(90 days)
The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kq).
The Powered PD-IO Intraosseous Infusion System (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a single use disposable intraosseous (IO) needle assembly. Upon activation, the drill bit rapidly penetrates the cortex of the bone to a desired depth within the bone marrow. The driver then separates from the hub of the IO needle assembly, leaving the cannula securely seated in the bone. The trocar/stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringes and IV lines for administration of drugs and fluids.
Based on the provided text, here's an analysis of the acceptance criteria and study data for the Powered PD-IO Intraosseous Infusion System:
It's important to note that the provided document is a 510(k) premarket notification summary and an FDA clearance letter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a full clinical study report. Therefore, some of the requested information (like specific numerical acceptance criteria, direct device performance against those criteria, and detailed ground truth methodology for studies) is not explicitly present. The document primarily discusses the comparison of technological characteristics to demonstrate equivalence.
Here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of pre-defined numerical acceptance criteria for a study. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing their technological characteristics. The "performance" assessment is qualitative, affirming similarity across various aspects.
| Acceptance Criteria Category (Inferred from Equivalence Claims) | Reported Device Performance (as stated in the document) |
|---|---|
| Indications for use | Similar to predicate devices |
| Target population | Similar to predicate devices (pediatric patients, birth to 21 years of age, 3 kg - 39 kg) |
| Drill Design | Similar to predicate devices |
| Needle Design | Similar to predicate devices |
| Technique | Similar to predicate devices |
| Performance | Similar to predicate devices (implicitly, it performs the function of providing intraosseous access) |
| Sterility | Similar to predicate devices |
| Biocompatibility | Similar to predicate devices |
| Mechanical Safety | Similar to predicate devices |
| Anatomical site | Similar to predicate devices (proximal tibia) |
| Where used | Similar to predicate devices (emergencies, as alternative to IV access) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the sense of a dataset used to evaluate the device's performance against specific ground truth. It's a submission for regulatory clearance based on substantial equivalence to existing devices. Therefore, details like sample size for a test set, country of origin, or retrospective/prospective nature of a clinical study are not provided. The comparison is primarily against the specifications and known performance of the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since a "test set" with established ground truth for a clinical performance evaluation is not described, this information is not available in the document. The ground truth for the equivalence assessment relies on regulatory standards, engineering principles, and the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable as a traditional "test set" with expert adjudication is not 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. The Powered PD-IO Intraosseous Infusion System is a medical device for physical access (a needle system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-assisted improvement effect size is not relevant or mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as it is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this 510(k) submission is the established safety and effectiveness of the predicate devices (PD-IO Disposable Intraosseous Infusion Needle K043490 and VidaPort Intraosseous Infusion System K032885). The new device is deemed substantially equivalent if its technological characteristics and performance are similar enough to these already-cleared devices, implying it also meets their established performance and safety profiles.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a machine learning model.
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4051992
307 8 0 2005
VIDACARE
722-A Isom Road San Antonio. TX 78216 210-375-8500
SUMMARY
Submitter's name: Address:
Phone: Fax number:
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821
VidaCare Corporation
San Antonio, TX 78216
722-A Isom Road
210-375-8500
210-375-8537
Date the summary was prepared: July 19, 2005
| Name of the device: | Powered PD-IO Intraosseous Infusion System |
|---|---|
| Trade or proprietary name: | Powered PD-IO Intraosseous Infusion System |
| Common or usual name: | Intraosseous Infusion System |
| Classification name: | Hypodermic single lumen needle |
The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
PD-IO Disposable Intraosseous Infusion Needle (K043490), manufactured by VidaCare. manufactured by Thusion System (K032885), manufactured by VidaCare.
Description of the device:
The Powered PD-IO Intraosseous Infusion System (which looks similar to a cordless drill) consists of a reusable battery powered driver connected to a cordloos anil) conclusions (IO) needle assembly. Upon activation, single ass aloposable most the cortex of the bone to a desired depth within the bone marrow. The driver then separates from the hub of the IO needle
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assembly, leaving the cannula securely seated in the bone. The trocar/stylet containing the drill bit is then removed. A standard Luer lock (part of the needle assembly) then permits attachment of standard syringes and IV lines for administration of drugs and fluids.
Indications:
The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kq).
Summary of the technological characteristics of our device compared to the predicate device:
The predicates PD-IO Disposable Intraosseous Infusion Needle (K043490), VidaPort Intraosseous Infusion System (K032885), and the Powered PD-IO Intraosseous Infusion System were compared in the following areas and found to have similar technological characteristics and to be equivalent.
Indications for use Target population Drill Design Needle Design Technique Performance Sterility Biocompatibility Mechanical Safety Anatomical site Where used
REGULATORY SPECIALISTS, INC.
Page 11
REGULATORY SPECIALISTS, INC.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2005
Vidacare Corporation C/O Ms. Grace Holland Regulatory Consultant Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K051992
Trade/Device Name: POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen necdle Regulatory Class: II Product Code: FMI Dated: July 19, 2005 Received: July 22, 2005
Dear Ms. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to commerce prof to they 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices mar nave been require approval of a premarket approval application (PMA). and Cosmetic Act (710c) market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manel after a Act include requirements for annual registration, listing of general controls provincial ground of the ling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a0070).
may be subject to such additional controls. Existing major regulations affective can may be subject to suerit additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Gode seements concerning your device in the Federal Register.
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Page 2 - Ms. Holland
Please be advised that I·DA's issuance of a substantial equivalence determination does not mean r lease be advised that 1 DTT is issumts a sour device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally it cach statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN Fart 607, laboring (21 OFR Part 820); and if applicable, the electronic forth in the quant) by bections (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control pro necess (sveting your device as described in your Section 510(k) This letter will and in your o organ finding of substantial equivalence of your device to a legally prematics noticate 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 If you ucare specific advice for your as (240) 276-0115. Also, please note the regulation entitled, Contact the Office or Society of Court (21CFR Part 807.97). You may obtain Misoranding of reference to promosibilities under the Act from the Division of Small other general involmation of your responser 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,
Sligte Y. Michiels Oms
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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510(k) Addendum K051992, Powered PD-IO
Indications For Use Statement
510(k) Number (if known):___K051992
Device Name: Powered PD-IO Intraosseous Infusion System
Indications For Use:
The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kq).
× AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony V. m
Avision Sig Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number:
§ 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).