(52 days)
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.
Circumaural Adhesive Replacement is acrylic hydrogel adhesive rings supplied on a release card in a packages of ten. After the original adhesive is removed from the disposable ear couplers, the top liner covers are removed to apply the adhesive rings to the earphones thereby making them reusable and reducing medical test costs. The then reusable ear couplers with the disposable adhesive rings are placed around the infant ears for the duration of the test. The Circumaural Adhesive Replacement is then removed and discarded. After an alcohol wipe of the same earphones, another Circumaural Adhesive Replacement is applied for the next patient test.
This document describes the Circumaural Adhesive Replacement, a disposable hydrogel adhesive for re-using earphones in newborn hearing screening tests.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Parameter) | Predicate Device (ALGO-3 Newborn Hearing Screener with Flexicoupler) Performance | Applicant Device (Circumaural Adhesive Replacement) Performance |
|---|---|---|
| Skin Contact Material | Acrylic Hydrogel | Acrylic Hydrogel |
| Ear Phone | Flexicoupler Rubber Molded Part | Flexicoupler Rubber Molded Part |
| Contact Area | 3.2 square inches | 3.2 square inches |
| Hydrogel Attachment 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 Screening | Newborn Hearing Screening |
| Shelf Life | Two Years | Two Years |
| Prescription/OTC Status | Prescription | Prescription |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for specific performance tests (e.g., bench testing for adhesive characteristics). However, it mentions that Biocompatibility testing was performed. For these types of tests (cytotoxicity, sensitization, primary skin irritation), standardized protocols typically involve a certain number of test subjects or samples. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The studies described are primarily technical performance tests and biocompatibility, not studies requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided in the document. The tests performed are objective measurements (e.g., passing ISO standards, 0% residue, 100% attachment), not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an adhesive replacement, not an imaging or diagnostic AI tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the device described. The "device" is a physical adhesive. The performance tests are for the adhesive's physical and biological properties.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Predicate device's established performance and characteristics: The comparison is against the Natus Flexicoupler's performance, which is already an approved device.
- Objective material and performance specifications: Such as ISO 10993 standards for biocompatibility, and quantitative measures like 100% attachment, 0% residue, and "none" for pain upon removal.
8. The Sample Size for the Training Set
This concept is not applicable as the device is a physical product (adhesive) and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a substantial equivalence evaluation compared to a legally marketed predicate device (ALGO-3 Newborn Hearing Screener and Accessories, specifically the Flexicoupler Disposable Earphone accessory, K013317).
The document states:
-
Performance Testing:
- Biocompatibility: Tests were performed, and the device "passed the required skin sensitivity testing criteria." It "met specifications as established in ISO 10993-1 for skin contact," including cytotoxicity, sensitization, and primary skin irritation tests. This directly addresses the "Biocompatibility: Passed ISO 10993" acceptance criterion. The predicate device uses the same materials and meets the same ISO 10993 specifications.
- Bench Testing: Bench testing "demonstrated that the adhesive characteristics of the Circumaural Adhesive Replacement are substantially equivalent to those of the predicate device." This supports the acceptance criteria related to "Hydrogel Attachment to Coupler" (100%), "Acoustic Seal" (100%), "Adhesive Residue" (0%), and "Pain Upon Removal" (None).
-
Technological Comparison & Materials: The device uses the same material (acrylic hydrogel) as the predicate device. The contact area, earphone component, indications for use, shelf life, and prescription status are also identical to the predicate.
The conclusion from testing is that "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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III5555
510(k) Summary
JUL 2 5 2011
| Submitter's Information: | R&D Medical Products, Inc.20492 Crescent Bay Drive, Building 106Lake Forest, CA 92630 | |
|---|---|---|
| Contact Person: | James PerraultPhone: (949) 472-9346 x202Fax: (949) 472-9347 | |
| 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 Componentmodification 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(specifically the Flexicoupler Disposable Earphone accessory),K013137 | |
| Description of Device: | Circumaural Adhesive Replacement is acrylic hydrogel adhesiverings supplied on a release card in a packages of ten. After theoriginal adhesive is removed from the disposable ear couplers, thetop liner covers are removed to apply the adhesive rings to theearphones thereby making them reusable and reducing medical testcosts. The then reusable ear couplers with the disposable adhesiverings are placed around the infant ears for the duration of the test.The Circumaural Adhesive Replacement is then removed anddiscarded. After an alcohol wipe of the same earphones, anotherCircumaural Adhesive Replacement is applied for the next patienttest. | |
| Indications for Use: | The Circumaural Adhesive Replacement is used to makeearphones 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.Flexicoupler | R&D Medical Products, Inc.Circumaural Adhesive Replacement | |
| Contract Manufacturer | R&D Medical Products, Inc (until 2005) | R&D Medical Products, Inc |
| Skin ContactMaterial | AcrylicHydrogel ( original ) | AcrylicHydrogel ( replacement ) |
| Ear Phone | Flexicoupler RubberMolded Part | Flexicoupler RubberMolded Part |
| Contact Area | 3.2 square inches | 3.2 square inches |
| Hydrogel Attachmentto 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 HearingScreening | Newborn Hearing Screening |
| Shelf Life | Two Years | Two Years |
| Prescription/OTCStatus | Prescription | Prescription |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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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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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
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).