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.

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.

AI/ML Overview

Since the provided text describes a 510(k) premarket notification for a medical device (SinuBand) and not an AI/ML medical device, the acceptance criteria and study information requested in the prompt (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth establishment for training set) are not applicable. The provided document details the testing performed to demonstrate substantial equivalence of the SinuBand to predicate devices rather than the performance of an AI/ML algorithm against specific criteria.

However, I can extract the closest analogous information based on the content available, focusing on the device's performance against its stated indications and comparison to predicate devices, as this is the core of a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance (Analogous to 510(k) Substantial Equivalence)

For a 510(k) submission, the "acceptance criteria" are generally demonstrating substantial equivalence to a legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. The performance data presented below are used to support this claim.

Criteria (Analogous to Acceptance Criteria for 510(k))	Reported Device Performance (SinuBand)	Comparison / Conclusion for Substantial Equivalence
Biocompatibility	All test results were acceptable.	In accordance with ISO 10993-1, supporting safety.
Mechanical & Physical Properties (vs. predicate MeroGel Nasal Dressing)	Comparable performance for: - Maximum sustained load - Flexibility - Ability to absorb water - pH - Ease of placement and removal from tissue - Conformability	All test results were comparable, supporting comparable functionality.
In Vivo Performance (Safety & Resorbability)	Rapidly adhered to sinus mucosa. Remained visible after 48 hours. Resorbed after 9-15 days. No significant histologic changes when placed on intact mucosa. Did not alter inflammation, fibrosis, or bone remodeling at injury sites. No complications encountered.	Demonstrated safety, biocompatibility, and performance. Residence time of approximately 2 weeks, comparable to predicate.
Intended Use	Same Indications for Use as predicate: "indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing intended to separate mucosal surfaces and prevent formation of adhesions."	Aligns with predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Animal Studies (Test Set):
- Sample Size: 16 intact or injured rabbit sinuses (for SinuBand implantation). 10 intact or injured rabbit sinuses served as controls (no implantation).
- Data Provenance: Pre-clinical in vivo study in a New Zealand white rabbit model. This is proprietary animal data generated specifically for this submission.
In Vitro Bench Testing: No specific sample sizes (e.g., number of devices tested) are quantified in the summary, but comparative testing was performed on SinuBand and the predicate device (MeroGel Nasal Dressing). This is proprietary in vitro bench data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the SinuBand's 510(k) submission as it focuses on physical device performance and not diagnostic algorithm accuracy requiring human expert ground truth. Histologic evaluation in the animal study would have been performed by qualified pathologists, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

This is not applicable, as the SinuBand is a physical device, not an AI/ML algorithm requiring expert adjudication of outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging AI/ML devices to assess their impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone performance study as described for AI/ML algorithms was not done. The SinuBand is a physical medical device.

7. The Type of Ground Truth Used

For Animal Studies: Histologic evaluation (hemorrhage, inflammation, fibrosis, bone remodeling, presence of device) of the sinus tissue was used to assess the device's in-vivo performance and safety. This is a form of pathology/histological assessment.
For Bench Testing: Objective measurements of physical and mechanical properties (e.g., load, flexibility, water absorption, pH) served as the "ground truth" to compare SinuBand against the predicate device.

8. The Sample Size for the Training Set

This is not applicable. The SinuBand is a manufactured physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a physical device.

Summary

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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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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.

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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 (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

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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

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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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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.

Regulation Number and Section

§ 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.