(448 days)
PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.
The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.
PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.
This document describes the PosiSep® EAR Fragmentable Ear Dressing, a medical device, and its acceptance criteria as demonstrated through a substantial equivalence submission to the FDA. The information provided focuses on comparing the device to a predicate device (NasoPore® Ear) and reference devices (PosiSep/PosiSep X) rather than detailing a specific clinical study with granular data on acceptance criteria and performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with numerical targets and corresponding reported device performance. Instead, substantial equivalence is claimed based on comparable characteristics to predicate devices. The key "acceptance criteria" are implied through the comparison parameters.
| Acceptance Criteria (Implied) | PosiSep® EAR Fragmentable Ear Dressing Performance (Reported/Claimed) |
|---|---|
| Classification | ENT Synthetic Polymer Material, Class II, Product Code NHB |
| Indications for Use | Same as predicate: Space-occupying stent, control minimal bleeding |
| Sterility | Supplied sterile (Gamma Sterilized) |
| Single-use | Single-use |
| Biocompatibility | Biocompatible (ISO 10993-1, non-cytotoxic, non-irritating, non-sensitive, non-pyrogenic, non-toxic) |
| Material Composition Effectiveness | Carboxymethyl Chitosan and Hydroxyethyl Cellulose (effective for stated indications) |
| Tamponade Effect | Helps control minimal bleeding by tamponade effect |
| Blood Absorption | Helps control minimal bleeding by blood absorption |
| Platelet Aggregation | Helps control minimal bleeding by platelet aggregation |
| Fragmentability/Elimination | Fragmentable and eliminated by natural excretion |
| Physical and Functional Requirements (Bench Testing) | Achieved after Design Verification Testing |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily relies on non-clinical performance data, specifically biocompatibility testing and performance bench testing. It does not mention a "test set" in the context of clinical data or patient samples for evaluating device performance against the specified indications. The evaluation appears to be based on:
- Biocompatibility testing: Performed internally, demonstrating compliance with ISO 10993 and FDA guidelines.
- Performance bench testing: Performed internally to demonstrate physical and functional requirements were met.
- Comparison to predicate devices: The primary data provenance is the established safety and effectiveness of the legally marketed predicate devices (NasoPore® Ear, PosiSep/PosiSep X).
The document does not specify a sample size for these non-clinical tests. As it's a 510(k) submission, the focus is on demonstrating "substantial equivalence" rather than conducting a de novo clinical trial with a large patient sample.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided because the submission primarily relies on non-clinical data and comparisons to predicate devices for demonstrating substantial equivalence, not on a clinical test set with human expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set with expert adjudication 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. The device described is a physical ear dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving 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
Not applicable, as the device is a physical medical dressing, not an algorithm.
7. The Type of Ground Truth Used
For biocompatibility, the ground truth is established by standardized biological tests (e.g., cytotoxicity, irritation, sensitization) following ISO 10993 guidelines, where "ground truth" means the objective results of these tests (e.g., non-cytotoxic). For performance, the "ground truth" relates to the physical and functional properties of the device meeting predetermined engineering specifications during bench testing.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as the device is not an AI/ML algorithm.
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May 19, 2022
Hemostasis LLC Lakshmi Ganesh Bollina Regulatory Associate 5000 Township Pkwy St Paul, Minnesota 55110
Re: K210411
Trade/Device Name: PosiSep® EAR Fragmentable Ear Dressing Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: NHB
Dear Lakshmi Ganesh Bollina:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 5, 2022. Specifically, FDA is updating this SE Letter to change the trade name from "PosiSep ME Fragmentable Ear Dressing" to "PosiSep® EAR Fragmentable Ear Dressing" as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shu-Chen Peng, OHT : Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6481.shu-chen.peng@fda.hhs.gov.
Sincerely,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the agency's acronym in a blue square, followed by the full name "U.S. Food & Drug Administration" in blue text.
