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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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NasalCEASE™ is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device.

NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) premarket notification for a medical device (NasalCEASE™), and it primarily focuses on establishing substantial equivalence to a predicate device.

Here's what can be extracted based on the provided text, and where the requested information is missing:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overall "acceptance criteria" here is substantial equivalence to the predicate device, ENTaxis (K985069).
• Reported Device Performance:
  • "NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity."
  • "Upon contact with blood or other physiological fluids in the nasal cavity it adsorbs those fluids and swells to apply a compressive force."
  • "Both physicians and patients were able to use the device correctly and effectively" (referring to the non-clinical testing).

Since the document is a 510(k) summary, detailed performance data against specific acceptance criteria (e.g., success rate, time to stop bleeding) is typically not included in this summary section but would have been part of the full submission.

2. Sample size used for the test set and the data provenance:

• Sample Size (Test Set): Not specified. The non-clinical testing mentions "A panel of physicians used the device and provided it to patients for use at home," but no number is given for either physicians or patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be from a clinical setting, but whether it was retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified. "A panel of physicians" is mentioned, but their number or specific qualifications (e.g., specialty, years of experience) are not provided.
• Qualifications of Experts: Only "physicians" is stated.

4. Adjudication method for the test set:

• Not specified. The text only says "A panel of physicians used the device and provided it to patients for use at home."

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:

• Not applicable. This device is a physical medical device (nasal packing), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

• Based on "Both physicians and patients were able to use the device correctly and effectively," the ground truth appears to be based on expert (physician) and user (patient) assessment of usability and effectiveness. This is closer to observational data or user feedback rather than a formal medical "ground truth" like pathology or clinical outcomes in a randomized controlled trial for therapeutic efficacy.

8. The sample size for the training set:

• Not applicable/Not specified. There is no mention of a "training set" in the context of this physical device. If "training set" refers to pre-market testing, it's covered by the "panel of physicians" and "patients" mentioned above, for which no sample size is given.

9. How the ground truth for the training set was established:

• Not applicable/Not specified. As above, no "training set" or explicit ground truth establishment method in this context. The "ground truth" for the non-clinical testing would be the real-world observation by physicians and patients regarding the device's functionality and effectiveness in stopping minor nosebleeds at home.

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