(72 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of a hydrogel patch for oral ulcers, with no mention of AI or ML technologies.
Yes
The device is intended to relieve pain and protect ulcer tissue, which are therapeutic claims. Clinical trials also demonstrate its efficacy in reducing pain.
No
The device is described as an oral wound dressing that forms a physical barrier to relieve pain, and its performance studies measure pain reduction, not the detection or diagnosis of a condition.
No
The device description clearly states it is a "vacuum-dried gel that contains hydrogel with calcium and phosphorus" and is a "round, white to off-white thin patch," indicating it is a physical, material-based device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to act as an oral wound dressing to protect ulcer tissue and relieve pain. This is a therapeutic or protective function applied directly to the body.
- Device Description: The description details a physical patch made of hydrogel with calcium and phosphorus. It does not mention any components designed to analyze samples from the body (like blood, urine, or tissue).
- Mechanism of Action: The mechanism described is forming a physical barrier on the wound tissue. This is a physical interaction, not a diagnostic test performed on a sample.
- Performance Studies: The performance studies focus on pain relief, which is a clinical outcome related to the device's therapeutic effect, not a diagnostic measurement.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis.
N/A
Intended Use / Indications for Use
Ulceloocin™ Oral Ulcer Patch is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and ill-fitting dentures.
Product codes (comma separated list FDA assigned to the subject device)
MGQ
Device Description
Ulceloocin™ Oral Ulcer Patch is a vacuum-dried gel that contains hydrogel with calcium and phosphorus. It does not contain any biological additives or drugs. It is a round, white to off-white thin patch. Ulcelocin™ Oral Ulcer patch is packaged in blister cards of two patches per card, three blister cards per carton, for a total of 6 patches per carton. Each patch is approximately 1 cm in diameter and 0.3 mm thick.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral mucosa
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)
NON-CLINICAL DATA:
In vitro study was conducted for cytotoxicity test of Ulceloocin™ Oral Ulcer Patch. Animal biocompatibility studies were conducted for skin irritation test and hypersensitivity test of Ulceloocin™ Oral Ulcer Patch. The studies indicated that Ulceloocin™ Oral Ulcer Patch does not have cytotoxic effect on human cells, and does not cause any irritation or hypersensitivity to the animals tested. The safety and biocompatibiltiy Ulceloocin™ Oral Ulcer Patch are confirmed by both in vitro and animal biocompatibility studies.
CLINICAL DATA:
Multi-centered clinical trials of Ulceloocin™ Oral Ulcer Patch were conducted in two hospitals as Trial 1 and Trial 2 on a total of 95 patients with oral mucosal ulcers according to the current good clinical practice procedures and IRB approval. Forty-five patients were studied in Trial 1 and fifty patients were studied in Trial 2. In these two trials, a total of fifty patients were treated with Ulceloocin™ Oral Ulcer Patch four times a day, before the meals and bedtime, as the study group; and a total of forty-five patients with the same lesions were not treated as the control group.
Effect on pain relief was mainly determined by measuring the pain index at the time of eating food during the time course of trial. Patients in both study and control groups had a starting pain index of 7.33 - 7.37 (Trial 1) and 7.30 - 7.40 (Trial 2) at the time of being enrolled into the study. At the 4th day of study, study group showed a significant reduction to 2.26 ± 2.20 (Trial 1) and 2.24 ± 2.40 (Trial 2) compared to a pain index of 5.31 ± 2.42 (Trial 1) and 6.10±2.33 (Trial 2) in control group. At 7th day, study group showed a pain index of 0.20 ± 0.72 (Trial 1) and 0.80 ± 1.80 (Trial 2) compared to a pain index of 1.53 ± 1.72 (Trial 1) and 2.31 ± 1.82 (Trial 2) in control group. Ulceloocin™ Oral Ulcer Patch demonstrated a significant effect on reducing the pain caused by oral mucosal ulcers (P
N/A
0
510(k) Summary (amended)
The Ulceloocin™ Oral Ulcer Patch
The following represents the summary for premarket notification of the Ulceloocin™ Oral Ulcer Patch, a product to be marketed by Sunshine International Group, Inc., located at 1333 Broadway, Suite 1222, New York, NY 10018, (212)268-7771.
