(129 days)
No reference devices were used in this submission.
No
The device description focuses on the chemical composition and physical properties of a gel for wound and skin management, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the management of various wounds and skin conditions, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device, IPM Wound Gel Bio/IPM Derm Gel Bio, is a wound dressing gel intended for the management and relief of symptoms associated with various skin conditions and wounds; it does not perform diagnostic functions.
No
The device description clearly states it is a gel composed of chemical ingredients and packaged in tubes, indicating it is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the management of wounds and skin conditions. This involves applying the gel directly to the body surface for therapeutic purposes.
- Device Description: The device is a gel composed of sodium hyaluronate and other ingredients, designed to maintain a moist environment for wound healing and skin relief.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The device described is a topical wound and skin care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- For Over-the-Counter Use: IPM Wound Gel Bio/IPM Derm 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: IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative and donor sites), mechanically debrided wounds, and for second degree burns. IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis.
Product codes
FRO
Device Description
IPM Wound Gel Bio/IPM Derm Gel Bio is a clear viscous, odorless, 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 in IPM Wound Gel Bio and IPM Derm Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio and IPM Derm Gel Bio serves to maintain a moist environment. The maintenance of moist environment is widely recognized to positively contribute to wound healing process. IPM Wound Gel Bio/ IPM Derm Gel Bio helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Other ingredients in IPM Wound Gel Bio and IPM Derm 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 and IPM Derm Gel Bio are presented in the following packaging formats: -a carton box with 4 laminated tubes of 10g (0.35oz) -a carton box with one laminated tube of 75g (2.65oz). IPM Wound Gel Bio and IPM Derm Gel Bio are exactly the same in all aspects and specifications; these 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, Under the supervision of a healthcare 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)
The safety of IPM Wound Gel Bio/Derm Gel Bio has been already demonstrated through the Biocompatibility evaluation of its predicate IPM Wound Gel Bio. There have been no changes made to this topical formulation from the currently cleared IPM Wound Gel Bio to the proposed IPM Wound Gel Bio/Derm Gel Bio. Hence the biocompatibility tests for IPM Wound Gel Bio/Derm Gel Bio were not required to be repeated. Bio fermented HA passed biocompatibility evaluations and thus demonstrated substantial equivalence to the predicate device in this respect, i.e. biocompatibility. Also, stability testing conducted on the predicate IPM Wound Gel Bio to support the proposed shelf-life confirmed that aged product met the acceptance criteria. Since there were no changes made to the formulation from the currently cleared IPM Wound Gel Bio to the proposed IPM Wound Gel Bio/Derm Gel Bio the stability testing are not required to be repeated for the proposed IPM Wound Gel Bio/Derm Gel Bio.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IPM® Wound Gel Bio (K123193), L.A.M. IPM Wound Gel and IPM Derm Gel (K130781)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2015
GlycoBioSciences Incorporated Mr. Kevin Drizen President 7 Timber Court Georgetown, Ontario L7G 4S4 CANADA
Re: K143527
Trade/Device Name: IPM Wound Gel Bio/IPM Derm Gel Bio Regulatory Class: Unclassified Product Code: FRO Dated: March 16, 2015 Received: March 18, 2015
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
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143527
Device Name IPM Wound Gel Bio/IPM Derm Gel Bio
Indications for Use (Describe)
For Over-the-Counter Use:
IPM Wound Gel Bio/IPM Derm 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.
| 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 G) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K143527
Device Name IPM Wound Gel Bio/IPM Derm Gel Bio
Indications for Use (Describe)
Prescription Use:
Under the supervision of a healthcare professional:
· IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative and donor sites), mechanically debrided wounds, and for second degree burns.
• IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(K)SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the IPM Wound Gel Bio and IPM Derm Gel Bio is provided below.
