← Product Code [MIA](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA) · K982269 # CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA (K982269) _Allegiance Healthcare Corp. · MIA · Jul 23, 1998 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K982269 ## Device Facts - **Applicant:** Allegiance Healthcare Corp. - **Product Code:** [MIA](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA.md) - **Decision Date:** Jul 23, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5150 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## 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. ## Device Story Clear Hub Spinal Needle consists of stainless steel cannula attached to blue-tinted transparent polycarbonate or acrylic hub; hub features wings and finger holds for grip and stability. Device used by clinicians in clinical settings for lumbar puncture, myelogram, spinal anesthesia, nerve block, and amniocentesis. Facilitates aspiration or administration of diagnostic and therapeutic fluids. Provides visual confirmation of fluid flow through transparent hub. ## Clinical Evidence Bench testing only. Biocompatibility testing performed including cytotoxicity, sensitization, irritation/intracutaneous reactivity, and systemic toxicity (acute). Materials met all testing requirements. ## Technological Characteristics Stainless steel cannula; polycarbonate or acrylic hub. Blue-tinted transparent hub design. Manual operation. Non-powered. Sterile. ## Regulatory Identification An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia. ## Predicate Devices - Baxter Pharmaseal Clear Hub Spinal Needle ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## JUL 23 1998 - -- K982269 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) Division of Cardiovascular, Respiratory, Division of Cardiovascular, Respiratory, Division of esile of envices ה לא האירופי המועד המועד המועד המונה למשמעות המועד המונה למשמעות המושב למשמעות המושב למשמעות המושב למשמעות המושב למשמעות המושב למשמעות המושב למשמעות המושב למשמעות המושב למשמ err.on 510(k) Number_ --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K982269](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/MIA/K982269) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com