(54 days)
Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.
Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-s-caprolactone) urethane that fragments within several days after insertion in the outer and / or middle ear, whereafter it will fall out of the ear or leaves the body by the natural mucus flow. The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.
The provided text describes a 510(k) premarket notification for the Nasopore® Ear device and focuses on its substantial equivalence to predicate devices rather than a detailed clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not explicitly present in the provided document.
However, based on the spirit of the request and what is available, here's a structured interpretation:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define quantitative "acceptance criteria" in the way one might expect for a diagnostic AI device (e.g., target sensitivity/specificity). Instead, the "performance" verification focuses on design characteristics demonstrating safety and equivalence.
| Acceptance Criteria (Implied from Submission) | Reported Device Performance (as demonstrated by design verification tests and analyses) |
|---|---|
| Material Degradation: Device fragments and is bioresorbable. | In-vitro Degradation Testing: Performed to demonstrate the material fragments and bioresorbable nature within several days after insertion. (Specific data not provided) |
| Shelf Life: Device maintains its properties over its stated shelf life. | Shelf Life Testing: Performed to confirm the device's stability over time. (Specific data not provided) |
| Biocompatibility: Device material is safe for use in the body. | Biocompatibility: Demonstrated by the fact that the material (poly(DL-lactide-co-s-caprolactone) urethane) is the same as the predicate Nasopore® Nasal Dressing (K052099), which has demonstrated satisfactory biocompatibility. |
| Functional Equivalence (Physical Characteristics): Similar physical properties to predicate. | Physical Characteristics: Stated to be equivalent to Nasopore® Nasal Dressing, as it's made from the same material and uses an identical manufacturing process. |
| Functional Equivalence (Intended Use): Performs similarly to predicate for its indicated use. | Intended Use: Stated to be substantially equivalent to Nasopore® Nasal Dressing for use as a space-occupying stent, preventing adhesions, and controlling minimal bleeding, differing only in anatomical location (outer/middle ear vs. nasal/sinus cavities). Also equivalent to Invotec Ear Tampon for its primary function. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as no "test set" in the sense of patient data for evaluating diagnostic performance (like an AI model) was used. The evaluation was based on design verification tests (in-vitro) and comparison to a predicate device.
- Data Provenance: The data primarily relates to in-vitro testing and manufacturing process descriptions. There is no mention of country of origin for patient data or whether it was retrospective or prospective, as no clinical study focused on patient outcomes was presented for this device. The biocompatibility claim relies on prior approval of the predicate device (Nasopore® Nasal Dressing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment by medical experts for a diagnostic performance test set is described.
4. Adjudication method for the test set
Not applicable. No diagnostic test set or adjudication process is described.
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
Not applicable. This device is a medical implant (ear packing) and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical implant and not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the established safety and efficacy of the predicate devices. For biocompatibility, the ground truth is the previous determination of "satisfactory biocompatible" for the poly(DL-lactide-co-s-caprolactone) urethane material used in the Nasopore® Nasal Dressing. For functional aspects, the ground truth is the known performance and indications for use of the predicate devices (Nasopore® Nasal Dressing and Invotec Ear Tampon).
8. The sample size for the training set
Not applicable. No training set for an AI/algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable.
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Nasopore® Ear
Ko 70715
Traditional 510(k) Premarket Notification
bioresorbable soft
POLYGANICS
:
.
| 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: | March 07, 2007 |
| MAY - 7 2007 | |
| General Provisions: | Trade Name: Nasopore®Common Name: Fragmentable ear dressingClassification Name: ENT synthetic polymer material21 CFR 874.3620, Class II |
| Predicate Devices: | Invotec Ear Tampon (Wick) w/String; Invotec Internat.; K973578Nasopore® nasal dressing, Polyganics, K052099 |
| 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® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption. |
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Traditional 510(k) Premarket Notification
Device Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-s-Description caprolactone) urethane that fragments within several days after insertion in the outer and / or middle ear, whereafter it will fall out of the ear or leaves the body by the natural mucus flow.
The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.
The safety and effectiveness of the Nasopore® have been demonstrated via Performance data collected from design verification tests and analyses. The design Data: verification testing consisted of the following:
- In vitro degradation testing -
- Shelf life testing -
The intended use of Nasopore Ear is substantially equivalent to those Summary of featured with the competitor device Invotec Ear Tampon (Wick) w/String (ref. Substantial 510(k)973578). The safety (biocompatibility) and efficacy of Nasopore® Ear Equivalence is demonstrated by its substantial equivalent Nasopore® Nasal dressing (ref. 510(k)052099; Polyganics BV).
Polyganics BV already markets Nasopore® Nasal Dressing. The subject device. Nasopore® Ear, is made from the same material as Nasopore® Nasal Dressing. The subject device is substantially equivalent to Nasopore® Nasal Dressing with respect to physical characteristics and with regard to the intended use of the device. i.e. a space occupying stent to separate and prevent adhesions between mucosal surfaces and help control minimal bleeding following surgery, by tamponade effect and blood absorption, Nasopore® Nasal dressing in the nasal/sinus cavities and Nasopore® Ear in the outer ear. The predicate device Nasopore® Nasal Dressing is made of a fragmentable poly(DL-lactide-co-s-caprolactone) urethane and the identical manufacturing process is used to produce the foam. The subject and predicate device are made of poly(DL-lactide-co-s-caprolactone) urethanen, which has demonstrated to be satisfactory biocompatible. Next to the Nasopore® nasal dressing, Polyganics also markets Nasopore® Ear (K062540). This product is intended as a packing used after outer ear surgery. However the middle ear possesses a connection to the Eustachian tube, which indicates that the fragments, obtained during fragmentation, can leave the body via the natural mucus flow.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Polyganics BV c/o Jan Nieuwenhuis L.J. Zielstraweg 1 NL-9713-GX Groningen The Netherlands
MAY - 7 2007
Re: K070715
Trade/Device Name: Polyganics Nasopore® Ear Regulation Number: 21 CFR 874.3620 Regulation Name: ENT Synthetic Polymer Material Regulatory Class: II Product Code: NHB Dated: March 12, 2007 Received: March 14, 2007
Dear Ms. Nieuwenhuis:
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.
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Page 2 – Jan Nieuwenhuis
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eickelman SiwD
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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Nasopore® Ear
Image /page/4/Picture/2 description: The image shows the words "bioresorbable solution" and "POLYGANICS". Above these words is the text "K070715" in a handwritten style. The words "bioresorbable solution" are in a smaller font size than the word "POLYGANICS".
Indications for Use Form
510(k) Number:
Device Name:
Nasopore® Ear
Indications for Use:
Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, 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)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off)
OR
510(k) Number__
Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Numbe 07 March 2007
Page 8 of 45
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.