(308 days)
Not Found
No
The summary describes a standard electrodiagnosis system with signal averaging and storage capabilities, but makes no mention of AI or ML technologies.
No.
The device is described as a multi-channel system for electrodiagnosis, indicating its purpose is for diagnostic evaluation rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests." The term "electrodiagnosis" directly indicates a diagnostic purpose.
No
The device description explicitly states it consists of a "two or four channel signal acquisition system coupled to a microcomputer" and includes "multiple mode evoked potential stimulators: auditory, visual, and electrical" and a "thermal printer". These are hardware components, making it a hardware and software system, not software-only.
Based on the provided information, the Amplaid MK12 is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the device as a "multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests." These tests involve measuring the electrical activity of the nervous system in response to external stimuli (visual, auditory, electrical). This is a physiological measurement performed on a living patient, not a test performed on a sample of biological material outside the body.
- Device Description: The description details a system for signal acquisition, processing, storage, and display, along with stimulators. This aligns with a device used for in vivo physiological testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with IVD devices.
In summary, the Amplaid MK12 is a device used for in vivo electrophysiological testing of patients, not for testing biological samples in vitro.
N/A
Intended Use / Indications for Use
The Amplaid MK12 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including:
- Electronystagmography
- Visual evoked potentials,
- Auditory evoked potentials, and
- Electrical (somatosensory) evoked potentials.
Product codes (comma separated list FDA assigned to the subject device)
GWF
Device Description
The Amplaid MK12 Multi-channel system for electrodiagnosis consists of a two or four channel signal acquisition system coupled to a microcomputer which can perform signal averaging, storage and display, along with microcomputer controlled multiple mode evoked potential stimulators: auditory, visual, and clectrical. A thermal printer is built in, and laser printer connection is supported.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).
0
MAR 1 6 1998
EXHIBIT 2
Amplifon S.p.A. Via Ripamonti, 133 20141 Milan, ITALY Tel ++39-2-57472.482 Fax ++39-2-57409427 Contact: Giovanni Rollier, President
March 12, 1997
510(k) Summary of Safety and Effectiveness
Identification of the Device: 1.
Proprietary-Trade Name: Amplaid MK22 Common/Usual Name: Evoked potential electrodiagnostic system Classification Names/ Device class: The electrodiagnostic system is a combination of devices which are Class II per regulations 882.1835, 882.1845, 882.1870. 882.1890. and 882.1900
Equivalent legally marketed devices This product is similar in design and 2. function to the Amplaid USA. Inc. Evoked Potentials System MK15 (K861014)
-
Indications for Use (intended use) Electronystagmography (for identification of middle ear conditions), Visual evoked notentials, Auditory evoked potentials, and Electrical (somatosensory) evoked potentials.
-
Description of the Device: The Amplaid MK12 Multi-channel system for electrodiagnosis consists of a two or four channel signal acquisition system coupled to a microcomputer which can perform signal averaging, storage and display, along with microcomputer controlled multiple mode evoked potential stimulators: auditory, visual, and clectrical. A thermal printer is built in, and laser printer connection is supported.
Safety and Effectiveness, comparison to predicate device. The results of hench న్. and user testing indicates that the new device is as safe and effective as the predicate devices.
1
Substantial Equivalence Chart હ.
| Characteristic | Predicate device: The
Amplaid MK15 | New device: "Amplaid
MK12TM" |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use: | Electronystagmography,
Visual Evoked Potentials,
Auditory Evoked Potentials,
Electrical (Somatosensory)
Evoked Potentials | (Same) |
| Physical characteristics: | | |
| Size/weight | 20.8"W x 18.9"D x 13.4"H,
44 Ibs. | 21.25"H x 19.7"D x 7.9"H
28.6 lbs. |
| Energy Source: | 115/230 Vac, ± 10%, 50-60
Hz. | (Same) |
| Hardcopy Output: | Possible via computer
interface | Built in via 640 point
thermal printer or laser
printer connection |
| Standards and Safety
characteristics: | | |
| Electrical safety: | UL-544, IEC 601 | (Same) |
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Amplifon S.p.A. that the "Amplaid MK12™" is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate Device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel Kamm ·c/o Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
K971740 Re: Amplaid MK12 Trade Name: Regulatory Class: II GWF Product Code: March 2, 1998 Dated: March 4, 1998 Received:
Dear Mr. Kamm:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
MAR 1 6 1998
Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
3
Page 2 - Mr. Kamm
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
j) Indications for Use
510(k) Number K971740
Device Name: Amplaid MK12
Indications for Use: The Amplaid MK12 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including:
- Electronystagmography ﻨﺴ
-
- Visual evoked potentials,
-
- Auditory evoked potentials, and
-
- Electrical (somatosensory) evoked potentials.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971740 |
| Prescription Use | OR | Over the Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |