(271 days)
Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor sites, venous stasis ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.
Hydrofera Blue READY - Border is a sterile absorptive foam dressings made of polyurethane (PU) foam, with methylene blue and gentian violet concentrations of at least 0.00005 g/g each with a combined total concentration of less than or equal to 0.0007 g/g. The dressings include an outer polyurethane film backing with silicone adhesive border.
This document describes the acceptance criteria and performance of the Hydrofera Blue READY - Border device, a wound dressing, as part of its 510(k) submission (K190268) to the FDA.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter Evaluated | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Antibacterial Efficacy (ASTM E2149-10, modified) | ≥ 4 log reduction over 7 days | - 8 gram-positive Organisms tested: 8 experienced ≥ 6 log reduction - 10 gram-negative Organisms tested: 10 experienced ≥ 6 log reduction |
| Zone of Inhibition (AATCC 147-2011) | No zone of inhibition | No evidence of growth surrounding the Dressing |
| Dye Leachable | < 0.5 ppm for each dye | Leachable amounts were measured at far less than 0.5 ppm for each dye (Methylene Blue and Gentian Violet) |
| LAL Endotoxin (ANSI/AAMI ST72:2011) | < 20 EU/device | Device contains less than 0.5 EU/device and meets the requirements of the test for Blood/Lymph Contact and Cerebrospinal Fluid Contact. |
| Device Performance - Wicking Speed | Absorb fluid in < 30 seconds | Absorbs fluid in < 3 seconds |
| Device Performance - Fluid Retention | ≥ 30% Fluid Retained | 37.47% (σ 1.35) |
| Device Performance - Border Adhesion | Comparable to market leaders | The adhesion performance of the perforated silicone adhesive was evaluated for peel strength in comparison to Hollister Triact Foam Dressing with silicone border and Coloplast Biatain silicone (with silicone border). The peel strength met the acceptance criteria. |
| Antibacterial Efficacy - Low Specification Dye Limit (Simulated Wound Fluid) | ≥ 4 log reduction over 7 days | All low specification dye limit test articles evaluated exceeded the antibacterial efficacy acceptance criteria by demonstrating complete kill of the bacteria Staphylococcus aureus, Streptococcus pneumoniae, Bacillus subtilis, Pseudomonas aeruginosa, Escherichia coli, and Enterobacter cloacae after 7 days of incubation, following a 7-day pre-conditioning period. |
| Antibacterial Efficacy - Lot Consistency (Simulated Wound Fluid) | ≥ 4 log reduction over 7 days | All lot consistency test articles evaluated exceeded the antibacterial efficacy acceptance criteria by demonstrating complete kill of the bacteria Staphylococcus aureus, Streptococcus pneumoniae, Bacillus subtilis, Pseudomonas aeruginosa, Escherichia coli, and Enterobacter cloacae after 7 days of incubation, following a 7-day pre-conditioning period. |
| Biocompatibility (Cytotoxicity per ISO 10993-5) | Non-cytotoxic | Device is considered non-cytotoxic. |
| Biocompatibility (Sensitization per ISO 10993-10) | Non-sensitizing | Device is considered non-sensitizing. |
| Biocompatibility (Irritation per ISO 10993-11) | Non-irritant | Device is considered non-irritant. |
| Biocompatibility (Pyrogenicity per ISO 10993-11 and USP <151>) | Non-pyrogenic | Device is considered non-pyrogenic. |
| Biocompatibility (Local effects after implantation per ISO 10993-6) | Considered passing | In the rabbit muscle study, the device was considered passing. |
| Biocompatibility (Acute systemic toxicity per ISO 10993-11) | No signs of acute systemic toxicity | Device showed no signs of acute systemic toxicity. |
| Biocompatibility (Hemolysis/Interaction with blood per ASTM Hemolysis Test) | Passed | Passed |
| Biocompatibility (Toxicology Risk Assessment per ISO 10993-1, 10993-11, 10993-3, 10993-17, 10993-18, 21726, and 14971) | Toxicity not expected from intended use | Toxicity is not expected from the intended use of the device. (Note: product has not been tested or evaluated on pediatric or neonatal patient populations). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each test in the acceptance criteria table. However, it indicates:
- Antibacterial Efficacy (ASTM E2149-10 modified): 8 gram-positive organisms and 10 gram-negative organisms were tested. The specific number of replicates or samples per organism is not provided.
