(262 days)
No
The 510(k) summary describes a mechanical stent and delivery system. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies are focused on mechanical properties, biocompatibility, and clinical outcomes related to the physical device.
Yes
The device is intended to maintain patency and reduce the need for post-operative intervention surgery following ethmoid sinus surgery, which is a therapeutic purpose. It supports healing and prevents complications like adhesions and obstruction.
No
The device, a removable sinus stent, is intended for therapeutic purposes following sinus surgery (maintaining patency, reducing intervention need, providing support, preventing obstruction/adhesions), not for diagnosing a medical condition.
No
The device description clearly outlines physical components including a stent made of polyurethane and Nitinol alloy, and a delivery system with a syringe, balloon, and rigid shaft. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Composite Removable Sinus Stent is a physical implant designed to maintain the patency of the ethmoid sinus cavity after surgery. It provides structural support and prevents adhesions.
- Intended Use: The intended use clearly states it's for use in adult patients following surgery to maintain patency and reduce the need for further intervention. It is placed directly within the body.
- Device Description: The description details a physical stent and a delivery system for implantation. There is no mention of analyzing biological specimens.
The device is a medical device, specifically an implantable device used in a surgical context, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, to maintain patency and reduce the need of post-operative intervention surgery. The Composite Removable Sinus Stent is intended for use following ethmoid sinus surgery, to prevent adhesions and middle turbinate lateralization into the septum. The composite stent is intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping.
Product codes (comma separated list FDA assigned to the subject device)
LYA
Device Description
The subject device is supplied sterile for single use.
The composite removable sinus stent provides sinus wall support following functional endoscopic sinus surgery. A delivery system is provided to insert the implant. The system contains the following components:
Stent
The stent is balloon expandable and composed of an outer polyurethane and inner Nitinol alloy bodies. The stent is designed to accommodate the size and variability of the post-surgical ethmoid cavity anatomy. Once expanded the stent is designed to support the walls of ethmoid cavity, in order to prevent adhesions and middle turbinate lateralization into the septum. Stent can be removed within 4 weeks by cooling and self-crimping
Delivery System
The delivery system is designed to insert, position and deploy the stent, following functional endoscopic sinus surgery, guided by endoscopic direct vision. The delivery system consists of a water filled syringe connected to high compliance low pressure balloon via rigid shaft. The balloon is supplemented with color marker.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ethmoid sinus, nasal walls, nasal meatus, frontal sinus cavity
Indicated Patient Age Range
adult patients
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)
Bench testing, Biocompatibility testing, Animal Study, Clinical Data
Bench testing:
Testing procedures performed under Design Verification Study included the following:
- Composite Stent Integrity
- Composite Stent Dimensional Verification Test
- Composite Stent Functional Test
- Composite Stent Crush Resistance Test
- Composite Stent Radial Strength Test
- Composite Stent Corrosion Resistance Test
- Delivery System Integrity Test
- Delivery System Dimensional Verification Test
- Delivery System Repeat Inflation Test
- Composite Stent System Crossing Profile Verification Test
- Composite Stent System Simulated Use Test
Bench testing met all acceptance criteria of the Design Verification tests and complied with 311001 Composite Removable Stent System Specifications.
Biocompatibility testing:
Conducted according to "ISO 10993-1 (2009/Cor.1: 2010): Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", " FDA General Program Memorandum #G95-1, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
Battery of testing included:
- Cytotoxicity
- Sensitization
- Irritation
- Chemical Characterization
Results: Composite Removable Sinus Stent System is biocompatible.
Animal Study:
GLP animal study, 5 sheep.
10 stents were implanted and 10 control sites were created.
3 sheep underwent stent removal after 4 weeks and remained to heal for additional 2 weeks. Thereafter stent and control sites were harvested 6 weeks' post-implantation for histopathological analysis.
2 sheep were sacrificed after 4 weeks' implantation time and stent and thereafter control sites were harvested for histopathological analysis.
Safety and feasibility were evaluated by macroscopic and histological analysis.
