CIRCUMAURAL ADHESIVE REPLACEMENT

K111555 · R & D Medical Products, Inc. · GWJ · Jul 25, 2011 · Neurology

Device Facts

• Record ID: K111555
• Device Name: CIRCUMAURAL ADHESIVE REPLACEMENT
• Applicant: R & D Medical Products, Inc.
• Product Code: GWJ · Neurology
• Decision Date: Jul 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1900
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Circumaural Adhesive Replacement is used to make earphones reusable for newborn hearing screening tests. It is a single use disposable to seal the earphones in place during the screening process. This skin adhesive is intended for use on the circumaural area of babies between the ages of 34 weeks (gestational age ) and 6 months. Sites appropriate for this screening test may include the well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

Device Story

Circumaural Adhesive Replacement consists of acrylic hydrogel adhesive rings supplied on release cards. Device enables reuse of disposable ear couplers for newborn hearing screening. Clinician removes original adhesive from earphone couplers, applies new adhesive ring, and secures coupler around infant's ear for test duration. After screening, adhesive is removed and discarded; earphone is cleaned with alcohol for subsequent use. Used in NICU, nurseries, audiology suites, and clinics. Benefits include reduced medical test costs by extending earphone utility. Device ensures acoustic seal during screening process.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, primary skin irritation) performed per ISO 10993-1; device passed all criteria. Adhesive performance characteristics demonstrated to be equivalent to predicate.

Technological Characteristics

Acrylic hydrogel adhesive rings; 3.2 square inch contact area. Designed for application to existing rubber molded earphone couplers. Biocompatible per ISO 10993. Single-use, disposable. No electronic components or software.

Indications for Use

Indicated for newborn hearing screening in infants aged 34 weeks gestational age to 6 months. Used to seal earphones to the circumaural area in clinical settings including NICU, nurseries, and outpatient clinics.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Predicate Devices

• ALGO-3 Newborn Hearing Screener and Accessories (specifically the Flexicoupler Disposable Earphone accessory) (K013137)

Submission Summary (Full Text)

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# 510(k) Summary

JUL 2 5 2011

| Submitter's Information: | R&D Medical Products, Inc.<br>20492 Crescent Bay Drive, Building 106<br>Lake Forest, CA 92630 | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | James Perrault<br>Phone: [phone] x202<br>Fax: [phone] | |
| Date Prepared: | May 31, 2011 | |
| Proprietary Name: | Circumaural Adhesive Replacement | |
| Common Name: | Disposable Ear Phone Hydrogel Adhesive | |
| Classification Name: | Stimulator, Auditory Evoked Response [an Accessory Component<br>modification to ] | |
| Regulation: | Evoked Response Auditory Stimulator, 21 C.F.R. §882.1900 | |
| Regulatory Class: | Class II | |
| Product Code: | GWJ | |
| Predicate Devices: | ALGO-3 Newborn Hearing Screener and Accessories<br>(specifically the Flexicoupler Disposable Earphone accessory),<br>K013137 | |
| Description of Device: | Circumaural Adhesive Replacement is acrylic hydrogel adhesive<br>rings supplied on a release card in a packages of ten. After the<br>original adhesive is removed from the disposable ear couplers, the<br>top liner covers are removed to apply the adhesive rings to the<br>earphones thereby making them reusable and reducing medical test<br>costs. The then reusable ear couplers with the disposable adhesive<br>rings are placed around the infant ears for the duration of the test.<br>The Circumaural Adhesive Replacement is then removed and<br>discarded. After an alcohol wipe of the same earphones, another<br>Circumaural Adhesive Replacement is applied for the next patient<br>test. | |
| Indications for Use: | The Circumaural Adhesive Replacement is used to make<br>earphones reusable for newborn hearing screening tests. It is a | |

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single use disposable to seal the earphones in place during the screening process. This skin adhesive is intended for use on the circumaural area of babies between the ages of 34 weeks (gestational age ) and 6 months. Sites appropriate for this screening test may include the well-baby nusery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

Technological Comparison: The Circumaural Adhesive Replacement on the Natus Flexicouplers has technological characteristics that are substantially equivalent to those of the predicate device as determined by testing and common materials.

