(467 days)
Not Found
No
The provided text describes a topical gel/fluid/spray/mouthrinse that forms a protective film. There is no mention of any computational analysis, image processing, or AI/ML terms.
Yes
The device is intended to relieve pain and protect against lesions and irritations, which are therapeutic actions.
No
The descriptions of the Gengigel® products indicate they form a protective film and relieve pain for various oral lesions and irritations. There is no mention of these devices being used to identify, detect, or monitor a medical condition or disease. They are therapeutic in nature, providing relief rather than diagnosis.
No
The device descriptions clearly indicate various physical forms (Gel, Fluid, Spray, Mouthrinse) which are applied to the oral mucosa, indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as forming a protective film on the oral mucosa to relieve pain and protect lesions and irritations. This is a physical barrier function applied directly to the body.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Claims: There are no claims in the intended use or other sections about analyzing samples, detecting biomarkers, or providing diagnostic information.
- Mechanism of Action: The described mechanism of action is forming a physical barrier, not performing a diagnostic test on a biological sample.
Therefore, based on the provided text, this device falls under the category of a medical device that provides a physical barrier and pain relief, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.
Gengigel® Prof Fluid adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.
Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Gengigel® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Gengigel® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Gengigel® Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Product codes (comma separated list FDA assigned to the subject device)
MGQ
Device Description
Not Found
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)
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.
K013056, K040950, K042722, K023155
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
N/A
0
Gengigel® Prof Gel Premarket Notification K053342 February 15, 2007
Summary of Safety and Effectiveness 3
MAR 1 3 2007
Date Summary Prepared:
February 15, 2007
Applicants Name:
Ricerfarma Srl Via Egadi, 7-20144 Milano, Italy
Contact Person:
Paul Ketteridge, (Consultant to Ricerfarma) 303 Patleigh Road Catonsville, MD 21228 443 729-0836 p.kett@comcast.net
Device Name: Classification Name:
- Product Code: CFR Section: Device Class: Classification Panel:
Indications:
Gengigel® Prof Gel. Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic MGQ None Unclassified General and Plastic Surgery
Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.
Predicate Device
| K013056 |
|---|
| Gelclair® Oral Gel |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey,UK |
| Product Code-MGQ |
1
Gengigel® Prof Fluid Premarket Notification K053342 February 15, 2007
Summary of Safety and Effectiveness 3
Date Summary Prepared:
February 15, 2007
Applicants Name:
Ricerfarma Srl Via Egadi, 7-20144 Milano, Italy
Contact Person:
Paul Ketteridge, (Consultant to Ricerfarma) 303 Patleigh Road Catonsville, MD 21228 443 729-0836 p.kett@comcast.net
Device Name: Classification Name:
- Product Code: CFR Section: Device Class: Classification Panel:
Gengigel® Prof Fluid. Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic MGQ None Unclassified General and Plastic Surgery
Indications: Gengigel® Prof Fluid adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.
Predicate Devices
| K013056 |
|---|
| Gelclair® Oral Gel |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey,UK |
| Product Code-MGQ |
2
Gengigel® Junior Premarket Notification K053342 February 15, 2007
Summary of Safety and Effectiveness 3
| Date Summary Prepared: | February 15, 2007 |
|---|---|
| Applicants Name: | Ricerfarma Srl |
| Via Egadi, 7-20144 | |
| Milano, Italy | |
| Contact Person: | Paul Ketteridge, (Consultant to Ricerfarma) |
| 303 Patleigh Road | |
| Catonsville, MD 21228 | |
| 443 729-0836 | |
| p.kett@comcast.net | |
| Device Name: | Gengigel® Junior. |
| Classification Name: | Dressing, Wound and Burn, Hydrogel w/Drug and/or |
| Biologic | |
| Product Code: | MGQ |
| CFR Section: | None |
| Device Class: | Unclassified |
| Classification Panel: | General and Plastic Surgery |
Indications: Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
: 1
Predicate Device
i .
| K040950 | |
|---|---|
| Aloclair™ Oral Gel | |
| Sinclair Pharmaceuticals, Ltd | |
| Godalming, Surrey,UK | |
| Product Code-MGQ |
3
Gengigel® Spray Premarket Notification K053342 February 15, 2007
Summary of Safety and Effectiveness 3
| Date Summary Prepared: | February 15, 2007 |
|---|---|
| Applicants Name: | Ricerfarma Srl |
| Via Egadi, 7-20144 | |
| Milano, Italy | |
| Contact Person: | Paul Ketteridge, (Consultant to Ricerfarma) |
| 303 Patleigh Road | |
| Catonsville, MD 21228 | |
| 443 729-0836 | |
| p.kett@comcast.net | |
| Device Name: | Gengigel® Spray. |
| Classification Name: | Dressing, Wound and Burn, Hydrogel w/Drug and/or |
| Biologic | |
| Product Code: | MGQ |
| CFR Section: | None |
| Device Class: | Unclassified |
| Classification Panel: | General and Plastic Surgery |
Indications: Gengigel® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Predicate Device:
.
