Hydrofera Blue READY - Border

K190268 · Hydrofera, LLC · FRO · Nov 6, 2019 · SU

Device Facts

• Record ID: K190268
• Device Name: Hydrofera Blue READY - Border
• Applicant: Hydrofera, LLC
• Product Code: FRO · SU
• Decision Date: Nov 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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 sites, venous stasis ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and other external wounds inflicted by trauma.

Device Story

Hydrofera Blue READY - Border is a sterile, absorptive polyurethane foam dressing containing methylene blue and gentian violet. It features a silicone adhesive border and a polycarbonate release liner. Used in hospitals, clinics, and homecare settings, the dressing is applied by healthcare providers or patients to manage moderate to heavily exuding wounds. The foam absorbs wound exudate while the antibacterial dyes provide a local antimicrobial environment. The device is passive; it does not require external energy or active monitoring. By absorbing fluid and maintaining an antibacterial environment, the dressing supports wound healing and protects the wound site from external contamination.

Clinical Evidence

No clinical data was required. Substantial equivalence is supported by bench testing, including antibacterial efficacy (ASTM E2149-10), zone of inhibition (AATCC 147-2011), dye leachables, endotoxin testing (ANSI/AAMI ST72:2011), wicking speed, fluid retention, and border adhesion. Biocompatibility was verified per ISO 10993-1, including cytotoxicity, sensitization, irritation, pyrogenicity, implantation, and systemic toxicity.

Technological Characteristics

Materials: Polyurethane foam, methylene blue, gentian violet, silicone adhesive, polycarbonate release liner. Principle: Passive absorption of exudate. Sterilization: Ethylene Oxide. Form factor: Bordered foam dressing. No energy source. Antibacterial content: 0.00005-0.0007 g/g combined dyes.

Indications for Use

Indicated for local management of moderate to heavily exuding wounds in patients with pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions, and traumatic wounds. Not evaluated for pediatric or neonatal populations.

Predicate Devices

• Hydrofera Blue PU Antibacterial Dressing (K130670)

Reference Devices

• Hollister Triact Foam Dressing
• Coloplast Biatain silicone

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> 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, LLC<br>340 Progress Drive<br>Manchester, CT 06042 USA Telephone:<br>860-337-7466<br>Fax: [phone] |
| Official Correspondent: | John O'Gara<br>Hydrofera, LLC<br>340 Progress Drive<br>Manchester, CT 06042 USA Telephone:<br>860-337-7741<br>Fax: [phone]<br>Email: [e-mail] |