- Other In Vitro Tests: Standard laboratory testing was performed (e.g., LAL Endotoxin, Wicking Speed, Fluid Retention, Dye Leacheable). The number of samples for these tests is generally small and typical for in vitro device characterization, but not specifically quantified in this summary.
- Biocompatibility: Testing was conducted according to ISO 10993 standards and included animal studies (rabbit for pyrogenicity, implantation, and acute systemic toxicity), but the specific number of animals or samples per test is not detailed in this summary.
Data Provenance: All data appears to be from non-clinical, in vitro, and animal studies conducted to demonstrate device performance and safety. There is no information regarding country of origin, or whether the data is retrospective or prospective, beyond the tests being performed "in support of the substantial equivalence determination." This is typically laboratory data derived from testing performed by or for the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This submission relies entirely on non-clinical (bench and animal) testing. It does not involve a clinical study with a "test set" requiring expert ground truth establishment in the context of diagnostic or interpretive performance.
- Therefore, there were no experts used to establish ground truth for a test set in the way one would for an AI-powered diagnostic device (e.g., radiologists interpreting images). The "ground truth" for these tests is defined by the objective metrics and outcomes of the established laboratory and animal test methods (e.g., bacterial log reduction, ppm of leachable dye, absence of cytotoxic effects).
4. Adjudication Method for the Test Set:
- Since there is no "test set" requiring expert interpretation or consensus for ground truth (as explained above), there was no adjudication method used. The results are direct measurements or observations from standardized tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not a diagnostic imaging device or an AI-assisted interpretation tool. The submission states, "No clinical data was required to support substantial equivalence."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical wound dressing and does not involve any algorithm or AI component. Therefore, no standalone performance evaluation in that context was performed.
7. The Type of Ground Truth Used:
The ground truth for the performance and safety evaluations are based on objective, standardized laboratory and animal testing results (bench data and in vivo animal study outcomes), verified against predefined acceptance criteria for each test. This includes:
- Microbiological growth/reduction data.
- Chemical concentration measurements.
- Physical property measurements (wicking speed, fluid retention, peel strength).
- Biological responses in cytotoxicity, sensitization, irritation, pyrogenicity, implantation, acute systemic toxicity, and hemolysis tests.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use machine learning or AI models, 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, no ground truth was established for it.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Hydrofera, LLC Sean Anderson Director of Regulatory Affairs and Quality Assurance 340 Progress Drive Manchester, Connecticut 06042
Re: K190268
Trade/Device Name: Hydrofera Blue READY - Border Regulatory Class: Unclassified Product Code: FRO Dated: October 2, 2019 Received: October 3, 2019
Dear Sean Anderson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cynthia J. Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190268
Device Name Hydrofera Blue READY - Border
Indications for Use (Describe)
Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor sites, venous stasis ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.
| 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) |
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| Section 5: 510(k) Summary | Hydrofera Blue READY - Border Traditional 510(k) |
|---|---|
| K190268 |
Date Prepared: November 6, 2019
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92(c):
| 1. Applicant | |
|---|---|
| Company: | Hydrofera, LLC340 Progress DriveManchester, CT 06042 USA Telephone:860-337-7466Fax: 860-337-7462 |
| Official Correspondent: | John O'GaraHydrofera, LLC340 Progress DriveManchester, CT 06042 USA Telephone:860-337-7741Fax: 860-337-7462Email: johno@hydrof.com |
| 2. Device Details | |
|---|---|
| Common Name: | Absorbent Wound Dressing |
| Trade Name(s) – Type: | • Hydrofera Blue READY™ – Border |
| Classification Name: | |
|---|---|
| Regulatory Class: | |
| Product Code: | |
| Panel: |
Dressing, Wound, Drug Unclassified FRO General & Plastic Surgery
3. Predicate Device(s)
Predicate Device Name:
Hydrofera Blue PU Antibacterial Dressing (K130670)
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| Section 5: 510(k) Summary | Hydrofera Blue READY - Border |
|---|---|
| Traditional 510(k) |
4. Device Description
Hydrofera Blue READY - Border is a sterile absorptive foam dressings made of polyurethane (PU) foam, with methylene blue and gentian violet concentrations of at least 0.00005 g/g each with a combined total concentration of less than or equal to 0.0007 g/g. The dressings include an outer polyurethane film backing with silicone adhesive border.
