(508 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological effects of the gel, with no mention of AI or ML technologies.
Yes
The device is indicated for the management of minor burns, abrasions, cuts, and relief of dry skin irritations (OTC), as well as exudating wounds like ulcers and surgical wounds (Rx), all of which are conditions that require therapeutic intervention. Its mechanism of action to maintain a moist wound environment also contributes to the healing process, a therapeutic function.
No
The device is a gel used for wound management, creating a moist environment to aid healing. It does not perform any diagnostic functions or analyze medical data.
No
The device description clearly states it is a "clear viscous, odorless, aqueous gel" composed of physical ingredients, indicating it is 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 describes the management of various types of wounds (burns, abrasions, cuts, ulcers, etc.) and skin irritations. This is a therapeutic or wound care application, not a diagnostic one.
- Device Description: The device is a topical gel applied to the wound surface. Its mechanism of action is to maintain a moist wound environment, which supports the healing process. This is a physical or chemical interaction with the wound itself, not an analysis of a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
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:
IPM Wound Gel Bio serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process. IPM Wound Gel Bio also helps to relieve dry waxy skin irritations associated with dry skin conditions.
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;
· IPM Wound Gel Bio is indicated for management of exudating wounds such as leg ulcers, diabetic ulcers, surqical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.
Product codes (comma separated list FDA assigned to the subject device)
MGQ, FRO
Device Description
IPM Wound Gel Bio is a clear viscous, odoriess, 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 is an extracellular matrix component of human skin. The Hyaluronic acid used in IPM Wound Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process.
Other ingredients in IPM Wound Gel Bio are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%).
IPM Wound Gel Bio is presented in carton boxes with 4 laminated tubes of 10g (0.35oz).
IPM Wound Gel Bio has similar specifications of L.A.M. IPM Wound Gel, with exception to its source of Hyaluronic acid.
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 / 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 tests. The biocompatibility test performed for L.A.M. IPM Wound Gel, included reports of Cytotoxicity Study, Modifiled 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 USP and resulted under the anticipated specifications. The Histological Study in Porcine is another study that demonstrated the effectiveness of L.A.M. IPM Wound Gel on partial thickness wound healing in porcine.
Bio fermented HA passed biocompatibility evaluations and thus demonstrated substantial equivalence to the predicate device in this respect, i.e., biocompatibility.
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.
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
MAR 0 3 2014
K123193 Page 1/3
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 name of device: IPM Wound Gel Bio
Generic/classification name: Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic
Product code (classification): Product Code MGQ; Unclassified
Legally Marketed Predicate Devices:
Bionect® Hydrogel (K984413) L.A.M. IPM Wound Gel (K020325)- L.A.M. IPM Wound Gel (K020325); April 15, 2002
Device Description:
IPM Wound Gel Bio is a clear viscous, odoriess, 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 is an extracellular matrix component of human skin. The Hyaluronic acid used in IPM Wound Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process.
Other ingredients in IPM Wound Gel Bio are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%).
1
IPM Wound Gel Bio is presented in carton boxes with 4 laminated tubes of 10g (0.35oz).
IPM Wound Gel Bio has similar specifications of L.A.M. IPM Wound Gel, with exception to its source of Hyaluronic acid.
Intended Use:
IPM Wound Gel Bio serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process. IPM Wound Gel Bio also helps to relieve dry waxy skin irritations associated with dry skin conditions.
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;
· IPM Wound Gel Bio is indicated for management of exudating wounds such as leg ulcers, diabetic ulcers, surqical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.
Device Technological Characteristics:
IPM Wound Gel Bio is a clear viscous, odorless, aqueous gel. Hyaluronic acid is an extracellular matrix component of human skin. The Hyaluronic acid used in IPM Wound Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process.
Products for topical use have their safety established through biocompatibility tests. The biocompatibility test performed for L.A.M. IPM Wound Gel, included reports of Cytotoxicity Study, Modifiled 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 USP and resulted under the anticipated specifications. The Histological Study in Porcine is another study that demonstrated the effectiveness of L.A.M. IPM Wound Gel on partial thickness wound healing in porcine.
