L.A.M. IMP WOUND GEL

K123113 · Glycobiosciences, Inc. · FRO · Dec 11, 2012 · SU

Device Facts

• Record ID: K123113
• Device Name: L.A.M. IMP WOUND GEL
• Applicant: Glycobiosciences, Inc.
• Product Code: FRO · SU
• Decision Date: Dec 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Over The Counter: L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-the-counter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts. Prescription (Rx): Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.

Device Story

L.A.M. IPM Wound Gel is a clear, viscous, aqueous gel composed of sodium hyaluronate. It functions by providing a moist wound environment to support healing. The device is applied topically to the wound site. It is intended for both over-the-counter use by patients for minor injuries and professional use in clinical settings for more complex, exudating wounds. The gel acts as a physical barrier/dressing to maintain moisture balance. It does not involve electronic components, software, or automated analysis.

Clinical Evidence

No clinical data. Substantial equivalence is based on the identical formulation to the predicate device and the established safety/effectiveness profile of the hydrogel material for the indicated wound types.

Technological Characteristics

Aqueous hydrogel composed of sodium hyaluronate. Clear, viscous, odorless. Topical application. Non-electronic, non-implantable. No software or connectivity.

Indications for Use

Indicated for management of minor burns, abrasions, and cuts (OTC); and for exudating wounds including leg, pressure, and diabetic ulcers, surgical wounds (incisions/donor sites), debrided wounds, and 2nd degree burns (Rx under professional supervision).

Predicate Devices

• Bionect® Hydrogel (K984413)
• L.A.M. IPM Wound Gel (K020325)

Reference Devices

• ConvaTec's HA Absorbent Wound Dressing (K984388)

Submission Summary (Full Text)

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### 510(K) SUMMARY

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: [phone] Fax: [phone]

Dressing, Wound And Burn, Hydrogel W/Drug

Date summary prepared:

L.A.M. IPM Wound Gel Proprietary name of device:

September 21, 2012

And/Or Biologic

Generic/classification name:

Product code (classification): Product Code FRO: Unclassified

Legally Marketed Predicate Devices: Bionect® Hydrogel (K984413); February 10, 1999 L.A.M IPM Wound Gel (K020325); April 15, 2002

#### Device Description:

L.A.M. IPM Wound Gel is a clear viscous, odoricss, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-thecounter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts. Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.

DEC 1 1 2012

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#### Intended Use:

Over The Counter:

L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-the-counter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts.

#### Prescription (Rx):

Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.

#### Comparison with Predicate Device:

There have not been any changes to L.A.M IPM Wound Gel (K020325) since FDA determined that it was substantially equivalent to ConvaTec's HA Absorbent Wound Dressing (K984388) and Fidia Pharmaceutical Corporation's Bionect® Hydrogel (K984413) on April 15, 2002.

| Trade Name | L.A.M. IPMT™ Wound<br>Gel<br>(K020325) | Bionect® Hydrogel<br>(Jaloplast™)<br>(K984413) | L.A.M. IPMTM Wound Gel<br>(Not Yet Assigned -<br>modified indication) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Hydrogel Wound and<br>Burn Dressing | Hydrogel Wound and Burn<br>Dressing | Hydrogel Wound and Burn<br>Dressing |
| Intended Use | Provides a moist wound<br>environment that is<br>supportive to wound<br>healing | Provides a moist wound<br>environment that is<br>supportive to wound<br>healing | Provides a moist wound<br>environment that is<br>supportive to wound healing |
| Indication for Use | Over-the-counter:<br>• Minor abrasions<br>• Minor cuts | Over-the-counter:<br>• Minor burns<br>• Superficial cuts<br>• Lacerations and<br>abrasions<br>• Minor skin irritations | Over-the-counter:<br>• Minor burns<br>• Minor abrasions<br>• Minor cuts<br>Rx:<br>Under the care of a healthcare<br>professional: |
| | Under the care of a<br>healthcare professional:<br>• Wounds such as leg<br>ulcers, pressure<br>ulcers, and diabetic<br>ulcers<br>• Mechanically or<br>surgically debrided<br>wounds | Under the care of a<br>healthcare professional:<br>• Wounds such as partial<br>to full thickness dermal<br>ulcers (pressure ulcers,<br>venous stasis ulcers,<br>arterial ulcers, diabetic<br>ulcers)<br>• Surgical wounds (post-<br>operative incisions and<br>donor sites)<br>• Second degree burns | • Wounds such as leg<br>ulcers, pressure ulcers,<br>and diabetic ulcers<br>• Mechanically or<br>surgically debrided<br>wounds<br>• Surgical wounds (post-<br>operative incisions and<br>donor sites)<br>• Second degree burns |

## . K123113 pg 2/2

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 8, 2013

Glycobiosciences. Incorporated % Focal Point Research, Incorporated Mr. Kevin Drizen President 7 Timber Court Gerogetown, Ontario L7G 4S4 Canada

Re: K123113 Trade/Device Name: L.A.M. IPM Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated (Date on orig SE ltr): September 25, 2012 Received (Date on orig SE Itr): October 03, 2012

Dear Mr. Drizen:

This letter corrects our substantially equivalent letter dated December 11, 2012.

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 (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 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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Page 2 - Mr. Kevin Drizen

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 vours. For

# Peter D. Romm -S

Mark Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### K123113

### Indications for Use

510(k) Number (ff known): K123113

Device Name: L.A.M. IPM Wound Gel

Indications For Use:

"OTC:

L.A.M. IPM Wound Gel is indicated for the manugement of minor burns (16 degree burns), minor abrasions and minor cuts.

Rx:

Under the supervision of a healthcare professional L.A.M. IPM Wound Gel is indicated for the 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 2nd degree burns"

Prescription Use _ ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jiyoung. Dang

(Division Sign-Off) Division of Surgical Devices 510 (k) Number _______________________________________________________________________________________________________________________________________________________________

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