| 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 Device<br>K130670, Hydrofera Blue PU<br>Antibacterial<br>Dressing | Modified Device<br>K190268, Hydrofera Blue<br>READY - Border | Substantial<br>Equivalence<br>Comments |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Indications for Use | Hydrofera Blue PU<br>antibacterial foam dressings<br>are intended as external<br>dressings for use in local<br>management of wounds such<br>as pressure ulcers, donor<br>sites, venous stasis ulcers,<br>arterial ulcers, diabetic<br>ulcers, abrasions, lacerations,<br>superficial burns, post-<br>surgical incisions, and other<br>external wounds inflicted by<br>trauma. | Hydrofera Blue READY –<br>Border is intended as an<br>external dressing for use in<br>local management of<br>moderate to heavily<br>exuding wounds such as<br>pressure ulcers, donor sites,<br>venous stasis ulcers, arterial<br>ulcers, diabetic ulcers,<br>abrasions, lacerations,<br>superficial burns, post-<br>surgical incisions, and other<br>external wounds inflicted<br>by trauma. | Same as predicate |
| Where Used | Hospitals, clinics, healthcare<br>facilities,<br>homecare | Hospitals, clinics, healthcare<br>facilities,<br>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 - Border<br>Traditional 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 - Border<br>Traditional 510(k) | | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--|
| Design/Materials<br>Comparison | Layers:<br>1. Polyurethane FoamPad<br>2. Polyurethane Film (with<br>printed white ink) | Layers:<br>1. Polyurethane Foam Pad<br>2. Polyurethane Film (with<br>printed white ink)<br>3. Silicone Adhesive<br>Border<br>4. Polycarbonate Release<br>Liner | 1. Same as predicate<br>2. Same as predicate<br>3. The subject device<br>adds a silicone<br>adhesive border,<br>which has a long<br>history of safe use<br>in wound<br>dressings.<br>4. The subject device<br>adds a<br>polycarbonate<br>release liner to<br>protect the<br>silicone adhesive<br>prior to<br>application. The<br>liner has a long<br>history of safe use<br>in wound<br>dressings and is<br>removed priorto<br>patient contact. | | |
| Primary Mode of<br>Action | Absorption of exudate | Absorption of exudate | Same as predicate | | |
| Section 5: 510(k) Summary | | Hydrofera Blue READY - Border<br>Traditional 510(k) | | | |
| | | | | | |
| Antibacterial<br>Content | PU Foam Pad contains:<br>• Gentian Violet: less<br>than or equal to<br>0.00035g/g<br>• Methylene Blue: less<br>than or equal to<br>0.00035g/g | PU Foam Pad contains:<br>• The combined total of<br>Gentian Violet and<br>Methylene Blue are less<br>than or equal to 0.0007<br>g/g<br>• Gentian Violet: greater<br>than or equal to<br>0.00005 g/g<br>• Methylene Blue: greater<br>than or equal to 0.00005<br>g/g | The subject and<br>predicate devices use<br>the same antibacterial<br>dyes. The maximum<br>combined total of<br>both dyes is the same<br>for the subject and<br>predicate.<br>The subject device<br>adds a minimum dye<br>specification.<br>Overall, a two-sided<br>specification is created<br>that is tighter than, yet<br>falls within, the<br>predicate<br>device's range. | | |
| Biocompatibility<br>Testing (per ISO<br>10993) | • Cytotoxicity<br>• Irritation<br>• Acute Systemic<br>Reactivity<br>• Sensitization<br>• Hemolysis | | • Cytotoxicity<br>• Irritation<br>• Acute Systemic<br>Reactivity<br>• Sensitization<br>• Hemolysis<br>• Material-Mediated<br>Pyrogenicity<br>• Implantation<br>• Toxicity Risk<br>Assessment | The subject device<br>adds, material-<br>mediated<br>pyrogenicity,<br>implantation, and a<br>Toxicity Risk<br>Assessment<br>All tests passed | |

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Section 5: 510(k) Summary

Hydrofera Blue READY - Border Traditional 510(k)

| In Vitro<br>Antibacterial<br>Testing in<br>Simulated Wound<br>Fluid | NA | Staphylococcus aureus Streptococcus<br>pneumoniae Bacillus subtilis Pseudomonas aeruginosa Escherichia coli Enterobacter cloacae | The subject device<br>adds test data using<br>simulated wound<br>fluid.<br>All tests passed. |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| In Vitro<br>Antibacterial<br>Testing in Saline | Methicillin Resistant<br>Staphylococcus Aureus<br>(MRSA) Staphylococcus aureus Staphylococcus<br>epidermidis (coagulase<br>neg.) Pseudomonas<br>aeruginosa Pseudomonas<br>florescens Escherichia coli Enterococcus faecalis Vancomycin Resistant<br>Enterococcus (VRE) Streptococcus<br>pyogenes Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Enterobacter<br>aerogenes Enterobacter cloacae Bacillus subtilis Yersinia enterocolitica Serratia marcescens Streptococcus<br>pneumoniae Candida albicans Candida krusei Candida glabrata | Methicillin Resistant<br>Staphylococcus Aureus<br>(MRSA) Staphylococcus aureus Staphylococcus<br>epidermidis (coagulase<br>neg.) Pseudomonas<br>aeruginosa Pseudomonas<br>florescens Escherichia coli Enterococcus faecalis Vancomycin Resistant<br>Enterococcus (VRE) Streptococcus<br>pyogenes Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Enterobacter<br>aerogenes Enterobacter cloacae Bacillus subtilis Yersinia enterocolitica Serratia marcescens Streptococcus<br>pneumoniae 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 - Border<br>Traditional 510(k) | | |
|---------------------------|-----------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization Method | Gamma Radiation | Ethylene Oxide | The subject and<br>predicate devices are<br>both provided sterile<br>and are sterilized<br>using traditional<br>methods. A Sterility<br>Assurance Level<br>(SAL) of 10-6 was<br>achieved for the<br>subject device. |
| Energy Source | No energy sources are<br>utilized | No energy sources are<br>utilized | Same as predicate |

