(36 days)
Not Found
No
The summary describes a physical guide device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an access guide to facilitate visualization and instrument manipulation during surgery, not to treat a disease or condition.
No
The device is described as an access guide used during surgery to facilitate visualization and manipulation of instruments, not to diagnose a condition.
No
The device description explicitly states it is a sterile, single patient use device made of a thermoplastic elastomer, indicating it is a physical hardware device.
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 procedure performed directly on the patient's body.
- Device Description: The device is a physical guide placed within the nasal cavity during surgery. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. The SPIWay Endonasal Access Guide is a surgical accessory used during a procedure, not a diagnostic test.
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 (comma separated list FDA assigned to the subject device)
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 a 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. Performance testing showed the device meets design specifications and performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
1
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, LLC |
| 1120 Calle Cordillera ste 102 | |
| San Clemente, CA 92673 | |
| c. Telephone: | |
| Fax: | (844)-565-1226 |
| (814)-295-1226 | |
| d. Contact Person: | Mary Lou Mooney |
| Regulatory 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
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.
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.