L.A.M. IPM WOUND GEL, IPM DERM GEL

K130781 · Glycobiosciences, Inc. · FRO · Feb 14, 2014 · SU

Device Facts

• Record ID: K130781
• Device Name: L.A.M. IPM WOUND GEL, IPM DERM GEL
• Applicant: Glycobiosciences, Inc.
• Product Code: FRO · SU
• Decision Date: Feb 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

L.A.M. IPM Wound Gel/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.

Device Story

L.A.M. IPM Wound Gel and IPM Derm Gel are clear, viscous, aqueous gels containing 2.5% sodium hyaluronate (avian-derived). Device functions as a topical dressing to maintain a moist wound environment and provide a protective barrier, facilitating healing and relieving symptoms of dry skin and dermatoses. Applied topically by patients (OTC) or healthcare professionals (Rx) to wounds or affected skin areas. Output is the physical gel layer itself, which retains moisture at the application site. Benefits include improved wound healing conditions and symptomatic relief of burning, itching, and pain. No electronic or mechanical components; purely chemical/physical mechanism of action.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, including cytotoxicity, modified ISO acute reactivity in rabbits, ISO acute systemic toxicity in mice, in vitro hemolysis, and ISO sensitization. Stability testing confirmed aged product met acceptance criteria.

Technological Characteristics

Aqueous gel containing 2.5% sodium hyaluronate, 1% hydroxyethyl cellulose, 0.2% methylparaben, 3% polyethylene glycol, and ~93% purified water. Viscous, odorless, clear form factor. Biocompatibility per ISO 10993. No energy source or software.

Indications for Use

Indicated for OTC use: minor burns (1st degree), minor abrasions, minor cuts, and relief of dry waxy skin irritations. Indicated for Rx use (under professional supervision): management of exudating wounds (leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds, debrided wounds), second degree burns, and relief of burning, itching, and pain associated with dermatoses (atopic dermatitis, allergic contact dermatitis, radio-dermatitis).

Predicate Devices

• Carrasyn Hydrogel Wound Dressing (K962218)
• Epicyn HydroGel (K102945)
• MimyX Cream (K041342)
• L.A.M. IPM Wound Gel (K020325)
• L.A.M. IPM Wound Gel (K123113)

Submission Summary (Full Text)

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# Section 10: REVISED 510(K) SUMMARY

## Sponsor Information:

| Name of 510(k) sponsor:<br>Address: | GlycoBioSciences, Inc.<br>7 Timber Court<br>Georgetown, Ontario L7G 4S4<br>Canada |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact information: | Kevin Drizen<br>President<br>GlycoBioSciences, Inc.<br>7 Timber Court<br>Georgetown, Ontario L7G 4S4 - Canada<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |

#### 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)<br>Number | Proprietary<br>Name | Product<br>Code | Classification<br>Name | Manufacturer | Classification<br>Panel |
|------------------|----------------------------------------|-----------------|--------------------------------------------------------------------|------------------------------------|---------------------------------|
| K962218 | Carrasyn<br>Hydrogel<br>Wound Dressing | MGQ | Dressing, Wound<br>and Burn,<br>Hydrogel W/Drug<br>and/or Biologic | Carrington<br>Laboratories Inc. | General &<br>Plastic Surgery |
| K102945 | Epicyn<br>HydroGel | FRO | Dressing, Wound,<br>Drug | Oculus Innovative<br>Sciences Inc. | General &<br>Plastic Surgery |
| K041342 | MimyX Cream | MGQ | Dressing, Wound<br>and Burn,<br>Hydrogel W/Drug<br>and/or Biologic | Stiefel<br>Laboratories Inc. | General &<br>Plastic<br>Surgery |
| K020325 | L.A.M. IPM<br>Wound Gel | MGQ | Dressing, Wound<br>and Burn,<br>Hydrogel W/Drug<br>and/or Biologic | LAM<br>Pharmaceutical<br>Corp. | General &<br>Plastic Surgery |
| K123113 | L.A.M. IPM<br>Wound Gel | MGQ | Dressing, Wound<br>and Burn,<br>Hydrogel W/Drug<br>and/or Biologic | GlycoBioSciences,<br>Inc. | General &<br>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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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

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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 [phone] or [phone] 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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