(341 days)
Not Found
No
The device description focuses on the material properties and mechanism of action of a calcium alginate wound dressing, with no mention of AI or ML technologies.
Yes
The device is intended for the local management of bleeding wounds and nasal epistaxis, which are conditions that require treatment or relief, thus classifying it as therapeutic.
No
Explanation: The device is used for the local management of bleeding wounds and nasal epistaxis by absorbing blood and releasing calcium to stop bleeding. It is a hemostatic device, not a diagnostic one.
No
The device is a physical product made of calcium alginate, a biopolymer, and is described as a sterile, non-woven packing. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: BleedCEASE/NasalCEASE is a topical wound dressing and nasal packing. Its function is to absorb blood and promote hemostasis (stopping bleeding) through physical and chemical interaction with the wound site. It does not analyze a sample from the body to provide diagnostic information.
- Intended Use: The intended use clearly states it's for the "local management of bleeding wounds" and "nasal epistaxis." This is a therapeutic or wound care function, not a diagnostic one.
- Device Description: The description focuses on the material (calcium alginate) and how it interacts with the wound (absorbing blood, forming a gel, releasing calcium). This is consistent with a wound dressing, not a diagnostic test.
Therefore, BleedCEASE/NasalCEASE falls under the category of a medical device used for wound management and hemostasis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OTC: For the local management of bleeding wounds such as minor lacerations, minor abrasions, and minor nosebleeds.
Prescription: For nasal epistaxis and the local management of topical wounds, including both non-infected:
- · Small bleeding surface wounds
- · Small post-surgical incisions
- Abrasions and lacerations
Product codes (comma separated list FDA assigned to the subject device)
QSY, LYA, FRO
Device Description
BleedCEASE® and NasalCEASE® are the same product with the same indications for use but branded under two different names. The remainder of this summary will refer to the product as BleedCEASE.
BleedCEASE® is made of calcium alginate, an all-natural biopolymer originating from seaweed. When in contact with the wound, BleedCEASE® absorbs blood and releases calcium, becoming a soft gel that conforms to the wound. BleedCEASE stops bleeding without sticking to the wound, reducing the likelihood of pain or rebleeds that may be associated with wound dressing removal.
BleedCEASE® is provided as a sterile, non-woven packing (2cm x 4cm), each packaged in an individual pouch. The product is sold in boxes of 5, 25 and 100 pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, topical wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
There have been no changes to the product materials, manufacturing, packaging, or sterilization processes. No safety or performance testing is required to support this 510(k) application, which is for labeling changes only.
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.
NasalCEASE® (K102742), Algosteril (K922540), ENTaxis (K984069)
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 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.
April 21, 2023
Les Laboratoires Brothier S.A. % Sheila Hemeon-Heyer President and Founder Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002
Re: K183622 Trade/Device Name: NasalCEASE and BleedCEASE Regulatory Class: Unclassified Product Code: QSY, LYA
Dear Sheila Hemeon-Heyer:
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 December 2, 2019. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA.
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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Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "U.S. Food & Drug Administration" in blue text.
December 2, 2019
Les Laboratoires Brothier S.A. % Sheila Hemeon-Heyer President and Founder Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002
Re: K183622
Trade/Device Name: NasalCEASE and BleedCEASE Regulatory Class: Unclassified Product Code: FRO Dated: July 29, 2019 Received: July 30, 2019
Dear Sheila Hemeon-Heyer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly Ferlin -S
Kimberly M. Ferlin, Ph.D. Assistant Director (acting) 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
Enclosure
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Indications for Use
510(k) Number (if known) K183622
Device Name
BleedCEASE® and NasalCEASE®
Indications for Use (Describe)
OTC: For the local management of bleeding wounds such as minor lacerations, minor abrasions, and minor nosebleeds.
Prescription: For nasal epistaxis and the local management of topical wounds, including both non-infected:
- · Small bleeding surface wounds
- · Small post-surgical incisions
- Abrasions and lacerations
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. 510(k) Submitter: Heyer Regulatory Solutions LLC P.O. Box 2151 Amherst, MA 01004-2151 Contact: Sheila Hemeon-Heyer Sheila@heyer-regulatory.com
- B. 510(k) Applicant / Manufacturer / Contact: Les Laboratoires Brothier S.A. 41 Rue de Neuilly 92735 Nanterre, France Contact: Erna Milos Tel: +33 0 1 56 38 30 00 Fax: +33 0 1 41 20 93 70 milos@brothier.com
- C. Date Prepared: December 2, 2019
D. Device Name and Classification Information:
| Trade Name: | BleedCEASE® and NasalCEASE® |
|---|---|
| Classification Name: | Dressing, wound, drug |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |
| Predicate Device: | For OTC use: NasalCEASE® (K102742) |
F. Device Description:
BleedCEASE® and NasalCEASE® are the same product with the same indications for use but branded under two different names. The remainder of this summary will refer to the product as BleedCEASE.
BleedCEASE® is made of calcium alginate, an all-natural biopolymer originating from seaweed. When in contact with the wound, BleedCEASE® absorbs blood and releases calcium, becoming a soft gel that conforms to the wound. BleedCEASE stops bleeding
5
without sticking to the wound, reducing the likelihood of pain or rebleeds that may be associated with wound dressing removal.
BleedCEASE® is provided as a sterile, non-woven packing (2cm x 4cm), each packaged in an individual pouch. The product is sold in boxes of 5, 25 and 100 pouches.
G. Indications for Use:
OTC: For the local management of bleeding wounds such as minor cuts, minor lacerations, minor abrasions, and minor nosebleeds.
Prescription: For nasal epistaxis and the local management of topical wounds, including both non-infected and infected:
- · Small bleeding surface wounds
- Small post-surgical incisions
- Abrasions and lacerations
Comparison to Predicate Device H.
BleedCEASE® and NasalCEASE® are the same product, and are manufactured, packaged, and sterilized using the same processes as the two predicate devices, both of which are non-woven calcium alginate wound dressings manufactured by the 510(k) applicant, Les Laboratoires Brothier. The purpose of this 510(k) is for labelling changes only. The labelling changes include:
- Modifications to the OTC instructions for use, including: .
- Removal of the statement that the product is not approved for nosebleeds by O children 12 and under
- Addition of a caution that use for nosebleeds in children 12 and under O should be with adult supervision
- Removal of warning regarding toxic shock syndrome (TSS) as there is no O evidence of TSS associated with many years of product use
- . Addition of labeling for prescription use to enable the product to be prescribed by clinicians. The proposed product is substantially equivalent to two predicate calcium alginate wound dressings manufactured by Les Laboratoires Brothier: Algosteril (K922540), which was cleared for prescription use in the local management of partial and full thickness wounds and other wounds such as abrasions and lacerations, and ENTaxis (K984069), cleared for nasal epistaxis and post-surgical nasal packing. BleedCEASE is made of the same material and manufacturing processes as these predicate devices. The only difference is that BleedCEASE is available as a smaller swab (2 cm x 4 cm), which limits the application of
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BleedCEASE to smaller wounds. However, BleedCEASE has the same mechanism of action as the predicate calcium alginate hemostatic wound dressings.
Safety and Performance Data: l.
There have been no changes to the product materials, manufacturing, packaging, or sterilization processes. No safety or performance testing is required to support this 510(k) application, which is for labeling changes only.
l. Conclusion
The information provided in this 510(k) Premarket Notification supports the proposed changes to the product labelling and a conclusion of substantial equivalence.