(53 days)
No
The device description focuses on mechanical components and manual or battery-powered operation for intraosseous access. There is no mention of AI, ML, or any computational analysis of data.
No.
The device facilitates the administration of fluids and drugs, but it does not directly treat a disease or condition itself.
No
The device is described as providing intraosseous access for the administration of fluids and drugs, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components (handle, shaft, needle set, stylet, catheter, battery-powered driver) and mechanical actions (manual insertion, powered penetration, detachment, removal, attachment), indicating it is a hardware-based medical device. There is no mention of software as a component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide intraosseous access in the distal tibia for administering fluids and drugs. This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device is a tool for inserting a needle into bone. It facilitates the delivery of substances into the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on a biological sample.
Therefore, this device falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic purpose.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Manual PD-IO, 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal tibia
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 or
Model Name | | Manufacturer |
|---|------------------|---|--------------------------------------------|--|----------------|
| 1 | K043490 | 1 | Manual PD-IO | | Vidacare Corp. |
| 2 | K051992 | 2 | Powered PD-IO | | Vidacare Corp. |
| 3 | K913258 | 3 | Disposable Introsseous
Infusion Needles | | Cook, Inc. |
1
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
2
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
3
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.
4
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
5
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jdh All for ABW 12/8/04
shopiclogy, General Hospith .