Results: No adverse local tissue adverse effects were observed after 4 weeks' implantation time. The study demonstrated that Composite Removable Sinus Stent can be safely implanted into nasal meatus for up to 28-day implantation time, similar to the predicate Sinexus Sinus Stent.
Clinical Data:
First in Man Clinical Study, 15 patients where 29 stents were successfully implanted and removed.
Results: Composite Stent implantation and removal procedures were not associated with any complications or adverse events. Patients' follow-ups demonstrated that Sinus Stent implantation has not induced any additional inflammatory reaction compared to the control group patients. Inflammation levels were lower in study group patients and post-surgical healing was faster compared to standard of care treatment. Study group patients showed lower adhesion and restenosis rate compared to control group patients, at stent removal day and after stent removal (6-12 weeks after FESS). Pain associated with stent removal was lower than pain associated with tampon removal. Study patients experienced an improvement during stent implantation, while standard of care patients experienced tampon associated discomfort. The mean difference in SNOT-20 scores before the FESS and 12 weeks after FESS, was higher in study group than in the control group. The discomfort level associated with pre-cooled saline wash was assessed on 11 study group patients on stent removal day, showing negligible discomfort, possibly even less than RT saline wash.
Conclusion: The Composite Removable Stent keeps the nasal passage open and promotes post-surgical healing.
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.
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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December 15, 2017
STS Medical % George Hattub Senior Staff Consultant Medicsense 291 Hillside Avenue Somerset, MA 02726
Re: K170913
Trade/Device Name: Composite Removable Sinus Stent System Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: November 14, 2017 Received: November 20, 2017
Dear George Hattub:
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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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 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 yours,
Denise L. Hampton -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)
K170913
Device Name
Composite Removable Sinus Stent System
Indications for Use (Describe)
Intended Use
The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, to maintain patency and reduce the need of post-operative intervention surgery. The composite stent is intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping.
| Type of Use ( Select one or both, as applicable ) | ||
|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Expert Building 2nd floor, 37 Amal Street, Kyriat Arie, Petah Tikva, 4951337, Israel
510(k) SUMMARY: K170913
Submitter's Name, address, telephone number, a contact person and date the summary was prepared:
| Submitter's Name: | STS Medical |
|---|---|
| Submitter's Address: | Expert Building 2nd floor, 37 Amal Street, Kyriat Arie, |
| Petah Tikva, 4951337, Israel | |
| Submitter's Telephone: | 972-54-7387188 |
| Submitter's Contact: | Lena Shlossberg M.Sc. QA / RA manager Tel: +972-52- |
| 6826962 E-mail: lena@ststent.com | |
| Date of Submission | March 22, 2017 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| Proprietary Name: | Composite Removable Sinus Stent System |
|---|---|
| Common or Usual Name: | Sinus Stent System |
| Classification Name: | Ear, Nose, and Throat Surgical Device, Intranasal splint |
| Regulatory Class | I |
| Product code: | LYA |
| Predicate Device: | K092401 Sinus Stent, product code LYA |
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Expert Building 2nd floor, 37 Amal Street, Kyriat Arie, Petah Tikva, 4951337, Israel
Reference Device:
K120280 Relieva Seeker Balloon Sinuplasty System, product code LRC.
This reference device comprises the feature of balloon dilatation inside intranasal structures, therefore helps to address the question of safety and effectiveness that is raised by the Delivery System of the subject device.
Device Description
The subject device is supplied sterile for single use.
The composite removable sinus stent provides sinus wall support following functional endoscopic sinus surgery. A delivery system is provided to insert the implant. The system contains the following components:
Stent
The stent is balloon expandable and composed of an outer polyurethane and inner Nitinol alloy bodies. The stent is designed to accommodate the size and variability of the post-surgical ethmoid cavity anatomy. Once expanded the stent is designed to support the walls of ethmoid cavity, in order to prevent adhesions and middle turbinate lateralization into the septum. Stent can be removed within 4 weeks by cooling and self-crimping
Delivery System
The delivery system is designed to insert, position and deploy the stent, following functional endoscopic sinus surgery, guided by endoscopic direct vision. The delivery system consists of a water filled syringe connected to high compliance low pressure balloon via rigid shaft. The balloon is supplemented with color marker.
