(110 days)
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.
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.
The provided 510(k) submission for POLYGANICS' KOS2099 Nasopore® nasal dressing is a submission for a Class I device and relies primarily on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints.
Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not typically required or present for a Class I device 510(k) relying on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Demonstrated via biocompatibility testing per ISO 10993. |
| No adverse events reported in summary, implied safe based on preclinical testing and equivalence to predicates. | |
| Effectiveness | In vitro fragmentation testing: Fragments within several days after insertion and is drained via natural mucus flow. |
| Shelf life testing: Demonstrated acceptable shelf life. | |
| Space occupying stent: Functions to separate and prevent adhesions between mucosal surfaces (by comparison to predicates). | |
| Control minimal bleeding: Provides tamponade effect and blood absorption (by comparison to predicates). | |
| Biocompatibility | Conforms to ISO 10993. |
| Mechanical/Physical Properties | Tested (details not specified, but implied to be comparable to predicates). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for specific tests. The submission mentions "design verification tests and analyses" and "biocompatibility, mechanical and physical property testing and in vitro fragmentation testing." These are typically conducted on a limited number of device samples in a lab setting, not a clinical "test set" in the context of human subjects.
- Data Provenance: The device's performance data is derived from in-vitro testing and pre-clinical analyses (e.g., biocompatibility) conducted by the manufacturer, Polyganics BV, likely in The Netherlands (their submitted address). It is retrospective in the sense that it's laboratory testing and comparisons, not a prospective clinical trial on human subjects for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in this type of 510(k) submission. For a Class I device demonstrating substantial equivalence, especially one relying on pre-clinical data and comparison to predicates, external experts determining ground truth for a clinical test set are not typically involved or required. The "ground truth" for the device's technical specifications and performance characteristics would be established by Polyganics' internal R&D and QA teams based on established test methods and standards (e.g., ISO 10993).
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies where multiple readers interpret clinical data (e.g., medical images) and their disagreements need resolution to establish a consensus ground truth. This 510(k) relies on lab-based testing and performance verification, not clinical interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of results and is not relevant for this device (a nasal dressing). The submission's focus is on the device's physical and biological properties and its equivalence to existing products.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This concept is not applicable to this device. "Standalone" performance is usually refers to the accuracy of an AI algorithm in performing a task without human intervention. The Nasopore® nasal dressing is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's safety and effectiveness is established through:
- Pre-clinical verification testing: This includes in-vitro fragmentation testing, shelf-life testing, biocompatibility testing (ISO 10993 standards), and mechanical/physical property testing. The results of these tests and their adherence to accepted scientific methods and standards form the basis of the "ground truth" for the device's functional characteristics.
- Comparison to predicate devices: The "ground truth" for its clinical utility (e.g., separating adhesions, controlling bleeding) is established through its substantial equivalence to legally marketed predicate devices with proven clinical histories.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The concept of a "training set" (used for machine learning algorithms) does not apply to this physical medical device. The device was designed and developed based on scientific and engineering principles, not trained on a dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided for the same reasons as point 8.
{0}------------------------------------------------
bioresorbable solution
POLYGANICS
KOS2099
NOV 2 1 2005
510(k) Summary of Safety and Effectiveness
| Submitter: | Polyganics BVL.J. Zielstraweg 19713 GX, GroningenThe Netherlandswww.polyganics.com |
|---|---|
| Contact Person: | Jan NieuwenhuisManaging DirectorTel : +31 50 588 6588Fax : +31 50 588 6599Mobile: +31 653 211 303E-mail : jan.nieuwenhuis@polyganics.com |
| Date Prepared: | July 27, 2005 |
| General Provisions: | Trade Name: Nasopore®Common Name: Nasal DressingClassification Name: Intranasal Splint, 21 CFR 874.4780Device 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. |
{1}------------------------------------------------
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 | fragmentablepoly(DL-lactide-co-ε-caprolactone)thane | Chemically modifiedhyaluronic acid andure-carboxymethylcellulose | Esterified hyaluronic acid | Esterified hyaluronic acidand collagen |
| Method of action | Hygroscopic, frag-ments in contactwith fluids | Hygroscopic, formsgelatinous mass incontact with fluids | Hygroscopic, forms gelatinous mass in contact withfluids | Hygroscopic, forms gelatinous mass in contactwith fluids |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | ISO 10993 and FDAguidance G95-1 |
Device Characteristics of the Subject and Predicate devices
{3}------------------------------------------------
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
{5}------------------------------------------------
bioresorbable solution
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
.
Page 8 of 44
§ 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.