PuraSinus® is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.

PuraSinus® is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period.

Device Description

PuraSinus® is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraSinus® forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue.

PuraSinus® is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraSinus® can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.

AI/ML Overview

This document ("510(k) Summary for PuraSinus®") does not describe an AI/ML device, nor does it present the acceptance criteria and study proving a device meets those criteria in a format applicable to AI/ML device performance. This is a 510(k) submission for a medical device (a bioresorbable nasal dressing and sinus stent) where the key demonstration of substantial equivalence relies on comparison to a predicate device through bench testing and a small retrospective case series, rather than formal performance goals met by an AI/ML algorithm.

Therefore, many of the requested categories for defining acceptance criteria and study details for an AI/ML device cannot be extracted from the provided text. However, I can still interpret the information regarding the "performance data" that was presented to support the device.

Here's an analysis based on the provided text, interpreted as much as possible in the context of your request for device performance, but noting the relevant limitations due to the nature of the device:

Device Name: PuraSinus®

Type of Device: Bioresorbable nasal dressing and sinus stent (not an AI/ML device)

Acceptance Criteria and Reported Device Performance (as far as applicable to this non-AI device):

Acceptance Criteria (Implied/Compared)	Reported Device Performance (PuraSinus®)
Prevent/reduce post-operative adhesions (Adhesion Rate)	16% adhesion rate in a retrospective case series of 19 patients. "The adhesions that formed in 3 patients were determined to be mild, soft and easy to separate."
Control minimal bleeding	"no post-operative re-bleeding was observed" in all 19 patients.
Safety (Adverse Events)	"no adverse events related to the operation/usage of PuraSinus®."
Biocompatibility (compared to predicate)	"The difference in the material did not impact the safety and effectiveness of PuraSinus® when compared to the MeroGel® predicate." and "The biocompatibility testing and product characterization studies performed on the PuraDerm reference device apply to PuraSinus®."
Functional equivalence (e.g., rheological properties, injection force)	Bench tests were conducted on PuraSinus® and the MeroGel® predicate including Complex Modulus, Complex Viscosity, Complex Modulus in Simulated Body Fluid, Complex Viscosity in Simulated Body Fluid, and Injection Force. (Specific results not provided, only that tests were done).

Study Details (as derived from the text):

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 19 sequential patients.
- Data Provenance: Retrospective case series. The country of origin is not explicitly stated but implied to be where the clinical institution(s) conducting the FESS procedures are located (no specific country mentioned).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the AI/ML sense. The "ground truth" for the clinical performance (re-bleeding, adhesion formation, adverse events) would have been established by the treating physicians/surgeons during post-operative patient follow-up. The document does not specify the number or qualifications of these clinical evaluators.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly described. Clinical outcomes (adhesions, re-bleeding, adverse events) were reported, presumably as direct observations during patient follow-up, not through a formal adjudication process like one used for AI/ML image review.
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:
- Not applicable. This is not an AI/ML device. The "comparison" was PuraSinus® performance to literature reported performance of a predicate device (MeroGel®).
- Comparison: PuraSinus® showed an adhesion rate of 16% compared to a literature-reported adhesion rate of 27% for MeroGel® in similar procedures. This is a comparison of device outcome, not human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
The type of ground truth used:
- Clinical Outcomes/Observations: Directly observed post-operative clinical outcomes (adhesion formation, re-bleeding, adverse events) by treating physicians.
- Bench Test Results: Quantitative measurements from laboratory tests (Complex Modulus, Viscosity, Injection Force).
- Rabbit Model: In vivo animal study data for material comparison.
The sample size for the training set:
- Not applicable, as this is not an AI/ML device that requires a "training set."
How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device.

Summary of Device Performance Evidence (based on the provided text):

The primary evidence presented to demonstrate the substantial equivalence and performance of PuraSinus® focused on:

Bench Testing: Comparative physical and mechanical properties of PuraSinus® and the predicate device (MeroGel®).
Animal Model: A side-by-side comparison in a rabbit model to address material differences between PuraSinus® and MeroGel®, concluding no impact on safety or effectiveness.
Retrospective Case Series (Human Data): A small series (19 patients) showing favorable clinical outcomes (no re-bleeding, low and mild adhesion rates) compared to literature data for the predicate device.

The document emphasizes that PuraSinus® is the "identical product" to the previously cleared PuraDerm Gel (K140358), leveraging its biocompatibility and product characterization studies.

The acceptance of this device by the FDA (as indicated by the clearance letter K183015) was based on the provided data demonstrating substantial equivalence to the predicate device, not on meeting specific, pre-defined performance thresholds for an AI/ML algorithm.

Summary

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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for PuraSinus® is provided below.

SUBMITTER 1.

Dr. Lisa Spirio, Chief Scientific Officer, Co-Founder 3-D Matrix, Inc. 250 First Ave., Suite 205 Needham, MA 02494

Contact Person: Stephen Rhodes, Affiliate, Biologics Consulting Group, Inc. Phone: 301-579-3700 Email: stephen.rhodes@streamlineregulatory.com

Date Prepared: April 11, 2019

DEVICE 2.

