(24 days)
Not Found
Not Found
No
The summary describes a physical medical device (spinal needle) and its materials, with no mention of software, algorithms, or AI/ML terms.
No.
The device is a spinal needle for aspiration and/or injection of fluids, which is a procedural tool rather than a device for "therapy" or treatment of a disease or condition. While used in medical procedures, it doesn't fit the common definition of a therapeutic device designed to cure, mitigate, treat, or prevent a disease.
Yes
The intended use explicitly mentions "parenteral diagnostic procedure" and lists specific procedures like "lumbar puncture, myelogram and amniocentesis," which are diagnostic in nature.
No
The device description clearly describes a physical medical device (needle, hub, cannula) and does not mention any software component.
Based on the provided information, the Clear Hub Spinal Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "aspiration and or injection of fluids during regional spinal anesthesia and parenteral diagnostic procedure, specifically lumbar puncture, myelogram and amniocentesis." These are procedures performed on the patient's body, not on samples outside the body for diagnostic purposes.
- Device Description: The description details a needle and hub assembly for physical insertion and fluid manipulation within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
Therefore, the Clear Hub Spinal Needle is a medical device used for procedures performed in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Clear Hub Spinal Needle is a device used in various clinical procedures, including but not limited to, lumbar puncture, myelogram, spinal anesthesia, nerve block (pain management) and amniocentesis. The primary intended use of the Clear Hub Spinal Needle is to accommodate the procedural aspiration and /or administration of diagnostic and therapeutic fluids.
The Clear Hub Spinal Needle is a device which is intended for patients requiring aspiration and or injection of fluids during regional spinal anesthesia and parenteral diagnostic procedure, specifically lumbar puncture, myelogram and amniocentesis.
Product codes (comma separated list FDA assigned to the subject device)
73 MIA
Device Description
The Clear Hub Spinal Needle is a blue tinted transparent polycarbonate or acrylic hub, connected to the stainless steel cannula and hub assembly. The cannula/hub assembly provides wings and finger holds for proper control, stability and grip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
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)
All materials used in the fabrication of this Clear Hub Spinal Needle device were evaluated through biological qualification safety tests. The biocompatibility tests performed were cytotoxicity, sensitization, irritation/ intracutaneous reactivity and systemic toxicity (acute) as identified on the tests for each material. These materials have met the testing requirements and were found to be acceptable for the intended use.
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
JUL 23 1998
Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a graphic of a plus sign made up of small squares. The word is in black and the background is white.
rk, Illinois 60085-6787
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS XII. CLEAR HUB SPINAL NEEDLE
Manufacturer:
Allegiance Healthcare Corporation 400 East Foster Road Mannford, OK 74044
Allegiance Healthcare Corporation 1500 Waukegan Road MP-WM
Pharmaseal Clear Hub Spinal Needle
for proper control, stability and grip.
owned by Baxter Healthcare Corporation
polycarbonate or acrylic hub, connected to the stainless steel cannula and hub assembly. The
The Clear Hub Spinal Needle is a blue tinted transparent
cannula/hub assembly provides wings and finger holds
Regulatory Affairs Contact:
Telephone:
(847) 785-3312
McGaw Park, IL 60085
Zarina Bilgrami
June, 1998 Date Summary Prepared:
Spinal Needle Common Name:
Class II per 21CFR § 868.5150, Spinal, Short term Classification: Needle
Predicate Device:
Description:
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CLEAR HUB SPINAL NEEDLE
Intended Use:
The Clear Hub Spinal Needle is a device used in various clinical procedures, including but not limited to, lumbar puncture, myelogram, spinal anesthesia, nerve block (pain management) and amniocentesis. The primary intended use of the Clear Hub Spinal Needle is to accommodate the procedural aspiration and /or administration of diagnostic and therapeutic fluids.
Substantial Equivalence:
The proposed Allegiance Clear Hub Spinal Needle is substantially equivalent to the currently marketed Baxter Pharmaseal Clear Hub Spinal Needle in that:
- intended use is the same
- performance attributes are the same
Summary of testing: All materials used in the fabrication of this Clear Hub Spinal Needle device were evaluated through biological qualification safety tests. The biocompatibility tests performed were cytotoxicity, sensitization, irritation/ intracutaneous reactivity and systemic toxicity (acute) as identified on the tests for each material. These materials have met the testing requirements and were found to be acceptable for the intended use.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 23 1998
Ms. Zarina Bilgrami Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085-6787
Re: K982269 Clear Hub Spinal Needle Regulatory Class: II (two) Product Code: 73 MIA Dated: June 26, 1998 Received: June 29, 1998
Dear Ms. Bilgrami:
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 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. requlatory 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.
3
Page 2 - Ms. Zarina Bilgrami
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, "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,
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
4
Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a graphic of small squares arranged in a grid-like pattern, resembling a stylized star or burst. The font is slightly slanted to the right, giving the word a dynamic appearance.
Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500
FAX: 847.786.2461
Indications for Use
510(k) Number (if known):
Not Known
Device Name:
Clear Hub Spinal Needle
Indications For Use:
The Clear Hub Spinal Needle is a device which is intended for patients requiring aspiration and or injection of fluids during regional spinal anesthesia and parenteral diagnostic procedure, specifically lumbar puncture, myelogram and amniocentesis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use $\underline{ \checkmark }$
(Division Sign-Off) (Division Sign-Olt)
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