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### 7. Performance Data

The following performance data is provided in support of the substantial equivalence determination:

| | Parameter<br>Evaluated | Acceptance<br>Criteria | Predicate Device<br>Testing (K130670)<br>(Appendix L) | Subject Device Testing (K190268) |
|---|----------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Antibacterial<br>Efficacy<br>ASTM E2149-10<br>(modified) | $\u2265$ 4 log<br>reduction<br>over 7 days | 20 Organisms tested<br>20 $\u2265$ 4 log reductions | 8 gram + Organisms tested<br>8 $\u2265$ 6 log reduction<br>10 gram - Organisms tested<br>10 $\u2265$ 6 log reduction |
| 2 | Zone of Inhibition<br>-AATCC 147-<br>2011 | no zone of<br>inhibition | No evidence of growth<br>surrounding the<br>Dressing | No evidence of growth surrounding<br>the Dressing |
| 3 | Dye Leachable | < 0.5 ppm for<br>each dye | Leachable amounts<br>were measured at far<br>less than 0.5 ppm for<br>each dye (Methylene<br>Blue and Gentian<br>Violet) | Leachable amounts were measured<br>at far less than 0.5 ppm for each<br>dye (Methylene Blue and Gentian<br>Violet) |
| 4 | LAL Endotoxin -<br>ANSI/AAMI<br>ST72:2011 | less than 20<br>EU/device | Device contains less<br>than 0.5 EU/device and<br>meets the requirements<br>of the test for<br>Blood/Lymph Contact<br>and Cerebrospinal Fluid<br>Contact. | Device contains less than 0.5<br>EU/device and meets the<br>requirements of the test for<br>Blood/Lymph Contact and<br>Cerebrospinal Fluid Contact. |
| 5 | Device<br>Performance -<br>Wicking Speed | absorb fluid<br>in less than 30<br>seconds | Absorbs fluid in $\u2264$ 5<br>seconds. | Absorbs fluid in <3 seconds |
| 6 | Device<br>Performance -<br>Fluid Retention | $\u2265$ 30% Fluid<br>Retained | 35.20% (σ 1.23) | 37.47% (σ 1.35) |
| 7 | Device<br>Performance -<br>Border Adhesion | comparable to<br>market<br>leaders | Predicate1 does not have<br>border. Data for other<br>commercial bordered<br>products are located in<br>K190268, Appendix 18-<br>5, Attachment 3. | The adhesion performance of the<br>perforated silicone adhesive was<br>evaluated for peel strength in<br>comparison to Hollister Triact Foam<br>Dressing with silicone border and<br>Coloplast Biatain silicone<br>(with<br>silicone<br>border). The peel<br>strength met the acceptance<br>criteria. |

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| 8 | Antibacterial<br>Efficacy<br>Low Specification<br>Dye Limit –<br>Simulated Wound<br>Fluid2 | ≥ 4 log<br>reduction<br>over 7 days | NA | All low specification dye limit test<br>articles evaluated exceeded the<br>antibacterial efficacy acceptance<br>criteria by demonstrating complete<br>kill of the bacteria Staphylococcus<br>aureus, Streptococcus pneumoniae,<br>Bacillus subtilis, Pseudomonas<br>aeruginosa, Escherichia coli and<br>Enterobacter cloacae after 7 days of<br>incubation, following a 7-day pre-<br>conditioning period. |
|---|--------------------------------------------------------------------------------------------|-------------------------------------|----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9 | Antibacterial<br>Efficacy<br>Lot Consistency -<br>Simulated Wound<br>Fluid3 | ≥ 4 log<br>reduction<br>over 7 days | NA | All lot consistency test articles<br>evaluated exceeded the antibacterial<br>efficacy acceptance criteria by<br>demonstrating complete kill of the<br>bacteria Staphylococcus aureus,<br>Streptococcus pneumoniae, Bacillus<br>subtilis, Pseudomonas aeruginosa,<br>Escherichia coli and Enterobacter<br>cloacae after 7 days of incubation,<br>following a 7-day pre-conditioning<br>period. |

## 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.