(52 days)
Not Found
No
The device is a simple adhesive ring and the description focuses on its material properties and reusability, with no mention of AI or ML.
No.
The device is an adhesive used to secure earphones for newborn hearing screening, which is a diagnostic test, not a therapeutic intervention.
No
Explanation: This device is an acrylic hydrogel adhesive ring used to secure earphones for newborn hearing screening tests, making the earphones reusable. It is an accessory to a diagnostic test, but it does not perform a diagnostic function itself.
No
The device description clearly states it is an acrylic hydrogel adhesive ring, which is a physical component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Circumaural Adhesive Replacement is a physical accessory used to secure earphones to a baby's head during a hearing screening test. It does not analyze any biological sample from the patient.
- Intended Use: Its purpose is to facilitate the proper placement of the earphones for the hearing test, not to perform a diagnostic test itself.
The device is a medical device, but it falls under a different classification than IVDs. It's an accessory used in conjunction with a diagnostic test (the newborn hearing screening), but it is not the diagnostic test itself.
N/A
Intended Use / 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.
Product codes
GWJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
circumaural area
Indicated Patient Age Range
babies between the ages of 34 weeks (gestational age) and 6 months
Intended User / Care Setting
well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
III5555
510(k) Summary
JUL 2 5 2011
| Submitter's Information: | R&D Medical Products, Inc.
20492 Crescent Bay Drive, Building 106
Lake Forest, CA 92630 | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | James Perrault
Phone: (949) 472-9346 x202
Fax: (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 Component
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
(specifically the Flexicoupler Disposable Earphone accessory),
K013137 | |
| Description of Device: | 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. | |
| Indications for Use: | The Circumaural Adhesive Replacement is used to make
earphones reusable for newborn hearing screening tests. It is a | |
1
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.
2
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 Contact | ||
| Material | Acrylic | |
| Hydrogel ( original ) | Acrylic | |
| Hydrogel ( replacement ) | ||
| 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 |
・
3
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
4
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
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
5
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