5. Intended Use/Indications for Use
Indications for Use:
Hydrofera Blue READY - Border is intended as an external dressing for use in local management of moderate to heavily exuding wounds such as pressure ulcers, donor stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.
6. Technological/Design Characteristics and Substantial Equivalence
Hydrofera Blue READY - Border is substantially equivalent to the predicate device with respect to material composition, device characteristics, and intended use. Table 5-1 below provides a comparison of the technological/design characteristics of the subject device compared to the predicate device.
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| Predicate DeviceK130670, Hydrofera Blue PUAntibacterialDressing | Modified DeviceK190268, Hydrofera BlueREADY - Border | SubstantialEquivalenceComments | |
|---|---|---|---|
| Indications for Use | Hydrofera Blue PUantibacterial foam dressingsare intended as externaldressings for use in localmanagement of wounds suchas pressure ulcers, donorsites, venous stasis ulcers,arterial ulcers, diabeticulcers, abrasions, lacerations,superficial burns, post-surgical incisions, and otherexternal wounds inflicted bytrauma. | Hydrofera Blue READY –Border is intended as anexternal dressing for use inlocal management ofmoderate to heavilyexuding wounds such aspressure ulcers, donor sites,venous stasis ulcers, arterialulcers, diabetic ulcers,abrasions, lacerations,superficial burns, post-surgical incisions, and otherexternal wounds inflictedby trauma. | Same as predicate |
| Where Used | Hospitals, clinics, healthcarefacilities,homecare | Hospitals, clinics, healthcarefacilities,homecare | Same as predicate |
Table 5-1. Comparison of Technological/Design Characteristics with the Predicate Device
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| Section 5: 510(k) Summary | Hydrofera Blue READY - BorderTraditional 510(k) | ||
|---|---|---|---|
| Anatomical Sites | |||
| ❖ Chronic wounds Pressure sores/ulcers Diabetic ulcers Venous stasis ulcers Arterial Ulcers ❖ Acute wounds Traumatic wounds Surgical wounds Post-surgical incisions Donor sites Superficial burns Skin abrasions Lacerations | ❖ Chronic wounds Pressure sores/ulcers Diabetic ulcers Venous stasis ulcers Arterial Ulcers ❖ Acute wounds Traumatic wounds Surgical wounds Post-surgical incisions Donor sites Superficial burns Skin abrasions Lacerations | Same as predicate |
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| Section 5: 510(k) Summary | Hydrofera Blue READY - BorderTraditional 510(k) | ||||
|---|---|---|---|---|---|
| Design/MaterialsComparison | Layers:1. Polyurethane FoamPad2. Polyurethane Film (withprinted white ink) | Layers:1. Polyurethane Foam Pad2. Polyurethane Film (withprinted white ink)3. Silicone AdhesiveBorder4. Polycarbonate ReleaseLiner | 1. Same as predicate2. Same as predicate3. The subject deviceadds a siliconeadhesive border,which has a longhistory of safe usein wounddressings.4. The subject deviceadds apolycarbonaterelease liner toprotect thesilicone adhesiveprior toapplication. Theliner has a longhistory of safe usein wounddressings and isremoved priortopatient contact. | ||
| Primary Mode ofAction | Absorption of exudate | Absorption of exudate | Same as predicate | ||
| Section 5: 510(k) Summary | Hydrofera Blue READY - BorderTraditional 510(k) | ||||
| AntibacterialContent | PU Foam Pad contains:• Gentian Violet: lessthan or equal to0.00035g/g• Methylene Blue: lessthan or equal to0.00035g/g | PU Foam Pad contains:• The combined total ofGentian Violet andMethylene Blue are lessthan or equal to 0.0007g/g• Gentian Violet: greaterthan or equal to0.00005 g/g• Methylene Blue: greaterthan or equal to 0.00005g/g | The subject andpredicate devices usethe same antibacterialdyes. The maximumcombined total ofboth dyes is the samefor the subject andpredicate.The subject deviceadds a minimum dyespecification.Overall, a two-sidedspecification is createdthat is tighter than, yetfalls within, thepredicatedevice's range. | ||
