NasalCEASE and BleedCEASE

K183622 · Les Laboratoires Brothier S.A. · QSY · Dec 2, 2019 · SU

Device Facts

• Record ID: K183622
• Device Name: NasalCEASE and BleedCEASE
• Applicant: Les Laboratoires Brothier S.A.
• Product Code: QSY · SU
• Decision Date: Dec 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended 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

Device Story

BleedCEASE/NasalCEASE are sterile, non-woven calcium alginate wound dressings derived from seaweed. Upon contact with blood, the dressing absorbs fluid and releases calcium ions, transforming into a soft gel that conforms to the wound site to promote hemostasis. The gel structure prevents adherence to the wound, facilitating painless removal and minimizing re-bleeding. The device is intended for use in clinical settings (prescription) or home environments (OTC) for managing minor surface wounds, lacerations, abrasions, and epistaxis. It is applied topically by clinicians or patients/caregivers. The device provides a physical barrier and hemostatic effect, aiding in the management of bleeding without requiring complex instrumentation or active monitoring.

Clinical Evidence

No clinical data or bench testing was required for this submission, as the application is limited to labeling changes for a device with no modifications to materials, manufacturing, or sterilization processes.

Technological Characteristics

Material: Calcium alginate (seaweed-derived biopolymer). Form factor: Sterile non-woven packing (2cm x 4cm). Principle: Passive absorption of blood and ion exchange (calcium release) to form a conformable gel. Sterilization: Not specified.

Indications for Use

Indicated for local management of bleeding wounds including minor cuts, lacerations, abrasions, and nosebleeds (OTC); and nasal epistaxis, small bleeding surface wounds, and small post-surgical incisions (Prescription). Suitable for all ages, with adult supervision recommended for nosebleeds in children under 12.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• NasalCEASE (K102742)
• Algosteril (K922540)
• ENTaxis (K984069)

Submission Summary (Full Text)

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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, [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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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 [phone] 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 [e-mail]
- B. 510(k) Applicant / Manufacturer / Contact: Les Laboratoires Brothier S.A. 41 Rue de Neuilly 92735 Nanterre, France Contact: Erna Milos Tel: [phone] Fax: [phone] [e-mail]
- 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) |

- E. For prescription use: Algosteril (K922540), and ENTaxis (K984069)
#### 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

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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.