(61 days)
Not Found
No
The device description focuses on the material composition and mechanical properties of a hemostatic wound dressing. There is no mention of AI, ML, or any computational processing of data.
Yes.
The device is intended to temporarily control bleeding, which is a therapeutic action.
No
The device is a hemostatic wound dressing used to control bleeding, not to diagnose a condition or disease.
No
The device description clearly states it is a textile technology manufactured from physical materials (fiber glass and bamboo yarn) and is a physical wound dressing. There is no mention of software components.
Based on the provided information, Stasilon FR™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "temporarily control bleeding in lacerations, punctures, abrasions and incisions." This is a direct application to a wound on the body, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device is a "single-use hemostatic wound dressing applied externally." This further reinforces its external application to a wound.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Stasilon FR™'s function is to physically help control bleeding on a wound, which is a therapeutic/hemostatic action, not a diagnostic one.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The device shows superior performance when compared to the gauze control in animal models. Stasilon FR™ has successfully completed biocompatibility testing, and has been shown to provide hemostasis in animal models.
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.
K043050, K051955, K061219, K053300
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.
Not Found
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and full name on the right. The Department of Health and Human Services seal is a stylized depiction of an eagle. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text to the right of the square.
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, Julie.Morabito@fda.hhs.gov.
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
1
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.
2
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
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
3
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
4
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™
5
K072890 11
510(k) Summary
| Submitted by: | Entegrion, Inc. |
|---|---|
| 79 Alexander Drive, Suite 200 | |
| 4401 Research Commons | |
| Research Triangle Park, NC 27709 | |
| (919) 536-1500 (phone) | |
| (919) 536-1700 (fax) | |
Stan Eskridge Contact: President and CEO (919) 423 6050 (cell) DEC 1 0 2007 stan.eskridge@entegrion.com
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 |
6
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