(141 days)
CELSTAT is indicated for topical external use in the management of topical wounds and to temporarily control moderate to severe bleeding from the skin.
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.
The provided document is a 510(k) summary for the CELSTAT Topical Hemostatic Dressing. It categorizes the device as unclassified and specifies its product code as FRO (later updated to QSY). The document asserts the device's substantial equivalence to a predicate device based on technological characteristics, performance, and intended use.
Here's an analysis based on the information provided, specifically addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "Device performance has been demonstrated according to a porcine liver square model animal study and biocompatibility testing." The conclusion further asserts that the device is "as safe and effective as the predicate device" based on testing against established standards and guidelines.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrated safety and effectiveness comparable to predicate device | Demonstrated in a porcine liver square model animal study and biocompatibility testing. Also, Baxter Healthcare Corporation conducts risk analysis according to ISO 14971:2007. |
| Meets material testing standards | Stated to meet "the same material testing standards" as the predicate device. |
| Meets sterilization process standards | Stated to meet "the same... sterilization process standards" as the predicate device. |
| Biocompatible | Demonstrated via "biocompatibility testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions a "porcine liver square model animal study" but does not specify the sample size (e.g., number of animals, number of liver squares).
- Data Provenance: The study was an animal study (porcine liver model). It is a preclinical study, not a human retrospective or prospective study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As an animal study, the "ground truth" would likely be objective measurements of hemostasis (e.g., time to hemostasis, blood loss) rather than expert consensus on interpretative data.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given it's an animal study, a formal adjudication process by multiple humans is unlikely to be relevant in the same way as an imaging study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The CELSTAT device is a topical hemostatic dressing, a therapeutic device, for which MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm only" performance would not be relevant for this device. The CELSTAT device is a physical dressing, not an AI algorithm. Its performance is inherent to its physical and chemical properties and how it interacts with biological tissue.
7. The Type of Ground Truth Used
The ground truth for the "porcine liver square model animal study" would likely be objective physiological measurements related to blood clotting, such as:
- Time to hemostasis
- Volume of blood loss
- Observed cessation of bleeding
This is based on the nature of a hemostatic dressing. The document does not explicitly detail the specific measurements.
8. The Sample Size for the Training Set
The concept of a "training set" is primarily applicable to machine learning or AI algorithms. Since the CELSTAT Topical Hemostatic Dressing is a physical medical device and not an AI-driven product, there is no training set in the context of an algorithm. The development of the device would involve materials science, engineering, and in vitro/in vivo testing, but not an algorithmic training process.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
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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
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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
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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
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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
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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:
| Predicate510(k) | DeviceName | Indication | ClearanceDate | Company |
|---|---|---|---|---|
| K072681 | BloodSTOPandBloodSTOPiXHemostaticGauze | CELSTAT is indicated for topicalexternal use in the management oftopical wounds and to temporarilycontrol moderate to severe bleedingfrom the skin. | November 2,2007 | LifeScience Plus,Inc., P.O. Box60783, Palo Alto,CA 94306 |
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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. |
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