(88 days)
No
The device description and performance studies focus on the physical characteristics and performance of a spinal needle, with no mention of AI or ML technology.
Yes
The device is used for the injection of local anesthetics to provide regional anesthesia, which is a therapeutic purpose.
No
The device is a spinal needle for injecting local anesthetics, not for diagnosing conditions.
No
The device description clearly outlines physical components (luer hub, stainless steel cannula, stainless steel stylete) and describes performance testing related to these physical attributes (inside diameter, outside diameter, wall thickness, strength, flow rate, flashback, penetration force). There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection of local anesthetics into a patient for regional anesthesia. This is a direct medical intervention on a patient's body.
- Device Description: The description details a physical instrument (needle) used for this injection.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological samples. This spinal needle is used in vivo (inside the body) for a therapeutic purpose (delivering anesthetic).
N/A
Intended Use / Indications for Use
"Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia."
Product codes
MIA
Device Description
"A spinal needle is an instrument used for the injection of local anesthetics into a patient to provide regional anesthesia. The needle consists of a luer hub, a stainless steel cannula, and a stainless steel stylete. The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The spinal needles are provided in three styles; Lancet Point (Quincke), Pencil Point (Whitacre), and European Style (Sprotte) (refer to drawings, attachment IX). The needles range in size as indicated in the following table:
| Needle Style | Gage Size Range | Length Range |
|---|---|---|
| Lancet Point | 18g to 25g | 2.0" to 6.0" |
| Pencil Point | 22g to 25g | 2.0" to 6.0" |
| European Style | 24g to 25g | 2.0" to 6.0" |
The introducer needle is a simple hypodermic needle, either 18g or 20g, to make the initial puncture through the skin to aid in the placement of the spinal needle."
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)
"To summarize, comparison testing between the proposed device and the predicate devices from Becton Dickinson, Pajunk, Sherwood, and AMI, the proposed devices compared well against the predicate devices. For the spinal needles, overall, an increased inside diameter was achieved with a reduced outside diameter and wall thickness, while still achieving increased strength of the cannula.
The greater inside diameter allowed for an increased flow rate for all of the Unisis needles tested. The flashback in the European Style (Sprotte) needles was generally quicker for the proposed device. The results of the Quincke (K-3 Lancet) type needles showed similar results for the 18, 20, and 22-gage cannula. The 25-gage cannula showed an improved rate of flashback. The Whitacre (Pencil Point) type needles also showed similar results between the predicate and proposed devices. When the stylete is retracted, the rate of flashback will be further increased.
Finally, the penetration force for all proposed needles was reduced by as much as 32.8% for the Whitacre (Pencil Point) type needle, except for the 22g and 25g Ouincke (K-3 Lancet) type needle, 1.9% and 13.3% respectively.
There are three proposed introducer needles. These compare favorably to the Sherwood and AMI needles for all criteria.
In summary, the differences in these needles are not significant and substantiate that the needles are safe and effective. This testing, and the marketing of the same spinal needles by Preferred Medical Products, substantiates this claim."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is split into two lines, with the first line showing the word "SIMS" in bold, block letters with a line above and below the word. To the right of "SIMS" is the text "SMITHS INDUSTRIES" in a smaller, bold font, also with a line above and below the text. The second line of the logo shows the text "Medical Systems" in a smaller, non-bold font.
JAN 29 1999
SIMS Portex Inc.
l 0 Bowman Drive PO Box 0724
Keene NH 03431 USA ji. Telephone: 603-352-3812 Fax: 603-352-3703
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 30, 1998
TRADE NAME:
Spinal Anesthesia Needles
COMMON NAME:
Spinal Anesthesia Needles
PRODUCT CLASS/CLASSIFICATION:
Class II, 80 MIA, 21 CFR 862.5150
1
PREDICATE DEVICE(S):
Becton-Dickinson spinal needles, marketed as preamendment devices.
- Pajunk Medizintechnologie, Germany, Sprotte spinal needles, marketed under 510(k) K911221 and K911202.
