(179 days)
The Amplaid MK22 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.
The Amplaid MK22 Multi-channel system for electrodiagnosis consists of a two 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 electrical. A thermal printer is built in, and laser printer connection is supported.
The Amplaid MK22 is an evoked potential electrodiagnostic system. The submission establishes substantial equivalence to the Amplaid MK15 (K861014).
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the acceptance criteria are based on substantial equivalence to the predicate device, Amplaid MK15. This means the new device must be as safe and effective as the predicate device and have the same intended uses, with no new indications for use. Performance is implicitly assessed by demonstrating that the key characteristics of the new device are either identical or comparable to the predicate device and that any differences do not raise new questions of safety or effectiveness.
| Characteristic | Acceptance Criteria (Predicate Device: Amplaid MK15) | Reported Device Performance (New Device: Amplaid MK22) |
|---|---|---|
| Intended Uses: | Electronystagmography, Electroneurography, Visual evoked potentials, Auditory evoked potentials, Electrical (somatosensory) evoked potentials | (Same) Electronystagmography, Electroneurography, Visual evoked potentials, Auditory evoked potentials, Electrical (somatosensory) evoked potentials |
| Physical characteristics: | ||
| Number of channels | 2 or 4 | 1 or 2 (Difference noted, but acceptable as it's a reduction in channels, not an increase in complexity or new functionality requiring more channels than available) |
| Size/weight | 20.8" W x 18.9" D x 13.4" H, 44 lbs. | 10" W x 14" D x 14" H, 22.2 lbs (Smaller and lighter, considered an improvement or neutral difference) |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | 95-250 VAC, 50-60 Hz 100 VA (Wider voltage range, acceptable as it signifies wider compatibility without compromising safety) |
| Display | CRT monochrome (green), 9" | CRT, monochrome (green), 9", 640 x 400 (Same) |
| Hardcopy Output: | Built in via 640 point thermal printer or laser printer connection | (Same) Built in via 640 point thermal printer or laser printer connection |
| Standards and Safety characteristics: | ||
| Electrical safety: | UL-544, IEC 601, Type BF | (Same) UL-544, IEC 601, Type BF |
| Conclusion: | The predicate device is safe and effective, with established performance for its intended uses. | The new device is as safe and effective as the predicate device, has fewer channels (which is not a new safety/effectiveness concern), and has no new indications for use, thus rendering it substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical performance study with human subjects or a defined set of data for algorithm evaluation. The assessment for this 510(k) is based on bench and user testing and a comparative analysis of specifications against the predicate device.
- Sample Size: Not applicable in the context of a traditional performance study. The evaluation focuses on the device hardware and software specifications, and its equivalence to a previously cleared device.
- Data Provenance: Not specified as there isn't a clinical data set being referenced for performance evaluation. The "bench and user testing" information is general and does not refer to specific patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This 510(k) submission is for an electrodiagnostic system, and its clearance is based on substantial equivalence to a predicate device, not on diagnostic accuracy against a ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable. There is no specific "test set" and corresponding adjudication process described for evaluating device performance in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. An MRMC comparative effectiveness study was not performed or referenced in this 510(k) submission. The device is an electrodiagnostic system and the clearance pathway relies on demonstrating equivalent technical specifications and intended uses to a predicate device, not on improving human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The Amplaid MK22 is a medical device (an electrodiagnostic system) that acquires and processes physiological signals for medical diagnosis by a clinician. It is not an AI algorithm that produces a diagnostic output on its own. While it involves signal averaging, storage, and display, this is part of standard electrodiagnostic equipment functionality, not an AI algorithm performing diagnostic interpretation without human input.
7. The Type of Ground Truth Used
Not applicable. The submission does not refer to a ground truth for diagnostic accuracy, as it focuses on demonstrating the device's technical specifications and intended uses are substantially equivalent to a predicate.
8. The Sample Size for the Training Set
Not applicable. The Amplaid MK22 is a hardware and software system for electrodiagnosis; it is not an AI algorithm that undergoes a "training" phase with a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
{0}------------------------------------------------
FEB - 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 M. Rollier, President
August 8, 1997
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: 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 Classification Names/Product Codes: 84GWL(Signal Amplifier), 84GWK(signal conditioner), 84GWF(electrical stimulator), 84GWE(photic stimulator), 84GWJ(auditory stimulator).
-
- Equivalent legally marketed devices This product is similar in design and function to the Amplaid USA, Inc. Evoked Potentials System MK15 (K861014)
-
- Indications for Use (intended uses) Electronystagmography (for identification of middle ear conditions), Electroneurography (for facial nerve and blink reflex), Visual evoked potentials, Auditory evoked potentials, and Electrical (somatosensory) evoked potentials.
-
- Description of the Device: The Amplaid MK22 Multi-channel system for electrodiagnosis consists of a two 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 electrical. A thermal printer is built in, and laser printer connection is supported.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices.
{1}------------------------------------------------
Substantial Equivalence Chart 6.
| Characteristic | Predicate device:Amplaid MK15 | New device:Amplaid MK22 |
|---|---|---|
| Intended Uses: | ElectronystagmographyElectroneurographyVisual evoked potentials,Auditory evoked potentials,Electrical (somatosensory)evoked potentials | (Same) |
| Physical characteristics: | ||
| Number of channels | 2 or 4 | 1 or 2 |
| Size/weight | 20.8" W x 18.9" D x 13.4 H,44 lbs. | 10" W x 14" D x 14" H22.2 lbs |
| Energy Source: | 115/230 Vac, ± 10%, 50-60 Hz | 95-250 VAC, 50-60 Hz 100 VA |
| Display | CRT monochrome (green), 9" | CRT, monochrome (green), 9"640 x 400 (Same) |
| Hardcopy Output: | Built in via 640 point thermalprinter or laser printerconnection | (Same) |
| Standards and Safetycharacteristics: | ||
| Electrical safety: | UL-544, IEC 601, Type BF | (Same) |
7. Conclusion
- Alter analyzing outh belief and assire and effective as the predicate device, has few that the Amplaid MRZ2 is as bare and case and has no new indications for use, thus rendering it substantially equivalent to the predicate Device.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 1998
Amplifon S.P.A. C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield. Illinois 60015
Re: K972959 Trade Name: Amplaid MK22 Regulatory Class: II Product Code: GWF Dated: November 17, 1997 Received: November 18, 1997
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Fithe 215, -----Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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
{3}------------------------------------------------
Page 2 - Mr. Kamm
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.D.
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 K972959
Device Name: Amplaid MK22
Indications for Use: The Amplaid MK22 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.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K972959 |
Prescription Use ✓ OR Over the Counter Use
(Per 21 CFR 801.109)
§ 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).