(163 days)
No
The device description and performance studies focus on the physical properties and clinical outcomes of a gel stent, with no mention of AI or ML.
Yes
The device is intended to separate and prevent adhesions, help control bleeding, and aid in the natural healing process, all of which are therapeutic actions.
No
This device is described as a gel stent or wound dressing intended to prevent adhesions and aid healing after nasal/sinus surgery or trauma, not to diagnose a condition.
No
The device description clearly states that PuraSinus® is a sterile gel composed of a synthetic peptide and sterile water, provided in a prefilled syringe. This describes a physical substance and delivery mechanism, not software.
Based on the provided information, PuraSinus® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of PuraSinus® is to be a space occupying gel stent used in vivo (within the body) following nasal/sinus surgery or trauma. It acts as a physical barrier and wound dressing to aid in healing and prevent complications.
- Device Description: The description details a sterile gel applied directly to tissue surfaces.
- Mechanism of Action: It forms a gel upon contact with physiological fluids and is designed to be rinsed away. This is a physical interaction within the body, not a test performed on a sample outside the body.
- Performance Studies: The studies described involve bench tests on the material properties and clinical evaluation in a rabbit model and human patients. These are typical studies for a medical device used in vivo.
In Vitro Diagnostic (IVD) devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. PuraSinus® does not perform any such testing on a specimen.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHB
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.
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)
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
- Injection Force.
Animal Study: 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.
Clinical Study: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Adhesion rate: 16% (PuraSinus®). This compared favorably to a literature reported adhesion rate of 27% for the predicate MeroGel®.
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
§ 874.3620 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
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 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.
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5. INDICATIONS FOR USE
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.
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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Image /page/4/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
5
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