(69 days)
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.
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.
The document provided describes the NASOPORE FD nasal dressing, a line extension of the NASOPORE nasal dressing. The purpose of this submission is to demonstrate substantial equivalence to the predicate device (K052099; NASOPORE nasal dressing). The performance data presented focuses on in vitro testing to show that the technological characteristics and performance criteria of the new NASOPORE FD are comparable to the currently cleared predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines "Performance Data" from in vitro testing to demonstrate comparability. While not explicitly termed "acceptance criteria," these are the parameters used to establish substantial equivalence.
| Properties | Method | Current NASOPORE® Performance (Predicate Device) | New NASOPORE FD Performance (New Device) | Acceptance Criteria (Implied: Comparable to Predicate) |
|---|---|---|---|---|
| Shape integrity (shape intact in saline at 37°C) | Visual | >36 hours (in Saline) | >36 hours (in Saline) | >36 hours |
| Fragmentation time (In saline at 37°C) | Fragmentation test | 96 hours | 48 hours | N/A (Intentionally faster fragmentation) |
| Compression | Compressive strength measurement | >3 kPa (Firm) | >3 kPa | >3 kPa |
| Porosity | Porosity measurement | 95-98 % | 95-98 % | 95-98 % |
| Color | Visual | Off-white | Blue/Green | N/A (Color is a difference, deemed not to raise safety/effectiveness issues) |
| IV (intrinsic viscosity) | IV measurement | IV ≥ 0.8 dl/g | 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 | Biocompatible |
| Sterility | ISO11135-1 | SAL 10-6 (half cycle validation) | SAL 10-6 (rationale, identical blister pack and density) | SAL 10-6 |
| EtO Residuals | ISO10993-7 | < 2 mg/device | < 2 mg/device | < 2 mg/device |
| Composition | In process verification | Conform Polyurethane specification | Conform Polyurethane specification, additionally blended with PEG20.000 and D&C Green | Conform Polyurethane specification |
| Package integrity | ISO11607 | Qualified, Sterilized blisterpack | Qualified, Sterilized blisterpack | Qualified, Sterilized blisterpack |
| Shelf-life | ASTM F1980: Real time aging | 18 months | 6 months (interim results) | N/A (Shorter shelf-life is a difference, deemed not to raise safety/effectiveness issues) |
Note: The "Acceptance Criteria" column is implied based on the comparison to the predicate device. The goal of a 510(k) is to demonstrate substantial equivalence, meaning the new device performs as safely and effectively as a legally marketed predicate device. For most parameters, this means matching or exceeding the predicate's performance. For fragmentation time, the change is intentional and a defining characteristic of the "FD" (fragmentable) line extension.
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify the exact sample sizes for each in vitro test. It generally refers to "in vitro testing" without providing specific numbers of samples tested for, for example, compressive strength or porosity measurements.
- Data Provenance: The data is generated from in vitro testing of the device. The country of origin for the data is implicitly The Netherlands, as the submitter, Polyganics BV, is located in Groningen, The Netherlands. The study is a comparative in vitro study rather than clinical retrospective or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the provided document. The performance data is based on in vitro physical and chemical property testing, not on clinical evaluation requiring expert interpretation or ground truth establishment by medical professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the testing is in vitro and does not involve adjudication by multiple human experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is an intranasal splint, a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the in vitro tests is the direct measurement of the physical and chemical properties of the device according to established test methods and standards (e.g., ISO 10993 for biocompatibility, ISO 11135-1 for sterility, ASTM F1980 for shelf-life, and internal methods for fragmentation, compression, porosity, etc.). The reference point (or "ground truth" in terms of performance comparison) is the performance of the legally marketed predicate device, NASOPORE® (K052099).
8. The sample size for the training set:
This information is not applicable. The device is not an AI algorithm and therefore does not involve a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this device.
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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 BVRozenburglaan 15A9727 DL GroningenThe Netherlandswww.polyganics.com | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Contact Person: | Betty IJmkerManager QA/RA | ||||||||||||
| Tel | : +31 50 588 6598 | ||||||||||||
| Fax | : +31 50 588 6599 | ||||||||||||
| : 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 | CurrentNASOPORE® | New NASOPORE FD |
|---|---|---|---|
| Shape integrity(shape intact insaline at 37°C) | Visual | >36 hour(in Saline) | >36 hour (in Saline) |
| Fragmentation time(In saline at 37°C) | Fragmentationtest | 96hours | 48 hours |
| Compression | Compressivestrengthmeasurement | >3 kPa (Firm) | >3 kPa |
| Porosity | Porositymeasurement | 95-98 % | 95-98 % |
| Color | Visual | Off-white | Blue/Green |
| IV (intrinsicviscosity) | IV measurement | IV ≥ 0.8 dl/g | IV ≥ 0.8 dl/g |
| Biocompatibility | ISO 10993 | Biocompatible:Non-cytotoxicNon-irritating(intracutaneous andoral)Non-sensitive | Biocompatible:Non-cytotoxicNon-irritating(intracutaneous andoral)Non-sensitive |
| Sterility | ISO11135-1 | SAL 10-6 (half cyclevalidation) | SAL 10-6 (rationale,identical blister packand density) |
| EtO Residuals | ISO10993-7 | < 2 mg/device | < 2 mg/device |
| Composition | In processverification | ConformPolyurethanespecification | ConformPolyurethanespecificationadditionally blendedwith with PEG20.000and D&C Green |
| Package integrity | ISO11607 | Qualified, Sterilizedblisterpack | Qualified, Sterilizedblisterpack |
| Shelf-life | ASTM F1980:Real time aging | 18 months | 6 months (interimresults) |
Table 1: Summary of bench testing
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Summary of Substantial Equivalence
The design, materials, fundamental technology and intended use (safety and effectiveness) featured with the NASOPORE® FD Nasal Dressing are substantially equivalent to those featured with the following cleared device: Nasopore nasal dressing (K052099; Polyganics BV). The basis for equivalence is demonstrated by the comparisons in the following table:
| NASOPORE® FD (thissubmission) | CURRENT NASOPORE®(K052099) | |
|---|---|---|
| Intended use | NASOPORE® is a fragmentablenasal dressing and is indicatedfor use in patients undergoingnasal/sinus surgery as a spaceoccupying stent to separateand prevent adhesionsbetween mucosal surfaces; tohelp control minimal bleedingfollowing surgery or nasaltrauma by tamponade effectand blood absorption. | NASOPORE® is a fragmentablenasal dressing and is indicatedfor use in patients undergoingnasal/sinus surgery as a spaceoccupying stent to separateand prevent adhesionsbetween mucosal surfaces; tohelp control minimal bleedingfollowing surgery or nasaltrauma by tamponade effectand blood absorption. |
| Materials | poly(urethane) blended with acolor additive and PEG20.000 | poly(urethane) |
| Design | Foam | Foam |
| Sizes | 8cm | 4 and 8 cm |
| Sterilization | EtO | EtO |
| Shelf-life | 6 months (interim result) | 18 months |
| Packaging | Single use, blister, aluminiumpouch and silica gel,cardboard box | Single use, blister, cardboardbox |
Differences between the devices do not raise any significant issues of safety and effectiveness.
§ 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.