(157 days)
The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Dressing may be used for management of:
- Pressure sores
- Diabetic ulcers
- Leg ulcers
- Donor sites and graft sites
- Surgical wounds
- Skin abrasions and lacerations
- 1st and 2nd degree burns
- Trauma wounds
Over-The-Counter Use (21 CFR 801 Subpart C):
- The gel-e Bandage may be used for the management of:
- Minor cuts
- Minor scalds and 1st degree burns
- Abrasions
- Lacerations
Gel-e Bandage is a sterile topical bandage comprising a lyophilized chitosanbased patch attached to a standard bandage backing with two adhesive strips on either side of the patch for secure attachment to skin. The gel-e Bandage is absorbent and conformable. As wound exudate is absorbed into the chitosanbased patch, the patch forms a gel, which maintains a moist environment for optimal wound healing, and allows intact removal.
The gel-e Bandage is intended for use as a primary dressing for a variety of chronic and acute wounds. It secured onto skin by manually pressing the adhesive strips on either side of the patch. Dressings are individually packed into aluminum foil pouches and terminally sterilized to achieve an SAL of 10-6.
The Gel-e Bandage (gel-e, Inc.) K172010 is a medical device and therefore the acceptance criteria are not based on performance metrics such as accuracy or sensitivity, but rather on demonstrating substantial equivalence to a legally marketed predicate device. The study that "proves" the device meets acceptance criteria is a 510(k) Pre-market Notification submission to the FDA, which includes various tests and comparisons to establish substantial equivalence.
Here's the breakdown of how the device meets its "acceptance criteria" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" are primarily established through demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The performance is reported in terms of various testing results compared to the predicate.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Gel-e Bandage) |
|---|---|
| Intended Use/Indications for Use Similarity | Matches Predicate: The gel-e Bandage has essentially the same intended use/indication for use as the predicate device (KA01 Chitosan Wound Dressing). Both are indicated for management of moderately to heavily exuding chronic wounds and acute wounds, with specific lists of conditions including pressure sores, diabetic ulcers, leg ulcers, donor/graft sites, surgical wounds, skin abrasions, lacerations, and 1st and 2nd degree burns (both prescription and OTC indications). |
| Device Design Similarity | Similar Principle: Single layer, non-woven pad attached to skin-adhesive backing. While the predicate can be cut or folded, the core design principle is similar. |
| Material Similarity | Similar Composition: Composed of a soft, sterile, non-woven palmitoyl-N-acetylglucomasine (chitosan), a cellulosic polymer. The predicate is also a non-woven poly-N- acetylglucosamine (chitosan), a cellulosic biopolymer. |
| Physical Characteristics (Mechanism of Action) | Similar Mechanism: Absorbs wound exudate, forms a gel to maintain a moist environment for optimal wound healing, and allows intact removal. This is identical to the predicate's described mechanism. |
| Sterility | Matches Predicate: 10^6 SAL - Terminally sterilized with gamma radiation, for single use only. |
| Biocompatibility Testing | Acceptable Results: Testing performed for cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity. These results were deemed acceptable to demonstrate substantial equivalence, and covered the same categories as the predicate (cytotoxicity, irritation, sensitization, systemic toxicity) plus pyrogenicity. |
| Performance Testing (Bench Testing) | Acceptable Results: Testing performed for pH, moisture content, absorbency. These results were deemed appropriate and covered the same categories as the predicate. |
| Animal Testing | Acceptable Results: Comparative animal testing was conducted, demonstrating equivalence. |
| Packaging Testing | Acceptable Results: Burst pressure and dye penetration testing were conducted. |
| Sterilization Validation Testing | Acceptable Results: Testing conducted to validate the sterilization process. |
| Shelf-life Stability Testing | Acceptable Results: Real-time shelf-life stability testing was conducted. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify the sample sizes used for the various tests (comparative animal testing, bench testing, biocompatibility, packaging, sterilization validation, shelf-life stability).
The data provenance is from the manufacturer, gel-e, Inc., as part of their 510(k) submission to the FDA. The data is pre-clinical, meaning it was generated in a controlled laboratory setting (bench, animal models) rather than human clinical trials. The country of origin of the data is not explicitly stated but is implicitly the country where gel-e, Inc. operates and where the testing facilities are located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to a 510(k) submission for a wound dressing based on substantial equivalence. The "ground truth" for these tests relates to established scientific methods and pass/fail criteria for biocompatibility, physical properties, etc., not subjective expert interpretation of medical images or patient outcomes. The FDA reviews the testing methodology and results against recognized standards.