| BiocompatibilityTesting (per ISO10993) | • Cytotoxicity• Irritation• Acute SystemicReactivity• Sensitization• Hemolysis | • Cytotoxicity• Irritation• Acute SystemicReactivity• Sensitization• Hemolysis• Material-MediatedPyrogenicity• Implantation• Toxicity RiskAssessment | The subject deviceadds, material-mediatedpyrogenicity,implantation, and aToxicity RiskAssessmentAll tests passed |
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Section 5: 510(k) Summary
Hydrofera Blue READY - Border Traditional 510(k)
| In VitroAntibacterialTesting inSimulated WoundFluid | NA | Staphylococcus aureus Streptococcuspneumoniae Bacillus subtilis Pseudomonas aeruginosa Escherichia coli Enterobacter cloacae | The subject deviceadds test data usingsimulated woundfluid.All tests passed. |
|---|---|---|---|
| In VitroAntibacterialTesting in Saline | Methicillin ResistantStaphylococcus Aureus(MRSA) Staphylococcus aureus Staphylococcusepidermidis (coagulaseneg.) Pseudomonasaeruginosa Pseudomonasflorescens Escherichia coli Enterococcus faecalis Vancomycin ResistantEnterococcus (VRE) Streptococcuspyogenes Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Enterobacteraerogenes Enterobacter cloacae Bacillus subtilis Yersinia enterocolitica Serratia marcescens Streptococcuspneumoniae Candida albicans Candida krusei Candida glabrata | Methicillin ResistantStaphylococcus Aureus(MRSA) Staphylococcus aureus Staphylococcusepidermidis (coagulaseneg.) Pseudomonasaeruginosa Pseudomonasflorescens Escherichia coli Enterococcus faecalis Vancomycin ResistantEnterococcus (VRE) Streptococcuspyogenes Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Enterobacteraerogenes Enterobacter cloacae Bacillus subtilis Yersinia enterocolitica Serratia marcescens Streptococcuspneumoniae Candida albicans Candida krusei Candida glabrata | Same as predicate |
Hydrofera, LLC Additional Information – K190268
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| Section 5: 510(k) Summary | Hydrofera Blue READY - BorderTraditional 510(k) | ||
|---|---|---|---|
| Sterilization Method | Gamma Radiation | Ethylene Oxide | The subject andpredicate devices areboth provided sterileand are sterilizedusing traditionalmethods. A SterilityAssurance Level(SAL) of 10-6 wasachieved for thesubject device. |
| Energy Source | No energy sources areutilized | No energy sources areutilized | Same as predicate |
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7. Performance Data
The following performance data is provided in support of the substantial equivalence determination:
| ParameterEvaluated | AcceptanceCriteria | Predicate DeviceTesting (K130670)(Appendix L) | Subject Device Testing (K190268) | |
|---|---|---|---|---|
| 1 | AntibacterialEfficacyASTM E2149-10(modified) | $\u2265$ 4 logreductionover 7 days | 20 Organisms tested20 $\u2265$ 4 log reductions | 8 gram + Organisms tested8 $\u2265$ 6 log reduction10 gram - Organisms tested10 $\u2265$ 6 log reduction |
| 2 | Zone of Inhibition-AATCC 147-2011 | no zone ofinhibition | No evidence of growthsurrounding theDressing | No evidence of growth surroundingthe Dressing |
| 3 | Dye Leachable | < 0.5 ppm foreach dye | Leachable amountswere measured at farless than 0.5 ppm foreach dye (MethyleneBlue and GentianViolet) | Leachable amounts were measuredat far less than 0.5 ppm for eachdye (Methylene Blue and GentianViolet) |
| 4 | LAL Endotoxin -ANSI/AAMIST72:2011 | less than 20EU/device | Device contains lessthan 0.5 EU/device andmeets the requirementsof the test forBlood/Lymph Contactand Cerebrospinal FluidContact. | Device contains less than 0.5EU/device and meets therequirements of the test forBlood/Lymph Contact andCerebrospinal Fluid Contact. |
| 5 | DevicePerformance -Wicking Speed | absorb fluidin less than 30seconds | Absorbs fluid in $\u2264$ 5seconds. | Absorbs fluid in <3 seconds |
