(152 days)
The SPIWay Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.
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.
The provided text describes the SPIWay Endonasal Access Guide, a medical device, and its 510(k) submission for FDA clearance. However, it does not contain specific acceptance criteria or a study with detailed performance metrics that would allow for the direct completion of the requested table.
The document mentions "Design verification bench testing" to demonstrate physical and functional requirements were met, and "Design validation cadaver testing" to demonstrate effectiveness for its intended use. However, it does not provide the acceptance criteria for these tests, nor does it report the quantitative results.
Therefore, I cannot populate the table with specific numerical acceptance criteria or reported device performance. I can only infer what kind of data the company would have gathered based on the mention of these tests.
Here's a breakdown of the information that can be extracted or inferred based on the prompt's request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from device type and general medical device testing) | Reported Device Performance (Not provided in detail in the text) |
|---|---|
| Physical/Functional Requirements: | |
| - Device integrity during use (e.g., no breakage, tearing) | Tested during design verification bench testing. Specific results or quantitative metrics not provided. |
| - Maintenance of shape/structure within nasal cavity | Tested during design verification bench testing. Specific results or quantitative metrics not provided. |
| - Compatibility with surgical instruments (e.g., smooth manipulation) | Tested during design validation cadaver testing. Specific results or quantitative metrics not provided. |
| - Ease of insertion and removal | Tested during design validation cadaver testing. Specific results or quantitative metrics not provided. |
| - Sterility (gamma radiation) | Device is supplied sterile via gamma radiation; verified as part of manufacturing and quality control. |
| - Biocompatibility (ISO 10993 compliance) | Complies with biocompatibility requirements for its intended use. Specific test results (e.g., cytotoxicity, sensitization) not provided. |
| Effectiveness for Intended Use (Cadaver Testing): | |
| - Facilitates visualization of surgical site | Demonstrated effectiveness in cadaver testing. Specific metrics (e.g., visual field improvement) not provided. |
| - Facilitates smooth manipulation of introduced instruments | Demonstrated effectiveness in cadaver testing. Specific metrics (e.g., instrument maneuverability scores) not provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document mentions "cadaver testing" but doesn't provide the number of cadavers or individual tests performed.
- Data Provenance: Not specified. Given the company (SPIWay, LLC) is in San Diego, CA, USA, and the FDA submission is in the US, it's highly likely the testing was conducted in the USA. The testing would be considered prospective as it's part of design validation, performed specifically to evaluate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, but given the "cadaver testing" for endoscopic sphenoid sinus or transsphenoidal surgery, it would logically involve surgeons specializing in these procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. The document only states "Design validation cadaver testing was performed for the SPIWay Endonasal Access Guide to demonstrate effectiveness for its intended use." Details about how "effectiveness" was objectively measured or adjudicated are absent.
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 study was not done. This device is a physical surgical aid, not an AI or imaging interpretation tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No, a standalone algorithm performance study was not done. This device is a physical instrument, not an algorithm. Its function is to assist a human surgeon ("human-in-the-loop").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for the cadaver study would have been expert observation and assessment by the surgeons performing the cadaver procedures, evaluating the device's ability to facilitate visualization and instrument manipulation. It's not pathology or outcomes data in the traditional sense, but rather a direct assessment of functional performance in a simulated surgical environment.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
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 200San Diego, CA 92121 | |
| c. Telephone:Fax: | (858) 369-5737(858) 369-5735 | |
| d. Contact Person: | Mary Lou MooneyRegulatory 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, 874.4780Product 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
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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'
Page 1 of _ 1
§ 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.