4. Adjudication Method for the Test Set
This concept is not applicable to the type of pre-clinical testing described. Adjudication methods like 2+1 or 3+1 typically refer to resolving discrepancies in expert interpretations (e.g., radiologists reviewing images). For the described tests, results are objective measurements (e.g., pH value, absorbency, successful sterilization) or observations (e.g., presence/absence of cytotoxicity) and do not require expert adjudication in that context.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use AI as an aid. The Gel-e Bandage is a physical wound dressing and does not involve AI or human readers for interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone algorithm performance study was not done. As mentioned, this device is a physical wound dressing and does not involve any algorithms or AI.
7. The Type of Ground Truth Used
The "ground truth" for the various tests includes:
- Established scientific standards and specifications: For biocompatibility (ISO standards for cytotoxicity, irritation, etc.), physical properties (pH, moisture content, absorbency), packaging integrity, and sterility (10^-6 SAL).
- Validated animal models: For comparative animal testing, where the "ground truth" would be the observed biological response to the device in comparison to a control or accepted standard.
- Reference predicate device performance: The "ground truth" for substantial equivalence is that the device's performance is comparable to or better than the legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. The Gel-e Bandage is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for one.
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December 7, 2017
gel-e, Inc. (formerly Remedium Technologies, Inc.) % Elsa Abruzzo CEO Cygnus Regulatory Cincinnati, Ohio 45226
Re: K172010 Trade/Device Name: gel-e Bandage Regulatory Class: Unclassified Product Code: FRO Dated: October 20, 2017 Received: October 30, 2017
Dear Elsa Abruzzo:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for 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)
K172010
Device Name gel-e Bandage
Indications for Use (Describe)
The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds.
Under medical supervision, the gel-e Bandage may be used for management of:
- · Pressure sores
- · Diabetic ulcers
- · Leg ulcers
- · Donor sites and graft sites
- · Surgical wounds
- Skin abrasions and lacerations
- 1st and 2nd degree burns
- · Trauma wounds
| 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."
{3}------------------------------------------------
Indications for Use
510(k) Number (if known)
K172010
Device Name gel-e Bandage
Indications for Use (Describe)
The gel-e Bandage may be used for the management of:
- Minor cuts
- · Minor scalds and 1st degree burns
- · Abrasions
- · Lacerations
Type of Use (Select one or both, as applicable)
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."
{4}------------------------------------------------
K172010 GEL-E BANDAGE 510(k) Summary
510(k) Summary
| A. Name and Address of Applicant : | gel-e, Inc. (formerly Remedium Technologies)387 Technology Dr., Suite 3110BCollege Park, MD 20742 |
|---|---|
| B. Contact Person: | Matthew Dowling, PhDChief Scientific OfficerPhone: (301) 405-3585Fax: (301) 314-9592 |
| C. Date of Submission : | June 30, 2017 |
| D. Device Trade Name: | gel-e Bandage |
| E. Device Common Name: | Dressing, Wound, Drug |
| F. Device Classification: | Unclassified Device (pre-amendment) |
| G. Classification Name: | Unclassified |
| H. Product Code: | FRO |
| I. Predicate Device: | Primary: Foshan United Medical Technologies'KA01 Chitosan WoundDressing (K143124) |
| J. Reference Device: | gel-e's Hemogrip™ Patch (K143466) |
- K. Intended Use:
Prescription Use (21 CFR 801 Subpart D)
The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Dressing may be used for management of:
- Pressure sores
- Diabetic ulcers
- Leg ulcers
- · Donor sites and graft sites
- Surgical wounds
- Skin abrasions and lacerations
{5}------------------------------------------------
- 1st and 2nd degree burns
- Trauma wounds
Over-The-Counter Use (21 CFR 801 Subpart C):
- The gel-e Bandage may be used for the management of:
- Minor cuts
- Minor scalds and 1st degree burns
- · Abrasions
- · Lacerations
- L. Device Description:
Gel-e Bandage is a sterile topical bandage comprising a lyophilized chitosanbased patch attached to a standard bandage backing with two adhesive strips on either side of the patch for secure attachment to skin. The gel-e Bandage is absorbent and conformable. As wound exudate is absorbed into the chitosanbased patch, the patch forms a gel, which maintains a moist environment for optimal wound healing, and allows intact removal.
The gel-e Bandage is intended for use as a primary dressing for a variety of chronic and acute wounds. It secured onto skin by manually pressing the adhesive strips on either side of the patch. Dressings are individually packed into aluminum foil pouches and terminally sterilized to achieve an SAL of 10-6.
