(185 days)
Not Found
No
The device description and intended use focus on the mechanical components and function of needles for anesthesia delivery, with no mention of AI or ML.
Yes.
The device is used for the administration of anesthetics and other drugs to provide regional anesthesia and pain relief, which are therapeutic interventions.
No
The device is intended for the injection of local anesthetics, not for diagnosing a condition or disease.
No
The device description clearly details physical needles and associated components, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a system of needles used to administer local anesthetics directly into the spinal and epidural spaces of a patient. This is a direct intervention on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states the device is for "injections of local anesthetics into the spinal and epidural spaces of a patient." This is a therapeutic or anesthetic procedure, not a diagnostic test.
Therefore, this device falls under the category of a medical device used for a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Combined Spinal/Epidural Anesthesia System is indicated for the injections of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The adminsistration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.
The combined spinal epidural needle kit is intended for injection of local anesthetics into the intrathecal space via a spinal needle introduced through the epidural needle, and injection of local anesthetics into the epidural space via the epidural needle, or via an epidural catheter passed through the epidural needle.
Product codes (comma separated list FDA assigned to the subject device)
73 BSP
Device Description
Combined Spinal/Epidural Anesthesia Needles are instruments used for a spinal (subarachnoid) injection of anesthetics, followed by the placement of an epidural catheter to allow modification of the spinal analgesia if necessary, or bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space for subsequent pain relief if required. The spinal needle consists of a luer hub, a stainless steel cannula with a pencil point tip, a stainless steel stylete, and a locking colar. The tuohy epidural needle consists of a luer hub, a stainless steel cannula with a Weiss tip, and a matching flange to accept the spinal needles locking colar. The needles are a matched set. The needles are provided as sterile, single use, disposable devices. They may be packaged as a set or included as a set in our regional anesthesia trays. The sizes are tabulated below:
| Spinal Needle | ||
|---|---|---|
| 26g 5 3/16" (132 mm) | 27g 5 3/16" (132 mm) | |
| Epidural Needle | ||
| 17g 3.5" (90 mm) | X | X |
| 18g 3.5" (90 mm) | X |
The Tuohy needle and the spinal needle have interlocking collars that enable the spinal needle to be locked into position once the dura has been pierced so that it is secured to the Tuohy needle to prevent acceidental displacement. The numbers on the Tuohy needle hub indicate the distance in millimeters that the spinal needle protrudes from the epidural Tuohy needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal and epidural spaces
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)
Comparison testing between the proposed device and the predicate device from Becton Dickinson compared well. There were no differences seen in performance accept for an increased flow rate of 28.6% in the 27g spinal needle. The differences in these needles are not significant and substantiate that the needles are safe and effective. The testing substantiates this claim.
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.
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/0 description: The image shows the logo for Smiths Industries Medical Systems. The logo consists of the word "SIMS" in a stylized font, with a circle above the "I". To the right of "SIMS" is the text "SMITHS INDUSTRIES" in a bold, sans-serif font. Below that is the text "Medical Systems" in a serif font.
SIMS Portex Inc.
10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703
APR 2 8 2000
H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY:
COMPANY INFORMATION:
SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Timothy J. Talcott Manager, Regulatory Affairs
PREPARATION DATE OF SUMMARY:
October 22, 1999
TRADE NAME:
CSEcure™ Combined Spinal/Epidural Anesthesia System with Lock
COMMON NAME:
Combined Spinal/Epidural Anesthesia Needle
PRODUCT CLASS/CLASSIFICATION:
Class II, 80 MIA, 21 CFR 862.5150
PREDICATE DEVICE(S):
Becton-Dickinson Durasafe™ Combined Spinal/Epidural Anesthesia Needle Set, K932249.
1
DESCRIPTION:
Combined Spinal/Epidural Anesthesia Needles are instruments used for a spinal (subarachnoid) injection of anesthetics, followed by the placement of an epidural catheter to allow modification of the spinal analgesia if necessary, or bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space for subsequent pain relief if required. The spinal needle consists of a luer hub, a stainless steel cannula with a pencil point tip, a stainless steel stylete, and a locking colar. The tuohy epidural needle consists of a luer hub, a stainless steel cannula with a Weiss tip, and a matching flange to accept the spinal needles locking colar. The needles are a matched set. The needles are provided as sterile, single use, disposable devices. They may be packaged as a set or included as a set in our regional anesthesia trays. The sizes are tabulated below:
| Spinal Needle | ||
|---|---|---|
| 26g 5 3/16" | ||
| (132 mm) | 27g 5 3/16" | |
| (132 mm) | ||
| Epidural Needle | ||
| 17g 3.5" (90 mm) | X | X |
| 18g 3.5" (90 mm) | X |
The Tuohy needle and the spinal needle have interlocking collars that enable the spinal needle to be locked into position once the dura has been pierced so that it is secured to the Tuohy needle to prevent acceidental displacement. The numbers on the Tuohy needle hub indicate the distance in millimeters that the spinal needle protrudes from the epidural Tuohy needle.
INDICATIONS FOR USE:
The Combined Spinal/Epidural Anesthesia System is indicated for the injections of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The adminsistration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.
TECHNICAL CHARACTERISTICS:
The device has the same technical characteristics as the predicate device marketed by Becton-Dickinson.
NON-CLINICAL DATA:
To summarize, comparison testing between the proposed device and the predicate device from Becton Dickinson compared well. There were no differences seen in performance accept for an increased flow rate of 28.6% in the 27g spinal needle. The differences in these needles are not significant and substantiate that the needles are safe and effective. The testing substantiates this claim.
2
CONCLUSION:
The testing performed and comparison to the predicate device demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device.
Very truly yours,
SIMS PORTEX INC.
Timothy J. Salient
Timothy J. Talcott Manager, Regulatory Affairs
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'APR 2 8 2000
Mr. Timothy J. Talcott SIMS Portex, Inc. 10 Bowman Drive Keene, NH 03431
K993619 Re : CSEcure™ Combined Spinal/Epidural Anesthesia System with Lock Regulatory Class: II (two) Product Code: 73 BSP Dated: February 17, 2000 February 22, 2000 Received:
Dear Mr. Talcott:
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 legally marketed predicate 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 reqistration, 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 requlations 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 requirements, 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 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 requlations.
4
Page 2 - Mr. Timothy J. Talcott
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
to the whish for
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K993619 510(k) Number (if known): Unknown
Device Name: CSEcure™ Combined Spinal/Epidural Anesthesia System with Lock
Indications For Use:
The combined spinal epidural needle kit is intended for injection of local anesthetics into the intrathecal space via a spinal needle introduced through the epidural needle, and injection of local anesthetics into the epidural space via the epidural needle, or via an epidural catheter passed through the epidural needle.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K993619