(70 days)
For Bone Marrow Aspiration of the Iliac Crest.
The Powered EZ-IO Bone Marrow Aspiration System consists of a reusable battery powered driver connected to a disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired depth within the bone marrow. The driver then is separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar/stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringe for aspiration. The needle is 15 gauge and 60mm long.
This document is a 510(k) summary for the Powered EZ-IO Bone Marrow Aspiration System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a full study to establish performance against acceptance criteria. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies or specific acceptance criteria performance) is not typically found in these types of submissions.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense with performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing their "technological characteristics." The "performance" is implied through this equivalence, suggesting the device performs comparably to already approved devices.
| Characteristic Compared | Predicate Devices (VidaPort Intraosseous Infusion System, Manan Biopsy Set) | Powered EZ-IO Bone Marrow Aspiration System | Equivalence Status |
|---|---|---|---|
| Indications for Use | Yes | For Bone Marrow Aspiration of the Iliac Crest. | Equivalent |
| Target Population | Yes | Yes | Equivalent |
| Driver Design Features | Yes | Reusable battery powered driver | Equivalent |
| Needle Design | Yes | Disposable intraosseous (IO) needle assembly, 15 gauge, 60mm long | Equivalent |
| Technique | Yes | Upon activation, drill penetrates through cortex to desired depth; driver separated, cannula seated, trocar/stylet removed, Luer lock permits aspiration. | Equivalent |
| Sterility | Yes | Yes | Equivalent |
| Biocompatibility | Yes | Yes | Equivalent |
| Anatomical Sites Where Used | Yes | Iliac Crest | Equivalent |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a performance "test set" in the traditional sense involving human subjects or patient data. The evaluation is based on comparing design characteristics and intended use with predicate devices. Therefore, there is no information provided on sample size or data provenance for a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical or performance "test set" is described, there's no mention of experts establishing ground truth. The substantial equivalence assessment is typically conducted by the manufacturer and reviewed by regulatory bodies (like the FDA).
4. Adjudication Method for the Test Set:
Not applicable, as no test set or clinical study requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, there is no mention of an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical medical instrument, not a software algorithm, so the concept of "standalone performance" in that context does not apply. The performance is assessed based on its functional design and equivalence to existing devices.
7. The Type of Ground Truth Used:
Ground truth, in the context of substantial equivalence for a physical device like this, refers to the established safety and effectiveness of the predicate devices. The "ground truth" is that these predicate devices are already legally marketed and considered safe and effective for their intended use. The new device is then compared to this established "truth." No specific "pathology" or "outcomes data" is referenced for the comparison, but rather the functional and design characteristics.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device (aspiration system), not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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5. 510(k) Summary
CARE
NOV 30 2006
722 Isom Road San Antonio, TX 78216 210-375-8500
SUMMARY
Submitter's name: Address:
Phone: Fax number: VidaCare Corporation 722 Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821
Date the summary was prepared: September 7, 2006
Name of the device: Powered EZ-IO Bone Marrow Aspiration System Trade or proprietary name: Bone Marrow Aspiration System Common or usual name: Aspiration Needle Classification name: Gastroenterology-urology biopsy instrument.
The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
| 510(k)Number | Trade or Proprietary or ModelName | Manufacturer |
|---|---|---|
| 1 K032885 | VidaPort Intraosseous InfusionSystem | VidaCare Corp. |
| 2 K980196 | Manan Biopsy Set for Boneand bone Marrow | Medical DeviceTechnologies, Inc. |
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Description of the device:
The Powered EZ-IO Bone Marrow Aspiration System consists of a reusable battery powered driver connected to a disposable intraosseous (IO) needle assembly. Upon activation, the drill penetrates through the cortex of the bone to a desired depth within the bone marrow. The driver then is separated from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar/stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringe for aspiration. The needle is 15 gauge and 60mm long.
Indications:
For Bone Marrow Aspiration of the Iliac Crest.
Summary of the technological characteristics of our device compared to the predicate device:
The predicates and the Powered EZ-IO Bone Marrow Aspiration System were compared in the following areas and found to have similar technological characteristics and to be equivalent.
Indications for Use Target Population Driver Design Features Needle Design Technique Sterility Biocompatibility Anatomical Sites Where Used
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three overlapping, curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vidacare Corporation % Regulatory Specialists, Inc. Ms. Grace Holland Regulatory Specialist 3722 Avenue Sausalito Irvine, California 92606
NOV 3 U 2006
Re: K062833
Trade/Device Name: Powered EZ-IO Bone Marrow Aspiration System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCF Dated: October 20, 2006 Received: October 26, 2006
Dear Ms. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not mean or any Federal statutes and regulations administered by other Federal agencies. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 -- Ms. Grace Holland
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manusing of substantial equivalence of your device to a legally premarket notification: "The Privation 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), please If you desire specific as no any liance at (240) 276-0115. Also, please note the regulation entitled, Connect the Office or Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Rok Pelloh
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement Indications for Use
510(k) Number (if known): _
Device Name: Powered EZ-IO Bone Marrow Aspiration System
Indications for Use:
For Bone Marrow Aspiration of the Iliac Crest.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pel
(Division Sign-O Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number L062833
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.