(223 days)
Not Found
No
The device description focuses on the material composition and physical properties of the hemostat/splint, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a hemostat/splint used to control bleeding, separate tissues, prevent adhesions, and aid in healing following nasal/sinus surgery or trauma, which are all therapeutic actions.
No
Explanation: The device is described as a hemostat dressing/intranasal splint used to control bleeding, separate tissue, and aid healing. Its function is therapeutic and supportive, not for diagnosing conditions.
No
The device is a physical dressing/splint made of modified Chitosan particles and polysaccharide binders, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a physical dressing/splint used in the nasal cavity to control bleeding, separate tissues, and aid healing. It does not mention analyzing samples from the body (like blood, urine, or tissue) to provide diagnostic information.
- Device Description: The description focuses on the material composition and how it physically interacts with blood and tissue within the nasal cavity. It doesn't describe any components or processes related to in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Reagents, calibrators, or controls used in laboratory testing.
The device is a therapeutic and supportive device used directly on or within the body, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
LYA, EMX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal cavity / sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare provider
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120958, K113585, K982731, K041381
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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: 651- 855-1466 Fax: 651-855-1465
Mr. Bernard Horwath Contact: Hemostasis Regulatory Affairs 5000 Township Parkway St. Paul, MN 55110 Telephone: 651-231-1761 Fax: 651-855-1465
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
1
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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