(181 days)
Not Found
Not Found
No
The provided 510(k) summary explicitly states "Mentions AI, DNN, or ML: Not Found" and lacks any description of AI/ML related components, training data, or performance metrics typically associated with such technologies.
Yes
The device aims to provide "symptomatic relief of chronic, intractable pain" and "management of pain," which are therapeutic actions.
No
The device is described as providing symptomatic relief and management of pain, which indicates a therapeutic rather than a diagnostic function.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes hardware components or is purely software-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are "Symptomatic relief of chronic, intractable pain" and "Management of pain associated with post-traumatic or post-operative conditions." These are therapeutic uses, not diagnostic uses. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Any components typically associated with IVDs (reagents, analyzers, test kits)
The intended uses clearly point towards a device used for pain management, likely a physical therapy device, a nerve stimulator, or something similar, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
1.Symptomatic relief of chronic, intractable pain
2.Management of pain associated with post-traumatic or post-operative conditions
Product codes
LIH
Device Description
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized image of a human figure in profile, with three lines extending from the head, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2000
George K.C. Chen, Ph.D., M.D. Skylark Device & Systems Co., Ltd. 34 Chung Shan North Road 12th Floor, Section 3 Taipei, Taiwan China
K992652 Re:
Trade Name: SD-730 IF-SDS, Perfect Pulse IF-SDS Regulatory Class: Unclassified Product Code: LIH Dated: Undated Received: November 12, 1999
Dear Dr. Chen:
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 (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 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
1
Page 2 - George K.C. Chen, Ph.D., M.D.
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,
Sincerely yours,
Mark N Milkeess
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 4 of 4
510(k) NUMBER (IF KNOWN): K 992652 DEVICE NAME: SD-730 IF-SDS
INDICATIONS FOR USE:
1.Symptomatic relief of chronic, intractable pain
2.Management of pain associated with post-traumatic or post-operative conditions
(PLEASE DO. NOT WRITE. BELOK THIS LLINE - CONTINUE - ON : ANGTHER - PAGE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K992652 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter-Use (Optional Format 1-2-96) |
|---|---|---|---|
| (Per 21 CFR 801.109) |