NASAL CEASE

K102742 · Catalina, Inc. · QSY · Feb 2, 2011 · SU

Device Facts

• Record ID: K102742
• Device Name: NASAL CEASE
• Applicant: Catalina, Inc.
• Product Code: QSY · SU
• Decision Date: Feb 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

NasalCEASE® is intended to be used as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and about and case is already approved for treatment of minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device. The device is not intended to be used for medium or severe wounds or bleeding.

Device Story

NasalCEASE® is a topical wound dressing composed of calcium alginate; available as interwoven thread sheets or particles. Applied directly to minor bleeding wounds; device adsorbs blood and physiological fluids upon contact; material swells to exert compressive force at the wound site. Intended for Over-The-Counter use by patients for minor cuts, lacerations, and nosebleeds. Device aids in local management of bleeding; not for medium or severe wounds.

Clinical Evidence

No clinical data provided. Evidence relies on biocompatibility testing and historical performance data from previous 510(k) submissions (K905314, K922540, K984069) supporting medical/surgical applications.

Technological Characteristics

Composed of calcium alginate; manufactured as interwoven thread sheets (2x4x0.5 cm) or particles. Operates via fluid adsorption and swelling to provide compressive force. No performance standards established under Section 514.

Indications for Use

Indicated for local management of minor bleeding wounds, including minor cuts, lacerations, and nosebleeds. Intended for Over-The-Counter use. Not indicated for medium or severe wounds or bleeding.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• BleedArrest® (K070211)
• NasalCEASE® (K041446)

Reference Devices

• K905314
• K922540
• K984069

Submission Summary (Full Text)

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July 28, 2023

Catalina, Inc. c/o Discovery Group, LLC Richard J. Freer, Ph.D. 8110 Westbury Drive Richmond, Virginia 23229

Re: K102742 Trade/Device Name: NasalCEASE® Regulatory Class: Unclassified Product Code: QSY

Dear Richard J. Freer, 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 February 2, 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].

Sincerelv.

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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The eagle is positioned to the right of the seal's center. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", arranged in a circular pattern around the seal's perimeter.

#### Public Health Service

FEB -- 2 201

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Catalina, Inc. % Discovery Group, LLC Richard J. Freer, PhD 8110 Westbury Drive Richmond, Virginia 23229

Re: K102742

Trade/Device Name: NasalCEASE® Regulatory Class: Unclassified Product Code: FRO, EMX Dated: January 6, 2011 Received: January 7, 2011

Dear Dr. Freer:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

:

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Page 2 - Richard J. Freer. PhD

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse cvents) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Al. B. n. h.

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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# INDICATIONS FOR USE STATEMENT

K102742

## Device Name: NasalCEASE®

#### Indications for Use:

This device has the following intended use.

NasalCEASE® is intended to be used as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and about and case is already approved for treatment of minor nosebleeds.

It is intended to be marketed and sold as an Over-The-Counter device.

The device is not intended to be used for medium or severe wounds or bleeding.

## LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_****_
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _X*

Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K102742

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K102742

## 510(k) Summary

FEB - 2 2011

| Submitter: | Catalina, Inc.<br>3870 Rush Mendon Road<br>Mendon, New York 14506.<br>Phone: [phone]<br>Fax: [phone]<br>Contact Mr. Bruce M. Ford, President |
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Name: Regulation Name: Dressing, wound, drug Regulatory Class: Unclassified Product Code: FRO Trade Name: NasalCEASE®

Substantially Equivalent to: BleedArrest® (K070211); NasalCEASE® (K041446)

Description of the device: NasalCEASE® is comprised of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) of interwoven threads or as particles.

Intended Use: NasalCEASE® is intended to be used as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions. NasalCease® is already approved for treatment of minor nosebleeds (K041446).

It is intended to be marketed and sold as an Over-The-Counter device.

The device is not intended to be used for medium or severe wounds or bleeding.

Technological Characteristics: NasalCEASE® is comprised of calcium alginate that can be applied topically. Upon contact with blood or other physiological fluids it adsorbs those fluids and swells to apply a compressive force. BleedArrest® is used in the same way but acts by adsorbing fluid and causing hemoconcentration at the wound site which accelerates coagulation.

Performance Testing: The products have been extensively tested and found to be biocompatible. They have been the test article used to support several previous 510(k) products (K905314, K922540, and K984069) used for medical/surgical applications.

No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act for this device.

Summary: The NasalCEASE® device described in this submission is substantially equivalent to the predicate devices, is safe and effective, and sufficiently simplified and explained to be sold as an OTC product.