(190 days)
Not Found
No
The summary describes a physical, bioresorbable nasal dressing and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
The device is described as a space-occupying dressing intended to separate mucosal surfaces and prevent adhesion formation after nasal/sinus surgery, which is a structural or mechanical function, not a therapeutic one in the sense of treating a disease or illness.
No
Explanation: The SinuBand is described as a "space-occupying dressing intended to separate mucosal surfaces and prevent formation of adhesions" after nasal/sinus surgery. Its function is therapeutic/preventative, not diagnostic.
No
The device description clearly states that SinuBand is a "sterile, single-use, bioresorbable two-layer film designed to be a temporary nasal dressing." This describes a physical, material-based device, not a software-only device. The performance studies also focus on biocompatibility, mechanical properties, and in vivo animal studies, which are relevant to a physical implantable device.
Based on the provided information, the SinuBand device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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).
- SinuBand's Function: SinuBand is a physical dressing applied inside the nasal/sinus cavity during surgery. Its purpose is to physically separate mucosal surfaces and prevent adhesions. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly states it's a "space-occupying dressing" for use in patients undergoing surgery.
- Device Description: The description details its physical form and composition as a film applied under endoscopic visualization.
Therefore, SinuBand is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
SinuBand is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing intended to separate mucosal surfaces and prevent formation of adhesions.
Product codes (comma separated list FDA assigned to the subject device)
LYA, QJL
Device Description
SinuBand is a sterile, single-use, bioresorbable two-layer film designed to be a temporary nasal dressing applied under endoscopic visualization after sinus surgery. SinuBand is composed of two layers, with one side designed to be placed against the nasal tissue and the other facing the nasal cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal/sinus
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)
Biocompatibility Testing: A biocompatibility evaluation for the patient-contacting materials of SinuBand was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. All test results were acceptable.
In Vitro Bench Testing: In vitro bench testing on SinuBand and the predicate device, MeroGel Nasal Dressing, evaluated mechanical and physical properties that are important to an effective nasal/sinus dressing, including: maximum sustained load, flexibility, ability to absorb water, pH, ease of placement and removal from tissue, and conformability. All test results were comparable for the two devices.
Animal Studies: Two (2) pre-clinical in vivo studies in a New Zealand white rabbit model of maxillary sinus surgery were completed as part of the evaluation of the SinuBand device. SinuBand was implanted in 16 intact or injured rabbit sinuses followed by histologic evaluation (hemorrhage, inflammation, fibrosis, bone remodeling, presence of device) of the sinus tissue for up to 28 days; 10 intact or injured rabbit sinuses that were not implanted served as controls. The results showed that the device rapidly adhered to the sinus mucosa and remained visible after 48 hours, but was no longer visible and appeared to be resorbed after 9-15 days. No significant histologic changes were identified when SinuBand was placed on intact mucosa (no injury), and the device did not alter inflammation, fibrosis or bone remodeling at injury sites. No complications were encountered during the study. The rabbit studies demonstrated the safety, biocompatibility and performance of SinuBand.
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.
K982731, K070496, K082276, K052099
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services seal, featuring an eagle. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 12, 2020
Bioinspire Technologies, Incorporated Margaret Dillon 2468 Embarcadero Way Palo Alto, California 94303-3313
Re: K160101
Trade/Device Name: SinuBand Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA
Dear Contact:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination. Specifically, FDA is assigning a new product code to replace the one listed on the original SE letter. FDA has created a new product code to better categorize your device technology. The new product code is as follows:
| Product Code | Device Name |
|---|---|
| QJL | Splint, Intranasal Septal, |
| CBER led |
In addition, the procode QJL has been assigned to CBER. Like CDRH, CBER also has regulatory authority of certain medical device led combination products. Assignment to CBER will better align this product with other products that include blood or cellular products. For questions regarding this letter please contact Sheryl Lard-Whiteford, Office of The Director, Center for Biologics Evaluation and Research, Food and Drug Administration, 240-402-7912, sherry.lard@fda.hhs.gov.
Sincerely, Marjorie G. Shulman -S Marjorie Shulman Assistant Director, 510(k), De Novo, 513(g), Device Determinations and Custom Devices Team, Office of Regulatory Programs Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2016
BioInspire Technologies, Inc. Ms. Margaret Dillon Vice President, Regulatory Affairs and Quality 2468 Embarcadero Wav Palo Alto, CA 94303-3313
Re: K160101
Trade/Device Name: SinuBand Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: June 23, 2016 Received: June 27, 2016
Dear Ms. Dillon:
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.
2
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 (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 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.
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
3
Indications for Use
510(k) Number (if known) K160101
Device Name SinuBand
Indications for Use (Describe)
SinuBand is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing intended to separate mucosal surfaces and prevent formation of adhesions.
| 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) |
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K160101 - SinuBand 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 CFR Part 807.92(c).