Sponsor Information:
| Name of 510(k) sponsor: | GlycoBioSciences Inc. |
|---|---|
| Address: | 7 Timber Court |
| Georgetown, Ontario L7G 4S4 | |
| Canada | |
| Contact information: | Kevin Drizen, |
| President | |
| GlycoBioSciences, Inc. | |
| 7 Timber Court | |
| Georgetown, Ontario L7G 4S4 | |
| Canada | |
| kdrizen@glycobiosciences.com | |
| Phone: 905-854-0631 | |
| Fax: 905-702-1709 | |
| Date Summary prepared: | March 14, 2015 |
Device Information:
| Proprietary names of device: | IPM Wound Gel Bio and IPM Derm Gel Bio |
|---|---|
| Common or Usual Name: | Wound Dressing |
| Regulatory Class: | Unclassified |
| Product code: | FRO |
Legally Marketed Predicate Devices:
IPM® Wound Gel Bio (K123193) L.A.M. IPM Wound Gel and IPM Derm Gel (K130781)
No reference devices were used in this submission.
Device Description:
IPM Wound Gel Bio/IPM Derm Gel Bio is a clear viscous, odorless, 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 IPM Wound Gel Bio and IPM Derm Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio and IPM Derm Gel Bio serves to maintain a moist environment. The maintenance of moist environment is widely recognized to positively contribute to wound healing process. IPM Wound Gel Bio/ IPM Derm Gel Bio helps to relieve dry
5
waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Other ingredients in IPM Wound Gel Bio and IPM Derm 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 and IPM Derm Gel Bio are presented in the following packaging formats: -a carton box with 4 laminated tubes of 10g (0.35oz) -a carton box with one laminated tube of 75g (2.65oz).
IPM Wound Gel Bio and IPM Derm Gel Bio are exactly the same in all aspects and specifications; these are the same device with two (2) different trade names.
Intended Use:
IPM Wound Gel Bio and IPM Derm 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 and IPM Derm Gel Bio helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Over-the-Counter:
IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for management of minor burns (1st degree burns), minor abrasions, minor cuts and helps to relieve dry waxy irritations associated with dry skin conditions.
Rx Only:
Under the supervision of a healthcare professional;
- . IPM Wound Gel Bio/IPM Derm Gel Bio 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.
- IPM Wound Gel Bio/IPM Derm Gel Bio is indicated in 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:
IPM Wound Gel Bio/IPM Derm 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/IPM Derm Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio/IPM Derm Gel Bio serves to maintain moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process.
6
IPM Wound Gel Bio/IPM Derm Gel Bio helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
The safety of IPM Wound Gel Bio/Derm Gel Bio has been already demonstrated through the Biocompatibility evaluation of its predicate IPM Wound Gel Bio. There have been no changes made to this topical formulation from the currently cleared IPM Wound Gel Bio to the proposed IPM Wound Gel Bio/Derm Gel Bio. Hence the biocompatibility tests for IPM Wound Gel Bio/Derm Gel Bio were not required to be repeated. Bio fermented HA passed biocompatibility evaluations and thus demonstrated substantial equivalence to the predicate device in this respect, i.e. biocompatibility.
Also, stability testing conducted on the predicate IPM Wound Gel Bio to support the proposed shelf-life confirmed that aged product met the acceptance criteria. Since there were no changes made to the formulation from the currently cleared IPM Wound Gel Bio to the proposed IPM Wound Gel Bio/Derm Gel Bio the stability testing are not required to be repeated for the proposed IPM Wound Gel Bio/Derm Gel Bio.
Comparison with Predicate Device:
IPM Wound Gel Bio is similar in technological characteristics and indications to the predicates (See Appendix 2A and 2B for predicates 510(k) summary) as shown in the Table below:
| Proprietary
Name of Device
&
510(k) Number | IPM Wound Gel Bio
(K123193)
(Multiple Predicate) | L.A.M. IPM Wound
Gel and IPM Derm
Gel
(K130781)
(Multiple Predicate) | IPM Wound Gel Bio
and IPM Derm Gel
Bio
(K143527)
(Proposed Device) | Diff-
eren-
ces
(Yes/
No) | Why differences do
not affect Safety &/
Performance |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturers | GlycoBioSciences | GlycoBioSciences | GlycoBioSciences | | |
| Intended Use | Serves to maintain
moist wound
environment. The
maintenance of a moist
wound environment is
widely recognized to
positively contribute to
wound healing process.