May 5, 2022
Hemostasis LLC Lakshmi Ganesh Bollina Regulatory Associate 5000 Township Pkwy St Paul. Minnesota 55110
Re: K210411
Trade/Device Name: PosiSep ME Fragmentable Ear Dressing Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: NHB Dated: April 6, 2022 Received: April 7, 2022
Dear Lakshmi Ganesh Bollina:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
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
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801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice ( https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210411
Device Name
PosiSep® EAR Fragmentable Ear Dressing
Indications for Use (Describe)
PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
PosiSep® EAR Fragmentable Ear Dressing
| Date Prepared: | 03 May 2022 |
|---|---|
| Submitter: | Hemostasis, LLC5000 Township ParkwaySt. Paul, MN 55110Telephone: 651-855-1466Fax: 651-855-1465 |
| Contact: | Mr. Lakshmi Ganesh BollinaHemostasis Regulatory Affairs Associate5000 Township ParkwaySt. Paul, MN 55110Telephone: 480-579-1239Fax: 651-855-1465 |
| Proprietary Name: | PosiSep® EAR Fragmentable Ear Dressing |
| Common/Usual Name: | Fragmentable Ear Dressing |
| Classification Name: | ENT Synthetic Polymer MaterialProduct Code – NHB, Class II, 21 CFR 874.3620 |
| Predicate Device: | NasoPore® | K070715 |
|---|---|---|
| ------------------- | ----------- | --------- |
Reference Devices: PosiSep/PosiSep X K120958/K122494
Establishment Registration Number: 3007225047
Description:
The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.
PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.
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Indications for Use:
PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
- · As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
- · To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® EAR is intended for use under the direction of a licensed healthcare provider.
Comparison with Predicates:
The PosiSep® EAR Fragmentable Ear Dressing is substantially equivalent to the primary predicate, the Nasopore® Ear, for the following reasons:
- · Both have the same FDA Classification, Indications for Use.
- Both are sterile, single use devices that are indicated for use in patients undergoing outer . ear surgery.
- · Both contain materials proven biocompatible for their intended use in accordance with ISO 10993-1.
- · Both are provided in foam configurations and both fragment in equivalent time intervals sufficient for the intended use.
The differences between the subject device PosiSep® EAR and NasoPore® EAR are not critical to the intended use of the device, and do not affect the safety and effectiveness of the subject device when used as labeled. Both the subject and predicate devices are indicated to separate and prevent adhesions between mucosal surfaces and to control minimal bleeding following surgery.
The primary differences appear to be the composition of the Ear Dressing and the sterilization method.
- · Dressing composition: PosiSep® EAR uses an animal sourced Chitosan that is derivatized to include Carboxymethyl groups and Nasopore® Ear contains a synthetic sourced Poly(DL-lactide-co-e-caprolactone) urethane. Both are effective to separate and prevent adhesions between mucosal surfaces and to control minimal bleeding following surgery and biocompatible.
- Sterilization Method: PosiSep® EAR uses the gamma radiation sterilization method and ● Nasopore® Ear uses Ethylene Oxide (EtO) Sterilization method.
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| Parameter | Classification Name | Indications for Use | PosiSep® EAR Fragmentable EarDressing | Nasopore® Ear Fragmentable EarDressing | Supplied Sterile | Single-use/ReusableMaterial Composition | Packaging | Comparison |
|---|---|---|---|---|---|---|---|---|
| Substantial Equivalence Comparison to Predicate Device | ENT Synthetic Polymer Material, Class IIProduct Code NHB | ENT Synthetic Polymer Material,Class IIProduct Code NHB | ||||||
| PosiSep® EAR is a fragmentable eardressing and is indicated for use inpatients undergoing outer ear surgery:• As a space occupying stent to separateand prevent adhesions between mucosalsurfaces; and• To help control minimal bleedingfollowing surgery or trauma bytamponade effect, blood absorptionand platelet aggregation.PosiSep® EAR is intended for use underthe direction of a licensed healthcareprovider. | Nasopore® Ear is a fragmentable earpacking and is indicated for use inpatients, undergoing ear surgery, as aspace occupying stent to separate andprevent adhesions between mucosalsurfaces; to help control minimalbleeding, following ear surgery, bytamponade effect and blood absorption | |||||||
| Gamma Sterilized | Single-useCarboxymethyl Chitosan andHydroxyethyl Cellulose | PET/Foil Pouch | ||||||
| EtO Sterilized | Single-usePoly(DL-lactide-co-e-caprolactone)urethane | Single use, blister, cardboard box | ||||||
| Same | ||||||||
| Same | ||||||||
| Different methods butboth devices aresupplied sterile | ||||||||
| SameDifferent materialcomposition but both areeffective.Equivalent |
The table below provides a comparison of PosiSep® EAR with Nasopore® Ear
