NASAL/EPISTAXIS PACK
Device Facts
| Record ID | K113585 |
|---|---|
| Device Name | NASAL/EPISTAXIS PACK |
| Applicant | Cogent Therapeutics, LLC |
| Product Code | LYA · Ear, Nose, Throat |
| Decision Date | Apr 25, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4780 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
The Nasal/Epistaxis Pack is a sterile, single use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing. The Nasal/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: - Separate tissue or structures compromised by surgical trauma; - Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; - Help control minimal bleeding following surgery or trauma; - Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; - Act as an adjunct to aid in the natural healing process. The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.
Device Story
Nasal/Epistaxis Pack is a sterile, single-use, dry co-polymer pack (polyethylene glycol and chitosan) measuring 4.0 cm x 2.4 cm x 0.3 cm. Upon placement in the nasal cavity by a clinician, the device absorbs fluids, swells, and conforms to mucosal surfaces. It functions as a space-occupying stent to separate tissues, prevent adhesions, and provide tamponade to control minimal bleeding. The device is intended for use following nasal/sinus surgery or trauma, or to treat epistaxis. It aids the natural healing process and is removed via natural elimination or aspiration by a physician.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Material: Co-polymer of polyethylene glycol (PEG) and chitosan. Form factor: 4.0 cm x 2.4 cm x 0.3 cm dry pack. Principle: Hygroscopic swelling upon fluid contact to conform to mucosal surfaces. Sterilization: Not specified. Biocompatibility: Complies with ISO 10993-1.
Indications for Use
Indicated for patients undergoing nasal/sinus surgery or experiencing epistaxis. Used as a space-occupying packing to separate tissues, prevent adhesions, control minimal bleeding via tamponade/absorption/platelet aggregation, and aid natural healing.
Regulatory Classification
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.
Predicate Devices
- Nasopore® (K052099)
- Sepragel ENT Bioresorbable Packing/Stent (K043035)
- Rhinocell® Nasal Packings (K972459)
- MeroPack Bioresorbable Nasal Packing and Sinus Stent (K041381)
- MeroGel™ Control Gel ENT Surgical Dressing (K002972)
Submission Summary (Full Text)
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K113585
## Section 5 - 510(k) Summary or 510(k) Statement
### General Information I.
Submitter:
ﺮ ﺍﻟ
CogENT Therapeutics, LLC 703 Sandoval Way Hayward, CA 94544 Telephone: 650-450-4956
Contact Person:
Glen Gong Principal Telephone: 650-450-4956 x 102
Summary Preparation Date:
April 3, 2012
- II. Names
Device Names:
Nasal/Epistaxis Pack
Intranasal splint, ENT polymer material, and Epistaxis Primary Classification Names: (packing)
### III. Predicate Devices
- Nasopore® manufactured by Polyganics BV (K052099) .
- Sepragel ENT Bioresorbable Packing/Stent manufactured by Genzyme Corporation . (K043035)
- Rhinocell® Nasal Packings manufactured by Boston Medical Products, Inc. . (K972459)
- MeroPack Bioresorbable Nasal Packing and Sinus Stent manufactured by Medtronic . Xomed Inc. (K041381)
- MeroGel" Control Gel ENT Surgical Dressing manufactured by Medtronic Xomed . Inc. (K002972)
### IV. Product Description
The Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol (PEG) and chitosan provided as a dry 4.0 cm x 2.4 cm x 0.3 cm pack. Upon placement, the Nasal/Epistaxis Pack absorbs fluids in the field and swells and conforms to the mucosal tissue/treatment site surfaces to separate tissues and prevent adhesions, control minimal bleeding following surgery or trauma, to treat epistaxis, and to act as an adjunct to aid in the natural healing process.
### V. Indications for Use
The Nasal/Epistaxis Pack is a sterile, single use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing.
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The Nasal/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to:
- Separate tissue or structures compromised by surgical trauma; ●
- Separate and prevent adhesions between mucosal surfaces during mesothelial cell . regeneration in the nasal cavity;
- Help control minimal bleeding following surgery or trauma; .
- Help control minimal bleeding following surgery or nasal trauma by tamponade ● effect, blood absorption and platelet aggregation; and
- Act as an adjunct to aid in the natural healing process. .
The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.
#### VI. Rationale for Substantial Equivalence
The Nasal/Epistaxis Pack shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices for use as a space-occupying stent/packing for nasal/sinus use.
In addition, comparative performance test data demonstrated adequate device performance.
## VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Nasal/Epistaxis Pack is substantially equivalent to the predicate devices (see Table on following page).
### VIII. Conclusion
The Nasal/Epistaxis Pack was found to be substantially equivalent to the predicate devices.
The Nasal/Epistaxis Pack shares identical indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.
