STASILON FR

K072890 · Entegrion, Inc. · QSY · Dec 10, 2007 · SU

Device Facts

• Record ID: K072890
• Device Name: STASILON FR
• Applicant: Entegrion, Inc.
• Product Code: QSY · SU
• Decision Date: Dec 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Stasilon FR™ is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.

Device Story

Stasilon FR™ is a single-use hemostatic wound dressing; composed of woven continuous filament fiberglass and bamboo yarns; edges sealed with high-melt pure paraffin wax. Applied externally to wounds with mechanical compression; functions by providing wound protection, reducing blood loss, and retaining clot integrity. Used in clinical or home settings for temporary bleeding control in lacerations, punctures, abrasions, and incisions. Healthcare providers or patients apply the dressing manually; compression facilitates hemostasis. Benefits include effective temporary hemorrhage control and improved clot stability during dressing removal compared to standard gauze.

Clinical Evidence

Bench testing and animal model studies provided. Device demonstrated superior hemostatic performance compared to gauze control in animal models. Biocompatibility testing completed successfully. No human clinical trial data reported.

Technological Characteristics

Textile-based wound dressing; materials: continuous filament fiberglass yarn and bamboo yarn; edges sealed with pure paraffin wax. Form factor: 4"x4" flat single-layer pad. Sterilization: Gamma radiation at 25 kGy (SAL 10^-6). Non-electronic; no software or algorithm.

Indications for Use

Indicated for temporary control of bleeding in minor cuts, lacerations, punctures, abrasions, and incisions in patients requiring external hemostatic wound dressing.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• HemCon Bandage and HemCon OTC (K043050)
• QuikClot ACS (K051955)
• D-Stat Dry Hemostatic Bandage (K061219)
• Syvekexcel (K053300)

Submission Summary (Full Text)

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Entegrion, Inc. c/o E.S. Eskridge, Jr. President 79 TW Alexander Drive, Suite 20 4401 Research Commons Research Triangle Park, North Carolina 27709 June 11, 2023

Re: K072890 Trade/Device Name: Stasilon FRTM Regulatory Class: Unclassified Product Code: QSY

Dear E.S. Eskridge, Jr .:

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 December 10, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, [e-mail].

> Sincerely, Julie A. Morabito -S Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing the bird's body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2007

Entegrion, Inc. % Mr E. S. Eskridge, Jr. President 79 TW Alexander Drive, Suite 20 4401 Research Commons Research Triangle Park, North Carolina 27709

Re: K072890 Trade/Device Name: Stasilon FR™ Regulatory Class: Unclassified Product Code: FRO Dated: October 10, 2007 Received: October 10, 2007

Dear Mr. Eskridge:

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 - Mr E. S. Eskridge, Jr.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stasilon FR™

Indications for Use:

and the same of the same of the same of the same of the same of the same of the same of

Stasilon FR™ is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Director Sign-Off) |
|--|----------------------------------|
| | All General, Restorative, 1 of 1 |
| | Neurologica. Devices |

| (Posted November 13, 2003) | 510 |
|----------------------------|----------|
| | 11022856 |

51

//022 BSC

Stasilon FR™

page 4-1

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stasilon FR™

Indications for Use:

Stasilon FR™ is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

XO72890

Page 1 of 1

(Posted November 13, 2003)

Stasilon FR™

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K072890 11

# 510(k) Summary

| Submitted by: | Entegrion, Inc. |
|---------------|----------------------------------|
| | 79 Alexander Drive, Suite 200 |
| | 4401 Research Commons |
| | Research Triangle Park, NC 27709 |
| | [phone] (phone) |
| | [phone] (fax) |
| | |

Stan Eskridge Contact: President and CEO [phone] (cell) DEC 1 0 2007 [e-mail]

October 9, 2007 Prepared on:

| Device name: | Stasilon™ |
|----------------------|--------------------------------------------|
| Trade name: | Stasilon FR™ |
| Common name: | Traumatic Wound Dressing, Topical Hemostat |
| Classification name: | Wound Dressing, Drug |
| Product Code: | FRO |
| Device Class: | Unclassified |

| Predicate Device Trade Name (510(k) Number) | Product Code |
|---------------------------------------------|--------------|
| HemCon Bandage and HemCon OTC (K043050) | FRO |
| QuikClot ACS (K051955) | FRO |
| D-Stat Dry Hemostatic Bandage (K061219) | FRO, DXC |
| Syvekexcel (K053300) | DXC |

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# Device Description

Stasilon™ is a textile technology that is manufactured from two component yarns: continuous filament fiber glass yarn and bamboo yarn. It is woven to a specific width and cut to length. The cut edges are sealed with a small amount of high melt temperature pure paraffin wax. The device is typically finished as a flat, four-inch square (4"x4"), single-layer pad that is individually packaged, sealed and Gamma sterilized at 25 kGy (SAL 10°) and sold under the trade name Stasilon FR™.

The component yarn materials and proprietary weave provide wound protection, reduce blood loss after contact with the wound, and help retain clot integrity during removal. The device shows superior performance when compared to the gauze control in animal models.

#### Intended Use

#### OTC

Stasilon FR™ is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.

#### RX

Stasilon FR™ is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.

# Substantial Equivalence Comparison Summary

Entegrion, Inc. has submitted information on indications for use, method of operation, composition, sterilization, packaging, labeling, and performance to operation/ composition FR™ is substantially equivalent to the currently marketed predicate devices. Stasilon FR™ has essentially the same intended use as the predicate devices, has successfully completed biocompatibility testing, and has been shown to provide hemostasis in animal models.

END OF SUMMARY