(29 days)
The SPIWay Endonasal Access Guide is indicated for use in endoscopic transnasal sphenoid sinus and skull base surgery.
The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic transnasal sphenoid sinus and skull base surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.
This document describes a 510(k) premarket notification for a medical device called the "SPIWay Endonasal Access Guide." The core of the submission revolves around demonstrating substantial equivalence to a legally marketed predicate device.
Based on the provided text, the device itself (SPIWay Endonasal Access Guide) is a physical, sterile, single-patient-use device, not an AI or software-based medical device. Therefore, the concepts of "acceptance criteria for an AI device," "test set," "number of experts for ground truth," "adjudication methods," "MRMC studies," "standalone performance," "training set," and "ground truth for training set" are not applicable to this physical device submission.
The document explicitly states:
- "Since the subject device is unchanged from the predicate device, repeat design verification and validation testing were not required." (Section 7. Performance Data)
- "Since the subject device is unchanged from the predicate device, repeat biocompatibility testing was not required." (Section 8. Biocompatibility)
- "The subject device is identical to the predicate device." (Section 9. Conclusion)
- "There are no differences in technological characteristics between the subject device and the predicate device." (Section 6. Technological Characteristics)
The only stated change compared to the predicate device is a modification to the "Indications for Use" statement "to more accurately describe use of the SPIWay Endonasal Access Guide in current endoscopic transnasal skull base surgical practice."
Therefore, it is not possible to provide the requested information regarding acceptance criteria and performance studies for an AI/software device, as this submission pertains to a physical, unchanged medical device being cleared based on substantial equivalence to an existing predicate with a minor label change.
To answer the prompt directly, but acknowledging the device type:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Substantial equivalence to the predicate device (SPIWay Endonasal Access Guide K180141) in terms of:
- Intended use (modified to allow for skull base surgery)
- Technological characteristics (identical)
- Design (identical)
- Function (identical)
- Basic materials (identical)
- Biocompatibility (identical, no repeat testing required)
- Packaging (identical)
- Sterilization (identical)
- Reported Device Performance: The device performs identically to the predicate because it is the identical device. No new performance data was required or provided as part of this 510(k) submission due to the device being unchanged from its predicate. The change was solely in the Indications for Use statement for clarity regarding current surgical practice.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device requiring a test set for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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October 27, 2021
SPIWay, LLC Mary Mooney Regulatory Consultant 3600 Corte Castillo Carlsbad, California 92009
Re: K213153
Trade/Device Name: SPIWay Endonasal Access Guide Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LY A Dated: September 27, 2021 Received: September 28, 2021
Dear Mary 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. 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 mis leading.
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 (QS) 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/cdrl-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,
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) K213153
Device Name SPIWay Endonasal Access Guide
Indications for Use (Describe)
The SPIWay Endonasal Access Guide is indicated for use in endoscopic transnasal sphenoid sinus and skull base surgery.
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)
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510(k) SUMMARY
This 510(k) summary 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:Fax: | (844)-565-1226614-737-4760 |
| d. Contact Person: | Mary Lou MooneyRegulatory Consultant |
| e. Date Summary Prepared: | October 21, 2021 |
DEVICE IDENTIFICATION
| a. Trade/Proprietary Name: | SPIWay Endonasal Access Guide |
|---|---|
| b. Common Name: | Nasal splint |
| c. Classification Name: | Intranasal splint, 874.4780 |
IDENTIFICATION OF PREDICATE DEVICES 3.
SPIWay Endonasal Access Guide (K180141).
DESCRIPTION OF THE DEVICE 4.
The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic transnasal sphenoid sinus and skull base surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.
Product code LYA
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ട്. INDICATIONS FOR USE
The SPIWay Endonasal Access Guide is indicated for use in endoscopic transnasal sphenoid sinus and skull base surgery.
TECHNOLOGICAL CHARACTERISTICS 6.
There are no differences in technological characteristics between the subject device and the predicate device.
The SPIWay Endonasal Access Guide and the predicate SPIWay device are the identical cylindrically-shaped, flexible thermoplastic elastomer placed within the nasal cavity. Both devices are supplied sterile (gamma radiation). Both devices are placed prior to endoscopic transnasal surgery and held in position by the proximal flare and conical distal body. Both devices have the same technological characteristics (i.e., principle of operation, design, function, basic materials, biocompatibility, packaging, sterilization) and intended use.
7. PERFORMANCE DATA
Since the subject device is unchanged from the predicate device, repeat design verification and validation testing were not required.
BIOCOMPATIBILITY 8.
Since the subject device is unchanged from the predicate device, repeat biocompatibility testing was not required.
CONCLUSION 9.
The Indications for Use statement was changed to more accurately describe use of the SPIWay Endonasal Access Guide in current endoscopic transnasal skull base surgical practice. The subject device is identical to the predicate device. The intended use, Instructions for Use and mechanism of action of the subject device are identical to the predicate device. As such, the change in the Indications for Use statement does not affect the substantial equivalence to the predicate device.
Through the 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.
§ 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.