(341 days)
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
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.
The provided text is a 510(k) summary for the medical devices "NasalCEASE" and "BleedCEASE." It details a submission for labeling changes only for an existing product. Therefore, no new device performance studies were conducted to prove the device meets acceptance criteria, as the device itself (materials, manufacturing, packaging, sterilization) has not changed.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not applicable to this 510(k) submission. The submission is solely for labeling changes, not for demonstrating new device performance against acceptance criteria. The existing devices (NasalCEASE and BleedCEASE) are considered substantially equivalent to previously cleared predicate devices (NasalCEASE (K102742), Algosteril (K922540), and ENTaxis (K984069)), meaning their performance was established as part of those prior clearances.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. No new performance testing was conducted for this 510(k) as it concerns labeling changes only.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. No new performance testing was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No new performance testing was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This device is a wound dressing/hemostatic agent, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical wound dressing, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. No new performance testing was conducted. The initial clearance of the predicate devices would have relied on clinical data and possibly in-vitro and in-vivo non-clinical studies to establish their hemostatic properties and safety.
8. The sample size for the training set
This information is not applicable. This device is a physical wound dressing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. This device is a physical wound dressing, not a machine learning model.
Summary based on the provided text:
The 510(k) submission K183622 for NasalCEASE and BleedCEASE is for labeling changes only. The manufacturer states:
"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."
Therefore, no new studies, test sets, expert reviews, or ground truth establishment relevant to device performance were conducted or described in this particular 510(k) summary. The substantial equivalence determination is based on the unchanged product being identical to previously cleared devices.
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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, 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
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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.
N/A