(133 days)
No
The summary describes a physical dressing made of calcium alginate for managing minor bleeding and does not mention any software, algorithms, or AI/ML components.
Yes
The device is intended for the "local management of bleeding wounds such as minor cuts, lacerations, and about and case is already approved for treatment of minor nosebleeds," indicating a therapeutic purpose.
No
Explanation: The "Intended Use" section states that 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." This describes a therapeutic, not a diagnostic, function.
No
The device description explicitly states it is comprised of calcium alginate and manufactured as a sheet or particles, indicating a physical, non-software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described 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." This describes a device that is applied externally to the body to manage bleeding.
- Device Description: The device is described as being comprised of calcium alginate and manufactured as a sheet or particles. This is consistent with a topical dressing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (on the body) use as a topical dressing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO, EMX
Device Description
NasalCEASE® is comprised of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) of interwoven threads or as particles.
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
Over-The-Counter 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)
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.
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.
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 two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
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, Julie.Morabito@fda.hhs.gov.
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
1
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
:
2
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 (800) 638-2041 or (301) 796-7100 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
3
INDICATIONS FOR USE STATEMENT
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
4
510(k) Summary
FEB - 2 2011
| Submitter: | Catalina, Inc.
3870 Rush Mendon Road
Mendon, New York 14506.
Phone: 585-624-7540
Fax: 585-624-9678
Contact Mr. Bruce M. Ford, President |
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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.