(87 days)
The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device.
The Smart Coupler is a non-invasive, cutaneous, passive, sound-delivery device accessory that provides a coupling interface between the patient's ear and the auditory stimulator used during audiometric testing. The device is a biocompatible, non-sterile, single patient use, disposable device.
The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.
Here's an analysis of the provided 510(k) summary for the "Smart Coupler" device, focusing on acceptance criteria and the study to prove it, as requested.
It's important to note that the provided document is a 510(k) summary for a device accessory (an acoustic coupler), not a complex AI-powered diagnostic device. Therefore, many of the requested elements like "multi reader multi case (MRMC) comparative effectiveness study," "standalone algorithm performance," "number of experts," and detailed "training set" information are not applicable or described in the context of this type of submission. The focus for this device is on safety, biocompatibility, and functional equivalence to a predicate device, rather than diagnostic accuracy.
Acceptance Criteria and Device Performance for Smart Coupler (K073384)
The "Smart Coupler" is a passive device accessory. The "acceptance criteria" for a device like this primarily revolve around demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness. This is achieved by showing similar performance characteristics and demonstrating that any new features (like an additional model or specific materials) do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit from Submission) | Reported Device Performance (Smart Coupler) |
|---|---|---|
| Biocompatibility | Meet ISO 10993 standards for short-term skin contact (cytotoxicity, skin irritation, skin sensitization). | All materials in contact with the patient successfully passed biocompatibility testing criteria specified in ISO 10993 for short-term skin contact. |
| Functional Equivalence | Provide a coupling interface for auditory stimulators for audiometric testing (same intended use as predicate). | Supports auditory evaluation studies (audiometers, auditory evoked potential, otoacoustic emissions devices). Same intended use as the predicate device. |
| Material Composition | Biocompatible, non-sterile, single-patient use, disposable. Materials similar to predicate (foam, flexible elastomeric material, adhesive). | Biocompatible, non-sterile, single-patient use, disposable. Similar materials (flexible elastomeric material, adhesive hydrogel) used, with the note "expect no foam" compared to predicate. |
| Safety (General) | No new issues of safety or effectiveness compared to predicate. | Device is passive, does not consume/produce energy, no chemicals involved, no mechanical parts, not electrical/thermal in nature. Results of performance testing were as expected, raising no new issues of safety or effectiveness. |
| Design | Provide coupling for circumaural or intra-aural application (at least, similar to predicate). | Available in circumaural, intra-aural, and supra-aural models. Offers an additional supra-aural model compared to the predicate's two models. |
| Human Factors | Simple, easy-to-follow instructions. | Same as predicate (implied to be simple, easy-to-follow instructions). |
2. Sample Size Used for the Test Set and Data Provenance
The submission primarily refers to "performance testing of prototype devices to specifications."
- Test Sample Size: Not explicitly stated as a number of devices or subjects. The context suggests that the testing was primarily focused on material properties (biocompatibility) and functional validation, not clinical trials with a defined "test set" sample size in the traditional sense for diagnostic accuracy.
- Data Provenance: Not specified regarding country of origin or retrospective/prospective. Given the nature of the device (acoustic coupler), it is highly likely that the biocompatibility testing was conducted in a laboratory setting. Functional testing would have involved prototypes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable in the context of this device. The "Smart Coupler" is an accessory; its "ground truth" is its ability to meet material safety standards and functionally couple an auditory stimulator. This is assessed via technical standards (ISO 10993) and engineering verification, not by expert interpretation of output.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication" necessary for this type of device's performance assessment.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size
- No. An MRMC study is relevant for AI-powered diagnostic tools where human readers are interpreting images or data. This device is a passive accessory and does not involve human interpretation of its output in a diagnostic capacity.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device does not contain an algorithm. It is a passive, mechanical accessory.
