shaped, 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.

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 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 using ISO 10993-Biological Evaluation of Medical Devices. 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.