CELSTAT

K103245 · Baxter Healthcare Corp · QSY · Mar 23, 2011 · SU

Device Facts

• Record ID: K103245
• Device Name: CELSTAT
• Applicant: Baxter Healthcare Corp
• Product Code: QSY · SU
• Decision Date: Mar 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

CELSTAT is a sterile, biocompatible, biodegradable topical hemostatic dressing composed of oxidized cellulose. It is applied topically to wounds to temporarily control moderate to severe bleeding from the skin. The device functions as a physical hemostatic agent. It is intended for use in clinical or wound management settings. By providing a matrix for hemostasis, it assists in bleeding control, thereby supporting wound management and patient recovery.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and an animal study using a porcine liver square model to demonstrate hemostatic performance, alongside biocompatibility testing conducted in accordance with ISO 14971:2007 risk management standards.

Technological Characteristics

Material: Oxidized cellulose. Form factor: Topical dressing. Properties: Sterile, biocompatible, biodegradable. Standards: ISO 14971:2007 (Risk Management).

Indications for Use

Indicated for topical external use in the management of topical wounds and temporary control of moderate to severe bleeding from the skin.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• BloodSTOP and BloodSTOP iX Hemostatic Gauze (K072681)

Submission Summary (Full Text)

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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, [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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## 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 [phone] or [phone] 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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K103245

### 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: [phone] Fax: [e-mail] Email:

DEVICE NAME:

CELSTAT Trade Name: Topical Hemostatic Dressing Common Name: Wound Dressing Classification: Unclassified Class: FRO Product Code:

#### PREDICATE DEVICE:

| Predicate<br>510(k) | Device<br>Name | Indication | Clearance<br>Date | Company |
|---------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------------------------------|
| K072681 | BloodSTOP<br>and<br>BloodSTOP<br>iX<br>Hemostatic<br>Gauze | CELSTAT is indicated for topical<br>external use in the management of<br>topical wounds and to temporarily<br>control moderate to severe bleeding<br>from the skin. | November 2,<br>2007 | LifeScience Plus,<br>Inc., P.O. Box<br>60783, Palo Alto,<br>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. <p>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.</p> |
| 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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