(330 days)
Not Found
No
The device description and intended use are for a topical gel composed of specific chemical ingredients. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on biocompatibility and stability, not algorithmic performance.
Yes.
The device is indicated for the management and relief of conditions such as burns, abrasions, cuts, ulcers, and various types of dermatoses, which are conditions that require therapeutic intervention to heal or alleviate symptoms.
No
Explanation: The device is a wound gel applied for management and relief of various skin conditions and wounds, not for diagnosing them.
No
The device is a gel, which is a physical substance, 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 states that the gel is for the management and relief of various skin and wound conditions. It is applied topically to the body.
- Device Description: The description details the composition of a topical gel designed to maintain a moist wound environment and relieve skin irritations.
- Mechanism of Action: The mechanism described is maintaining a moist environment, which is a physical effect on the wound/skin surface, not an in vitro analysis of a biological sample.
- Lack of In Vitro Testing: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) outside of the body. The performance studies focus on biocompatibility and stability, which are relevant for a topical device.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended Use:
L.A.M. IPM Wound Gel and IPM Derm Gel serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process.
L.A.M. IPM Wound Gel/ IPM Derm Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Indications for Use:
"OTC":
L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of minor burns (1ª degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.
Rx:
Under the supervision of a health care professional;
· L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.
· L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis and radio-dermatitis.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
L.A.M. IPM Wound Gel/IPM Derm Gel is a clear viscous, odourless, aqueous gel, composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. The proportion of sodium hyaluronate "w/w" in the formulation is 2.5%.
Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid in L.A.M. IPM Wound Gel and IPM Derm Gel is derived from avian sources. L.A.M. IPM Wound Gel and IPM Derm Gel serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process. L.A.M. IPM Wound Gel/ IPM Derm Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Other ingredients in L.A.M. IPM Wound Gel and IPM Derm Gel are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%).
L.A.M. IPM Wound Gel and IPM Derm Gel are presented in carton boxes with 4 laminated tubes of 10g (0.35oz).
L.A.M. IPM Wound Gel and IPM Derm Gel are exactly the same in every aspect and specifications; they are the same device with two (2) different trade names.
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
Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Additionally, some indications specify "Under the supervision of a health care professional".
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)
Products for topical use have their safety established through biocompatibility test performed for L.A.M. IPM Wound Gel, included reports of Cytotoxicity Study, Modified ISO Accute Reactivity in Rabbits, ISO Accute Systemic Toxicity in Mouse. In Vitro Hemolysis and ISO Sensitization. All of them meet the requirements of the ISO 10993 and resulted under the anticipated specifications.
Concluding, the biocompatibility test for L.A.M. IPM Wound Gel demonstrated similar results to the ones of its predicates, which is: the product safe and effective for its intended use.
Also, stability testing conducted to support the proposed shelf life confirmed that aged product met the acceptance criteria.
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.
K962218, K102945, K041342, K020325, K123113
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
Section 10: REVISED 510(K) SUMMARY
Sponsor Information:
| Name of 510(k) sponsor:
Address: | GlycoBioSciences, Inc.
7 Timber Court
Georgetown, Ontario L7G 4S4
Canada |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact information: | Kevin Drizen
President
GlycoBioSciences, Inc.
7 Timber Court
Georgetown, Ontario L7G 4S4 - Canada
Phone: 905-854-0631
Fax: 905-702-1709
kdrizen@glycobiosciences.com |
Device Information:
Proprietary names of device: L.A.M. IPM Wound Gel and IPM Derm Gel
Generic/classification name: Dressing, Wound, Drug
Product code (classification): FRO
Legally Marketed Predicate Devices:
- Carrasyn Hydrogel Wound Dressing (K962218); September 12, 1996
- Epicyn HydroGel (K102945); February 2, 2011
- MimyX Cream (K041342); July 19, 2005
- L.A.M. IPM Wound Gel (K020325); April 15, 2002
- L.A.M. IPM Wound Gel (K123113); December 11, 2012
Device Description:
L.A.M. IPM Wound Gel/IPM Derm Gel is a clear viscous, odourless, aqueous gel, composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. The proportion of sodium hyaluronate "w/w" in the formulation is 2.5%.
Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid in L.A.M. IPM Wound Gel and IPM Derm Gel is derived from avian sources. L.A.M. IPM Wound Gel and IPM Derm Gel serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process. L.A.M. IPM Wound Gel/ IPM Derm Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Other ingredients in L.A.M. IPM Wound Gel and IPM Derm Gel are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%).
FEB 1 4 2014
1
L.A.M. IPM Wound Gel and IPM Derm Gel are presented in carton boxes with 4 laminated tubes of 10g (0.35oz).
L.A.M. IPM Wound Gel and IPM Derm Gel are exactly the same in every aspect and specifications; they are the same device with two (2) different trade names.
Intended Use:
L.A.M. IPM Wound Gel and IPM Derm Gel serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process.
L.A.M. IPM Wound Gel/ IPM Derm Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Indications for Use:
"OTC":
L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of minor burns (1ª degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.
Rx:
Under the supervision of a health care professional;
· L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.
· L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis and radio-dermatitis.
