(478 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the granules and astringent, with no mention of AI or ML algorithms for analysis, prediction, or decision-making.
Yes.
The device is intended to absorb body fluid and stop minor bleeding in traumatic superficial lacerations or wounds, which is a direct therapeutic benefit to the patient.
No
Explanation: The device is indicated for use to absorb body fluid and stop minor bleeding in traumatic superficial lacerations or wounds. It is a treatment device, not a diagnostic one.
No
The device description clearly states it consists of "fine granules of a biocompatible polymer which encapsulate micron-sized particles of an astringent product," indicating a physical, material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Sorbastace's Function: Sorbastace is applied directly to the wound to absorb fluid and stop bleeding. It acts externally on the wound site and does not analyze a sample taken from the body.
- Intended Use: The intended use clearly states it's for absorbing body fluid and stopping minor bleeding in fresh traumatic superficial lacerations or wounds. This is a topical, wound management function, not an in vitro diagnostic test.
Therefore, Sorbastace falls under the category of a wound dressing or hemostatic agent, not an IVD.
N/A
Intended Use / Indications for Use
Sorbastace is indicated for use to absorb body fluid and to stop minor bleeding in fresh traumatic superficial lacerations or wounds. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied. It is intended to be distributed as an Over-The-Counter (OTC) device.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
The device consists of fine granules of a biocompatible polymer which encapsulate micron-sized particles of an astringent product. The granular product is packaged in single-patient use packets for convenient sprinkling into fresh traumatic, superficial lacerations or wounds.
The device in intended to be applied to fresh, traumatic, superficial lacerations or wounds to absorb body fluid and stop minor bleeding. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied.
The polymeric granules absorb fluid into their interior spaces and adsorb fluid onto their surfaces, in volume approximately equal to the volume of the granules. The relatively large surface area of the granules fosters coagulation. Within the interior space of the granules, the astringent is dissolved by the fluid. The astringent released from the granules then acts within the wound site to have a local and limited protein coagulant effect to help arrest secretion and stop minor bleeding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh traumatic superficial lacerations or wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter (OTC) device.
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)
Non-clinical testing:
Sorbastace has been evaluated for biocompatibility by subjecting it to the following battery of in vitro and animal tests: cytotoxicity, dermal sensitization, dermal irritation, acute system toxicity, and hemolysis. The retention and deposition of Sorbastace was evaluated through histopathological examination of animals treated with the device. Also, the absorbed dose of the astringent was measured and compared to that of absorption of aluminum sulfate of OTC styptic pencils subject to an FDA monograph. The capacity to absorb fluid was measured in an in vitro test. Tests in animals were performed to evaluate the ability of Sorbastace to stop minor bleeding in comparison to predicate device intended for the same use. Bacteriostatic and bactericidal activity of Sorbastace was evaluated for some common wound pathogens.
Clinical testing:
Clinical studies were not performed.
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.
Iodosorb Powder, Intrasite Cavity Wound Dressing, Kaltostat Wound Dressing, ClearSite Hydrogel Wound Dressing, and DeRoyal Hydrogel Dressing.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 11, 2023
Hemostace LLC. % David L. West, Ph.D. Senior Technical Adviser MTC Quintiles 15825 Shady Grove Road, Suite 90 Rockville, Maryland 20850
Re: K965034 Trade/Device Name: Sorbastace Regulatory Class: Unclassified Product Code: QSY
Dear David L. West, Ph.D.:
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 April 9, 1998. 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 1998
Hemostace, L.L.C. c/o David L. West. Ph.D. Senior Technical Advisor MTC Quintiles 15825 Shady Grove Road, Suite 90 Rockville, Maryland 20850
Re: K965034/S2 Trade Name: Sorbastace Regulatory Class: Unclassified Product Code: FRO Dated: January 9, 1998 Received: January 9, 1998
Dear Dr. West:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
-
This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
This device may not be labeled as a treatment or a cure for any type of wound. 4.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
2
Page 2 - Dr. West
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely vours.
Sincerely, yours,
[signature]
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
3
510(k) Number
None assigned at this time.
Device Name
Sorbastace
Indications for Use
Sorbastace is indicated for use to absorb body fluid and to stop minor bleeding in fresh traumatic superficial lacerations or wounds. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied. It is intended to be distributed as an Over-The-Counter (OTC) device.
Concurrence of CDRH, Office of Device Evaluation (ODE)
o Prescription Use ( per 21 CFR 801.109 )
প্র Over-The-Counter Use
FR 801.109 )
。
(Division Sinn off Division of General Ac 510(k) Num
4
510(k) Summary
Submitter:
Edgar Cohen Hemostace, L.L.C. 4123 Vinncennes Place New Orleans, Louisiana 70125
APR - 9 1998 K965034
Date Summary was Prepared:
April 8, 1998
Name(s) of the device:
Sorbastace
Identification of predicate device(s):
Iodosorb Powder, Intrasite Cavity Wound Dressing, Kaltostat Wound Dressing, ClearSite Hydrogel Wound Dressing, and DeRoyal Hydrogel Dressing.
Description of the device:
The device consists of fine granules of a biocompatible polymer which encapsulate micron-sized particles of an astringent product. The granular product is packaged in single-patient use packets for convenient sprinkling into fresh traumatic, superficial lacerations or wounds.
The device in intended to be applied to fresh, traumatic, superficial lacerations or wounds to absorb body fluid and stop minor bleeding. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied.
The polymeric granules absorb fluid into their interior spaces and adsorb fluid onto their surfaces, in volume approximately equal to the volume of the granules. The relatively large surface area of the granules fosters coagulation. Within the interior space of the granules, the astringent is dissolved by the fluid. The astringent released from the granules then acts within the wound site to have a local and limited protein coagulant effect to help arrest secretion and stop minor bleeding.
Intended Use:
Sorbastace in indicated for use to absorb body fluid and to stop minor bleeding in fresh traumatic superficial lacerations or wounds. Once exudation and bleeding has stopped, it is irrigated from the wound and a protective dressing can be applied. It is intended to be distributed as an Over-The-Counter (OTC) device.
5
Comparison of device characteristics to predicate:
Sorbastace consists of fine granules of a biocompatible polymer which encapsulate micron-sized particles of an astringent product. These characteristics compare to the cross-linked cadexomer beads with iodine of the Iodosorb Powder, the calcium-sodium alginate fiber of Kaltostat Wound Dressing, and the polyurethane foam chips and polymeric cover of Intrasite Cavity Wound Dressing.
Non-clinical testing:
Sorbastace has been evaluated for biocompatibility by subjecting it to the following battery of in vitro and animal tests: cytotoxicity, dermal sensitization, dermal irritation, acute system toxicity, and hemolysis. The retention and deposition of Sorbastace was evaluated through histopathological examination of animals treated with the device. Also, the absorbed dose of the astringent was measured and compared to that of absorption of aluminum sulfate of OTC styptic pencils subject to an FDA monograph. The capacity to absorb fluid was measured in an in vitro test. Tests in animals were performed to evaluate the ability of Sorbastace to stop minor bleeding in comparison to predicate device intended for the same use. Bacteriostatic and bactericidal activity of Sorbastace was evaluated for some common wound pathogens.
Clinical testing:
Clinical studies were not performed.
Conclusion:
Sorbastace has intended use in common with predicate devices. Sorbastace has technological characteristics common to these predicate devices. With regard to safety, Sorbastace is biocompatible as are the predicate devices and would present less absorbed dose of aluminum sulfate than the OTC styptic pencils subject to an FDA monograph. Therefore, Sorbastace is substantially equivalent to predicate, preamendment devices.