(27 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, intended use, or any mention of AI, ML, or related concepts.
No
The provided information is completely empty and thus does not contain any details to determine if the device is therapeutic.
No
Explanation: The provided information does not contain any details regarding the device's intended use or indications for use, which are crucial for determining if it is a diagnostic device. All fields are marked "Not Found."
Unknown
The provided 510(k) summary is completely empty, offering no information about the device's nature, components, or function. Therefore, it's impossible to determine if it's a software-only medical device.
Based on the information provided, it is impossible to determine if this device is an IVD.
The document contains "Not Found" for all the key sections that would typically describe a medical device, including its intended use, description, and any mention of diagnostic processes.
To determine if it's an IVD, you would need information about:
- Intended Use: Does it analyze samples taken from the human body (like blood, urine, tissue)?
- Device Description: What does the device actually do?
- Any mention of diagnostic testing: Does it perform tests to diagnose diseases or conditions?
Without any of this information, we cannot classify the device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
LYA
Device Description
Not Found
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
Not Found
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)
Not Found
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.
Not Found
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
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
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
Z-Medica Corporation c/o Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K080247
Trade/Device Name: QuikClot® Nosebleed™ Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: Class I Product Code: LYA
Dear Mary McNamara-Cullinane:
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 27, 2008 and correction letter dated January 4, 2010. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code 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