(672 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
Yes
The intended use "to relax muscle spasm" clearly indicates a therapeutic purpose.
No
The intended use is "to relax muscle spasm," which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states "powered muscle stimulator," which indicates a hardware component is involved in delivering electrical stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to relax muscle spasm." This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a "powered muscle stimulator." This type of device delivers electrical impulses to muscles for therapeutic effects.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Function: to relax muscle spasm
Product codes
Not Found
Device Description
XH-1 Neuromuscular Stimulator is a powered muscle stimulator with the following technical features: Frequency 0.9 Hz, Biphasic wave without direct current, Pulse peak output voltage and current of +110V/-110V and +11mAmp/-11mAmp respectively (at 10,000 ohms load), fixed output frequency, fixed output pulse-width under a constant resistant load, interpulse rest of approximately 1.1 second, and continuous output at 0.9 Hz frequency. It operates on two AA batteries (3volts) for 700 hours. Electrode Coupling Medium is a paper towel moistened with water.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The summary focused on comparing the technical features of the XH-1 Neuromuscular Stimulator with a preamendment device, Myopulse Neuromuscular Stimulator, and other predicate devices to demonstrate substantial equivalence in terms of safety and effectiveness. Key results indicated equivalence for 14 main technical features compared to the Myopulse.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Myopulse, K840346, K926510, K850013, K893878, K893879
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
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
"This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92."
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION OF SUBSTANTIAL EQUIVALENCE ON THE MAIN TECHNICAL FEATURES BETWEEN THE XH-1 NEUROMUSCULAR STIMULATOR AND THE MYOPULSE NEUROMUSCULAR STIMULATOR
| No. | Item | XH-1, a
powered
muscle
stimulator | Myopulse, a
powered
muscle
stimulator | Level of
Safety and
Effectiveness |
|-----|-----------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------------------|
| 1 | Frequency 0.9 Hz | Equivalent | Equivalent | Equivalent |
| 2 | Biphasic wave without
direct current | Equivalent | Equivalent | Equivalent |
| 3 | Wave Form | Similar | Similar | Equivalent |
| 4 | Pulse peak output
voltage and current,
10,000 ohms load. | +110volts,
-110volts.
+11mAmp,
-11mAmp. | +90volts
-115volts.
+9mAmp,
-11.5mAmp. | Equivalent |
| 5 | Output frequency fixed. | Equivalent | Equivalent | Equivalent |
| 6 | Output pulse-width
fixed under a constant
resistant load. | Equivalent | Equivalent | Equivalent |
| 7 | Interpulse rest of
approximately 1.1
second. | Equivalent | Equivalent | Equivalent |
| 8 | @ 0.9 Hz frequency,
continuous output | Equivalent | Equivalent | Equivalent |
| 9 | Average output current,
10,000 ohms load. | 0.18mAmp | 0.013 mAmp | Equivalent* |
| 10 | Frugal on electrical
consumption | Two AA
batteries,
3volts,
can
operate
for
700 hours. | One 9volt
batter. can
operate
for
350 hours. | Equivalent |
| 11 | Electrode Coupling
Medium | Paper
towel
moistened
with water. | Sponge
moistened
with water. | Equivalent |
| 12 | Function: to relax
muscle spasm | Equivalent | Equivalent | Equivalent |
| 13 | History of clinical
usage | Since 1987
to present | Since 1968
to present | Equivalent |
| 14 | Adverse effects are | Equivalent | Equivalent | Equivalent |
according to the Federal Engineering department associated with the National Electric Code and according to the State of California OSHA Consultation Group.
The 14 main technical features in the summary prove that the XH-1 Neuromuscular Stimulator is substantially equivalent, in terms of safety and effectiveness, to the Myopulse Neuromuscular Stimulator, which is a preamendment device marketed prior to May 28, 1976.
text
Fa Lin
Dr. Laiyin Yan alias Fa Lin
CALIFORNIA MEDICAL RESEARCH INSTITUTE
January 17, 1995
ਤੇ
The requested image does not appear to contain any text.
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COMPARISON CHART OF THE SIMILARITIES OF MAIN TECHNICAL FEATURES BETWEEN THE XH-1 NEUROMUSCULAR STIMULARDE AND OTHER ELECTRICAL MUSCLE STIMULATORS WITH 510(K) RUMBER
| No. | Item | XH-1 | Other Products |
|---|---|---|---|
| 1 | Neuromuscular | ||
| Stimulator as | |||
| proprietary | |||
| name | Equivalent | Those with equivalent | |
| proprietary names: | |||
| K840346 | |||
| K926510 | |||
| 2 | Frequency of 1 Hz | 0.9 Hz | Those that can be adjusted |
| to 1 Hz output: | |||
| K850013 | |||
| K893878 | |||
| K893879 | |||
| 3 | Interpulse resting | ||
| time of | |||
| approximately 1 | |||
| second | 1.1 second | Those that can be adjusted | |
| to 1-second off time: | |||
| K893878 | |||
| K893879 | |||
| K926510 | |||
| 4 | Pulses with | ||
| continuous output | At 0.9 Hz, | ||
| continuous | |||
| output | Those that can be adjusted | ||
| to continuous output: | |||
| K840346 | |||
| K926510 |
fa Lin
Dr. Laiyin Yan CALIFORNIA MEDICAL RESEARCH INSTITUTE U.S.A. January, 1995
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