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| Devices<br>↓ | Characteristic | K052099<br>Nasopore®<br>Polyganics BV | K043035<br>Sepragel ENT<br>Bioresorbable<br>Packing/Stent<br>Genzyme Corp. | K972459<br>Rhinocell® Nasal<br>Packings<br>Boston Medical<br>Products, Inc. | K041381<br>MeroPack Bioresorbable<br>Nasal Packing and Sinus<br>Stent<br>Medtronic Xomed Inc. | K002972<br>MeroGel™ Control Gel<br>ENT Surgical Dressing<br>Medtronic Xomed Inc. | |
|--------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Product<br>Codes | LYA = Intranasal splint | KHJ = ENT Synthetic<br>Polymer Material | EMX = Epistaxis balloon | LYA = Intranasal Splint | KHJ = ENT Synthetic<br>Polymer Material | |
| | Regulations | 21 CFR 874.4780 | 21 CFR 874.3620 | 21 CFR 874.4100 | 21 CFR.874.4780 | 21 CFR 874.3620 | |
| | Indications<br>For Use | | See Section V above | | | | |
| | Ingredients | Crosslinked Polyethylene<br>Glycol (PEG) and Chitosan | Fragmentable<br>poly(DL-lactide-co-ε-<br>caprolactone) urethane | Derivative of<br>hyaluronic acid | Polyvinyl alcohol (PVA)<br>sponge using a patented<br>formula. | Esterfied hyaluronic acid<br>(HYAFF®) and Collagen | Esterfied hyaluronic acid<br>(HYAFF®) |
| | Method of<br>action/<br>removal | • Hygroscopic, forms<br>gelatinous mass in contact<br>w/ fluids<br>• Natural elimination,<br>aspiration or gentle<br>irrigation of residues<br>• Upon application device<br>swells and conforms to<br>mucosal surfaces. | • Hygroscopic,<br>fragments in contact<br>with fluids<br>• Fragments within<br>several days after<br>insertion in the nasal<br>cavity<br>• Drained from the nasal<br>cavity via the natural<br>mucus flow. | • Fills nasal/sinus<br>cavities<br>• Leaves placement<br>site by natural<br>elimination, or may<br>be aspirated from<br>the cavity earlier at<br>physician's<br>discretion | • The packings will<br>expand as fluid is<br>introduced, giving the<br>surgeon time for<br>accurate positioning. | • Hygroscopic, forms<br>gelatinous mass in<br>contact with fluids.<br>• Absorbent >10 times<br>weight of device<br>• The stent gradually<br>degrades over time and<br>is slowly absorbed<br>within 14 days, or it<br>may be aspirated from<br>the cavity earlier at the<br>discretion of the<br>physician. | • Hygroscopic, forms<br>gelatinous mass in<br>contact with fluids.<br>• Absorbent >6 times<br>weight of device<br>• Dressing may be<br>compressed/ shaped by<br>surgeon as needed<br>• Gel eventually<br>dissolves, or it may be<br>aspirated from the<br>cavity earlier at the<br>discretion of the<br>physician. |
| | Sterility | Sterile by E-Beam<br>Irradiation | Sterile by EO gas | Sterile | Sterile by Gamma<br>Irradiation | Sterile by Gamma<br>Irradiation | Sterile by Gamma<br>Irradiation |
| | Biocompat | Complies with ISO 10993-1 | Complies with<br>ISO 10993-1 | Unknown - not<br>specified | Unknown - not specified | Complies with<br>ISO 10993-1 | Complies with<br>ISO 10993-1 |
| | How<br>Supplied | • 4.0 cm x 2.4 cm x 0.3 cm<br>pack<br>• Single use<br>• Single barrier Foil pouch<br>• Sterile, ready to use | • Single use<br>• Single barrier Tyvek<br>pouch | • Single use<br>• Transparent<br>viscoelastic gel | • Variety of shapes and<br>sizes to choose from,<br>both with and without<br>integral airways<br>• Sterile, ready to use | • Single use<br>• Lyophilized (freeze<br>dried) and compressed<br>dressing | • Single use |
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Section 5: 510(k) Summary - Page 5-3
CogENT Therapeutics, LLC 510(k) Submission for:
Nasal/Epistaxis Pack
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
CogENT Therapeutics, LLC % Ms. Anne Worden Regulatory Consultant 703 Sandoval Way Hayward, CA 94544
APR 2 5 2012
Re: K113585
Trade Name: Nasal/Epistaxis Pack Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: I Product Code: LYA, EMX Dated: April 3 2012 Received: April 4, 2012
Dear Ms. Worden:
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.
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 that I Dr mas intact and regulations administered by other Federal agencies. You must or any I 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2-Ms. Anne Worden
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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 If you desire specific advice for your a vite soffices/CDRHOffices/ucm115809.html for go to mightwww.ida.gov/About Bril Sellers's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radionagiou. Heath of (con" (2) Children (2) (CFR Patt note the regulation entitied, "Misolanding of reference events under the MDR regulation (21 CFR Part 803), please go to
CFK Part 803), prease go to nttp://www.raa.governers/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general informations on your Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
(800) 030-2041 01 (50%) ical Devices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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 Statement
510(k) Number (if known): K11
#### Nasal/Epistaxis Pack Device Name:
Indications for Use:
The Nasal/Epistaxis Pack is a sterile, single use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing.
The Nasal/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to:
- Separate tissue or structures compromised by surgical trauma; .
- Separate and prevent adhesions between mucosal surfaces during mesothelial cell . regeneration in the nasal cavity;
- Help control minimal bleeding following surgery or trauma; .
- Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood . absorption and platelet aggregation;
- Act as an adjunct to aid in the natural healing process. .
The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.
イ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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*(Division Sign-Off)*
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number k 113585
Page: 1 of 1
CogENT Therapeutics, LLC 510(k) Submission for: Nasal/Epistaxis Pack
Section 4: Indications for Use - Page 4-2
