(330 days)
"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.
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.
The provided text describes a medical device called "L.A.M. IPM Wound Gel and IPM Derm Gel". However, the document does not contain information about a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, or reader improvement, as would be expected for a diagnostic or AI-driven device.
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a common pathway for approval of Class I and Class II medical devices by the FDA. The acceptance criteria and "studies" mentioned relate to the device's technological characteristics, biocompatibility, and stability, rather than clinical performance studies with specific performance metrics against a ground truth.
Here's an analysis based on the information provided, highlighting why it doesn't fit the requested format for performance studies:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics against such criteria. The "acceptance criteria" discussed are related to:
- Biocompatibility tests: These tests ensure the device does not cause adverse biological reactions. The report states: "All of them meet the requirements of the ISO 10993 and resulted under the anticipated specifications."
- Stability testing: This confirms the product maintains its characteristics over its proposed shelf life. The report states: "stability testing conducted to support the proposed shelf life confirmed that aged product met the acceptance criteria."
- Substantial Equivalence: The primary "acceptance criterion" for marketing approval under a 510(k) is demonstrating that the device is as safe and effective as a legally marketed predicate device. The document argues that the device's technological characteristics, intended use, and indications are similar to its predicates.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical performance study with a test set of data points (e.g., images, patient records). The "testing" mentioned is for biocompatibility and stability, which are laboratory-based and not clinical performance studies on a "test set" of patients or data in the context of AI or diagnostic devices.
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)
Not applicable. There is no mention of a test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set or adjudication.
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 wound gel, not an AI or diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no ground truth, as this is not a diagnostic device.
8. The sample size for the training set
Not applicable. There is no training set for an AI model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI model.
Summary of the document's "studies" and demonstration of "acceptance criteria":
The document focuses on establishing the safety and effectiveness of the L.A.M. IPM Wound Gel and IPM Derm Gel through the following:
- Biocompatibility Testing:
- Tests conducted: Cytotoxicity Study, Modified ISO Acute Reactivity in Rabbits, ISO Acute Systemic Toxicity in Mouse, In Vitro Hemolysis, and ISO Sensitization.
- Acceptance Criteria: Met the requirements of ISO 10993 and "resulted under the anticipated specifications."
- Conclusion: "demonstrated similar results to the ones of its predicates, which is: the product safe and effective for its intended use."
- Stability Testing:
- Purpose: To support the proposed shelf life.
- Acceptance Criteria: "aged product met the acceptance criteria."
- Comparison to Predicate Devices (Substantial Equivalence):
- Argument: The device is "similar in technological characteristics and indications to the predicates." It provides a moist environment and protective barrier, which is the same principle of operation as its predicates.
- Indications for Use: The proposed indications for L.A.M. IPM Wound Gel/IPM Derm Gel "only includes indications that are already approved to the predicates."
- Conclusion: Quality, safety, and effectiveness are demonstrated and comparable to the predicates, leading to a "Substantial Equivalence" determination by the FDA.
In conclusion, the provided text describes a medical device submission focused on substantial equivalence based on physical/chemical characteristics, biocompatibility, stability, and comparison to existing products, rather than a performance study for a diagnostic or AI device with specific acceptance criteria like sensitivity or specificity.
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Section 10: REVISED 510(K) SUMMARY
Sponsor Information:
| Name of 510(k) sponsor:Address: | GlycoBioSciences, Inc.7 Timber CourtGeorgetown, Ontario L7G 4S4Canada |
|---|---|
| Contact information: | Kevin DrizenPresidentGlycoBioSciences, Inc.7 Timber CourtGeorgetown, Ontario L7G 4S4 - CanadaPhone: 905-854-0631Fax: 905-702-1709kdrizen@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
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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.
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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 | ProprietaryName | ProductCode | ClassificationName | Manufacturer | ClassificationPanel |
|---|---|---|---|---|---|
| K962218 | CarrasynHydrogelWound Dressing | MGQ | Dressing, Woundand Burn,Hydrogel W/Drugand/or Biologic | CarringtonLaboratories Inc. | General &Plastic Surgery |
| K102945 | EpicynHydroGel | FRO | Dressing, Wound,Drug | Oculus InnovativeSciences Inc. | General &Plastic Surgery |
| K041342 | MimyX Cream | MGQ | Dressing, Woundand Burn,Hydrogel W/Drugand/or Biologic | StiefelLaboratories Inc. | General &PlasticSurgery |
| K020325 | L.A.M. IPMWound Gel | MGQ | Dressing, Woundand Burn,Hydrogel W/Drugand/or Biologic | LAMPharmaceuticalCorp. | General &Plastic Surgery |
| K123113 | L.A.M. IPMWound Gel | MGQ | Dressing, Woundand Burn,Hydrogel W/Drugand/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.
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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.
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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
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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)
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N/A