Device Technological Characteristics:
L.A.M. IPM Wound Gel/IPM Derm Gel is a clear viscous, odorless, aqueous gel. Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid in L.A.M. IPM Wound Gel and IPM Derm Gel is derived from avian sources.
L.A.M. IPM Wound Gel and IPM Derm Gel serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process.
L.A.M. IPM Wound Gel/ IPM Derm Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Products for topical use have their safety established through biocompatibility test performed for L.A.M. IPM Wound Gel, included reports of Cytotoxicity Study, Modified ISO Accute Reactivity in Rabbits, ISO Accute Systemic Toxicity in Mouse. In Vitro Hemolysis and ISO Sensitization. All of them meet the requirements of the ISO 10993 and resulted under the anticipated specifications.
Concluding, the biocompatibility test for L.A.M. IPM Wound Gel demonstrated similar results to the ones of its predicates, which is: the product safe and effective for its intended use.
2
Also, stability testing conducted to support the proposed shelf life confirmed that aged product met the acceptance criteria.
Comparison with Predicate Device:
L.A.M. IPM Wound Gel (K123113) is similar in technological characteristics and indications to the predicates.
| 510(k)
Number | Proprietary
Name | Product
Code | Classification
Name | Manufacturer | Classification
Panel |
|------------------|----------------------------------------|-----------------|--------------------------------------------------------------------|------------------------------------|---------------------------------|
| K962218 | Carrasyn
Hydrogel
Wound Dressing | MGQ | Dressing, Wound
and Burn,
Hydrogel W/Drug
and/or Biologic | Carrington
Laboratories Inc. | General &
Plastic Surgery |
| K102945 | Epicyn
HydroGel | FRO | Dressing, Wound,
Drug | Oculus Innovative
Sciences Inc. | General &
Plastic Surgery |
| K041342 | MimyX Cream | MGQ | Dressing, Wound
and Burn,
Hydrogel W/Drug
and/or Biologic | Stiefel
Laboratories Inc. | General &
Plastic
Surgery |
| K020325 | L.A.M. IPM
Wound Gel | MGQ | Dressing, Wound
and Burn,
Hydrogel W/Drug
and/or Biologic | LAM
Pharmaceutical
Corp. | General &
Plastic Surgery |
| K123113 | L.A.M. IPM
Wound Gel | MGQ | Dressing, Wound
and Burn,
Hydrogel W/Drug
and/or Biologic | GlycoBioSciences,
Inc. | General &
Plastic Surgery |
Considering that the change of indication proposed by this 510(k) only includes indications that are already approved to the predicates indicated by Glyco, it is fair to understand that quality, safety and effectiveness are demonstrated and are comparable to the predicates.
Analysis of why any differences between the subject device and predicate(s) do not render the device NSE
Though L.A.M. IPM Wound Gel/ IPM Derm Gel contain different materials compared to some of the predicates, the basic technological characteristics of L.A.M. IPM Wound Gel/ IPM Derm Gel and all the predicates listed are the same; all devices provide a moist environment and protective barrier that retains moisture; this is beneficial in the wound healing process and also in the relief of symptoms associated with dermatitis. Similar to other cases of dermatitis treatment with emollients and dressings with wet wrap is recommended for the management of atopic eczema. This is the principle of operation of L.A.M. IPM Wound Gel/ IPM Derm Gel and all its predicates; provide and retain moisture on skin and wounds environments.
3
We used as a source of our understanding the publication "Management of atopic eczema in primary care. A national clinical guideline. 2011 Mar. NGC:008790"
In summary, L.A.M IPM Wound Gel/IPM Derm Gel is similar in function and intended use as its predicates; Epicyn HydroGel (K102945), Carrasyn Hydrogel Wound Dressing (K962218), MimyX Cream (K041342), L.A.M IPM Wound Gel (K020325) and L.A.M IPM Wound Gel (K123113)listed.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 14, 2014
GlycoBioSciences, Inc. Kevin Drizen President 7 Timber Court Georgetown, Ontario, L7G 4S4, Canada
Re: K130781
Trade/Device Name: L.A.M. IPM™ Wound Gel and IPM Derm Gel Regulatory Class: Unclassified Product Code: FRO Dated: January 06, 2014 Received: January 07, 2014
Dear Mr. Drizen:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita Ashar, MD, MBA, FACS Acting Director . Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K130781
Device Name L.A.M. IPM Wound Gel/IPM Derm Gel
Indications for Use (Describe) "OTC":
L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of minor burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.
Rx:
Under the supervision of a health care professional;
· L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of exudating wounds such as leg ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.
• L.A.M. IPM Wound Gel/IPM Denn Gel is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatits, allergic contact dermatits and radio-dematitis.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
CHANNEW YORK FOR FOR FOR FOR FOR USE ONLY - CARRET - THE START FOR WARRE
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/6/Picture/17 description: The image shows the text "JiyoungDang -S" in a simple, sans-serif font. The word "Jiyoung" is written in a clear, legible font, while the word "Dang" is stylized with a decorative, outlined font. The "-S" is written in the same font as "Jiyoung" and is slightly smaller in size. The overall impression is a combination of simplicity and ornamentation.