(766 days)
Not Found
Not Found
No
The summary describes a physical medical device (spinal needle) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is a spinal needle, which is used for diagnostic or interventional purposes (e.g., administering medication, collecting fluid), but it does not inherently provide a therapeutic effect itself beyond facilitating these procedures.
No
The device description "Double-Holed Pencil Point Spinal Needle (DHPP)" indicates it is a tool for accessing the spinal area, likely for procedures or drug delivery, rather than for diagnosing conditions.
No
The device description explicitly states "Double-Holed Pencil Point Spinal Needle (DHPP)", which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: The device is described as a "Double-Holed Pencil Point Spinal Needle (DHPP)". This is a physical medical device used for procedures involving the spine.
- Intended Use / Indications for Use: While "Not Found" is listed, the nature of a spinal needle strongly suggests it's used for procedures on the body, not for testing samples from the body.
- Lack of IVD Indicators: There is no mention of:
- Testing biological samples (blood, urine, tissue, etc.)
- Analyzing biomarkers or analytes
- Providing diagnostic information based on laboratory tests
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. A spinal needle is a tool used for accessing the spinal space, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
Not Found
Product codes
73 BSP
Device Description
Double-Holed Pencil Point Spinal Needle (DHPP)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 30 1997
Ms.. Rochelle Froloff CSEN Ltd. ... c/o Alexander Medical 9055 Northwest 13th Court Coral Springs, Florida 33071
K951928 Re: Double-Holed Pencil Point Spinal Needle (DHPP) Regulatory Class: II (two) Product Code: 73 BSP Dated: March 1, 1997 Received: March 3, 1997
Dear Ms. Froloff:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 - Ms. Rochelle Froloff
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) 594-4646. 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,
Thomas J. Callahan
Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health