(448 days)
No
The device description and intended use focus on the material properties and physical function of the dressing for hemostasis and stenting. There is no mention of AI, ML, image processing, or data-driven analysis.
Yes
It is indicated for use in patients undergoing outer ear surgery to prevent adhesions between mucosal surfaces and to control minimal bleeding, directly treating a medical condition.
No
The device is described as a "space occupying stent" and a "dressing to help control minimal bleeding" after surgery or trauma. Its function is therapeutic (hemostasis and stenting), not diagnostic.
No
The device description clearly states it is a sterile dressing comprised of physical materials (modified Chitosan particles and polysaccharide binder), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in patients undergoing outer ear surgery as a space occupying stent and to help control bleeding. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a sterile dressing used in vivo (within the body) to absorb blood and promote clotting. This is consistent with a surgical or therapeutic device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test samples like blood, urine, or tissue in vitro to diagnose a condition, monitor treatment, or screen for diseases.
Therefore, the PosiSep® EAR Fragmentable Ear Dressing is a medical device used during surgery, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHB
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
outer ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Testing:
Design verification testing was performed on PosiSep® EAR Fragmentable Ear Dressing to demonstrate physical and functional requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
1
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
2
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
3
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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4
510(k) Summary
PosiSep® EAR Fragmentable Ear Dressing
| Date Prepared: | 03 May 2022 |
|---|---|
| Submitter: | Hemostasis, LLC |
| 5000 Township Parkway | |
| St. Paul, MN 55110 | |
| Telephone: 651-855-1466 | |
| Fax: 651-855-1465 | |
| Contact: | Mr. Lakshmi Ganesh Bollina |
| Hemostasis Regulatory Affairs Associate | |
| 5000 Township Parkway | |
| St. Paul, MN 55110 | |
| Telephone: 480-579-1239 | |
| Fax: 651-855-1465 | |
| Proprietary Name: | PosiSep® EAR Fragmentable Ear Dressing |
| Common/Usual Name: | Fragmentable Ear Dressing |
| Classification Name: | ENT Synthetic Polymer Material |
| Product 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.
5
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.
6
| Parameter | Classification Name | Indications for Use | PosiSep® EAR Fragmentable Ear
Dressing | Nasopore® Ear Fragmentable Ear
Dressing | Supplied Sterile | Single-use/Reusable
Material Composition | Packaging | Comparison |
|--------------------------------------------------------|---------------------|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------|
| Substantial Equivalence Comparison to Predicate Device | | | ENT Synthetic Polymer Material, Class II
Product Code NHB | ENT Synthetic Polymer Material,
Class II
Product Code NHB | | | | |
| | | | PosiSep® EAR is a fragmentable ear
dressing and 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. | 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 | | | | |
| | | | | | Gamma Sterilized | Single-use
Carboxymethyl Chitosan and
Hydroxyethyl Cellulose | PET/Foil Pouch | |
| | | | | | EtO Sterilized | Single-use
Poly(DL-lactide-co-e-caprolactone)
urethane | Single use, blister, cardboard box | |
| | | | | | | | | |
| | | | | | | | | Same |
| | | | | | | | | Same |
| | | | | | | | | Different methods but
both devices are
supplied sterile |
| | | | | | | | | Same
Different material
composition but both are
effective.
Equivalent |
The table below provides a comparison of PosiSep® EAR with Nasopore® Ear
Fraditional 510(k)
Hemostasis LLC
May 03, 2022
ಳು
7
| Biocompatibility | Cardboard Carton
Biocompatible (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
8
| Parameter | Comparison | ||
|---|---|---|---|
| Indications for Use | PosiSep® EAR Fragmentable Ear | ||
| Dressing |
PosiSep® EAR is a fragmentable ear
dressing and 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. | PosiSep® Family Hemostat
Dressings/Intranasal Splints
PosiSep®/ PosiSep® X Hemostat
Dressings/Intranasal Splints are indicated for
use in patients undergoing nasal/sinus
surgery as a space occupying hemostat/splint
to:
• Separate tissue or structures compromised
by surgical trauma;
• Separate and prevent adhesions between
mucosal surfaces during mesothelial cell
regeneration in the nasal cavity;
• Help control minimal bleeding following
surgery or trauma;
• Help control minimal bleeding following
surgery or nasal trauma by tamponade
effect, blood absorption and platelet
aggregation; and
• Act as an adjunct to aid in the natural
healing process.
PosiSep®/ PosiSep® X are indicated for use
as a nasal hemostat to treat epistaxis.
PosiSep®/ PosiSep® X are intended for use
under the direction of a licensed healthcare
provider. | All Devices are indicated
for use as Space occupying
stents to separate tissue and
help control minimal
bleeding.
PosiSep EAR is indicated
for Outer Ear surgery,
while the currently
marketed PosiSep Devices
are 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
9
| 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 Pouch | |
| Cardboard 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
10
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.