- Preferred Medical Products ( a division of Ballard Medical Products), spinal needles purchased from Unisis Corp., Tokyo, Japan, marketed under K885277.
Sherwood Medical, introducer needle, marketed as preamendment device.
American Medical Instruments, Inc., New Bedford, MA, introducer needles, marketed as preamendment devices.
DESCRIPTION:
A spinal needle is an instrument used for the injection of local anesthetics into a patient to provide regional anesthesia. The needle consists of a luer hub, a stainless steel cannula, and a stainless steel stylete. The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The spinal needles are provided in three styles; Lancet Point (Quincke), Pencil Point (Whitacre), and European Style (Sprotte) (refer to drawings, attachment IX). The needles range in size as indicated in the following table:
| Needle Style | Gage Size Range | Length Range |
|---|---|---|
| Lancet Point | 18g to 25g | 2.0" to 6.0" |
| Pencil Point | 22g to 25g | 2.0" to 6.0" |
| European Style | 24g to 25g | 2.0" to 6.0" |
The introducer needle is a simple hypodermic needle, either 18g or 20g, to make the initial puncture through the skin to aid in the placement of the spinal needle.
INDICATIONS FOR USE:
Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.
TECHNICAL CHARACTERISTICS:
The device has the same technical characteristics as the predicate device marketed by Preferred Medical Products, Becton-Dickinson, Pajunk, Sherwood, and AMI.
NON-CLINICAL DATA:
To summarize, comparison testing between the proposed device and the predicate devices from Becton Dickinson, Pajunk, Sherwood, and AMI, the proposed devices compared well against the predicate devices. For the spinal needles, overall, an increased inside diameter
2
was achieved with a reduced outside diameter and wall thickness, while still achieving increased strength of the cannula.
The greater inside diameter allowed for an increased flow rate for all of the Unisis needles tested. The flashback in the European Style (Sprotte) needles was generally quicker for the proposed device. The results of the Quincke (K-3 Lancet) type needles showed similar results for the 18, 20, and 22-gage cannula. The 25-gage cannula showed an improved rate of flashback. The Whitacre (Pencil Point) type needles also showed similar results between the predicate and proposed devices. When the stylete is retracted, the rate of flashback will be further increased.
Finally, the penetration force for all proposed needles was reduced by as much as 32.8% for the Whitacre (Pencil Point) type needle, except for the 22g and 25g Ouincke (K-3 Lancet) type needle, 1.9% and 13.3% respectively.
There are three proposed introducer needles. These compare favorably to the Sherwood and AMI needles for all criteria.
In summary, the differences in these needles are not significant and substantiate that the needles are safe and effective. This testing, and the marketing of the same spinal needles by Preferred Medical Products, substantiates this claim.
CONCLUSION:
The testing performed and comparison to the predicate devices demonstrate that the proposed devices are safe and effective and are substantially equivalent to the predicate devices.
Very truly yours.
SIMS PORTEX INC.
Timothy J. Fallon
Timothy J. Talcott Manager, Regulatory Affairs
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three overlapping heads, representing the department's focus on health, human services, and the well-being of the nation. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 29 1999
Mr. Timothy J. Talcott Manager, Regulatory Affairs SIMS Portex, Inc. 10 Bowman Drive P.O. Box 0724 Keene, NH 03431
K983858 Re: Spinal Anesthesia Needles and Introducer Needles Regulatory Class: II (two) Product Code: MIA Dated: October 30, 1998 Received: November 2, 1998
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 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 Requlations, 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 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
4
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.
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) 594-4648. 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, 2 Misbranding by reference to premarket notification² (21CFR 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,
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
Enclosure
5
B: INTENDED USE OF DEVICE
PROPOSED INDICATIONS FOR USE:
Page 1 of 1
510(k) Number (if known): Unknown
Device Name: Spinal Anesthesia Needles
Indications For Use:
Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.
(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
Mark Kramer