CONTACT PERSON:
Liping He Vice President (212) 268-7771
DATE OF SUMMRY:
February 24, 2007
DEVICE NAME:
Proprietary Name: Ulceloocin™ Oral Ulcer Patch
Oral Wound Dressing Common Name:
Unclassified. Classification Name:
The SaliCept™ Oral Patch K012126 (Carrington PREDICATE DEVICE: Laboratories, Inc.)
DEVICE DESCRIPTION:
Ulceloocin™ Oral Ulcer Patch is a vacuum-dried gel that contains hydrogel with calcium and phosphorus. It does not contain any biological additives or drugs. It is a round, white to off-white thin patch. Ulcelocin™ Oral Ulcer patch is packaged in blister cards of two patches per card, three blister cards per carton, for a total of 6 patches per carton. Each patch is approximately 1 cm in diameter and 0.3 mm thick.
INTENDED USE:
Ulceloocin™ Oral Ulcer Patch is intended for use as an oral wound dressing to protect ulcer tissue by forming a physical barrier on the wound tissue to avoid further irritation and thus to relieve pain. It is indicated for use with all types of ulcers and small wounds of the oral mucosa including canker sores, aphthous ulcers, and injuries such as traumatic ulcers caused by self-biting, braces, and ill-fitting dentures.
CLAIMS:
1
Ulceloocin™ Oral Ulcer Patch relieves pain by adhering to and protecting affected tissues from further irritation. It is safe if swallowed.
TECHNOLOGICAL CHARACTERISTICS:
Ulceloocin™ Ora! Ulcer Patch is a vacuum-dried hydrogel that adheres to oral mucosa. It is slowly reverts to a soft and gel-type thin sheet in the oral environment while it adheres to and protects affected tissue as a physical barrier to reduce irritation and pain.
NON-CLINICAL DATA:
In vitro study was conducted for cytotoxicity test of Ulceloocin™ Oral Ulcer Patch. Animal biocompatibility studies were conducted for skin irritation test and hypersensitivity test of Ulceloocin™ Oral Ulcer Patch. The studies indicated that Ulceloocin™ Oral Ulcer Patch does not have cytotoxic effect on human cells, and does not cause any irritation or hypersensitivity to the animals tested. The safety and biocompatibiltiy Ulceloocin™ Oral Ulcer Patch are confirmed by both in vitro and animal biocompatibility studies.
CLINICAL DATA:
Multi-centered clinical trials of Ulceloocin™ Oral Ulcer Patch were conducted in two hospitals as Trial 1 and Trial 2 on a total of 95 patients with oral mucosal ulcers according to the current good clinical practice procedures and IRB approval. Forty-five patients were studied in Trial 1 and fifty patients were studied in Trial 2. In these two trials, a total of fifty patients were treated with Ulceloocin™ Oral Ulcer Patch four times a day, before the meals and bedtime, as the study group; and a total of forty-five patients with the same lesions were not treated as the control group.
Effect on pain relief was mainly determined by measuring the pain index at the time of eating food during the time course of trial. Patients in both study and control groups had a starting pain index of 7.33 - 7.37 (Trial 1) and 7.30 - 7.40 (Trial 2) at the time of being enrolled into the study. At the 4th day of study, study group showed a significant reduction to 2.26 ± 2.20 (Trial 1) and 2.24 ± 2.40 (Trial 2) compared to a pain index of 5.31 ± 2.42 (Trial 1) and 6.10±2.33 (Trial 2) in control group. At 7th day, study group showed a pain index of 0.20 ± 0.72 (Trial 1) and 0.80 ± 1.80 (Trial 2) compared to a pain index of 1.53 ± 1.72 (Trial 1) and 2.31 ± 1.82 (Trial 2) in control group. Ulceloocin™ Oral Ulcer Patch demonstrated a significant effect on reducing the pain caused by oral mucosal ulcers (P