Not Found
No
The device description and performance studies focus on the material properties and hemostatic function of oxidized cellulose, with no mention of AI or ML.
No
CELSTAT is a hemostatic dressing used to control bleeding, which falls under wound management rather than a therapeutic device for treating diseases or conditions.
No
Explanation: The device is a hemostatic dressing used to control bleeding from wounds; it does not diagnose any conditions or provide diagnostic information.
No
The device description clearly states it is a "topical hemostatic dressing made of oxidized cellulose," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "topical external use in the management of topical wounds and to temporarily control moderate to severe bleeding from the skin." This describes a device that is applied directly to the body surface for a therapeutic purpose (hemostasis).
- Device Description: The description confirms it's a "topical hemostatic dressing made of oxidized cellulose." This is a physical material used externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of biological specimens outside the body.
Therefore, CELSTAT is a topical hemostatic device, not an IVD.
N/A
Intended Use / Indications for Use
CELSTAT is indicated for topical external use in the management of topical wounds and to temporarily control moderate to severe bleeding from the skin.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
CELSTAT is a topical hemostatic dressing made of oxidized cellulose. It is a sterile, biocompatible, biodegradable hemostatic material designed to temporarily control moderate to severe bleeding from the skin.
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)
Device performance has been demonstrated according to a porcine liver square model animal study and biocompatibility testing.
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.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
July 28, 2023
Baxter Healthcare Corporation c/o Jesse K. Seidman, M.S. Associate Director, Global Regulatory Affairs 1620 Waukegan Road McGaw Park, Illinois 60085
Re: K103245 Trade/Device Name: CELSTAT Topical Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY
Dear Jesse K. Seidman, M.S.:
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 March 23, 2011. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Baxter Healthcare Corporation % Mr. Jesse K. Seidman, M.S. Associate Director, Global Regulatory Affairs 1620 Waukegan Road McGaw Park, Illinois 60085
MAR 2 3 2011
Re: K103245
Trade/Device Name: CELSTAT Topical Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 13, 2011 Received: January 18, 2011
Dear Mr. Seidman:
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, Orug 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 I (The general controls provisions of the Act include requirements for annual registration, Insting 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 micheading.
If your device is classified (see above) into either class I! (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can he 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
2
Page 2 - Mr. Jesse K. Seidman, M.S.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the eectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers0ffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 the (800) 638-2041 or (301) 796-7100 or at its Internet oorlaan http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
A. B. R.
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K103245
Device Name:
CELSTAT Topical Hemostatic Dressing
Indication for Use:
CELSTAT is indicated for topical external use in the management of topical wounds and to temporarily control moderate to severe bleeding from the skin.
ি Prescription Use:
21 CFR 801 Subpart D
AND/OR
Over-the-Counter Use: Г
21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krane for MKM
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103245
Page I of I
4
MAR 2 3 2011
K10.3245
pase 1 of 2
Traditional 510(k) Premarket Notification CELSTAT Topical Hemostatic Dressing
Page 1 of 2 Section 5 510(k) Summary
5. 510(K) SUMMARY
DATE:
October 29, 2010
CONTACT PERSON: Jesse Seidman Baxter Healthcare Corporation Associate Director, Global Regulatory Affairs 1620 Waukegan Road, MPGR-AL McGaw Park, IL 60085 847-948-3031 Telephone: 847-785-5116 Fax: jesse_seidman@baxter.com Email:
DEVICE NAME:
CELSTAT Trade Name: Topical Hemostatic Dressing Common Name: Wound Dressing Classification: Unclassified Class: FRO Product Code:
PREDICATE DEVICE:
| Predicate
510(k) | Device
Name | Indication | Clearance
Date | Company |
|---------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------------|
| K072681 | BloodSTOP
and
BloodSTOP
iX
Hemostatic
Gauze | CELSTAT is indicated for topical
external use in the management of
topical wounds and to temporarily
control moderate to severe bleeding
from the skin. | November 2,
2007 | LifeScience Plus,
Inc., P.O. Box
60783, Palo Alto,
CA 94306 |
5
K 103245
page 2 of 2
Traditional 510(k) Premarket Notification CELSTAT Topical Hemostatic Dressing
Section 5 510(k) Summary
| DEVICE DESCRIPTION: | CELSTAT is a topical hemostatic dressing made of oxidized cellulose. It is a sterile, biocompatible, biodegradable hemostatic material designed to temporarily control moderate to severe bleeding from the skin. |
|---|---|
| STATEMENT OF INTENDED USE: | CELSTAT is indicated for topical external use in the management of topical wounds and to temporarily control moderate to severe bleeding from the skin. |
| TECHNOLOGICAL CHARACTERISTICS: | The CELSTAT device is substantially equivalent to the predicate device with regard to technological characteristics, performance, and intended use. |
| ASSESSMENT OF NONCLINICAL DATA: | Baxter Healthcare Corporation conducts risk analysis according to the requirements of ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices. The device continues to meet the same material testing standards and sterilization process standards as the predicate device. Device performance has been demonstrated according to a porcine liver square model animal study and biocompatibility testing. |
| CONCLUSIONS: | The CELSTAT device is substantially equivalent to the predicate device. Testing against established standards and guidelines for its intended use demonstrate that the proposed device is as safe and effective as the predicate device. |
·