-
M. Performance Data
Representative samples of the device underwent testing including comparative animal testing, bench testing (pH, absorbency, moisture content), biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity), packaging testing (burst pressure and dye penetration testing), sterilization validation testing, and shelf-life stability testing (real time). The performance data from this pre-clinical testing demonstrates that the gel-e Bandage is substantially equivalent to the predicate device. -
N. Summary of Substantial Equivalence:
Gel-e has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the gel-e Bandage is substantially equivalent to the currently marketed predicate device. Gel-e Bandage has essentially the same intended use/indication for use as the predicate device. Moreover, the gel-e Bandage has similar patient contacting materials and technology as the reference device, Hemogrip Patch.
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| Gel-e Bandage(Subject Device) | KA01 Chitosan Wound Dressing(Predicate Device) | |
|---|---|---|
| 510K Number | K172010 | K143124 |
| Manufacturer | Gel-e, Inc. | Foshan United Medical Technologies |
| Classification | Unclassified | Unclassified |
| Product Code | FRO | FRO |
| Indications forUse | The gel-e Bandage is indicated for the management ofmoderately to heavily exuding chronic wounds andacute wounds.Under medical supervision the gel-e Bandage may beused for management of:• Pressure sores• Diabetic ulcers• Leg ulcers• Donor sites and graft sites• Surgical wounds• Skin abrasions and lacerations• 1st and 2nd degree burns• Trauma woundsOTC:The gel-e Bandage may be used for the managementof:• Minor cuts• Minor scalds and 1st degree burns• Abrasions• Lacerations | The KA01 Chitosan Wound Dressing is indicatedfor the management of moderately to heavilyexuding chronic wounds and acute wounds.Under medical supervision the KA01 ChitosanWound Dressing may be used for managementof:• Pressure sores• Diabetic ulcers• Leg ulcers• Donor sites and graft sites• Surgical wounds• Skin abrasions and lacerations• 1st and 2nd degree burns• Trauma woundsOTC:The KA01 Chitosan Wound Dressing may beused for the management of:• Minor cuts• Minor scalds and 1st degree burns• Abrasions• Lacerations |
| Device Design | Single layer, non-woven pad attached to skin-adhesivebacking | Absorbable, single layer, needle punched non-wovenpad or ribbon dressing that can be cut or folded |
| Material | Gel-e Bandage is composed of a soft, sterile, non- wovenpalmitoyl-N-acetylglucomasine (chitosan), a cellulosicpolymer, with a skin-adhesive backing made of flexiblewoven cellulosic fabric for simple application | The KA01 Chitosan Wound Dressing is a soft, sterile,non-woven poly-N- acetylglucosamine (chitosan), acellulosic biopolymer. |
| PhysicalCharacteristics | Gel-e Bandage is a sterile topical bandage comprising alyophilized chitosan-based patch attached to a standardbandage backing with two adhesive strips on either sideof the patch for secure attachment to skin. The gel-eBandage is absorbent and conformable. As woundexudate is absorbed into the chitosan-based patch, thepatch forms a gel, which maintains a moist environmentfor optimal wound healing, and allows intact removal. | The KA01 Chitosan Wound Dressing is a sterile non-woven chitosan dressing comprising 100% chitosanfibers. The KA01 Chitosan Wound Dressing is ahighly absorbent, conformable and wet integral. Aswound exudate is absorbed the chitosan forms a gel,which assists in maintaining a moist environment foroptimal wound healing, aids autolytic debridement,and allows intact removal. |
| Size | 19 mm x 76 mm (12 mm x 25 mm patch in center) | 25 mm x 25 mm40 mm x 40 mm |
| Thickness | 3 mm (patch) | 5 mm5 mm |
| Weight | 0.4 g | 0.5 g0.8 g |
| Sterility | 106 SAL - Terminally sterilized with gamma radiation,for single use only | 106 SAL - Terminally sterilized with gammaradiation, for single use only |
| BiocompatibilityTesting | Cytotoxicity, irritation, sensitization, systemic toxicity,pyrogenicity | Cytotoxicity, irritation, sensitization, systemictoxicity |
| PerformanceTesting | pH, moisture content, absorbency | pH, moisture content, absorbency |
Results of scientific testing have ensured that all materials are biocompatible and physical properties are appropriate for the intended use. Non-clinical testing was conducted.
In conclusion, gel-e, Inc. considers the gel-e Bandage to be equivalent to the primary predicate device listed above based upon the device's similarities in intended use, design, mechanism of action, technology and materials.
N/A