(27 days)
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Not Found
No
The summary does not mention any AI or ML terms, image processing, or descriptions of training/test sets, which are common indicators of AI/ML use in medical devices. The intended uses are typical for electrical muscle stimulation devices, which generally do not incorporate AI/ML.
Yes
The device is intended for therapeutic purposes such as muscle spasm relaxation, prevention of disuse atrophy, increasing blood circulation, muscle re-education, prevention of venous thrombosis, and maintaining or increasing range of motion. These are all therapeutic indications.
No
The provided 'Intended Use / Indications for Use' lists therapeutic applications (e.g., muscle relaxation, atrophy prevention, circulation increase, muscle re-education, thrombosis prevention, range of motion maintenance), none of which involve diagnosing a condition.
Unknown
The provided text only includes the intended use and indications for use. It lacks a device description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed (muscle spasm relaxation, atrophy prevention, blood circulation increase, muscle re-education, post-surgical stimulation, range of motion maintenance) are all related to directly treating or affecting the human body, not analyzing samples taken from it.
- The description focuses on therapeutic applications. The indications for use describe therapeutic benefits and actions on muscles and circulation.
- There is no mention of analyzing biological samples. The information does not mention any analysis of blood, urine, tissue, or any other biological specimen.
Therefore, this device appears to be a therapeutic device, likely an electrical stimulator, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use of this device are:
- Relaxation of muscle spasm.
- Prevention or retardation of disuse atrophy.
- Increasing local blood circulation.
- Muscle re-education.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
- Maintaining or increasing range of motion.
Product codes
IRO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads and two sets of wings. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1999
Mr. R.H. Hopkins Technical Director Metron Medical Australia Pty. Ltd. 57 Aster Avenue Carrum Downs, Victoria, Australia 3201
Re: K993821
Trade Name: Vectorsurge 4 Interferential Therapy Unit Regulatory Class: II Product Codes: IRO Dated: November 9, 1999 Received: November 12, 1999
Dear Mr. Hopkins:
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. 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 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. R. H. Hopkins
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 vour 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) 594-4659. 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 vours.
Nil RP. Galang
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment Ib
| Page | |
|---|---|
| of | |
| 0 | - |
| AND THE |
l |
1 . . .
510(k) Number (if known): K 99382 |
ﻠﻘﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
Vectorsurge 4 ________________________________________________________________________________________________________________________________________________________________ Device Name:
Indications For Use:
The indications for use of this device are:
- Relaxation of muscle spasm. 1.
- Prevention or retardation of disuse atrophy. 2.
- Increasing local blood circulation. 3.
- Muscle re-education. 4.
- Immediate post-surgical stimulation of calf muscles to prevent venous 5. thrombosis.
- Maintaining or increasing range of motion. 6.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | PROF |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K993821 |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |