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The EZ-10 Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-IO Intraosseous Infusion System including previously cleared K091140 EZ-MIO Distal Tibia, EZ-10 Distal Tibia; EZ-10 (formerly Vidaport) Intraosseous Infusion System ; EZ-IO Humeral Head and K101026 Powered PD IO Infusion System; EZ-IO Humeral Head; Powered PD-IO is designed to allow the user to 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 intraosseous infusion of desired fluids for vascular access. All system materials are medical grade. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (3-39 kg); 25 mm (40 kg or over) and 45 mm (40 kg or over). Black lines on the needle set catheter serve as depth markers. The needle sets connect to the driver/drill/ manual handle shaft with a magnetic disc. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. The EZ-MIO consists of a manual handle device which is primarily used by the armed forces.

Clinicians locate anatomical landmarks and clean the insertion site. Using the cordless driver or manual handle with needle set attached the needle set is pressed through the soft tissue to the outer cortex of the bone. Depth markers on the catheter must be visible prior to powering driver or manually inserting the needle set to ensure placement within the medullary space. If using the powered driver clinicians then squeeze the driver trigger and apply moderate, steady pressure. Trigger is released when a sudden "give" or "pop" is felt, which indicates entry into medullary space; the catheter will not always be inserted to the hub. If using the manual handle, clinicians apply downward pressure and rotation through the bone until a change in pressure is felt as a "give" or "pop" or desired depth is reached. For both methods after insertion of the needle set, the driver unit 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 medications and fluids.

This submission requests a label change only to the 25 mm needle set from "40 kg or over" to" 3 kg or over" utilizing the same technique and devices previously cleared via 510(k)s K091140 and K101026.

The provided text describes the EZ-IO Intraosseous Infusion System and a 510(k) submission for a label change. However, it does not contain information about acceptance criteria, specific studies proving the device meets those criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The submission is for a label change for a physical medical device (intraosseous needle) to expand its approved weight range, not for a software-as-a-medical-device (SaMD) or an AI/ML component. The "study" mentioned refers to cadaveric pediatric studies demonstrating safety for the expanded needle length, rather than performance metrics of an AI model.

Therefore, I cannot fulfill your request for the specific AI/ML related information (such as reported device performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details) because this information is not present in the provided document.

The document states:

• "This submission requests a label change only to the 25 mm needle set from '40 kg or over' to '3 kg or over' utilizing the same technique and devices previously cleared via 510(k)s K091140 and K101026."
• "The labeling change requires no new technology to facilitate the safe application of the product."
• "There have been no changes to the design or components of the Vidacare devices..."

This indicates that no new performance studies (especially not for an AI/ML component) were conducted or are being presented here. The "performance data" mentioned in the summary refers to existing data and clinical observations supporting the expanded weight range of the physical needle.

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Sternal IO Access is indicated for adult patients when rapid fluid or pharmacological resuscitation is required in emergencies.

The T.A.L.O.N.™ (Tactically Advanced Lifesaving IntraOsseous Needle) by Vidacare® has the same indications as the EZ-MIO Sternal, previously cleared by K063567. Both devices are for the purpose of obtaining vascular access during emergencies; both devices utilize a 15g 304 stainless steel manual needle set with a stylet and catheter that is manually inserted through the cortex of bone to the desired set depth within the medullary space to facilitate the infusion of medications and fluids.

This document is a 510(k) summary for the T.A.L.O.N.™ (Tactically Advanced Lifesaving IntraOsseous Needle) by Vidacare®. The purpose of this summary is to demonstrate substantial equivalence to previously marketed predicate devices (EZ-MIO Sternal and PYNG F.A.S.T. 1 Intraosseous Infusion System).

This is NOT a study describing acceptance criteria and device performance in the typical sense. It is a regulatory submission demonstrating substantial equivalence for a medical device. Therefore, many of the requested points are not applicable or cannot be extracted from this document, as a formal "study" with acceptance criteria and a test set (as one would evaluate an AI/software device) was not performed. Instead, the submission focuses on comparing technological characteristics and performance to predicate devices to prove safety and effectiveness.

Here's an attempt to address your points based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not explicitly stated as a numerical sample size in the context of human subjects or distinct "test cases" for performance evaluation. The "bench testing and design validation tests" likely involved multiple units of the device.
   • Data Provenance: Not provided. The studies are described as "post-clinical studies, bench testing and design validation tests."

2. 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. This is a hardware medical device submission; the concept of "ground truth established by experts" for image interpretation or diagnosis (as in AI/software evaluation) is not relevant here. The "ground truth" for this device's performance would be its ability to consistently and safely achieve intraosseous access and allow fluid/medication administration.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. See point 2.

4. 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:

   • No. This device is a manual intraosseous needle, not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study is not relevant.