7. The Type of Ground Truth Used
The "ground truth" for this device relates to its fundamental safety and functional attributes:
- Biocompatibility: Established by adherence to ISO 10993 standards (e.g., cell viability assays for cytotoxicity, visual assessment for skin irritation/sensitization).
- Functional Performance: Established by engineering specifications and physical testing to confirm its ability to serve as a coupling interface for auditory stimulators, consistent with the intended use and predicate device. This would likely involve acoustic measurements and fit testing.
8. The Sample Size for the Training Set
- Not applicable. This device does not use an algorithm or machine learning, 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, there is no ground truth establishment for one.
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KO73384
510(k) Summary (per 21 CFR 807.92)
ಿದ್ದಾರೆ. ಇದರ ಪ್ರ
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| Submitter: | Intelligent Hearing Systems6860 SW 81st StreetMiami, FL 33143 |
|---|---|
| Contact : | Edward Miskiel, Ph.D.Telephone: (305) 668-6102Facsimile: (305) 668-6103 |
| Date Summary Prepared: | November 29, 2007 |
| Device Identification:Common Name:Proprietary Name: | Acoustic CouplerSmart Coupler |
| Predicate Device: | VIASYS Healthcare Comfort Cup & Ear Tip Accessories(K031713) |
| Device Description: | The Smart Coupler is a non-invasive, cutaneous, passive, sound-delivery device accessory that provides a coupling interface between the patient's ear and the auditory stimulator used during audiometric testing. The device is a biocompatible, non-sterile, single patient use, disposable device.The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient. |
| Intended Use: | The Smart Coupler is intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. This is the same intended use as that of the predicate device. |
| Parameter forComparison | Predicate Device | Similarity or Difference toPredicate Device |
|---|---|---|
| Target Population | Newborns and all ages (assumed). | Same. |
| Where Used | Clinical setting. | Same. |
| Anatomical Sites | Head and external ear. | Same. |
| Sterility | Not supplied sterile. | Same. |
Comparison Summary of Technological Characteristics:
:
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| Parameter forComparison | Predicate Device | Similarity or Difference toPredicate Device |
|---|---|---|
| Biocompatibility | Unknown. | All material in contact with thepatient successfully passed thebiocompatibility testing criteriaspecified in the ISO 10993 standardfor short-term skin contact(cytotoxicity, skin irritation, & skinsensitization). |
| Design | 2 models available:• Circumaural• Intra-aural | 3 models available:• Circumaural• Intra-aural• Supra-aural |
| Materials | Foam, flexible elastomeric material,and adhesive material to adhere toskin surface. | Same (expect no foam). |
| Human Factors | Simple, easy-to-follow instructions. | Same. |
| Standards | None known. | Same. |
| Energy Used and/orDelivered | Device is passive and does notconsume or produce any energy.Only acoustic energy from a differentsource is conveyed. | Same. |
| Chemical Safety | No chemicals are involved in the useof this device. | Same. |
| Mechanical Safety | No mechanical parts. | Same. |
| Electrical Safety | Device is not electrical in nature. | Same. |
| Thermal Safety | Device is not thermal in nature. | Same. |
Substantial Equivalence:
This submission includes the results of performance testing of prototype devices to specifications. The results were as expected and no new issues of safety and effectiveness were raised as a result of the testing.
Conclusions:
Based on the information presented in this submission, the Smart Coupler device is as safe and effective as and is substantially equivalent to the identified predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2008
Intelligent Hearing Systems c/o Edward Miskiel, Ph.D. 6860 S.W. 81st Street Miami, FL 33143
Re: K073384
Trade/Device Name: Smart Coupler Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: February 14, 2008 Received: February 15, 2008
Dear Dr. Miskiel:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Maling B. Eglitis, ud
Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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073384
Page 3 -
Indications for Use
510(k) Number (if known): K073384
Device Name: Smart Coupler
The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device.
The Smart Coupler is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or other appropriate setting.
The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medicalgrade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel C Clapp
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number KD73384
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§ 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).