(62 days)
No
The device description focuses on mechanical components and a powered drill for insertion, with no mention of AI or ML capabilities for analysis, guidance, or other functions. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device's intended use is for bone marrow aspiration, which is a diagnostic procedure for obtaining samples, not for directly treating a disease or condition.
Yes
The device is intended for the aspiration of bone marrow samples, which are then typically used for diagnostic purposes.
No
The device description explicitly details hardware components including a reusable battery-powered driver, an intraosseous device, and a disposable needle set assembly.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For Bone Marrow Aspiration of the Iliac Crest in pediatric patients." This describes a procedure to collect a sample from the body.
- Device Description: The device is a system for inserting a needle into bone to facilitate aspiration. It's a tool for sample collection, not for analyzing the sample itself.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis or testing on the bone marrow sample. It simply helps to obtain the sample.
The device is a tool for a medical procedure (bone marrow aspiration), which is a step that precedes any potential in vitro diagnostic testing that might be performed on the collected bone marrow sample.
N/A
Intended Use / Indications for Use
For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.
Product codes
FCF
Device Description
The Powered EZ-IO® Pediatric Bone Marrow Aspiration System consists of a reusable battery powered driver [previously cleared for aspiration in adults via 510(k) K062833], and a 25mm intraosseous (IO) device fcleared under 510(k) K032885] connected to a disposable, single use intraosseous aspiration needle set assembly. Upon activation, the drill assists the operator with needle set insertion into the bone. The driver is then separated from the hub of the needle set assembly, leaving the needle set securely seated in the bone. The trocar/stylet is then removed from the needle set leaving the 15 gauge catheter. A standard Luer lock (part of the catheter hub) then permits attachment of standard syringe for aspirating bone marrow samples. The needle set is 25mm in length [previously cleared for IO use in adults via 510(k] number K032885). This submission does not include new devices; it only requests new indications for use of the 510(k) device listed above as an aspiration product for pediatric applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Iliac Crest
Indicated Patient Age Range
pediatric patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062833, K051506, K032885, K51992
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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5. 510(k) Summary
vidcare®
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
MAY 2 1 2007
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821 Email: grace@regulatoryspecialists.com
March 16, 2007 Date the summary was prepared:
| Name of the device: | Powered EZ-IO® Pediatric 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 Model Name | Manufacturer |
|---|---|---|
| K062833 | Powered EZ-IO® Bone Marrow | |
| Aspiration System | Vidacare Corp. | |
| K051506 | MIELO-CAN® | Sterylab |
| K032885 | VidaPort Intraosseous Infusion System | |
| (Powered Adult IO) | Vidacare Corp. | |
| K51992 | Powered Pediatric IO (PD-IO) | Vidacare Corp. |
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Description of the device:
The Powered EZ-IO® Pediatric Bone Marrow Aspiration System consists of a reusable battery powered driver [previously cleared for aspiration in adults via 510(k) K062833], and a 25mm intraosseous (IO) device fcleared under 510(k) K032885] connected to a disposable, single use intraosseous aspiration needle set assembly. Upon activation, the drill assists the operator with needle set insertion into the bone. The driver is then separated from the hub of the needle set assembly, leaving the needle set securely seated in the bone. The trocar/stylet is then removed from the needle set leaving the 15 gauge catheter. A standard Luer lock (part of the catheter hub) then permits attachment of standard syringe for aspirating bone marrow samples. The needle set is 25mm in length [previously cleared for IO use in adults via 510(k] number K032885). This submission does not include new devices; it only requests new indications for use of the 510(k) device listed above as an aspiration product for pediatric applications.
Indications:
For Bone Marrow Aspiration of the Iliac Crest in pediatric patients,
Summary of the technological characteristics of our device compared to the predicate device:
The predicates and the Powered EZ-IO® Pediatric 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vidacare Corporation % Regulatory Specialist, Inc. Ms. Grace Holland Regulatory Specialist 3722 Avenue Sausalito Irvine, California 92606
MAY 2 1 2007
Re: K070759
Trade/Device Name: Powered EZ-IO® Pediatric Bone Marrow Aspiration System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCF Dated: May 10, 2007 Received: May 14, 2007
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. Iisting 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You 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 product radiation control provisions (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) 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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 yours,
For
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® Pediatric Bone Marrow Aspiration System
Indications for Use:
For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.
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)
(Divis ion Sign-Off Division of General, Restorative, and Neurological Devices
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510(k) Number L670754