Also, helps to relieve
dry waxy skin by
maintaining a moist
wound and skin
environment, which is
beneficial to the healing
process. | Serves to maintain
moist wound
environment. The
maintenance of a moist
wound environment is
widely recognized to
positively contribute to
wound healing process.
Also, helps to relieve
dry waxy skin by
maintaining a moist
wound and skin
environment, which is
beneficial to the healing
process. | Serves to maintain
moist wound
environment. The
maintenance of a moist
wound environment is
widely recognized to
positively contribute to
wound healing process.
Also, helps to relieve
dry waxy skin by
maintaining a moist
wound and skin
environment, which is
beneficial to the healing
process. | No | N/A |
| Indications for
Use | OTC:
IPM Wound Gel Bio is
indicated for the
management of minor
burns (1st degree burns),
minor abrasions
and minor cuts and
helps to relieve dry
waxy skin irritations
associated with dry skin
conditions. | OTC:
IPM Wound Gel Bio/
IPM Derm 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 | OTC:
IPM Wound Gel Bio/
IPM Derm 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 | Yes | The proposed
additional indications
"management and
relief of burning,
itching and pain
experienced with
various types of
dermatoses:
including atopic
dermatitis, allergic
contact dermatitis
and radio-dermatitis." |
7
| Proprietary
Name of Device
&
510(k) Number | IPM Wound Gel Bio
(K123193)
(Multiple Predicate) | L.A.M. IPM Wound
Gel and IPM Derm
Gel
(K130781)
(Multiple Predicate) | IPM Wound Gel Bio
and IPM Derm Gel
Bio
(K143527)
(Proposed Device) | Diff-
eren-
ces
(Yes/
No) | Why differences do
not affect Safety &/
Performance |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Rx Only:
Under the supervision
of a healthcare
professional:
IPM Wound Gel Bio 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
for 2nd degree burns" | Rx Only:
Under the supervision
of a healthcare
professional:
• IPM Wound Gel Bio/
IPM Derm Gel Bio is
indicated for
management of
exudating wounds such
as leg ulcers, pressure
ulcers, diabetic ulcers,
surgical wounds (post-
operative and donor
sites), mechanically or
surgically debrided
wounds, and for second
degree burns.
• IPM Wound Gel
Bio/IPM Derm Gel Bio
is indicated in the
management and relief
of burning, itching and
pain experienced with
various types of
dermatoses: including
atopic dermatitis,
allergic contact
dermatitis and radio-
dermatitis. | Rx Only:
Under the supervision
of a healthcare
professional:
• IPM Wound Gel Bio/
IPM Derm Gel Bio is
indicated for
management of
exudating wounds such
as leg ulcers, pressure
ulcers, diabetic ulcers,
surgical wounds (post-
operative and donor
sites), mechanically or
surgically debrided
wounds, and for second
degree burns.
• IPM Wound Gel
Bio/IPM Derm Gel Bio
is indicated in the
management and relief
of burning, itching and
pain experienced with
various types of
dermatoses: including
atopic dermatitis,
allergic contact
dermatitis and radio-
dermatitis. | No | do not affect the
Safety and
Performance of the
proposed device
because maintaining
a moist wound
environment can
provide relief of
symptoms associated
with dermatitis. |
| Device
Description | Aqueous gel composed
principally of sodium
hyaluronate | Aqueous gel composed
principally of sodium
hyaluronate | Aqueous gel composed
principally of sodium
hyaluronate | No | N/A |
| Hyaluronate
source | Bacterial fermentation | Avian | Bacterial fermentation | Yes | The formulation and
raw material HA of
the proposed device
is the same as that of
IPM Wound Gel Bio
K123193. |
| Shelf Life | 18 Months | 18 Months | 18 Months | No | |
Considering that the change of indication proposed by this 510(k) only includes indications that are already approved to the predicates indicated by GlycoBioSciences, it is fair to understand that quality, safety and effectiveness are demonstrated and are comparable to the predicates.