(69 days)
Not Found
No
The 510(k) summary describes a physical nasal dressing and its material properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to prevent adhesions, control bleeding, and absorb blood, all of which are actions aimed at managing or treating a condition post-surgery.
No
Explanation: The device, NASOPORE FD, is a nasal dressing used as a space-occupying stent, to prevent adhesions, and to help control bleeding. Its function is therapeutic and supportive, not to diagnose a condition or disease.
No
The device is a physical nasal dressing made of bioresorbable material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a "fragmentable nasal dressing" used "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." This describes a device used within the body for a therapeutic and supportive purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description focuses on the material composition, fragmentation properties, and physical characteristics of the nasal dressing. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies described evaluate physical properties (shape integrity, fragmentation time, compression, porosity), chemical composition, biocompatibility, and sterility. These are typical evaluations for a medical device used in surgery, not for an IVD which would focus on analytical performance (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
NASOPORE ® FD 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
LYA
Device Description
- NASOPORE "FD is composed of a bioresorbable poly(DL-lactide-co-s-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® FD size and type are indicated on the label and are packed in a blister. NASOPORE "FD is indicated for single-use.
The modification in this submission concerns a line extension to the predicate device NASOPORE "with a NASOPORE" FD that fragments faster than the cleared predicate device.
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
In vitro testing for this line extension demonstrated that the technological characteristics and performance criteria of the additional NASOPORE type are comparable to the currently cleared NASOPORE nasal dressing and that they can perform in a manner equivalent to NASOPORE devices currently on the market for the same intended use. The results of the in vitro testing are summarized below:
Properties: Shape integrity (shape intact in saline at 37°C), Fragmentation time (In saline at 37°C), Compression, Porosity, Color, IV (intrinsic viscosity), Biocompatibility, Sterility, EtO Residuals, Composition, Package integrity, Shelf-life.
Method: Visual, Fragmentation test, Compressive strength measurement, Porosity measurement, Visual, IV measurement, ISO 10993, ISO11135-1, ISO10993-7, In process verification, ISO11607, ASTM F1980: Real time aging.
Current NASOPORE® results:
36 hour(in Saline)
96hours
3 kPa (Firm)
95-98 %
Off-white
IV ≥ 0.8 dl/g
Biocompatible: Non-cytotoxic, Non-irritating (intracutaneous and oral), Non-sensitive
SAL 10-6 (half cycle validation)
36 hour (in Saline)
48 hours
3 kPa
95-98 %
Blue/Green
IV ≥ 0.8 dl/g
Biocompatible: Non-cytotoxic, Non-irritating (intracutaneous and oral), Non-sensitive
SAL 10-6 (rationale, identical blister pack and density)
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a single, continuous line. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Ms. Betty Ijmker Manager OA/RA c/o Polyganics Bv Rozenburglaan 15A GRONINGEN, NL 9727-DL
Re: K141423
Trade/Device Name: Nasopore-fd Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: July 8, 2014 Received: July 14, 2014
Dear Ms. Ijmker:
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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for 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 | K |
|---|---|
| Device Name | NASOPORE ® FD nasal dressing |
| Indications for Use | NASOPORE ® FD 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. |
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ x___________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801. 109)
OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
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Special 510(k) Summary of Safety and Effectiveness Line extension to NASOPORE nasal dressing
| Submitter: | Polyganics BV
Rozenburglaan 15A
9727 DL Groningen
The Netherlands
www.polyganics.com | | | | | | | | | | | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------|--------------|----------------|----------------------|-------------------|-------------------|---------|--------------|---------------|---------------|-----|
| Contact Person: | Betty IJmker
Manager QA/RA | | | | | | | | | | | | |
| Tel | : +31 50 588 6598 | | | | | | | | | | | | |
| Fax | : +31 50 588 6599 | | | | | | | | | | | | |
| E-mail | : b.ijmker@polyganics.com | | | | | | | | | | | | |
| Date Prepared: | 27 May 2014 | | | | | | | | | | | | |
| General Provisions: | | | | | | | | | | | | | |
| | Trade Name:NASOPORE® FD Nasal DressingCommon Name:Nasal DressingClassification Name:Intranasal splintRegulatory class:Class IRegulation #21CFR874.4780Product code:LYA | Trade Name: | NASOPORE ® FD Nasal Dressing | Common Name: | Nasal Dressing | Classification Name: | Intranasal splint | Regulatory class: | Class I | Regulation # | 21CFR874.4780 | Product code: | LYA |
| Trade Name: | NASOPORE ® FD Nasal Dressing | | | | | | | | | | | | |
| Common Name: | Nasal Dressing | | | | | | | | | | | | |
| Classification Name: | Intranasal splint | | | | | | | | | | | | |
| Regulatory class: | Class I | | | | | | | | | | | | |
| Regulation # | 21CFR874.4780 | | | | | | | | | | | | |
| Product code: | LYA | | | | | | | | | | | | |
| Predicate Device: | Nasopore Polyganics BV K052099 | | | | | | | | | | | | |
| Performance Standards | For the performance of intranasal splints, the FDA, under section 514 of the Food, Drug and Cosmetic Act, has not established standards. | | | | | | | | | | | | |
| Indications for Use | NASOPORE ® FD 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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- NASOPORE "FD is composed of a bioresorbable poly(DL-lactide-co-s-Device Description 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® FD size and type are indicated on the label and are packed in a blister. NASOPORE "FD is indicated for single-use.
The modification in this submission concerns a line extension to the predicate device NASOPORE "with a NASOPORE" FD that fragments faster than the cleared predicate device.
- Performance Data: In vitro testing for this line extension demonstrated that the technological characteristics and performance criteria of the additional NASOPORE type are comparable to the currently cleared NASOPORE nasal dressing and that they can perform in a manner equivalent to NASOPORE devices currently on the market for the same intended use. The results of the in vitro testing are summarized below:
| Properties | Method | Current
NASOPORE® | New NASOPORE FD |
|--------------------------------------------------------|----------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Shape integrity
(shape intact in
saline at 37°C) | Visual | >36 hour(in Saline) | >36 hour (in Saline) |
| Fragmentation time
(In saline at 37°C) | Fragmentation
test | 96hours | 48 hours |
| Compression | Compressive
strength
measurement | >3 kPa (Firm) | >3 kPa |
| Porosity | Porosity
measurement | 95-98 % | 95-98 % |
| Color | Visual | Off-white | Blue/Green |
| IV (intrinsic
viscosity) | IV measurement | IV ≥ 0.8 dl/g | IV ≥ 0.8 dl/g |
| Biocompatibility | ISO 10993 | Biocompatible:
Non-cytotoxic
Non-irritating
(intracutaneous and
oral)
Non-sensitive | Biocompatible:
Non-cytotoxic
Non-irritating
(intracutaneous and
oral)
Non-sensitive |
| Sterility | ISO11135-1 | SAL 10-6 (half cycle
validation) | SAL 10-6 (rationale,
identical blister pack
and density) |
| EtO Residuals | ISO10993-7 |