(29 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of a surgical guide, with no mention of AI or ML capabilities.
No
The device is described as a "temporary working channel sheath" to facilitate surgical procedures, not to treat or diagnose a disease or condition. Its function is to provide access and aid visualization, which are supportive roles in surgery rather than therapeutic.
No
The device description indicates it is a temporary working channel sheath to facilitate visualization and instrument manipulation during surgery, not to diagnose a condition.
No
The device description clearly states it is a physical object made of thermoplastic polymer, designed to be inserted into the nasal cavity. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SPIWay® Endonasal Access Guide Function: The description clearly states that the SPIWay® Endonasal Access Guide is a temporary working channel sheath used during surgical procedures (endoscopic sphenoid sinus and transsphenoidal surgery). It facilitates visualization and instrument manipulation within the body, not the analysis of specimens outside the body.
The device is a surgical accessory, not a diagnostic tool that analyzes biological samples.
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
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
1
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
2
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, LLC |
| 3600 Corte Castillo | |
| Carlsbad, CA 92009 | |
| c. Telephone: | (844)-565-1226 |
| Fax: | 614-737-4760 |
| d. Contact Person: | Mary Lou Mooney |
| Regulatory 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
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
Product code LYA
4
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.
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 Access | ||
| Guide, K153686) | Modified Device | |
| Indications for | ||
| Use | For use endoscopic sphenoid | |
| sinus and transsphenoidal | ||
| surgery. | Same | |
| Sterilization | ||
| Method | Gamma radiation | Same |
| Packaging | A pair of devices are | |
| mounted on a high density | ||
| polyethylene (HDPE) insert | ||
| card and placed into a | ||
| labeled, Tyvek pouch. | ||
| Pouches are placed into a | ||
| labeled carton. | Same | |
| Single Use | Yes | Same |
| Sizes | Length : | |
| Nominal total length= 8.8cm; | ||
| Nominal inf. length =7.5 cm; | ||
| device trimmable by MD to | ||
| desired working length |
Height and width (3 sizes):
9.3 x 4.9mm, 11.2 x 6.5 mm
and 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 cm
Height and width:
12.5 x 8.5 mm |
| Material | Thermoplastic elastomer
with hydrophilic coating | Thermoplastic polymer (PET)
with silicone coating |
| Mechanism of
Action | Positioned in nostril to create
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 | Same |
| Method of
insertion into
nasal cavity | Forceps | Same |
| Duration of use | Removed at conclusion of
surgical 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
6
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.