Who is the manufacturer of IPM Wound Gel Bio, IPM Derm Gel Bio?

Glycobiosciences, Inc. filed the 510(k) submission for IPM Wound Gel Bio, IPM Derm Gel Bio (K143527).

What is the FDA product code for IPM Wound Gel Bio, IPM Derm Gel Bio?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for IPM Wound Gel Bio, IPM Derm Gel Bio?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like IPM Wound Gel Bio, IPM Derm Gel Bio?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IPM Wound Gel Bio, IPM Derm Gel Bio

Q: What are the predicate devices for IPM Wound Gel Bio, IPM Derm Gel Bio?

IPM Wound Gel Bio (K123193); L.A.M. IPM Wound Gel and IPM Derm Gel (K130781).

K143527 · Glycobiosciences, Inc. · FRO · Apr 20, 2015 · SU

Device Facts

Record ID	K143527
Device Name	IPM Wound Gel Bio, IPM Derm Gel Bio
Applicant	Glycobiosciences, Inc.
Product Code	FRO · SU
Decision Date	Apr 20, 2015
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

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.

Device Story

Clear, viscous, odorless, aqueous gel; composed of 2.5% sodium hyaluronate (bacterial fermentation), 1% hydroxyethyl cellulose, 0.2% methylparaben, 3% polyethylene glycol, and ~93% purified water. Maintains moist wound/skin environment to facilitate healing and relieve symptoms. Applied topically by patients (OTC) or healthcare professionals (Rx). No electronic components or active mechanisms. Benefits include symptom relief (burning, itching, pain) and support of wound healing process.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical formulation, technological characteristics, and biocompatibility/stability data from previously cleared predicate devices.

Technological Characteristics

Aqueous gel; 2.5% sodium hyaluronate (bacterial fermentation), 1% hydroxyethyl cellulose, 0.2% methylparaben, 3% polyethylene glycol, ~93% purified water. Non-active, topical dressing. No electronic or software components.

Indications for Use

Indicated for OTC use: management of minor burns (1st degree), minor abrasions, minor cuts, and relief of dry waxy skin irritations. Indicated for Rx use under healthcare professional supervision: management of exudating wounds (leg, pressure, diabetic ulcers, surgical wounds, debrided wounds, 2nd degree burns) and management/relief of burning, itching, and pain associated with dermatoses (atopic dermatitis, allergic contact dermatitis, radio-dermatitis).

Predicate Devices

IPM Wound Gel Bio (K123193)
L.A.M. IPM Wound Gel and IPM Derm Gel (K130781)

Related Devices

K123193 — IPM WOUND GEL BIO · Glycobiosciences, Inc. · Mar 3, 2014
K130781 — L.A.M. IPM WOUND GEL, IPM DERM GEL · Glycobiosciences, Inc. · Feb 14, 2014
K190224 — Medline Burn and Wound Dressing (OTC) · Medline Industries, Inc. · Mar 8, 2019
K150799 — Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula · Innovacyn, Inc. · Nov 19, 2015
K024367 — SINCLAIR WOUND AND SKIN EMULSION · Sinclair Pharmaceuticals, Ltd. · Jul 28, 2003

Submission Summary (Full Text)

{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.