The Manual PD-IO, and Powered PD-IO provide intraosseous access in the distal tibia of pediatric patients as an alternative to IV access during emergencies.

Device Description

The Manual PD-IO consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The manual driver is designed to allow the user to manually insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set into the bone, the manual driver is detached from the needle set, leaving the stylet and catheter firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied).

The Powered PD-IO consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill supplies power to the needle set in order to penetrate through the cortex of the bone to a desired depth within the bone marrow. After insertion of the needle set, the power driver is detached from the needle set, leaving the stylet and catheter firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied).

AI/ML Overview

The provided text describes a 510(k) submission for the Manual PD-IO and Powered PD-IO intraosseous infusion systems. It seeks to extend the indication for use to include the distal tibia in pediatric patients. The submission argues for substantial equivalence to previously cleared devices (K043490 and K051992 for the same devices in proximal tibia, and K913258 for Cook, Inc.'s Disposable Intraosseous Infusion Needles which include distal tibia access).

Based on the provided text, there is no detailed study proving device performance against specific acceptance criteria in the sense of a clinical trial with quantitative results, sample sizes, expert ground truth, or adjudication methods for this specific extended indication. The submission relies on the concept of substantial equivalence to predicate devices.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The submission is based on the premise that since there are "no changes to the design or components" of the Manual PD-IO and Powered PD-IO systems previously cleared for proximal tibia use, and similar devices (Cook, Inc. needles) already have the indication for distal tibia, their devices are "substantially equivalent." Therefore, the acceptance criteria are implicitly met by demonstrating this substantial equivalence and by the predicate devices having met their own, unstated, acceptance criteria in their original clearances.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document for the new indication. The submission asserts "no changes to the design or components."	The devices are "substantially equivalent" to predicate devices already cleared for the specified uses or similar indications. The argument is that the technology is identical and the new site (distal tibia) is similar to the already cleared site (proximal tibia) or to sites cleared for predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/Not provided. There is no specific "test set" or clinical data presented for this 510(k) submission to evaluate the devices for the extended indication. The submission relies on substantial equivalence to existing devices.
Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable/Not provided. No new ground truth assessment by experts for a test set is mentioned.
Qualifications of Experts: Not applicable/Not provided.

4. Adjudication method for the test set

Adjudication Method: Not applicable/Not provided. There is no "test set" requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No, an MRMC study was not done. This type of study is not relevant for this kind of device and its 510(k) submission, which focuses on mechanical function and equivalence rather than interpretive accuracy by human readers (like in imaging devices).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: No, a standalone performance study was not done. This is fundamentally a medical device submission, not an AI algorithm submission. The device is a tool used by a human operator, making "standalone" performance in an AI context inapplicable.

7. The type of ground truth used

Type of Ground Truth: The concept of "ground truth" as typically applied in AI or diagnostic imaging studies (e.g., pathology, outcomes data) is not directly applicable here. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate devices (Manual PD-IO and Powered PD-IO for proximal tibia, and Cook Inc. needles for distal tibia) through their various clearances and historical use. The argument is that the technology is the same, just applied to a new anatomical site with similar characteristics or to a site already covered by a predicate.

8. The sample size for the training set

Sample Size: Not applicable/Not provided. There is no "training set" in the context of this device and submission.

9. How the ground truth for the training set was established

Ground Truth Establishment: Not applicable/Not provided.

Summary

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5. 510(k) Summary

DEC - 8 2006

vidacare

722 Isom Road. San Antonio, TX 78216 Tel (210) 375 8500 Fax (210) 375 8537 Toll Free (within US) 866 479 8500 www.vidacare.com

SUMMARY

Submitter's name: Address:

Vidacare Corporation 722 Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537

Name of contact person:

Phone:

Fax number:

Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821

Date the summary was prepared: October 10, 2006

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Manual PD-IO and Powered PD-IO Manual PD-IO and Powered PD-IO Intraosseous Infusion System Hypodermic single lumen needle

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

	510(k)Number		Trade or Proprietary orModel Name	Manufacturer
1	K043490	1	Manual PD-IO	Vidacare Corp.
2	K051992	2	Powered PD-IO	Vidacare Corp.
3	K913258	3	Disposable IntrosseousInfusion Needles	Cook, Inc.

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Description of the device:

The following descriptions, for the manual and powered drivers include two different drivers. The same needle set is used for both drivers.

The Manual PD-IQ, previously cleared under 510(k) K043490, consists of a proprietary pentagon shaft permanently attached to an ergonomically designed handle. The manual driver is designed to allow the user to manually insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set into the bone, the manual driver is detached from the needle set, leaving the stylet and catheter firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied). The Manual PD-IO system is approved for use in the proximal tibia under 510(k) K043490. The size needle that can be used in the distal tibia utilizing the Manual PD-IO is identical to the predicate, 15G X 15mm. This submission extends the indication for use of the manual device to include the distal tibia in pediatrics utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K043490.

The Powered PD-IO, previously cleared under 510(k) K051992 for pediatric use, consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill supplies power to the needle set in order to penetrate through the cortex of the bone to a desired depth within the bone marrow. After insertion of the needle set, the power driver is detached from the needle set, leaving the stylet and catheter firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise leaving a standard Luer lock catheter securely seated in the bone. The catheter Luer lock permits attachment of standard syringes and IV tubing for administration of drugs and fluids (not supplied). The Powered PD-IO intraosseous system is cleared for use in the proximal tibia under 510(k) K051992. The size needle that can be used with the Powered PD-IO is identical to the predicate 15G X

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15mm. This submission extends the indication for use of the powered device to include the distal tibia in pediatric patients utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K051992.

Indications:

The Manual PD-IO and Powered PD-IO provide intraosseous access in the distal tibia of pediatric patients as an alternative to IV access during emergencies.

Summary of the technological characteristics of our device compared to the predicate devices:

The Manual PD-IO for Distal Tibia access has the exact same technology as the Manual PD-IO (K043490). The Powered PD-IO for Distal Tibia access has the exact same technology for use as the Powered PD-IO (K051992).

Vidacare also wishes to use as a predicate Disposable Intraosseous Infusion Needles, K913258, by Cook, Inc., as these needles have the exact same indications for use for which we are applying. These needles are used as an alternative to intravenous access during pediatric emergencies. The distal tibia is one of the access sites in their instructions for use.

This submission extends the indication for use to include the distal tibia site in pediatrics of the Manual PD-IO and the Powered PD-IO intraosseous systems. There have been no changes to the design or components of the Manual PD-IO and the Powered PD-IO intraosseous systems cleared under 510(k) K043490 and K051992 and therefore the comparison of technological characteristics listed below are identical.

Target Population Driver Design Features Needle Design Technique Sterility Biocompatibility Where Used

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2006

Vidacare Corporarion C/O Ms. Grace Holland Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606

Re: K063142

Trade/Device Name: Manual PD-IO and Powered PD-IO Regulation Number: 21 CFR 880.5570 Regulation Name: Single Lumen Hypodermic Needle Regulatory Class: II Product Code: FMI Dated: October 10, 2006 Received: October 16, 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.

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Page 2 - Ms. Holland

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 prestice requirements as set 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.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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: Manual PD-IO and Powered PD-IO

The Manual PD-IO, and Powered PD-IO provide intraosseous access in the distal tibia of pediatric patients as an alternative to IV access during emergencies.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).