(129 days)
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.
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.
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 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.
The provided text is a 510(k) summary for a medical device (IPM Wound Gel Bio/IPM Derm Gel Bio). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial report for an AI/ML medical device.
Therefore, the information required to directly answer your request regarding acceptance criteria, sample sizes, expert involvement, and statistical studies (like MRMC or standalone performance) is NOT present in the provided document. The document primarily discusses:
- Device Description: A clear viscous, odorless, aqueous gel composed principally of sodium hyaluronate.
- Intended Use: To maintain a moist wound environment and relieve dry waxy skin.
- Indications for Use (OTC): Minor burns (1st degree), minor abrasions, minor cuts, and dry waxy skin irritations.
- Indications for Use (Rx): Management of exudating wounds (leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds, 2nd-degree burns) and management/relief of burning, itching, and pain associated with dermatoses (atopic, allergic contact, radio-dermatitis).
- Comparison to Predicate Devices: Demonstrates that the proposed device is substantially equivalent to previously cleared devices (K123193 and K130781) by showing similar intended use, device description, shelf life, and that any differences in indications or hyaluronic acid source do not affect safety and performance.
- Biocompatibility and Stability: States that these tests were conducted on the predicate device and found acceptable, and since no changes were made to the formulation, re-testing was not required.
Based on the provided text, I cannot fill out the requested table or answer most of your detailed questions about a performance study, as this document is a regulatory submission for substantial equivalence, not a clinical study report.
Here's what can be inferred or stated from the document, along with what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics but implied through the comparison to predicate devices. The "acceptance criteria" here are essentially that the device is "substantially equivalent" in terms of safety and effectiveness to the predicates.
- Reported Device Performance: No quantitative performance data (e.g., healing rates, pain reduction scores, error rates) from a dedicated study are reported. The "performance" is implicitly deemed equivalent to the predicates based on its composition and mechanism of action (maintaining a moist environment).
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This document does not describe a test set or data from a clinical performance study. It relies on the substantial equivalence of the device's formulation and indications to previously approved devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No "ground truth" establishment in the context of a performance study is described. The FDA review process itself involves internal experts, but this isn't detailed in the submission itself.
4. Adjudication method for the test set:
- Not applicable/Not provided. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a topical wound gel, not an AI/ML medical device. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a topical wound gel, not an AI/ML medical device.
7. The type of ground truth used:
- Not applicable/Not provided. For this device, "ground truth" would be related to clinical outcomes (wound healing, symptom relief). However, no new clinical studies are presented. The basis for approval relies on the known effects of the ingredients and the equivalence to predicate devices that have already demonstrated safety and effectiveness.
8. The sample size for the training set:
- Not applicable/Not provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. There is no "training set" as this is not an AI/ML device.
In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a wound gel, not a clinical trial report for an AI/ML device. Therefore, the specific details you requested regarding acceptance criteria, study design, and performance metrics for an AI/ML model are not present.
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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
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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."
