(508 days)
"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.
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 burns.
IPM Wound 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 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).
The provided text describes a 510(k) premarket notification for a medical device called "IPM Wound Gel Bio", which is a hydrogel wound dressing. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove meeting those criteria.
Therefore, the input does not contain the specific information requested about acceptance criteria and a study to prove the device meets these criteria. It focuses on comparing the new device's characteristics and intended use to already legally marketed predicate devices to establish substantial equivalence.
Here's a breakdown of why many of your questions cannot be answered from the provided text:
- Acceptance Criteria Table: No specific performance acceptance criteria are listed for the IPM Wound Gel Bio. The submission relies on establishing similarity to predicate devices.
- Device Performance: The document states that the device is "comparable to the predicates" in terms of quality, safety, and effectiveness due to similar indications and technological characteristics (except for the source of hyaluronic acid). However, no specific performance metrics of the IPM Wound Gel Bio are reported.
- Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Sample Size, and Training Set Ground Truth: These questions relate to clinical or performance studies that would typically involve a test set, expert evaluation, etc. The provided 510(k) summary does not describe such a study for the IPM Wound Gel Bio itself. Instead, it refers to biocompatibility evaluations and a histological study done on one of its predicate devices (L.A.M. IPM Wound Gel).
Information that can be extracted related to the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993 and USP <10317> | Met (for Bio fermented HA): "Bio fermented HA passed biocompatibility evaluations and thus demonstrated substantial equivalence to the predicate device in this respect, i.e., biocompatibility." |
| Effectiveness (Wound Healing): Maintain a moist wound environment, contribute to wound healing process. | Implied substantially equivalent to predicates: "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." (Note: The histological study mentioned was for a predicate device, not the new device directly). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not describe a test set or clinical study for "IPM Wound Gel Bio." It references biocompatibility tests conducted for the "bio fermented HA" (the new type of HA used in IPM Wound Gel Bio), which likely involved in vitro or in vivo animal testing. It also references a "Histological Study in Porcine" for the predicate device, L.A.M. IPM Wound Gel, which "demonstrated the effectiveness... on partial thickness wound healing." No sample sizes for these tests are provided, nor is the country of origin of the data or whether they were retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided. The document does not detail any expert consensus or ground truth establishment process for the IPM Wound Gel Bio in a clinical study context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided as there is no described test set with human adjudication.
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 MRMC comparative effectiveness study was done. This device is a hydrogel dressing, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable as this is a physical medical device (wound gel), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For biocompatibility, the ground truth would be established through standard test methods and their interpretation against ISO and USP guidelines. For the histological study on the predicate device, it would involve pathological examination of tissue samples from porcine wounds. No ground truth is specified for a clinical study of "IPM Wound Gel Bio."
8. The sample size for the training set:
Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable.
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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%).
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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 <10317> 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.
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K123193 Page 3/3
| Name of Device | L.A.M. IPM™Wound Gel(K020325) | Bionect® Hydrogel(Jaloplast™)(K984413) | IPM™ Wound Gel Bio(K123193) |
|---|---|---|---|
| ClassificationName | Dressing, Wound AndBurn, Hydrogel W/DrugAnd/Or Blologic | Dressing, Wound AndBurn, Hydrogel W/DrugAnd/Or Biologic | Dressing, Wound AndBurn, Hydrogel W/DrugAnd/Or Biologic |
| Intended Use | Provides a moist woundenvironment that is supportiveto wound healing | Provides a moist woundenvironment that is supportiveto wound healing | Serves to maintain a moist woundenvironment. The maintenance ofa moist wound environment iswidely recognized to positivelycontribute to wound healingprocess. IPM Wound Gel Bio alsohelps to relieve dry waxy skinirritations associated with dry skinconditions. |
| Indications for Use | Over the counter:L.A.M. IPM Wound Gel isindicated for the managementof minor burns (1° degreeburns), minor abrasionsand minor cuts. | Over the counter:Bionect isindicated for the managementof minor burns (1° degreeburns), minor abrasionsand minor cuts, minorirritations of the skin | OTC:IPM Wound Gel Bio is indicated formanagement of minor burns (1stdegree burns), minor abrasions,minor cuts and helps to relieve drywaxy skin irritations associatedwith dry skin conditions. |
| Under the supervision of ahealthcare professional:L.A.M. IPM Wound Gel Isindicated for the managementof exudating wounds such asleg ulcers, pressure ulcers,diabetic ulcers, surgicalwounds (post-operativeincisions and donor sites),mechanically or surgicallydebrided wounds, and 2nddegree burns" | Under the supervision of ahealthcare professional:Bionect is indicated for themanagement of exudatingwounds such as leg ulcers,pressure ulcers, diabetic ulcers,surgical wounds (post-operative incisions and donorsites), mechanically orsurgically debrided wounds,and 2nd degree burns" | Rx:Under the supervision of a healthcare professional;• IPM Wound Gel Bio is indicatedfor management of exudatingwounds such as leg ulcers,pressure ulcers, diabetic ulcers,surgical wounds (postoperativeincisions and donor sites),mechanically or surgically debridedwounds, and for second degreebums. | |
| Device Description | Aqueous gelcomposedprincipally ofsodium hyaluronate | Aqueous gel preparedfrom hyaluronate andpurified water | Aqueous gelcomposedprincipally ofsodium hyaluronate |
| HyaluronateSource | 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.
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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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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
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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)
N/A