(142 days)
Not Found
No
The device description and intended use focus on the physical properties and function of a nasal packing material, with no mention of AI or ML capabilities.
Yes.
The device's intended use includes controlling bleeding, preventing adhesions, and aiding in the natural healing process, all of which are considered therapeutic functions.
No
This device is described as a "space-occupying packing" intended for use during and after nasal/sinus surgery to separate tissues, prevent adhesions, control minimal bleeding, and aid in healing. It treats conditions rather than diagnosing them.
No
The device description clearly states it is a physical, sterile, single-use pack made of a co-polymer, which is a hardware component.
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 packing material used in vivo (within the body) during and after nasal/sinus surgery and for treating epistaxis. It acts as a space-occupying packing, separates tissues, prevents adhesions, controls bleeding, and aids healing.
- Device Description: The description details a physical pack made of PEG and chitosan that absorbs fluids and swells in vivo.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used to test blood, urine, tissue samples, etc., to detect diseases, conditions, or infections.
This device falls under the category of a surgical packing or dressing, which is a medical device used for therapeutic purposes within the body, not for in vitro diagnosis.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LYA, EMX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal/sinus, nasal cavity
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)
Comparative performance test data demonstrated adequate device performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K052099, K043035, K972459, K041381, K002972
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.
Not Found
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
§ 874.4780 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
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.
1
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.
יר
2
| Devices
↓ | Characteristic | K052099
Nasopore®
Polyganics BV | K043035
Sepragel ENT
Bioresorbable
Packing/Stent
Genzyme Corp. | K972459
Rhinocell® Nasal
Packings
Boston Medical
Products, Inc. | K041381
MeroPack Bioresorbable
Nasal Packing and Sinus
Stent
Medtronic Xomed Inc. | K002972
MeroGel™ Control Gel
ENT Surgical Dressing
Medtronic Xomed Inc. | |
|--------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Product
Codes | LYA = Intranasal splint | KHJ = ENT Synthetic
Polymer Material | EMX = Epistaxis balloon | LYA = Intranasal Splint | KHJ = ENT Synthetic
Polymer Material | |
| | Regulations | 21 CFR 874.4780 | 21 CFR 874.3620 | 21 CFR 874.4100 | 21 CFR.874.4780 | 21 CFR 874.3620 | |
| | Indications
For Use | | See Section V above | | | | |
| | Ingredients | Crosslinked Polyethylene
Glycol (PEG) and Chitosan | Fragmentable
poly(DL-lactide-co-ε-
caprolactone) urethane | Derivative of
hyaluronic acid | Polyvinyl alcohol (PVA)
sponge using a patented
formula. | Esterfied hyaluronic acid
(HYAFF®) and Collagen | Esterfied hyaluronic acid
(HYAFF®) |
| | Method of
action/
removal | • Hygroscopic, forms
gelatinous mass in contact
w/ fluids
• Natural elimination,
aspiration or gentle
irrigation of residues
• Upon application device
swells and conforms to
mucosal surfaces. | • Hygroscopic,
fragments in contact
with fluids
• Fragments within
several days after
insertion in the nasal
cavity
• Drained from the nasal
cavity via the natural
mucus flow. | • Fills nasal/sinus
cavities
• Leaves placement
site by natural
elimination, or may
be aspirated from
the cavity earlier at
physician's
discretion | • The packings will
expand as fluid is
introduced, giving the
surgeon time for
accurate positioning. | • Hygroscopic, forms
gelatinous mass in
contact with fluids.
• Absorbent >10 times
weight of device
• The stent gradually
degrades over time and
is slowly absorbed
within 14 days, or it
may be aspirated from
the cavity earlier at the
discretion of the
physician. | • Hygroscopic, forms
gelatinous mass in
contact with fluids.
• Absorbent >6 times
weight of device
• Dressing may be
compressed/ shaped by
surgeon as needed
• Gel eventually
dissolves, or it may be
aspirated from the
cavity earlier at the
discretion of the
physician. |
| | Sterility | Sterile by E-Beam
Irradiation | Sterile by EO gas | Sterile | Sterile by Gamma
Irradiation | Sterile by Gamma
Irradiation | Sterile by Gamma
Irradiation |
| | Biocompat | Complies with ISO 10993-1 | Complies with
ISO 10993-1 | Unknown - not
specified | Unknown - not specified | Complies with
ISO 10993-1 | Complies with
ISO 10993-1 |
| | How
Supplied | • 4.0 cm x 2.4 cm x 0.3 cm
pack
• Single use
• Single barrier Foil pouch
• Sterile, ready to use | • Single use
• Single barrier Tyvek
pouch | • Single use
• Transparent
viscoelastic gel | • Variety of shapes and
sizes to choose from,
both with and without
integral airways
• Sterile, ready to use | • Single use
• Lyophilized (freeze
dried) and compressed
dressing | • Single use |
.
Section 5: 510(k) Summary - Page 5-3
CogENT Therapeutics, LLC 510(k) Submission for:
Nasal/Epistaxis Pack
:1
. "*
1
.
3
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
4
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
5
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) |
|---|
| -------------------------------------------------------- |
(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