Basis for Equivalence: R&D Medical Products, Inc. has manufactured predicate device accessories for Natus and now seeks to make the adhesive replacement component under private label for distribution. See Substantial Equivalence Table on following page.

-Performance testing: Biocompatibility testing was performed and the device passed the required skin sensitivity testing criteria. According to the performance data, the Circumaural Adhesive Replacement met specifications as established in ISO 10993-1 for skin contact. The tests included cytotoxicity, sensitization and primary skin irritation tests. The predicate device uses the same materials and meet the same ISO 10993 specifications.

> Bench testing demonstrated that the adhesive characteristics of the Circumaural Adhesive Replacement are substantially equivalent to those of the predicate device.

-Labeling: The labeling of the Circumaural Replacement Adhesive is substantially equivalent to that of the predicate device after the replacement is done.

Conclusions from Testing: In all material respects, the Circumaural Adhesive Replacement on the Natus Flexicoupler is substantially equivalent to the predicate device. Both use acrylic hydrogel adhesives. Test results support the conclusion that the adhesive performance is substantially equivalent to the predicate devices, and there are no differences in construction and materials between the devices to pose new questions of safety or effectiveness.

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## Substantial Equivalence Table

| Parameter | Predicate | Applicant |
|-----------------------------------|----------------------------------------|----------------------------------------------------------------|
| | K013137 | Kxxxxxxx |
| | Natus Medical Inc.<br>Flexicoupler | R&D Medical Products, Inc.<br>Circumaural Adhesive Replacement |
| Contract Manufacturer | R&D Medical Products, Inc (until 2005) | R&D Medical Products, Inc |
| Skin Contact<br>Material | Acrylic<br>Hydrogel ( original ) | Acrylic<br>Hydrogel ( replacement ) |
| Ear Phone | Flexicoupler Rubber<br>Molded Part | Flexicoupler Rubber<br>Molded Part |
| Contact Area | 3.2 square inches | 3.2 square inches |
| Hydrogel Attachment<br>to Coupler | 100% | 100% |
| Acoustic Seal | 100% | 100% |
| Adhesive Residue | 0% | 0% |
| Pain Upon Removal | None | None |
| Biocompatibility | Passed ISO 10993 | Passed ISO 10993 |
| Indications for Use | Newborn Hearing<br>Screening | Newborn Hearing Screening |
| Shelf Life | Two Years | Two Years |
| Prescription/OTC<br>Status | Prescription | Prescription |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

R & D Medical Products, Inc. c/o James Perrault 20492 Crescent Bay Drive Building 106 Lake Forest, CA 92630

JUL 2 5 2011

Re: K111555

Trade/Device Name: Circumaural Adhesive Replacement Regulation Number: 21 CFR 882.1900 Regulation Name: Evoke Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: May 31, 2011 Received: June 03, 2011

Dear Mr. Perrault:

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. Isting 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

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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 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. 1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Image /page/4/Picture/7 description: The image contains a handwritten word "for" in cursive. The letters are connected, and the word is written in a flowing style. The "f" is elongated and curves downward, while the "o" and "r" are smaller and more rounded.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K111555

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Circumaural Adhesive Replacement

### Indications for Use:

The Circumaural Adhesive Replacement is used to make earphones reusable for newborn hearing screening tests. It is a single use disposable to seal the earphones in place during the screening process. This skin adhesive is intended for use on the circumaural area of babies between the ages of 34 weeks (gestational age ) and 6 months. Sites appropriate for this screening test may include the well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )

Concurrence of CDRH, Office of Device Evaluation (ODE)

ODE)

Phabolut-

(Division Sig Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111555