(24 days)
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.
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.
This document describes the 510(k) submission for the Allegiance Clear Hub Spinal Needle (K982269). The submission focuses on demonstrating substantial equivalence to a predicate device, the Baxter Pharmaseal Clear Hub Spinal Needle, rather than establishing de novo acceptance criteria through clinical trials and performance studies with novel metrics.
Here's a breakdown based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for device performance as a diagnostic or analytical tool. Instead, the acceptance criteria are framed in terms of biocompatibility and functional equivalence to the predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use | Identical to predicate device | "intended use is the same" |
| Performance Attributes | Identical to predicate device | "performance attributes are the same" |
| Biocompatibility | Meet biological qualification safety tests for all materials. | "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." |
| Material Composition | Polycarbonate or acrylic hub, stainless steel cannula. | "polycarbonate or acrylic hub, connected to the stainless steel cannula and hub assembly." (Matches description of predicate/general spinal needles). |
| Design Features | Provides wings and finger holds for proper control, stability, and grip. | "The cannula/hub assembly provides wings and finger holds for proper control, stability and grip." (Implied to be equivalent to predicate). |
| Clinical Procedures | Suitable for lumbar puncture, myelogram, spinal anesthesia, nerve block (pain management), and amniocentesis. | Device is for use in "various clinical procedures, including but not limited to, lumbar puncture, myelogram, spinal anesthesia, nerve block (pain management) and amniocentesis." (Matches predicate's utility). |
| Fluid Management | Accommodate aspiration and/or administration of diagnostic and therapeutic fluids. | "The primary intended use... is to accommodate the procedural aspiration and /or administration of diagnostic and therapeutic fluids." (Matches predicate's utility). |
Note: This is a Class II medical device (Spinal Needle, product code 73 MIA). For such devices seeking 510(k) clearance, the primary "study" is often a demonstration of substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy trials. The "performance" is largely around material safety and functional similarity.
2. Sample Size for the Test Set and Data Provenance
The document does not describe a "test set" in the context of diagnostic performance (e.g., images for an AI algorithm). The "testing" referred to is related to the biocompatibility of the materials.
- Sample Size: Not explicitly stated as a number of devices or units tested. Biocompatibility testing is typically performed on material samples rather than a large batch of finished products for each test.
- Data Provenance: The biocompatibility tests were "performed" on the materials. The document does not specify where these tests were conducted (e.g., an independent lab, manufacturer's own lab) or the country of origin of the data beyond the manufacturer being US-based. These tests are inherently prospective in nature, as they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to this 510(k) submission.
- There is no "test set" requiring ground truth established by experts in the context of diagnostic interpretation (e.g., radiologists interpreting images).
- The "ground truth" for biocompatibility is based on established scientific protocols and standards for biological safety testing (e.g., ISO 10993 series), which are interpreted by qualified toxicologists or material scientists. Their specific number or qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable. As there's no diagnostic test set requiring human interpretation, no adjudication method (like 2+1 or 3+1 consensus) was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a physical medical instrument (spinal needle), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established through:
- Predicate device comparison: The primary "ground truth" for substantial equivalence is the legally marketed Baxter Pharmaseal Clear Hub Spinal Needle. The performance attributes and intended use of the new device are compared directly to those of the predicate.
- Biocompatibility standards: The "ground truth" for material safety is based on established scientific protocols and regulatory standards for biocompatibility testing (e.g., tests for cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity). Satisfactory results against these standards indicate biological safety.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
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JUL 23 1998
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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:
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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.
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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.
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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
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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.
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§ 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).