Name of Device: PuraSinus® Common Name: polymer, ear, nose and throat, synthetic, absorbable Classification Regulation: 21 CFR 874.3620 Regulatory Class: II Product Code: NHB Panel: Ear Nose & Throat

PREDICATE DEVICE 3.

Predicate Device: Medtronic Xomed, Inc. MeroGel Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel (K122434)

Reference Device: 3-D Matrix, Inc. PuraDerm Gel (K143058)

DEVICE DESCRIPTION 4.

PuraSinus® is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

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5. INDICATIONS FOR USE

PuraSinus® is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

The similarities and differences in technological characteristics between the subject device (PuraSinus®), predicate device (MeroGel® - K122434), and the reference device (PuraDerm Gel - K143058) are summarized below.

PuraSinus® and the predicate MeroGel® (K122434) are both space-occupying gel stents intended to be used in nasal surgery to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding, and act as an adjunct to aid in the natural healing process.

The PuraSinus® solution is sterile-filtered and filled into 5-ml syringes made of cyclo-olefin polymers with a high-density polyethylene plunger and a butyl rubber head cap and gasket. Each syringe is filled with either 1, 3, or 5 ml of gel. The device is terminally sterilized, and the resorbable gel is delivered to the intended application site(s) via a polypropylene applicator nozzle tip.

The predicate MeroGel® is also a space-occupying gel provided in a prefilled syringe. The gel is cross-linked polymers of hyaluronic acid and is resorbable. Like the predicate device, it is terminally sterilized.

Both devices need to deliver the gel via a syringe and both need to function as a temporary space-occupying gel stent.

In terms of technological differences, PuraSinus® consists of a synthetic peptide-based hydrogel material provided in a prefilled syringe. The predicate MeroGel® is made from cross-linked polymers of hyaluronic acid. Both devices are hydrogels designed to be used as a barrier to prevent adhesion formation and bleeding after nasal and/or sinus surgical procedures. The differences in the material compositions of the two devices raises no new questions of safety and effectiveness. Additionally, the difference in material between the devices was addressed by a side-by-side comparison of the devices in a rabbit model. The difference in the material did not impact the safety and effectiveness of PuraSinus® when compared to the MeroGel® predicate.

Overall, the differences in technological characteristics of the subject and predicate devices do not raise any new questions of safety and effectiveness.

Lastly, the subject PuraSinus® is the identical product cleared as the PuraDerm Gel reference device (K140358) although for different indications.

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PERFORMANCE DATA 7.

The following bench tests were conducted on PuraSinus® and the MeroGel® predicate:

Complex Modulus ●
Complex Viscosity
Complex Modulus, Simulated Body Fluid
Complex Viscosity, Simulated Body Fluid
. Iniection Force.

The difference in material between the devices was addressed by a side-by-side comparison of the devices in a rabbit model. The difference in the material did not impact the safety and effectiveness of PuraSinus® when compared to the MeroGel® predicate.

PuraSinus® was also evaluated in a retrospective case series of 19 sequential patients requiring functional endoscopic sinus surgery (FESS). There were no adverse events related to the operation/usage of PuraSinus®. In all 19 patients, no post-operative re-bleeding was observed. Three of 19 patients developed adhesions for a rate of 16 %. The adhesions that formed in 3 patients were determined to be mild, soft and easy to separate. The adhesion results were compared to a literature article that reported adhesion rates with the predicate MeroGel® for similar procedures. [Miller RS. Steward DL. Tami TA et al. The clinical effects of hyaluronic acid ester nasal dressing (MeroGel®) on intranasal wound healing after functional endoscopic sinus surgery. Otolaryngology Head and Neck Surgery 2003 Jun; 128(6):862-9.] In this study, an adhesion rate of 27% was found after MeroGel® use following ethmoid surgery. The adhesion rate of 16% in this case series using PuraSinus® compares favorably to the 27% rate of adhesion formation with the predicate MeroGel® device.

CONCLUSIONS 8.

The subject PuraSinus® has the same intended use and similar indications for use at the predicate MeroGel® Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel (K122434). Both devices are space occupying gel stents that are intended to separate and prevent adhesions between mucosal surfaces, help control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.

The indications for use for the subject are a subset of the predicate device, with the difference being that the predicate device includes indications for specific surgical procedures not included in the subject device indications for use. Thus, PuraSinus® does not have a new intended use.

The subject and predicate device are both bioresorbable gels that are intended to fill ENT cavities after trauma or surgery. Both gel devices are provided sterile in syringes.

The subject device is the identical product as the PuraDerm reference device (K143058). The biocompatibility testing and product characterization studies performed on the PuraDerm reference device apply to PuraSinus®.

In conclusion. PuraSinus® is substantially equivalent to the predicate MeroGel® Injectable Bioresorbable Nasal Dressing and Sinus Stent and Otologic Gel (K122434).

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April 12, 2019

3-D Matrix, Inc. % Stephen Rhodes Affiliate Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, Virginia 22314

Re: K183015

Trade/Device Name: PuraSinus Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: NHB Dated: February 28, 2019 Received: March 4, 2019

Dear Stephen Rhodes:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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.

for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Regulation Number and Section

§ 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.