(63 days)
The PD-IO Disposable Intraosseous Infusion Needle and Handle provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients.
The PD-IO Disposable Intraosseous Infusion Needle and Handle consists of a sterile single use handle with trocar and a sterile disposable single use intraosseous (IO) catheter with standard Luer lock. During use, the PD-IO needle is manually inserted through the cortex of the bone to a desired depth within the bone marrow. The insertion handle with trocar is then separated from the hub of the catheter by turning the handle counter clockwise and then removed leaving the catheter securely seated in the bone. The catheter has a standard Luer lock that permits attachment of standard syringes and IV tubing for administration of drugs and fluids.
The provided document is a 510(k) premarket notification for a medical device (PD-IO Disposable Intraosseous Infusion Needle and Handle). It is a regulatory submission for demonstrating substantial equivalence to a predicate device, not a study designed to prove the device meets specific acceptance criteria through performance metrics. Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.
However, I can provide what is available and explain why other information is not present.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance metrics in the way a clinical study report would. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance thresholds for a novel device.
The "Summary of the technological characteristics" section (page {1}) lists areas where the submitted device was compared to predicate devices for similarity, not for performance against specific acceptance criteria. These areas are:
- Indications for use
- Design features
- Needle design
- Technique
- Sterility
- Biocompatibility
- Anatomical site
- Where used
- Standards met
- Target population
- Mechanical safety
The document states that the submitted device was "found to have similar technological characteristics and to be equivalent to the PD-IO Disposable Intraosseous Infusion Needle" in these areas. This is the "performance" relative to the 510(k) process – demonstrating equivalence, not achieving a specific numerical metric.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document does not describe a clinical study with a test set of data. The "comparison" is based on technological characteristics and design features relative to the predicate devices. There is no mention of data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software device and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is established as there's no diagnostic task or performance measurement against a definitive standard. The "ground truth" for a 510(k) is essentially the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would involve a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or ground truth in that context.
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FEB 1 8 2005
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11:2
K 643490
SUMMARY
| Submitter's name: | VidaCare Corporation |
|---|---|
| Address: | 722-A Isom RoadSan Antonio, TX 78216 |
| Phone: | 210-375-8500 |
| Fax number: | 210-375-8537 |
| Name of contact person: | Greg Holland |
| Regulatory Specialists, Inc3722 Ave. SausalitoIrvine, CA 92606Phone: 949-262-0411 fax: 949-552-2821 | |
| Date the summary was prepared: | December 16, 2004 |
| Name of the device: | PD-IO, Disposable Intraosseous InfusionNeedle and Handle |
| Trade or proprietary name: | PD-IO, Disposable Intraosseous InfusionNeedle and Handle |
| Common or usual name: | Intraosseous Infusion Needle |
| Classification name | Hypodermic single lumen needle |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
VidaCare Corporation, EZ-IO* Intraosseous Infusion System, K032885 Cook, Inc., Disposable Intraosseous Infusion Needles, K913258 WaisMed BIG for Pediatrics, K022415
Description of the device:
The PD-IO Disposable Intraosseous Infusion Needle and Handle consists of a sterile single use handle with trocar and a sterile disposable single use intraosseous (IO) catheter with standard Luer lock. During use, the PD-IO needle is manually inserted through the cortex of the bone to a desired depth within the bone marrow. The insertion handle with trocar is then separated from the hub of the catheter by turning the handle counter clockwise and then removed
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P. 202
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leaving the catheter securely seated in the bone. The catheter has a standard Luer lock that permits attachment of standard syringes and IV tubing for administration of drugs and fluids.
indications for Use:
The PD-IO Disposable Intraosseous Infusion Needle and Handle THE FD Diopeous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients.
Summary of the technological characteristics of the VidaCare PD-10 Disposable Intraosseous Infusion Needle and Handle compared to the predicate devices:
The predicate Cook, Disposable Intraosseous Infusion Needles K913258, VidaCare Corporation EZ-IO K032885 and the WaisMed Ltd BIG Pediatric K022415 were compared in the following areas and found to have similar technological characteristics and to be equivalent to the PD-IO Disposable Intraosseous Infusion Needle.
- Indications for use Design features Needle design Technique Sterility Biocompatibility Anatomical site Where used Standards met Target population Mechanical safety
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2005
VidaCare Corporation C/O Mr. Greg Holland Regulatory Specialist Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K043490
Trade/Device Name: PD-IO Disposable Intraosseous Infusion Needle and Handle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 16, 2004 Received: December 17, 2004
Dear Mr. 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 releveloca above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 the Federal Pova, Drag, Drag, therefore, market the device, subject to the general approvin applivation of the Act. The general controls provisions of the Act include controls provisions or 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 (1 Mr), It may of burgest to fact 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 - Mr. 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 mean that 127 mas and regulations and regulations administered by other Federal agencies. or the For of all , I outh all the Act's requirements, including, but not limited to: registration r our max compry with a 807); labeling (21 CFR Part 801); good manufacturing practice und fisting (21 es read of the quality systems (QS) regulation (21 CFR Part 820); and if requirents as betronic 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), 11 you dontact 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 maj South Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Cure
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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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K043490
Device Name: PD-IQ Disposable Intraosseous Infusion Needle and Handle ______________________________________________________________________________________________________
Indications For Use:
The PD-IO Disposable Intraosseous Infusion Needle and Handle provides The PD-IO Disposable intraosseous this, as an alternative to IV access during
intraosseous access in the proximal tibia, as an alternative to IV access during
intraosseous ac Intraosseous access in the province in pediatric patients.
Prescription Use__X (Per 21 CFR 801.109) OK
Over-The-Counter Use_ (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clater V. West
- Lision Sign-Cif) Consion of Anesthesiology, General Hospital. In Schon Control, Dental Devices
3(k) Number. K4424494
§ 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).