(56 days)
To assist in conversation, meetings and TV-listening by amplifying sound.
The indications for use of the assistive listening device in this submission is to amplify-sound for individuals with impaired-hearing. The device is indicated for individuals with hearing loss in the following category(ies).
Severity: Mild, Moderate
Configuration: Gradually Sloping, Flat
Air Conduction Assistive Listening Device. Personal Amplifier.
Features: Adjustable volume control, Microphone/Telephone/Off switch, Gain, Treble and AGC adjustment trimmers, Internal/External microphone switch.
Assembly: Assembled from standard components widely used in electronic products.
Technical Characteristics: Technical specifications comply with ANSI S3.22-1987.
Controls: Volume control, Microphone/Telephone/Off switch, Internal/External microphone switch and sound adjustment trimmers similar to those used on other assistive listening devices/Personal amplifiers.
Power: Standard alkaline AAA (or LR03) size battery.
Here's an analysis of the provided text to extract the requested information about the Bellman Response model 1050:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Technical Characteristics) | Reported Device Performance |
|---|---|
| Complies with ANSI S3.22-1987 | Technical specifications comply with ANSI S3.22-1987 |
| Adjustable volume control | Adjustable volume control |
| Microphone/Telephone/Off switch | Microphone/Telephone/Off switch |
| Gain, Treble and AGC adjustment trimmers | Gain, Treble and AGC adjustment trimmers |
| Internal/External microphone switch | Internal/External microphone switch |
| Power: Standard alkaline AAA (or LR03) size battery | Standard alkaline AAA (or LR03) size battery |
| Controls similar to other assistive listening devices/personal amplifiers | Controls similar to those used on other assistive listening devices/Personal amplifiers |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not mention a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective) for a study to prove the device meets acceptance criteria. The document appears to be focused on a 510(k) premarket notification for substantial equivalence, which often relies on comparison to predicate devices and technical standards rather than new clinical trials with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As no specific clinical study with a test set and ground truth establishment is described, there's no information about experts or their qualifications.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. without AI Assistance
Not applicable. This device is an analog assistive listening device, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Not applicable. The Bellman Response model 1050 is an assistive listening device, not an algorithm. Its performance is inherent in its hardware and amplification capabilities, not in a standalone algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of a typical clinical study requiring ground truth. The "ground truth" for this device's performance relies on its adherence to technical specifications (ANSI S3.22-1987) and its ability to amplify sound, rather than on expert consensus, pathology, or outcomes data from a clinical trial. The basis for its approval is substantial equivalence to legally marketed predicate devices, implying that their "ground truth" performance and safety were already established.
8. The Sample Size for the Training Set
Not applicable. This device is hardware for audio amplification. There is no concept of a "training set" as understood in machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this type of device, no ground truth was established for it.
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Safety And Effectiveness Summary - Bellman Response model 1050. j
| 1050. | K970340 | |
|---|---|---|
| MAR 26 1987 | ||
| Name of device: | Bellman Response model 1050 | |
| Type of device: | Air Conduction Assistive Listening Device. Personal Amplifier. | |
| Intended use: | To assist in conversation, meetings and TV-listening byamplifying sound. | |
| Features: | Adjustable volume control, Microphone/Telephone/Off switch,Gain, Treble and AGC adjustment trimmers, Internal/Externalmicrophone switch. | |
| Assembly: | Assembled from standard components widely used inelectronic products. | |
| TechnicalCharacteristics: | Technical specifications comply with ANSI S3.22-1987. | |
| Controls: | Volume control, Microphone/Telephone/Off switch,Internal/External microphone switch and sound adjustmenttrimmers similar to those used on other assistive listeningdevices/Personal amplifiers. | |
| Power: | Standard alkaline AAA (or LR03) size battery. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol appears to be an abstract representation of a human figure or a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Martin Eriksson Engineer, Product Development Bellman AB Gustaf Werners Gata 2 S-421 32 Vastra Frolunda Gothenburg, Sweden
JAN 1 0 2017
Re: K970340
Trade/Device Name: Bellman Response Model 1050 Assistive Listening Device Regulation Number: 21 CFR 874.3320 Regulation Name: Group hearing aid or group auditory trainer Regulatory Class: Class II Product Code: LZI Dated: January 17, 1997 Received: January 29, 1997
Dear Mr. Eriksson:
This letter corrects our substantially equivalent letter of March 26, 1997.
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. 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
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Page 2 - Mr. Martin Eriksson
(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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
for Malvina B. Eydelman, M.D. 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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| 510(k) Number (if known): | K970340 |
|---|---|
| Device Name: | Bellman Response, model 1050 |
| Indications For Use: |
A. General Indications:
The indications for use of the assistive listening device in this submission is to amplify-sound for individuals with impaired-hearing. The device is indicated for individuals with hearing loss in the following category(ies). (Check appropriate space(s)):
| Severity: | Configuration: | Other |
|---|---|---|
| 1. Slight | 1. High Frequency - Precipitously Sloping | 1. Low tolerance To Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | 3. Reverse Slope | 3. |
| 4. Severe | X 4. Flat | |
| 5. Profound | 5. Other |
B. Specific Indications (Only if appropriate.):
(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K970340 |
|---|---|
| --------------- | --------- |
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
Over-the-Counter Use
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・・・
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§ 874.3320 Group hearing aid or group auditory trainer.
(a)
Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.