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510(k) Data Aggregation
(62 days)
For Bone Marrow Aspiration of the Iliac Crest in pediatric patients.
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.
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:
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.
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(67 days)
The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults as an alternative to IV access during emergencies.
The EZ-MIO manual driver, previously cleared under 510(k) K052195, 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, the manual driver is detached from the needle set, leaving the stylet and cannula 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 size needle that can be used in the distal tibia utilizing the MIO manual driver is identical to the predicate 15q X 25mm. The EZ-MIO system is approved for use in the proximal tibia under 510(k) K052195. This submission extends the indication for use of the manual device to include the distal tibia in adults utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K052195.
The EZ-IO powered driver, previously cleared under 510(k) K032885 for adult use, consists of a reusable battery powered driver connected to a single use disposable intraosseous (IQ) 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 cannula 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 size needle that can be used with the EZ-IO powered driver is identical to the predicate 15g X 25mm. The EZ-IO powered intraosseous system is cleared for use in the proximal tibia under 510(k) K032885. This submission extends the indication for use of the powered device to include the distal tibia in adults utilizing the same technique and device previously cleared for the proximal tibia via 510(k) K032885.
This document is a 510(k) summary for the EZ-MIO and EZ-IO Intraosseous Infusion Systems, seeking to extend their indications for use to include the distal tibia in adults. The submission primarily relies on equivalence to previously cleared devices (K052195 and K032885) and does not describe a new study with specific acceptance criteria or performance metrics directly comparable to a table.
Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, expert qualifications, and ground truth establishment for a new study validating the extended indication are not present in this summary. The submission argues that since there are "no changes to the design or components," the devices are substantially equivalent to their predicates for the new anatomical site based on existing technology.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner or present a new study with specific performance metrics for the distal tibia insertion that would traditionally be reported in such a table. The argument for expanded indication is based on the devices being identical to their cleared predicates and the technique being similar.
Inferred Acceptance Criteria:
- Substantial Equivalence: The primary "acceptance criterion" for this 510(k) is demonstrating substantial equivalence to the predicate devices (EZ-MIO, K052195; EZ-IO, K032885) for the new indication (distal tibia in adults). This implies that the device performs similarly in terms of safety and effectiveness as demonstrated by the predicate devices for their cleared indications.
- No Design Changes: The device must have no changes to its design or components compared to the cleared predicate devices.
- Same Technique: The insertion technique for the distal tibia must be the same as the technique cleared for the proximal tibia.
Reported Device Performance (Inferred from Substantial Equivalence):
Since no new performance data for the distal tibia is presented, the "reported device performance" is essentially that the EZ-MIO and EZ-IO systems, when used in the distal tibia with the specified 15g x 25mm needle, are expected to perform comparably to their performance in the proximal tibia, which was deemed safe and effective in their original 510(k) clearances. This includes:
- Successfully facilitating the infusion of desired fluids.
- Firmly seating the stylet and cannula in the bone.
- Allowing separation and removal of the stylet, leaving a standard Luer lock catheter.
2. Sample size used for the test set and the data provenance
The document does not describe a new "test set" or a new clinical study to evaluate performance in the distal tibia. The submission is based on the technological characteristics being identical to the predicate devices. Therefore, details like sample size, country of origin, or retrospective/prospective nature are not applicable to this specific submission for an expanded indication. The "data provenance" would refer to the original studies conducted for the predicate devices, which are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new test set or ground truth establishment for an expanded indication study is described in this summary.
4. Adjudication method for the test set
Not applicable, as no new 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 a medical device for intraosseous infusion, not an AI-assisted diagnostic or imaging 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, as this is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this particular 510(k) expanding the indication, the "ground truth" is implied to be the established safety and effectiveness of the predicate devices for their original indications, and the argument that the same principles apply due to identical device characteristics and technique. No new empirical "ground truth" for the distal tibia is presented.
8. The sample size for the training set
Not applicable, as no new training set or new study is described.
9. How the ground truth for the training set was established
Not applicable, as no new training set or new study is described. The relevant "ground truth" in this submission pertains to the established performance of the predicate devices.
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