(152 days)
K-Splint Invotec (Product No 20-10644)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of a guide for surgical access, with no mention of AI/ML, image processing, or data-driven analysis.
No
The device facilitates visualization and instrument manipulation during surgery, it does not directly treat a disease or condition.
No
The device is described as an access guide to facilitate visualization and instrument manipulation during surgery, not to diagnose a condition.
No
The device description explicitly states it is a physical device made of medical-grade thermoplastic elastomer and is placed within the nostril/nasal cavity. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for facilitating visualization and instrument manipulation during endoscopic sphenoid sinus and transsphenoidal surgery. This is a surgical aid, not a device used to diagnose a condition by examining samples outside the body.
- Device Description: The description clearly states it's a guide placed within the nasal cavity during surgery. It's a physical tool for surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SPIWay Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.
Product codes
LYA
Device Description
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 medical-grade thermoplastic elastomer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nostril/nasal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-Splint Invotec (Product No 20-10644)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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JAN 2 9 2014
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: | 11575 Sorrento Valley Rd., Suite 200 | |
| San Diego, CA 92121 | ||
| c. Telephone: | ||
| Fax: | (858) 369-5737 | |
| (858) 369-5735 | ||
| d. Contact Person: | Mary Lou Mooney | |
| Regulatory Consultant | ||
| e. Date Summary Prepared: | December 26, 2013 | |
| DEVICE IDENTIFICATION | ||
| a. Trade/Proprietary Name: | SPIWay Endonasal Access Guide | |
| b. Common Name:Nasal splint | ||
| c. Classification Name: | Intranasal splint, 874.4780 | |
| Product code LYA |
IDENTIFICATION OF PREDICATE DEVICES 3.
K-Splint Invotec (Product No 20-10644)
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 sphenoid sinus or transsphenoidal surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of medical-grade thermoplastic elastomer.
న్. INDICATIONS FOR USE
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The SPIWay Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.
6. TECHNOLOGICAL CHARACTERISTICS
The SPIWay Endonasal Access.Guide is a cylindrically-shaped, flexible thermoplastic elastomer placed within the nasal cavity. The K-splint is a flat. malleable fluoroplastic placed within the nasal cavity against the nasal septum. Both devices are supplied sterile, either via gamma radiation (SPIWay) or EtO (K-splint). Both devices are placed prior to transnasal surgery. The SPIWay device is held in position by its proximal flare and conical distal body. The K-splint is held in position with a transseptal suture.
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.
8. BIOCOMPATIBILITY
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. SP1Way, LLC, considers the SPIWay Endonasal Access Guide substantially equivalent to the K-splint in terms of indications for use, technological characteristics, design and functional performance and that it presents no new concerns about safety or effectiveness.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 29, 2014
SPIWay, LLC Ms. Mary Lou Mooney Regulatory Consultant 11575 Sorrento Valley Rd., Suite 200 San Diego, CA 92121
Re: K132721
Trade/Device Name: SPIWay Endonasal Access Guide Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class 1 Product Code: LY A Dated: December 27, 2013 Received: December 30, 2013
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.
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Page 2 - Ms. Mary Lou Mooney
: . . 。
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance 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,
Eric A. Mann -S
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): K132721
Device Name: SPIWay Endonasal Access Guide
Indications For Use:
The SPIWay Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Park 2014.01.27 16:52:59 -05'00'
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