(344 days)
Not Found
Not Found
No
The summary describes a vapocoolant and its dispenser, with no mention of AI, ML, or any related technologies.
Yes
The device is intended for the management of pain, restricted motion, and muscle spasm, and for the temporary relief of pain associated with injections, minor surgical procedures, and minor sports injuries, which are all therapeutic indications.
No
Explanation: The device is described as a vapocoolant used for pain management, not for diagnosing medical conditions.
No
The device description clearly states it is a "Dispenser Containing a Vapocoolant," indicating a physical product with a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a topical application for pain management and temporary relief of minor injuries. This is a therapeutic or symptomatic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a dispenser containing a vapocoolant, which is a substance applied externally.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a disease or condition
- Using reagents or assays
IVDs are used to diagnose diseases or conditions by examining samples from the body. This device's function is to provide temporary relief through cooling, which is a physical effect applied externally.
N/A
Intended Use / Indications for Use
A vapocoolant intended for topical application in management of myofacial pain, restricted motion, and muscle spasm, and for the control of pain associated with injections, minor surgical procedures and the temporary relief of minor sports injuries.
Product codes
MLY
Device Description
Dispenser Containing a Vapocoolant
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.
Not Found
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
N/A
0
| DEC | 2 |
|---|---|
| 1999 |
K19845564
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)
3234 Ella Lane
New Port Richey, FL 34655 | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| | Phone:
Fax: | 727-376-4154
727-376-7186 |
| Contact Person: | Ed Ransom or Pat Lamb | |
| Date of Summary: | December 2,,1999 | |
| Trade Name: | Ethyl Chloride and Dispenser | |
| Classification Name: | Unknown | |
| Predicate Device: | Gebauer Fluori-Methane | |
| Device Description/
Comparison: | Dispenser Containing a Vapocoolant | |
| Intended Use: | A vapocoolant intended for topical application in
management of myofacial pain, restricted motion, and
muscle spasm, and for the control of pain associated
with injections, minor surgical procedures and the
temporary relief of minor sports injuries. | |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1999
Mr. Ed Ransom Consultant Regulatory and Marketing Services, Inc. Representing Dukal Corporation P.O. Box 1108 Elfers, Florida 34680
Re : K984564 Ethyl Chloride Dispenser Trade Name: Unclassified Regulatory Class: Product Code: MLY September 2, 1999 Dated: September 3, 1999 Received:
Dear Mr. Ransom:
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 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. ਜੋ 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 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 regulations.
2
Page 2 - Mr. Ed Ransom
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) 594-4659. 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 yours,
Mark N. Milkerse
Dillard III James E. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Ethyl Chloride Spray
Indications For Use:
A vapocoolant intended for topical application in management of myofacial pain, restricted motion, and muscle spasm, and for the control of pain associated with injections, minor surgical procedures and the temporary relief of minor sports injuries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milberson
fr
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K984564
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)