: 上一篇: 上一篇:
. .
| K042722 |
|---|
| Aloclair™ Oral Spray |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey,UK |
| Product Code-MGQ |
4
Gengigel® Gel Premarket Notification K053342 February 15, 2007
Summary of Safety and Effectiveness 3
February 15, 2007 Date Summary Prepared:
Applicants Name:
Ricerfarma Srl Via Egadi, 7-20144 Milano, Italy
Contact Person:
Paul Ketteridge, (Consultant to Ricerfarma) 303 Patleigh Road Catonsville, MD 21228 443 729-0836 p.kett@comcast.net
Device Name: Classification Name:
- Product Code: CFR Section: Device Class: Classification Panel:
Gengigel® Gel. Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic MGQ None Unclassified General and Plastic Surgery
Indications: Gengigel® Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Predicate Devices
| K040950 |
|---|
| Aloclair™ Oral Gel |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey,UK |
| Product Code-MGQ |
5
K053342
Gengigel® Mouthrinse Premarket Notification K053342 February 15, 2007
Summary of Safety and Effectiveness 3
| Date Summary Prepared: | February 15, 2007 |
|---|---|
| Applicants Name: | Ricerfarma Srl |
| Via Egadi, 7-20144 | |
| Milano, Italy | |
| Contact Person: | Paul Ketteridge, (Consultant to Ricerfarma) |
| 303 Patleigh Road | |
| Catonsville, MD 21228 | |
| 443 729-0836 | |
| p.kett@comcast.net | |
| Device Name: | Gengigel® Mouthrinse. |
| Classification Name: | Dressing, Wound and Burn, Hydrogel w/Drug and/or |
| Biologic | |
| Product Code: | MGQ |
| CFR Section: | None |
| Device Class: | Unclassified |
| Classification Panel: | General and Plastic Surgery |
Indications: Gengigel® Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Predicate Device
.
| K023155 |
|---|
| Aloclair™ Oral Rinse |
| Sinclair Pharmaceuticals, Ltd |
| Godalming, Surrey, UK |
| Product Code-MGQ |
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ricerfarma SRL C/O Mr. Paul Ketteridge Consultant PD Regulatory Consulting, LLC 303 Patleigh Road Catonsville, Maryland 21228
MAR 1 3 2007
Re: K053342
Trade/Device Name: Gengigel® Mouthrinse Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MGQ Dated: February 15, 2007 Received: February 16, 2007
Dear Mr. Ketteridge:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
7
Page 2 -Mr. Ketteridge
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Gengigel® Junior Premarket Notification K053342 February 15, 2007
Indications for Use 1
510(k) Number (if known): K053342
Device Name: Gengigel® Junior
Indications for Use:
- Gengigel® Gengigel® Junior provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use XXX (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of (Posted November 13, 2003)
Susan Bunner
KC53342
9
Gengigel® Prof Fluid Premarket Notification K053342 February 15, 2007
Indications for Use 1
510(k) Number (if known): K053342
Device Name: _Gengigel® Prof Fluid
Indications for Use:
Gengigel® Prof Fluid adheres to the oral mucosa and forms a Gengigel® protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Fluid relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of (Posted November 13, 2003)
Susan Runor
KCS3342
10
Gengigel® Spray Premarket Notification K053342 February 15, 2007
Indications for Use 1
510(k) Number (if known): K053342
Device Name: Gengigel® Spray
Indications for Use:
Gengigel Spray provides temporary pain relief by adhering to the Gengigel® oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use __ XX AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of (Posted November 13, 2003)
Susan Rumpes
11
K05334.2
Gengigel® Prof Gel Premarket Notification K053342 February 15, 2007
1 Indications for Use
510(k) Number (if known):
Device Name: _Gengigel® Prof Gel
Indications for Use:
Gengigel® Gengigel® Prof Gel adheres to the oral mucosa and forms a protective film over the lesions and irritation due to various etiologies, including: oral surgery; traumatic ulcers caused by, braces or ill fitting dentures; diffuse aphthous ulcers; and oral mucositis/stomatitis (which may be caused by chemotherapy or radiotherapy). Gengigel® Prof Gel relieves pain by providing a barrier to protect the area from ongoing insult and discomfort.
Prescription Use XX AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of (Posted November 13, 2003)
Susan Runne
KC53342
12
Gengigel® Gel Premarket Notification K053342 February 15, 2007
Indications for Use 1
510(k) Number (if known): K053342
Device Name: Gengigel® Gel
Indications for Use:
Gengigel®
Gengigel Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use XX (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of (Posted November 13, 2003)
Susan Runore
13
Gengigel® Mouthrinse Premarket Notification K053342 February 15, 2007
Indications for Use 1
510(k) Number (if known): K053342
Device Name: Gengigel® Mouthrinse
Indications for Use:
Gengigel Mouthrinse provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: oral surgery; traumatic ulcers caused by braces or ill fitting dentures; and aphthous ulcers.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use XX (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of (Posted November 13, 2003)
Susan Pamon
transportation
justification