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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 CourtGeorgetown, Ontario L7G 4S4Canada |
| Contact information: | Kevin Drizen,PresidentGlycoBioSciences, Inc.7 Timber CourtGeorgetown, Ontario L7G 4S4Canadakdrizen@glycobiosciences.comPhone: 905-854-0631Fax: 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:
| ProprietaryName of Device&510(k) Number | IPM Wound Gel Bio(K123193)(Multiple Predicate) | L.A.M. IPM WoundGel and IPM DermGel(K130781)(Multiple Predicate) | IPM Wound Gel Bioand IPM Derm GelBio(K143527)(Proposed Device) | Diff-eren-ces(Yes/No) | Why differences donot affect Safety &/Performance |
|---|---|---|---|---|---|
| Manufacturers | GlycoBioSciences | GlycoBioSciences | GlycoBioSciences | ||
| Intended Use | Serves to maintainmoist woundenvironment. Themaintenance of a moistwound environment iswidely recognized topositively contribute towound healing process.Also, helps to relievedry waxy skin bymaintaining a moistwound and skinenvironment, which isbeneficial to the healingprocess. | Serves to maintainmoist woundenvironment. Themaintenance of a moistwound environment iswidely recognized topositively contribute towound healing process.Also, helps to relievedry waxy skin bymaintaining a moistwound and skinenvironment, which isbeneficial to the healingprocess. | Serves to maintainmoist woundenvironment. Themaintenance of a moistwound environment iswidely recognized topositively contribute towound healing process.Also, helps to relievedry waxy skin bymaintaining a moistwound and skinenvironment, which isbeneficial to the healingprocess. | No | N/A |
| Indications forUse | OTC:IPM Wound Gel Bio isindicated for themanagement of minorburns (1st degree burns),minor abrasionsand minor cuts andhelps to relieve drywaxy skin irritationsassociated with dry skinconditions. | OTC:IPM Wound Gel Bio/IPM Derm Gel Bio isindicated formanagement of minorburns (1st degreeburns), minor abrasions,minor cuts and helps torelieve dry waxy skinirritations associatedwith dry skinconditions | OTC:IPM Wound Gel Bio/IPM Derm Gel Bio isindicated formanagement of minorburns (1st degreeburns), minor abrasions,minor cuts and helps torelieve dry waxy skinirritations associatedwith dry skinconditions | Yes | The proposedadditional indications"management andrelief of burning,itching and painexperienced withvarious types ofdermatoses:including atopicdermatitis, allergiccontact dermatitisand radio-dermatitis." |
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| ProprietaryName of Device&510(k) Number | IPM Wound Gel Bio(K123193)(Multiple Predicate) | L.A.M. IPM WoundGel and IPM DermGel(K130781)(Multiple Predicate) | IPM Wound Gel Bioand IPM Derm GelBio(K143527)(Proposed Device) | Diff-eren-ces(Yes/No) | Why differences donot affect Safety &/Performance |
|---|---|---|---|---|---|
| Rx Only:Under the supervisionof a healthcareprofessional:IPM Wound Gel Bio isindicated for themanagement ofexudating wounds suchas leg ulcers, pressureulcers, diabetic ulcers,surgical wounds (post-operative incisions anddonor sites),mechanically orsurgicallydebrided wounds, andfor 2nd degree burns" | Rx Only:Under the supervisionof a healthcareprofessional:• IPM Wound Gel Bio/IPM Derm Gel Bio isindicated formanagement ofexudating wounds suchas leg ulcers, pressureulcers, diabetic ulcers,surgical wounds (post-operative and donorsites), mechanically orsurgically debridedwounds, and for seconddegree burns.• IPM Wound GelBio/IPM Derm Gel Biois indicated in themanagement and reliefof burning, itching andpain experienced withvarious types ofdermatoses: includingatopic dermatitis,allergic contactdermatitis and radio-dermatitis. | Rx Only:Under the supervisionof a healthcareprofessional:• IPM Wound Gel Bio/IPM Derm Gel Bio isindicated formanagement ofexudating wounds suchas leg ulcers, pressureulcers, diabetic ulcers,surgical wounds (post-operative and donorsites), mechanically orsurgically debridedwounds, and for seconddegree burns.• IPM Wound GelBio/IPM Derm Gel Biois indicated in themanagement and reliefof burning, itching andpain experienced withvarious types ofdermatoses: includingatopic dermatitis,allergic contactdermatitis and radio-dermatitis. | No | do not affect theSafety andPerformance of theproposed devicebecause maintaininga moist woundenvironment canprovide relief ofsymptoms associatedwith dermatitis. | |
| DeviceDescription | Aqueous gel composedprincipally of sodiumhyaluronate | Aqueous gel composedprincipally of sodiumhyaluronate | Aqueous gel composedprincipally of sodiumhyaluronate | No | N/A |
| Hyaluronatesource | Bacterial fermentation | Avian | Bacterial fermentation | Yes | The formulation andraw material HA ofthe proposed deviceis the same as that ofIPM Wound Gel BioK123193. |
| 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.
N/A