(110 days)
Not Found
No
The description focuses on the material properties and physical function of the device as a nasal dressing, with no mention of AI or ML capabilities.
Yes.
The device is used to prevent adhesions between mucosal surfaces and help control bleeding following surgery or nasal trauma, which are therapeutic effects.
No
The device description indicates that Nasopore is a "fragmentable nasal dressing" used as a "space occupying stent" and to "help control minimal bleeding" after surgery or trauma. These functions are therapeutic and supportive, not diagnostic.
No
The device description clearly states it is a physical nasal dressing made of a polymer, 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 states that Nasopore is a "nasal dressing" used in patients undergoing nasal/sinus surgery. It acts as a physical barrier and helps with bleeding control. This is a therapeutic and mechanical function within the body.
- Device Description: The description details the material and how it fragments and is cleared from the nasal cavity. This further reinforces its role as a physical implant/dressing.
- 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 the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are used to test samples like blood, urine, or tissue outside of the body to provide diagnostic information. Nasopore is used directly within the body for a therapeutic and supportive purpose.
N/A
Intended Use / Indications for Use
Nasopore is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption.
Product codes (comma separated list FDA assigned to the subject device)
LYA
Device Description
Nasopore is composed of a fragmentable poly(DL-lactide-co-e-caprolactone) urethane that fragments within several days after insertion in the nasal cavity, whereafter it is drained from the nasal cavity via the natural mucus flow. The Nasopore size and type are indicated on the label and are packed in a Tyvek pouch. Nasopore is indicated for single-use.
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 safety and effectiveness of the Nasopore Nasal Dressing have been demonstrated via data collected from design verification tests and analyses. The design verification testing consisted of the following: In vitro fragmentation testing i Shelf life testing Biocompatibility, mechanical and physical property testing and in vitro fragmentation testing provide scientific evidence that Nasopore nasal dressing is substantially equivalent to the predicate devices. Evaluation of the Polyganics Nasopore® nasal dressing based on biocompatibility testing, clinical trial, and the comparison of the Nasopore nasal dressing with its predicate devices, shows that the Nasopore® is safe for use as a nasal dressing.
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.
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.
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POLYGANICS
KOS2099
NOV 2 1 2005
510(k) Summary of Safety and Effectiveness
| Submitter: | Polyganics BV
L.J. Zielstraweg 1
9713 GX, Groningen
The Netherlands
www.polyganics.com |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jan Nieuwenhuis
Managing Director
Tel : +31 50 588 6588
Fax : +31 50 588 6599
Mobile: +31 653 211 303
E-mail : jan.nieuwenhuis@polyganics.com |
| Date Prepared: | July 27, 2005 |
| General Provisions: | Trade Name: Nasopore®
Common Name: Nasal Dressing
Classification Name: Intranasal Splint, 21 CFR 874.4780
Device Classification: Class I |
| Predicate Devices: | - Seprapack/Sepragel; Genzyme; K012532
- Merogel™ nasal dressing; Xomed; K982731
- Meropack™ nasal dressing; Medtronic Xomed; K041381 |
| Performance Standards | For the Nasopore performance, the FDA, under section 514 of the Food, Drug and Cosmetic Act, has not established standards. |
| Indications for Use | Nasopore is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding following surgery or nasal trauma by tamponade effect and blood absorption. |
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bioresorbable solution
POLYGANICS
Device De-Nasopore is composed of a fragmentable poly(DL-lactide-co-e-caprolactone) scription urethane that fragments within several days after insertion in the nasal cavity, whereafter it is drained from the nasal cavity via the natural mucus flow. The Nasopore size and type are indicated on the label and are packed in a Tyvek pouch. Nasopore is indicated for single-use. The safety and effectiveness of the Nasopore Nasal Dressing have been Performance demonstrated via data collected from design verification tests and analyses. Data: The design verification testing consisted of the following: In vitro fragmentation testing i Shelf life testing
The design, fundamental technology and intended use (safety and efficacy) Summary of Substantial featured with the Nasopore Nasal dressing are substantially equivalent to Equivalence those featured with the competitor devices Seprapack/Sepragel (ref. Genzyme, Corp.), Merogel™ nasal dressing (ref. 510(k)012532; 510(k)982731, Xomed Surgical products, Inc) and Meropack™ nasal dressing (ref. 510(k)041381; Medtronic Xomed).
Biocompatibility, mechanical and physical property testing and in vitro fragmentation testing provide scientific evidence that Nasopore nasal dressing is substantially equivalent to the predicate devices. Evaluation of the Polyganics Nasopore® nasal dressing based on biocompatibility testing, clinical trial, and the comparison of the Nasopore nasal dressing with its predicate devices, shows that the Nasopore® is safe for use as a nasal dressing.
2
Image /page/2/Picture/2 description: The image shows the words "bioresorbable solution" in a small font at the top. Below that, the word "POLYGANICS" is written in a large, bold font. The text appears to be a logo or brand name.
sopore® nasal dressing is substantially equivalent to the currently marketed predicate devices.
| | Nasopore® | Sepra-
pack/Sepragel | MeroGel™ | MeroPack™ |
|----------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|
| Company | Polyganics | Genzyme corporation | Xomed Surgical Products | Medtronic Xomed Inc. |
| 510(k) Reference | This 510(k) | K012532 | K982731 | K041381 |
| Device name | Intranasal Splint | Intranasal Splint | Intranasal Splint /
woven wound dressing | non Intranasal Splint |
| Indications | Nasal/sinus surgery | Nasal/sinus surgery | Nasal/sinus surgery | Nasal/sinus surgery |
| Material composition | fragmentable
poly(DL-lactide-co-ε-
caprolactone)
thane | Chemically modified
hyaluronic acid and
ure-carboxymethylcellulose | Esterified hyaluronic acid | Esterified hyaluronic acid
and collagen |
| Method of action | Hygroscopic, frag-
ments in contact
with fluids | Hygroscopic, forms
gelatinous mass in
contact with fluids | Hygroscopic, forms gelatinous mass in contact with
fluids | Hygroscopic, forms gelatinous mass in contact
with fluids |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | ISO 10993 and FDA
guidance G95-1 |
Device Characteristics of the Subject and Predicate devices
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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
NOV 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Polyganics BV c/o J.B. Hak, Ph.D. Manager Clinical and Regulatory Affairs L.J. Zielstraweg 1 NL-9713-GX Groningen The Netherlands
Re: K052099
Trade/Device Name: Polyganics Nasopore® nasal dressing Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA Dated: November 7, 2005 Received: November 9, 2005
Dear Mr. Hak:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - J.B. Hak, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
David M. Whipple
Acting 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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POLYGANICS
Indications for Use Form
510(k) Number:
Device Name:
Nasopore® nasal dressing
Indications for Use:
Nasopore® nasal dressing is a fragmentable nasal dressing and is indicated for reacopying hasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control suparate and provent following surgery or nasal trauma by tamponade effect and blood absorption.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
(Division Sign-Off)
Prescription Use × (Per 21 CFR 801.109)
510(k) Number _
Over-The-Counter Use_
(Optional Format 1-2-96)
Amablit
(Divis on Sion-Nose an
510(k) Number K052099
29-Jul-2005
.
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