I.SUBMITTER
BioInspire Technologies, Incorporated 2468 Embarcadero Way Palo Alto, CA 94303 Phone: 707-239-5707 Fax: 707-239-5259 Contact Person: Margaret Dillon mdillon@bioinspiretechnologies.com Date Prepared: July 26, 2016
II. DEVICE
| • Name of Device: | SinuBand |
|---|---|
| • Common or Usual Name: | Temporary Nasal Dressing |
| • Regulation Description: | Intranasal Splint (21 CFR 874.4780) |
| • Regulatory Class: | I |
- LYA ● Product Code:
III. PREDICATE DEVICES
- MeroGel Nasal Dressing and Sinus Stent (K982731) ●
- AdvaCoat Gel and Stent (K070496)
- Synthemed Device (K082276)
- NasoPore Nasal Dressing (K052099)
IV. DEVICE DESCRIPTION
SinuBand is a sterile, single-use, bioresorbable two-layer film designed to be a temporary nasal dressing applied under endoscopic visualization after sinus surgery. SinuBand is composed of two layers, with one side designed to be placed against the nasal tissue and the other facing the nasal cavity.
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Image /page/5/Picture/0 description: The image shows the logo for BioInspire Technologies. The word "BioInspire" is written in a large, green font. Above and to the right of "BioInspire" is the word "Technologies" in a smaller, black font. The logo is simple and clean, with a focus on the company name.
V. INDICATIONS FOR USE
SinuBand is indicated for use in patients undergoing nasal/sinus surgery as a spaceoccupying dressing intended to separate mucosal surfaces and prevent formation of adhesions.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The SinuBand placement and method of action is the same as the predicate devices, using manual application to place the device in the nasal cavity after sinus/nasal surgery. The SinuBand and predicate devices are hygroscopic, forming a gelatinous mass when in contact with fluid and serving as mechanical/physical barrier which prevents adhesions from forming. The SinuBand and predicate devices separate the mucosal surfaces and perform as an adjunct to the healing process.
The SinuBand and predicate devices are resorbable within 14 days of placement. The SinuBand and predicate devices can be removed from the nasal cavity after endoscopic placement by gentle irrigation. Comparative testing of SinuBand and MeroGel Nasal Dressing and Sinus Stent was performed to demonstrate substantial equivalence.
Any differences in properties between the SinuBand and the identified predicate devices do not alter the intended use of the SinuBand nor affect the safety and effectiveness of the SinuBand relative to the predicate devices.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
A biocompatibility evaluation for the patient-contacting materials of SinuBand was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. All test results were acceptable.
In Vitro Bench Testing
In vitro bench testing on SinuBand and the predicate device. MeroGel Nasal Dressing, evaluated mechanical and physical properties that are important to an effective nasal/sinus dressing, including: maximum sustained load, flexibility, ability to absorb water, pH, ease of placement and removal from tissue, and conformability. All test results were comparable for the two devices.
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Image /page/6/Picture/0 description: The image shows the logo for BioInspire Technologies. The text "BioInspire" is in a large, green, sans-serif font. Above and to the right of "BioInspire" is the word "Technologies" in a smaller, dark gray, serif font. The logo is simple and clean, with a focus on the company name.
Animal Studies
Two (2) pre-clinical in vivo studies in a New Zealand white rabbit model of maxillary sinus surgery were completed as part of the evaluation of the SinuBand device. SinuBand was implanted in 16 intact or injured rabbit sinuses followed by histologic evaluation (hemorrhage, inflammation, fibrosis, bone remodeling, presence of device) of the sinus tissue for up to 28 days; 10 intact or injured rabbit sinuses that were not implanted served as controls. The results showed that the device rapidly adhered to the sinus mucosa and remained visible after 48 hours, but was no longer visible and appeared to be resorbed after 9-15 days. No significant histologic changes were identified when SinuBand was placed on intact mucosa (no injury), and the device did not alter inflammation, fibrosis or bone remodeling at injury sites. No complications were encountered during the study. The rabbit studies demonstrated the safety, biocompatibility and performance of SinuBand.
VIII. CONCLUSION
Testing on SinuBand has demonstrated the desired properties of a nasal/sinus dressing, including lack of toxicity, biocompatibility, and non-dislocation after application. In addition, comparative bench testing has established substantial equivalence of SinuBand to the predicate device. MeroGel Nasal Dressing and Sinus Stent, in several tests critical to the function of an effective nasal/sinus dressing, including maximum sustained load, flexibility, ability to absorb water, pH to support a wound healing environment, ease of placement and removal, and ability to conform to nasal anatomy. SinuBand and MeroGel also have a comparable residence time in the sinus cavity of approximately 2 weeks. The nonclinical and bench testing data demonstrate that SinuBand is substantially equivalent to MeroGel and the other identified predicate devices that are currently marketed for the same intended use.