POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT

K122494 · Hemostasis, LLC · LYA · Mar 27, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K122494
• Device Name: POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
• Applicant: Hemostasis, LLC
• Product Code: LYA · Ear, Nose, Throat
• Decision Date: Mar 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4780
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint are indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint 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 PosiSep™ and PosiSep™ X are indicated for use as a nasal hemostat to treat epistaxis. PosiSep™ and PosiSep™ X are intended for use under the direction of a licensed healthcare provider.

Device Story

PosiSep™ and PosiSep™ X are sterile, foam-type nasal dressings/splints composed of modified chitosan particles and polysaccharide binders (carboxymethylcellulose and hydroxyethylcellulose). Used in clinical settings by healthcare providers following nasal/sinus surgery or trauma. Device functions by absorbing water and dehydrating blood, promoting rapid hemoconcentration of platelets, serum proteins, and fibrinogen to limit bleeding and edema. Acts as a space-occupying stent to separate mucosal surfaces and prevent adhesions during healing. Material is designed to be removed via natural excretion and routine flushing, eliminating need for physical removal. Benefits include improved hemostasis, reduced post-surgical adhesions, and simplified post-operative care.

Clinical Evidence

No clinical data. Evidence consists of bench testing and animal studies demonstrating appropriate hemostatic and tissue separation properties. Biocompatibility testing performed per ISO 10993 and FDA guidance.

Technological Characteristics

Sterile foam-type dressing composed of modified chitosan particles, carboxymethylcellulose, and hydroxyethylcellulose binders. Functions via physical absorption and hemostatic properties of chitosan. Sterilized via validated gamma radiation (SAL 10^-6).

Indications for Use

Indicated for patients undergoing nasal/sinus surgery or experiencing epistaxis. Used as a space-occupying hemostat/splint to separate tissues, prevent adhesions, control minimal bleeding via tamponade/absorption/platelet aggregation, and aid natural healing. Intended for use under direction of licensed healthcare provider.

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

• Hemostasis PosiSep™ and PosiSep™ X Topical Hemostat (K120958)
• CogENT Therapeutics Nasal/Epistaxis Pack (K113585)
• MeroGel Nasal Dressing and Sinus Stent (K982731)
• MeroPack Nasal Dressing and Sinus Stent (K041381)

Submission Summary (Full Text)

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K122494

## 510(k) Summary PosiSep" and PosiSep™ X Hemostat Dressing/Intranasal Splint

Date Prepared: August 15, 2012 March 8, 2013 Updated

- Hemostasis, LLC Submitter: 5000 Township Parkway St. Paul, MN 55110 Telephone: [phone] Fax: [phone]
Mr. Bernard Horwath Contact: Hemostasis Regulatory Affairs 5000 Township Parkway St. Paul, MN 55110 Telephone: [phone] Fax: [phone]

Proprietary Name: PosiSep™ and PosiSep™X Hemostat Dressing/Intranasal Splint

Common/Usual Name: Nasal Hemostat and Intranasal Splint

Classification Name: Intranasal Splint, Class I, Product Code L Y A ENT Epistaxis Hemostat, Class I, Product Code EMX

#### Establishment Registration Number: 3007225047

#### Description:

The Hemostasis PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint are sterile hemostats comprised of modified Chitosan particles and polysaccharide binders. Chitosan has well known hemostasis properties and, when combined with carboxymethylcellulose and hydroxyethylcellulose binders, forms a foam-type dressing that has an affinity to absorb and hold
water. PosiSep" and PosiSep" X Hemostat Dressing/Intranasal Splint have the material composition as the currently market cleared Hemostasis PosiSep™ and PosiSep Topical Hemostat. The PosiSep " and PosiSep" X Hemostat Dressing /Intranasal Splint are used for topical wounds and placed in the nasal cavity after surgery or trauma for the treatment of bleeding and as a space occupying stent to separate sinus tissue and prevent adhesions between mucosal surfaces. The dressings quickly dehydrate blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.

PosiSep™ and PosiSep™X are removed from the sight of application by natural excretion and routine flushing to eliminate the material from the nasal cavity and avoid the issues involved with physical removal of a non-fragmenting dressing.

MAR 2 7 2013

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#### Indications for Use:

PosiSen " and PosiSep" X Hemostat Dressing/Intranasal Splint are indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint 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

PosiSep™ and PosiSep™X are indicated for use as a nasal hemostat to treat epistaxis.

PosiSep™ and PosiSep™X are intended for use under the direction of a licensed healthcare provider.

#### Substantial Equivalence:

The PosiSep" and PosiSep" X Hemostat Dressing/Intranasal Splint are substantially equivalent to the following predicate devices:

- Hemostasis PosiSep™and PosiSep™X Topical Hemostat K120958 . �
- CogENT Therapeutics Nasal/Epistaxis Pack K113585 .
- MeroGel Nasal Dressing and Sinus Stent K982731 .
- MeroPack Nasal Dressing and Sinus Stent K041381 .

#### Biocompatibility:

Biocompatibility testing was performed using ISO 10993 - Biological Evaluation of Medical Devices and FDA guidance document Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1). The PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint comply with the biocompatibility requirements for their intended use.

#### Sterilization:

The PosiSep™ and PosiSep"" X Hemostat Dressing/Intranasal Splint are sterilized using a validated gamma radiation method to assure a sterility assurance level (SAL) of 10-6.

#### Performance Bench Testing:

Design verification testing was performed for the PosiSep "and PosiSep" X Hemostat Dressing/Intranasal Splint to demonstrate physical and functional requirements were met. Animal and bench testing demonstrated appropriate hemostatic and tissue separation properties, respectively, to assure effectiveness for their intended use.

#### Conclusion:

Through the data and information presented, Hemostasis, LLC, considers the PosiSep" and PosiSep™ X Hemostat Dressing/Intranasal Splint substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design and functional performance and present no new concerns about safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird-like figure.

March 27, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Hemostasis, LLC % Mr. Bernard Horwath Consultant to Hemostasis, LLC 5000 Township Parkway Saint Paul, MN 55110

Re: K122494

Trade/Device Name: PosiSep X™ Hemostat Dressing/Intranasal Splint Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA, EMX Dated: March 8, 2013 Received: March 11, 2013

Dear Mr. Horwath:

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. Iisting 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 requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Bernard Horwath

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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

# Eric Miann

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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# 4.0 Indications for Use Statement

#### 510(k) Number (if known): K122494

# PosiSep™ and PosiSep™X Hemostat Dressing/Intranasal Splint:

#### Indications for Use:

PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint are indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint 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

PosiSep™ and PosiSep™ X are indicated for use as a nasal hemostat to treat epistaxis.

PosiSep" and PosiSep" X are intended for use under the direction of a licensed healthcare provider.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### Concurrence of Office of Device Evaluation (ODE)

Daniel C. Clupper 2013.03.25 17:06:48 -04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K122494

PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint Traditional 510(k)

Hemostasis LLC

August 15, 2012