DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)

K951928 · Csen , Ltd. · BSP · May 30, 1997 · Anesthesiology

Device Facts

• Record ID: K951928
• Device Name: DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
• Applicant: Csen , Ltd.
• Product Code: BSP · Anesthesiology
• Decision Date: May 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Double-Holed Pencil Point Spinal Needle (DHPP) used for spinal anesthesia or diagnostic lumbar puncture. Device features pencil-point tip with dual apertures to facilitate cerebrospinal fluid flow or anesthetic delivery. Operated by clinicians in clinical settings. Design intended to reduce post-dural puncture headache compared to traditional cutting needles.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Spinal needle with pencil-point tip and dual apertures. Materials and sterilization methods consistent with standard medical grade stainless steel spinal needles. Manual operation; no energy source or software.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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

Re: K951928
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) regulation (21 CFR Part 820) and that, through periodic GMP 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 - 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health