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.

AI/ML Overview

It seems there's a misunderstanding in the request or the provided document. The provided text is a 510(k) summary for the "Powered EZ-IO Pediatric Bone Marrow Aspiration System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria, test sets, ground truth establishment, or multi-reader multi-case studies, as would be expected for a novel AI/software-as-a-medical-device.

The document states: "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." It further emphasizes that the device was compared to predicates and found to have "similar technological characteristics and to be equivalent" in several areas.

Therefore, the information requested in points 1-9 (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided 510(k) summary because this type of detailed performance study is not typically required or included for a 510(k) seeking a new indication for an already cleared device through substantial equivalence.

Based on the provided text, I can extract the following relevant information, but I cannot fulfill the request for a detailed performance study description:

Summary of Device and Regulatory Status:

Device Name: Powered EZ-IO® Pediatric Bone Marrow Aspiration System
Submitter: Vidacare Corporation
510(k) Number: K070759
Date Prepared: March 16, 2007
Classification Name: Gastroenterology-urology biopsy instrument
Regulatory Class: II
Product Code: FCF
Predicate Devices:
- 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.)

Indications for Use:

For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.

Description of the Device:

Consists of a reusable battery-powered driver (previously cleared for aspiration in adults via K062833) and a 25mm intraosseous (IO) device (cleared under K032885) connected to a disposable, single-use intraosseous aspiration needle set assembly.
The driver assists with needle set insertion into the bone.
Driver is separated, trocar/stylet removed, leaving a 15 gauge catheter.
Standard Luer lock permits attachment of a syringe for aspirating bone marrow samples.
The needle set is 25mm in length (previously cleared for IO use in adults via K032885).

Basis for Substantial Equivalence:

The technological characteristics of the Powered EZ-IO® Pediatric Bone Marrow Aspiration System were compared to the predicate devices and found to be similar and equivalent in the following areas:

Indications for Use
Target Population
Driver Design Features
Needle Design
Technique
Sterility
Biocompatibility
Anatomical Sites Where Used

In conclusion, for a 510(k) submission based on substantial equivalence for a new indication for an existing device, a detailed "study that proves the device meets the acceptance criteria" in the way you've described (with test sets, ground truth, experts, etc.) is not typically performed or presented. The primary evidence presented is the comparison to legally marketed predicate devices to demonstrate equivalent technological characteristics and safety/effectiveness.

Summary

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5. 510(k) Summary

K070759

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 MarrowAspiration 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 MarrowAspiration 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:

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

Page 1 of 1

510(k) Number L670754

Regulation Number and Section

§ 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.