| 6 | DevicePerformance -Fluid Retention | $\u2265$ 30% FluidRetained | 35.20% (σ 1.23) | 37.47% (σ 1.35) |
| 7 | DevicePerformance -Border Adhesion | comparable tomarketleaders | Predicate1 does not haveborder. Data for othercommercial borderedproducts are located inK190268, Appendix 18-5, Attachment 3. | The adhesion performance of theperforated silicone adhesive wasevaluated for peel strength incomparison to Hollister Triact FoamDressing with silicone border andColoplast Biatain silicone(withsiliconeborder). The peelstrength met the acceptancecriteria. |
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| 8 | AntibacterialEfficacyLow SpecificationDye Limit –Simulated WoundFluid2 | ≥ 4 logreductionover 7 days | NA | All low specification dye limit testarticles evaluated exceeded theantibacterial efficacy acceptancecriteria by demonstrating completekill of the bacteria Staphylococcusaureus, Streptococcus pneumoniae,Bacillus subtilis, Pseudomonasaeruginosa, Escherichia coli andEnterobacter cloacae after 7 days ofincubation, following a 7-day pre-conditioning period. |
|---|---|---|---|---|
| 9 | AntibacterialEfficacyLot Consistency -Simulated WoundFluid3 | ≥ 4 logreductionover 7 days | NA | All lot consistency test articlesevaluated exceeded the antibacterialefficacy acceptance criteria bydemonstrating complete kill of thebacteria Staphylococcus aureus,Streptococcus pneumoniae, Bacillussubtilis, Pseudomonas aeruginosa,Escherichia coli and Enterobactercloacae after 7 days of incubation,following a 7-day pre-conditioningperiod. |
Biocompatibility:
Biocompatibility testing for the Hydrofera Blue READY - Border was assessed in accordance with "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process," issued on June 16, 2016, effective September 14, 2016, as recognized by the FDA. Testing included:
- Cytotoxicity: Performed per ISO 10993-5 (ISO elution method), device is considered non-● cytotoxic.
- . Sensitization: Performed per ISO 10993-10 (Magnusson-Kligman method), device is considered non-sensitizing.
- Irritation: Performed per ISO 10993-11 (intracutaneous reactivity testing), device is ● considered non-irritant.
- Pyrogenicity: Performed per ISO 10993-11 and USP <151>, (rabbit pyrogen test) device ● is considered non-pyrogenic.
- Local effects after implantation: Performed per ISO 10993-6. In the rabbit muscle study, ● the device was considered passing.
- Acute systemic toxicity: Performed per ISO 10993-11 (implantation in rabbit abdomen), ● device showed no signs of acute systemic toxicity.
- Hemolysis/Interaction with blood: Performed per ASTM Hemolysis Test and passed ●
- . Toxicology Risk Assessment: Performed per ISO standards 10993-1. 10993-11. 10993-3, 10993-17, 10993-18, 21726, and 14971. Toxicity is not expected from the intended use of the device. However, the product has not been tested or evaluated on the pediatric or neonatal patient populations
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| Section 5: 510(k) Summary | Hydrofera Blue READY - Border |
|---|---|
| Traditional 510(k) |
No clinical data was required to support substantial equivalence, and the testing performed demonstrates that the Hydrofera Blue READY - Border meets all performance specifications and is as safe and effective as the predicate device .
8. Conclusion
Based on the information provided in this 510(k), Hydrofera, LLC believes that the proposed Hydrofera Blue READY - Border is substantially equivalent to Hydrofera Blue PU Antibacterial Dressing (K130670) in terms of its intended use, design, operational and technological characteristics. The subject device raises no new issues of safety and met all test specifications, and the non-clinical testing performed effectiveness. demonstrates that the subject device is as safe, as effective, and performs as well as the predicate device.
N/A