Fraditional 510(k)
Hemostasis LLC
May 03, 2022
ಳು
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| Biocompatibility | Cardboard CartonBiocompatible (10993-1) | Biocompatible (10993-1) | Same |
|---|---|---|---|
| In addition, the PosiSep® EAR Fragmentable Ear Dressing is same as the Hemostasis PosiSep® Family Hemostat Dressings/Intranasal Splints in terms of:• Material composition• Mechanism of action• Manufacturing• Sterilization• Packaging/Distribution | |||
| The only difference between PosiSep® EAR and the other PosiSep® Family devices is the compression of the device before packaging.• PosiSep® EAR devices are not compressed before packaging where the other PosiSep® Family devices are compressed before packaging. | |||
| Due to the differences in Intended Use PosiSep® EAR Fragmentable Ear Dressing has undergone additional biocompatibility testing based on the relevant endpoints defined by ISO 10993-1:2018 and the FDA: Use of International Standard ISO 10993, Biological evaluation of medical devices Part 1: Evaluation and Testing as a surface device with breached or compromised contacting device. |
() rr TT
Traditional 510(k)
Hemostasis LLC
May 03, 2022
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| Parameter | Comparison | ||
|---|---|---|---|
| Indications for Use | PosiSep® EAR Fragmentable EarDressingPosiSep® EAR is a fragmentable eardressing and is indicated for use inpatients undergoing outer ear surgery:• As a space occupying stent toseparate and prevent adhesionsbetween mucosal surfaces; and• To help control minimal bleedingfollowing surgery or trauma bytamponade effect, blood absorptionand platelet aggregation.PosiSep® EAR is intended for useunder the direction of a licensedhealthcare provider. | PosiSep® Family HemostatDressings/Intranasal SplintsPosiSep®/ PosiSep® X HemostatDressings/Intranasal Splints are indicated foruse in patients undergoing nasal/sinussurgery as a space occupying hemostat/splintto:• Separate tissue or structures compromisedby surgical trauma;• Separate and prevent adhesions betweenmucosal surfaces during mesothelial cellregeneration in the nasal cavity;• Help control minimal bleeding followingsurgery or trauma;• Help control minimal bleeding followingsurgery or nasal trauma by tamponadeeffect, blood absorption and plateletaggregation; and• Act as an adjunct to aid in the naturalhealing process.PosiSep®/ PosiSep® X are indicated for useas a nasal hemostat to treat epistaxis.PosiSep®/ PosiSep® X are intended for useunder the direction of a licensed healthcareprovider. | All Devices are indicatedfor use as Space occupyingstents to separate tissue andhelp control minimalbleeding.PosiSep EAR is indicatedfor Outer Ear surgery,while the currentlymarketed PosiSep Devicesare Nasal/Sinus Dressings |
The table below provides a comparison of PosiSep® EAR Fragmentable Ear Dressing with Reference Device
omparison to Reference Device
May 03, 2022
raditional 510(k)
Hemostasis LLC
ഗ
osiSep® EAR Fragmentable Ear Dressing
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| Mechanism of Action | Supplied Sterile | Single-use/Reusable | Material Composition | Compression | Packaging | Biocompatibility |
|---|---|---|---|---|---|---|
| Blood dehydration and concentration of serum proteins, platelets and fibrinogen leading to clotting | Gamma Sterilized | Single-use | Carboxymethyl Chitosan and Hydroxyethyl Cellulose | No | PET/Foil PouchCardboard Carton | Biocompatible:• Non-cytotoxic• Non-Irritating (Intracutaneous)• Non-Sensitive• Non-Pyrogenic• Non-Toxic (Acute Systemic Toxicity) |
| Same | Same | Same | Same | Lack of compression is specific for Ear Use. | Same | Biocompatible:• Non-Cytotoxic• Non-Irritating (Intracutaneous)• Non-Sensitive |
PosiSep® EAR Fragmentable Ear Dressing
Traditional 510(k)
Hemostasis LLC
May 03, 2022
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Biocompatibility:
Biocompatibility testing was performed using the guidelines of ISO 10993 - Biological Evaluation of Medical Devices and FDA guidance document Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices. The PosiSep® EAR Fragmentable Ear Dressing passed biocompatibility requirements for their intended use.
Sterilization, Packaging, Shelf Life:
The PosiSep® EAR Fragmentable Ear Dressing are sterilized using the same validated gamma radiation method as the PosiSep® family of devices to assure a sterility assurance level (SAL) of 10-6. The packaging/distribution and shelf-life are same as the PosiSep family of devices.
Performance Bench Testing:
Design verification testing was performed on PosiSep® EAR Fragmentable Ear Dressing to demonstrate physical and functional requirements were met.
Conclusion:
Through the data and information presented, Hemostasis, LLC considers the PosiSep® EAR Fragmentable Ear Dressing substantially equivalent to the Nasopore Ear Predicate device already in the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design, and functional performance and is supported by the reference predicate device. PosiSep EAR presents no new concerns about safety and effectiveness and is suitable for its intended use.
§ 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.