(266 days)
Not Found
No
The description focuses on the material composition, physical dimensions, and mechanical properties of an absorbable implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an absorbable implant indicated for supporting nasal septal cartilage, which suggests it is used for treatment or mitigation of an injury or disease, fitting the definition of a therapeutic device.
No
This device is an absorbable implant used to support nasal septal cartilage. Its function is to provide physical support for tissue, not to diagnose or detect a condition.
No
The device description clearly states it is an "implantable sheet" made of a physical material (poly (L-lactide) 70:30) and is implanted using "standard surgical tools and techniques." This indicates a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Spirox INEX Function: The Spirox INEX is an implantable device designed to provide structural support to nasal septal cartilage within the body. It is a surgical implant, not a diagnostic test performed on a specimen.
The description clearly states its purpose is to be implanted and support tissue, which is the function of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Spirox INEX absorbable implant is indicated for supporting nasal septal cartilage.
Product codes (comma separated list FDA assigned to the subject device)
NHB
Device Description
The Spirox INEX implantable sheet is an absorbable device comprised of a poly (L-lactide) 70:30. The product is provided as a perforated sheet comprised of multiple "rod" like elements. The sheet is nominally 24.5 x 20.0 mm with a thickness of 1.1 mm. The bridge sections are nominally 3.0 x 1.9 mm and the voids are nominally 2.4 x 1.9 mm. The implant can be trimmed and shaped to dimensions suitable for the surgical need. The device is implanted using standard surgical tools and techniques The Spirox INEX implantable sheet is a sterile, single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal septal cartilage
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 testing confirmed that the Spirox INEX Device performs according to the product specifications. Device evaluation consisted of mechanical and functional testing performed pursuant to Spirox’ design / system verification protocol; comparative testing with the cited predicate devices and human factors / usability assessments. Additionally, the device safety, biocompatibility and use was verified in a GLP animal study. Biocompatibility testing was conducted according to ISO 10993 "Biological Evaluation of Medical Devices" and FDA's recent guidance. The sterilization validation complies with the requirements prescribed in ISO 11137 for radiation sterilization. Packaging and shipping validation studies were conducted pursuant to the applicable ISO and ISTA 3A guidelines.
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.
K092590, K012769, K021928, K062789, K083621
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
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
JUN 1 0 2014
K132920
510(k) Summary (21 CFR § 807.92(c))
| Submitter: | Spirox, Inc. |
|---|---|
| 3475-0 Edison Way | |
| Menlo Park, CA 94025 | |
| Contact: | Mike Rosenthal |
| Vice President, Research & Development, Spirox | |
| Phone: 650.503.3329 | |
| Fax: 650.741.0029 | |
| Email: mrosenthal@d3dc.com | |
| Date Summary Prepared: | 03 June 2014 |
| Device Trade Name: | Spirox INEX Device |
| Common Name: | Ear, nose and throat synthetic polymer material |
| Classification Name: | Polymer, Ear, Nose and Throat, Synthetic, Absorbable |
| (21 CFR §874.3620) | |
| Product Code: | NHB |
| Equivalent Devices: | Ethicon's PDS Flexible Plate (K092590 - 17 Feb 2010) |
| MacroPore's ENT Reconstruction Film (K012769 - 25 Oct 2001) | |
| Synthes' Resorbable Fixation Systems (K021928 - 09 Jan 03) | |
| Synthes' Rapid Resorbable Fixation Systems (K062789 27 Feb 2007) | |
| Porex Surgical MedPor Customized Surgical Implant (K083621 Feb 2009) |
Device Description:
The Spirox INEX implantable sheet is an absorbable device comprised of a poly (L-lactide) 70:30. The product is provided as a perforated sheet comprised of multiple "rod" like elements. The sheet is nominally 24.5 x 20.0 mm with a thickness of 1.1 mm. The bridge sections are nominally 3.0 x 1.9 mm and the voids are nominally 2.4 x 1.9 mm. The implant can be trimmed and shaped to dimensions suitable for the surgical need. The device is implanted using standard surgical tools and techniques The Spirox INEX implantable sheet is a sterile, single use device.
Intended Use / Indications for Use:
The Spirox INEX absorbable implant is indicated for supporting nasal septal cartilage.
1
Technological Characteristics & Substantial Equivalence:
The Spirox INEX Device is substantially equivalent to Ethicon's PDS Flexible Plate cleared under K092590 (17 February 2010), MacroPore's ENT Reconstruction Film cleared under K012769 (25 October 2001), Synthes' Resorbable Fixation Systems cleared under K021928 and K062789 (09 January 2003 and 27 February 2007) and Porex's MedPor Customized Surgical Implant (03 February 2009). The intended use of the Spirox INEX Device is consistent with a more limited intended use cleared as compared to the above referenced predicate devices. The Spirox INEX device is indicated for use in procedures requiring nasal cartilage support only. Both the subject and predicate devices share similar technological characteristics, in that, all devices are long-term or permanent implants that employ the use of absorbable or nonabsorbable polymers and are formed, shaped and placed using standard surgical instruments and tools.
Non-Clinical Performance Data:
Design verification testing confirmed that the Spirox INEX Device performs according to the product specifications. Device evaluation consisted of mechanical and functional testing performed pursuant to Spirox' design / system verification protocol; comparative testing with the cited predicate devices and human factors / usability assessments. Additionally, the device safety, biocompatibility and use was verified in a GLP animal study. Biocompatibility testing was conducted according to ISO 10993 "Biological Evaluation of Medical Devices" and FDA's recent guidance. The sterilization validation complies with the requirements prescribed in ISO 11137 for radiation sterilization. Packaging and shipping validation studies were conducted pursuant to the applicable ISO and ISTA 3A guidelines.
Summarv:
Based on the product technical information, intended use / indications for use and non-clinical performance data provided in this premarket notification, the Spirox INEX Device has been shown to be substantially equivalent to the currently marketed predicate devices. Test data included in this 510(k) submission demonstrate similar performance of the Spirox INEX device as compared to the predicate devices. The differences between the subject and predicate devices do not raise new types of safety or effectiveness questions.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
June 10, 2014
Spirox. Inc. c/o Mr. Michael Rosenthal Vice President of Research & Development 3475-0 Edison Way Menlo Park. CA 94025
Re: K132920
Trade/Device Name: Spirox Inex Device Regulation Number: 21 CFR 874.3620 Regulation Name: Ear. Nose and Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: NHB Dated: May 8. 2014 Received: May 9. 2014
Dear Mr. Rosenthal:
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 docs 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 cither 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 - Mr. Michael Rosenthal
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 (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safety/ReportalProblem/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
K132920
Indications for Use Statement
510(k) Number if Known: K132920
Device Name: Spirox INEX Device
Indications for Use:
The Spirox INEX absorbable implant is indicated for supporting nasal septal cartilage.
Prescription Use 图 (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)
Concurrent of CDRH, Office of Device Evaluation (ODE)