Intended Use
The Composite Removable Sinus Stent is intended for use following ethmoid sinus surgery, to prevent adhesions and middle turbinate lateralization into the septum. The composite stent is intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping.
Technological Characteristics
Provided below is a table summarizing and comparing the technological characteristics of Composite Removable Sinus Stent System and the predicate device.
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Expert Building 2nd floor, 37 Amal Street, Kyriat Arie, Petah Tikva, 4951337, Israel
| Predicate Device | Subject Device | |
|---|---|---|
| Company Name | Sinexus Inc | STS Medical |
| Code / Class | LYA. Class I | LYA. Class I |
| Device Name | Sinus Stent | Composite Removable Sinus Stent System |
| Intended Use | Post-operation separate mucosal tissues and prevent adhesions. | Post-operation separate mucosal tissues and prevent adhesions. |
| Material / Construction | Absorbable poly-L-lactide-co-glycolide | Nitinol alloy & polymer |
| Sterility | Radiation | EtO |
| Bioresorbable | Yes | No |
| Biocompatibility | ISO 10993- 1 | ISO 10993- 1 |
| Method of Action | Mechanical support of the surgically enlarged sinus. | Mechanical support of the surgically enlarged sinus. |
| Method of Removal | Resorption or aspiration | Cooling induced self-crimp and removal with medical grasper |
| Reference Device | Subject Device Delivery System | |
|---|---|---|
| Company Name | Acclarent Inc. | STS Medical |
| Code / Class | LRC | LYA. Class I |
| Device Name | Relieva Seeker Balloon | |
| Sinuplasty System | Composite Removable Sinus | |
| Stent System | ||
| Intended Use | Access and dilate spaces | |
| within frontal sinus cavity. | Insert, position and deploy | |
| the stent within ethmoid | ||
| sinus | ||
| Material / Construction | Nylon balloon with stainless | |
| steel shaft | Nylon/silicone balloon with | |
| stainless steel shaft | ||
| Sterility | EtO | EtO |
| Bioresorbable | No | No |
| Biocompatibility | ISO 10993- 1 | ISO 10993- 1 |
| Method of Action | Balloon inflation under | |
| endoscopic visualization for | ||
| dilatation of intranasal | ||
| structures | Balloon inflation for stent | |
| deployment | ||
| Method of Removal | Balloon deflation and | |
| system retraction | Balloon deflation and | |
| system retraction |
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Expert Building 2nd floor, 37 Amal Street, Kyriat Arie, Petah Tikva, 4951337, Israel
The following technological differences exist between the subject and predicate devices:
- Sinexus Sinus Stent is bioabsorbable device, whether STS Composite Sinus Stent ■ manufactured from non-bioabsorbable, biocompatible materials.
- Sinexus Sinus Stent removed by resorption, whether STS Composite Sinus Stent removed mechanically.
There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness.
Performance Data
Bench testing
Testing procedures performed under Design Verification Study included the following:
- Composite Stent Integrity
- Composite Stent Dimensional Verification Test
- Composite Stent Functional Test ■
- Composite Stent Crush Resistance Test
- I Composite Stent Radial Strength Test
- I Composite Stent Corrosion Resistance Test
- I Delivery System Integrity Test
- I Delivery System Dimensional Verification Test
- I Delivery System Repeat Inflation Test
- I Composite Stent System Crossing Profile Verification Test
- Composite Stent System Simulated Use Test l
Bench testing met all acceptance criteria of the Design Verification tests and complied with 311001 Composite Removable Stent System Specifications.
Biocompatibility testing
Biocompatibility testing conducted according to "ISO 10993-1 (2009/Cor.1: 2010): Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", " FDA General Program Memorandum #G95-1, Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" demonstrate that Composite Removable Sinus Stent System is biocompatible. The battery of testing included the following tests:
- Cytotoxicity ■
- Sensitization
- Irritation
- . Chemical Characterization
When used as intended, the Composite Sinus Stent is categorized as a surface device in contact with breached or compromised surfaces for prolonged duration (> 24h but