Bio fermented HA passed biocompatibility evaluations and thus demonstrated substantial equivalence to the predicate device in this respect, i.e., biocompatibility.
Comparison with Predicate Device:
IPM Wound Gel Bio is similar in technological characteristics and indications to the predicates.
2
K123193 Page 3/3
| Name of Device | L.A.M. IPM™
Wound Gel
(K020325) | Bionect® Hydrogel
(Jaloplast™)
(K984413) | IPM™ Wound Gel Bio
(K123193) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Dressing, Wound And
Burn, Hydrogel W/Drug
And/Or Blologic | Dressing, Wound And
Burn, Hydrogel W/Drug
And/Or Biologic | Dressing, Wound And
Burn, Hydrogel W/Drug
And/Or Biologic |
| Intended Use | Provides a moist wound
environment that is supportive
to wound healing | Provides a moist wound
environment that is supportive
to wound healing | Serves to maintain a moist wound
environment. The maintenance of
a moist wound environment is
widely recognized to positively
contribute to wound healing
process. IPM Wound Gel Bio also
helps to relieve dry waxy skin
irritations associated with dry skin
conditions. |
| Indications for Use | Over the counter:
L.A.M. IPM Wound Gel is
indicated for the management
of minor burns (1° degree
burns), minor abrasions
and minor cuts. | Over the counter:
Bionect is
indicated for the management
of minor burns (1° degree
burns), minor abrasions
and minor cuts, minor
irritations of the skin | OTC:
IPM Wound Gel Bio is indicated for
management of minor burns (1st
degree burns), minor abrasions,
minor cuts and helps to relieve dry
waxy skin irritations associated
with dry skin conditions. |
| | 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" | Under the supervision of a
healthcare professional:
Bionect 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" | Rx:
Under the supervision of a health
care professional;
• IPM Wound Gel Bio is indicated
for management of exudating
wounds such as leg ulcers,
pressure ulcers, diabetic ulcers,
surgical wounds (postoperative
incisions and donor sites),
mechanically or surgically debrided
wounds, and for second degree
bums. |
| Device Description | Aqueous gel
composed
principally of
sodium hyaluronate | Aqueous gel prepared
from hyaluronate and
purified water | Aqueous gel
composed
principally of
sodium hyaluronate |
| Hyaluronate
Source | Avlan | Unknown | Bacterial fermentation |
| Shelf Life | 24 months | 24 months | 24 months |
Considering that the only difference is the source of HA and that proposed indications are similar to 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.
3
Image /page/3/Picture/1 description: The image shows the words "Public Health Service" in a bold, sans-serif font. The text is arranged in a single line, with each word clearly legible. The overall impression is one of official communication, likely indicating an organization or department related to public health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2014
GlycoBioSciences Incorporated Mr. Kevin Drizen President 7 Timber Court Georgetown. Ontario L7G 4S4 CANADA
Re: K123193
Trade/Device Name: IPM Wound Gel Bio Regulatory Class: Unclassified Product Code: FRO Dated: January 10, 2014 Received: January 13, 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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4
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Data: Jamuary 31, 2017 Sob PRA Stotoment on last page.
Indications for Use
510(k) Number (II Known) K123193
Davios Nams IPM Wound Gel Bio
Indications for Use (Describe)
"OTC":
IPM Wound Gel Bio is indicated for management of minor abrasions, minor abrasions, minor cols and itelys to relieve dry wasy skin inteliges associated with dry skin conditions.
Rx:
Under the supervision of a licaliti care professional:
· IPM Wound Gel Bio is indicated for management of exudating wounds such as leg ulcers, disbetic ulcers, surgical wounds (post-operative incisions and dones sites), mechanically debrided wounds, and for second degree burns.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON A SEPARATE PAGE IF NEEDED.
، : FOR FDA USE ONLY . ... :: :C. = : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . .
Concurrence of Center for Devices and Radiological Hoalth (CDRH) (Signature)
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FORM FDA 3881 (1/14)