(108 days)
HEMOPORE® is intended for use in patients undergoing nasal/simus surgery as a temporary wound dressing.
HEMOPORE® functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation.
It acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema.
HEMOPORE® is a sterile fragmentable nasal dressing of 8 cm composed of poly(DL-lactide-cos-caprolactone) urethane and blended with a chitosan derivate and a violet color additive.
After insertion of HEMOPORE®in the nasal cavity, fluids will be absorbed by the dressing, which helps to control bleeding after surgery.
The dressing fragments within several days by hydrolyzing ester bonds, whereafter it is drained from the nasal cavity via the natural mucus flow.
The HEMOPORE® is sterilized in a blister package. The device is single-use, cannot be resterilized, and is a prescription product.
This document is a 510(k) Pre-market Notification for the HEMOPORE® device. The provided text describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria, detailed study results with reported device performance metrics against those criteria, or information regarding sample sizes, data provenance, expert involvement, or MRMC studies that would be typically found in a clinical study report or a more comprehensive technical document.
Therefore, many of the requested items cannot be extracted from this document.
Here's what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Complies with ISO 10993 and FDA guidance (G95-1) for biological evaluation. | HEMOPORE® complies with the biocompatibility requirements for their intended use. |
| Degradation: (Implicit: Fragments within several days by hydrolyzing ester bonds) | Degradation test performed, criteria met (specifics of criteria not provided). |
| Shelf-life: (Implicit: Maintains functionality over stated shelf-life) | Shelf-life test performed, criteria met (specifics of criteria not provided). |
| Absorption: (Implicit: Absorbs fluids to control bleeding) | Absorption test performed, criteria met (specifics of criteria not provided). |
| Thrombogenicity/Hemostasis: (Implicit: Has appropriate hemostatic properties, at least equivalent to predicates) | Thrombogenicity testing demonstrated HEMOPORE® has appropriate hemostatic properties to assure effectiveness and performs at least equivalent to predicate devices. |
| Technological Characteristics: Similar to predicate devices, with color additive not raising safety/effectiveness concerns. | HEMOPORE shares the same indications for use, device operation, and overall technical and functional capabilities. Performance test data demonstrated at least adequate device performance. |
| Safety and Effectiveness: As safe and effective as predicate devices. | Results of all testing demonstrate substantial equivalence and no concerns about safety and/or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided. The document mentions "in vitro testing" and "biocompatibility testing" but does not specify the number of samples used for these tests.
- Data provenance: Not provided. The type of study (e.g., retrospective or prospective) is not mentioned beyond "in vitro testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. The testing described (biocompatibility, degradation, shelf-life, absorption, thrombogenicity) appears to be laboratory-based physical and chemical performance testing, not human-read clinical data that would require expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided, for the same reasons as item 3.
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
- No. This is not an AI/imaging device. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (intranasal splint/dressing), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance testing mentioned (biocompatibility, degradation, shelf-life, absorption, thrombogenicity), the "ground truth" would be established by standardized laboratory methods, physical/chemical measurements, and potentially comparison to predicate devices' known performance characteristics. There is no mention of clinical ground truth such as pathology or outcomes data in this summary.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. (See item 8).
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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 consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
Polyganics BV Ms. Betty IJmker Manager QA/RA Rozenburglaan 15a 9727 DL Groningen The Netherlands
Re: K141816 Trade/Device Name: Hemopore Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: September 18, 2014 Received: September 23, 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 devicerelated 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" (21 CFR 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
510(k) Number (if known) K141816
Device Name HEMOPORE®
Indications for Use (Describe)
HEMOPORE® is intended for use in patients undergoing nasal/simus surgery as a temporary wound dressing.
HEMOPORE® functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation.
It acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary of Safety and Effectiveness
Submitter
Polyganics BV Rozenburglaan 15A 9727 DL Groningen The Netherlands www.polyganics.com
Contact person:
Betty IJmker Manager QA/RA Tel : +31 50 588 6599 Fax E-mail : b.ijmker@polyganics.com
Date Prepared: July 2, 2014
General Provisions:
HEMOPORE® Trade Name: Common Name: Hemostatic Nasal Dressing Classification Name: Intranasal splint CFR Section: 21 CFR 874.4780 Product Code: LYA Device Class: Class I
Predicate Devices:
K052099 - Nasopore® nasal dressing K122494 - PosiSep™ and PosiSep™ X Hemostat Dressing/Intranasal Splint
Performance Standards: None
Device Description
HEMOPORE® is a sterile fragmentable nasal dressing of 8 cm composed of poly(DL-lactide-cos-caprolactone) urethane and blended with a chitosan derivate and a violet color additive.
After insertion of HEMOPORE®in the nasal cavity, fluids will be absorbed by the dressing, which helps to control bleeding after surgery.
The dressing fragments within several days by hydrolyzing ester bonds, whereafter it is drained from the nasal cavity via the natural mucus flow.
The HEMOPORE® is sterilized in a blister package. The device is single-use, cannot be resterilized, and is a prescription product.
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Indications for Use
HEMOPORE® is intended for use in patients undergoing nasal/sinus surgery as a temporary wound dressing.
HEMOPORE® functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation.
lt acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema.
Comparison of technological characteristics with the predicate device
The technological principle is based on the use of nasal dressings as a space-occupying device in the nasal and sinus cavities after nasal and sinus surgery. The predicate devices, NASOPORE® and POSISEP®, as well as the subject device HEMOPORE®, have the same technological principle as HEMOPORE®: to function as a temporary wound dressing, controlling mild bleeding by tamponade effect and blood absorption. The subject device and the predicate devices are made from fragmentable biomaterials, meaning that the material is spontaneously cleared from the nasal cavities.
The technological difference between the subject and predicate devices is the addition of a color additive in the subject device, but this does not raise issues of safety and effectiveness.
HEMOPORE shares the same indications for use, device operation, and overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices for use as a space-occupying stent/packing for nasal/sinus use. Additionally, performance test data has demonstrated at least adequate device performance.
Performance data
Biocompatibility testing
Biocompatibility testing was performed using ISO 10993 - Biological Evaluation of Medical Devices, and FDA guidance document Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1). HEMOPORE® complies with the biocompatibility requirements for their intended use.
Bench testing
The following in vitro testing demonstrated that the technological characteristics and performance criteria of HEMOPORE® were met:
- Degradation test -
- Shelf-life test ।
- Absorption test
Thrombogenicity testing was performed to compare the predicate devices with the subject device. The data demonstrated that HEMOPORE® has appropriate hemostatic properties to assure effectiveness for its intended use and performs in a manner that is at least equivalent to the predicate devices.
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Summary of substantial equivalence
The results of all testing conducted demonstrate that the HEMOPORE® device is substantially equivalent to its predicate devices NASOPORE®, POSISEP™, and POSISEP™ -X, in terms of indications for use, technological characteristics and design, and presents no concerns about safety and/or effectiveness.
lt can be concluded that HEMOPORE® is as safe, as effective, and performs at least equivalent to its predicate devices.
§ 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.