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

   • Not Applicable. This is a manual medical device; there is no "algorithm" in the sense of a standalone software component. Its function inherently requires human operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device is its ability to perform its mechanical function as intended – achieving safe and effective intraosseous vascular access through the sternum for fluid/medication infusion. This was likely evaluated through bench testing (functional and dimensional testing), design validation measures, and "post-clinical studies" (though details of these post-clinical studies are not provided in this summary). The ultimate "ground truth" or standard it had to meet was substantial equivalence to the predicate devices in terms of safety and effectiveness.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not a machine learning model. The concept of a "training set" is not relevant.

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

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The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.

The OnControl Bone Access and Bone Biopsy System by Vidacare consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve. 1 beveled needle set and 2 sharps protectors. The OnControl Bone Access System Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the OnControl Bone Access System (cleared via K112468, The OnControl Bone Access System by Vidacare®) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K112468, The OnControl Bone Access System by Vidacare®.

Under fluoroscopic imaging quidance, activation of the driver assists the clinician to insert the needle set through the cortex of the bone, into the vertebral body or area of lesion. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn.

The driver is then separated from the needle assembly for specimen removal.

The provided text is a 510(k) summary for the OnControl™ Bone Access and Bone Biopsy System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria.

Therefore, the requested information, specifically:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Cannot be extracted directly from the provided text.

The document describes the device, its intended use, and compares its technological characteristics to predicate devices (K112468, K022169, K962425) to establish substantial equivalence. It highlights similarities in anatomical sites, biocompatibility, dimensional specifications, driver design, energy type, environmental specifications, ergonomics, firmware, and indications for use.

The FDA's letter (pages 3-5) confirms the substantial equivalence determination based on the premarket notification, but it does not detail specific performance studies with acceptance criteria, sample sizes, or ground truth methodologies as would be found in a clinical study report. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through bench testing and comparison of technical characteristics, rather than de novo clinical efficacy trials against specific performance targets.

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The Powered PD-IO provides intraosseous access in the distal tibia of pediatric patients as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours.

The Humeral Head EZ-IO provides vascular access when standard venous access is not possible. Humeral head IO access is indicated in pediatrics in emergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain for up to 24 hours.

The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in pediatric patients (approximate weight range: 3kg-39kg).

This submission seeks to extend the indications for use for the Powered PD-IO Intraosseous Infusion System (K051992); EZ-IO Humeral Head (K052408) and Powered PD-IO (K063142) for emergent, urgent and medically necessary intraosseous vascular access for the delivery of drugs and fluids to pediatric patients. Vidacare manufactures all of these products. The expansion of indications for these products requires no new technology to facilitate the safe application of the product. There have been no changes to the design or components of the devices cleared under 510(k) K051992, K052408, K063142 and therefore the comparison of technological characteristics listed below are identical.

I am sorry, but the provided text is a 510(k) summary and FDA clearance letter for a medical device (Powered PD-IO Intraosseous Infusion System). This type of document describes the device, its intended use, and its substantial equivalence to previously cleared devices.

It does not contain information about acceptance criteria, specific device performance metrics, study designs (sample sizes, data provenance, ground truth establishment, adjudication methods), multi-reader multi-case (MRMC) studies, or standalone algorithm performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is focused on regulatory clearance based on equivalence, not on detailed performance studies of the kind you are asking about.

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EZ-MIO and EZ-IO: The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

Vidaport Intraosseous Infusion System: The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.

EZ-IO Humeral Head: The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia. The VidaPort provides intraosseous access in the proximal tibia. The EZ-IO Humeral Head provides intraosseous access in the Humeral Head. These devices are used when intravenous access is difficult or impossible to obtain.

The provided text is a 510(k) summary for the Vidacare® Needle for EZ-MIO and EZ-IO, Vidaport Intraosseous Infusion System, and EZ-IO Humeral Head. This document does not contain information about acceptance criteria or a study proving device performance in the manner requested. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.

The key points from the document are:

• Device: Intraosseous infusion systems (needles and drivers) for providing access in the distal tibia, proximal tibia, or humeral head.
• Purpose of Submission: Extends the indications for use to include usage for up to 24 hours.
• Method of Equivalence: The submission states, "There have been no changes to the design or components of the devices cleared under 510(k) K062956, K032885 and K052408, and therefore the comparison of technological characteristics listed below are identical." This means the product's performance is assumed to be equivalent to the predicate devices because its design and components are unchanged.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies because the provided text does not contain that information. The document is a regulatory submission focused on substantial equivalence, not a detailed performance study report.

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The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.

The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.

This document describes a 510(k) submission for the "Vertebral Access System by Vidacare®". This submission is for substantial equivalence to existing devices, not for demonstrating new clinical effectiveness. Therefore, the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" as might be seen for a novel device demonstrating performance metrics are not directly applicable in the terms you've presented for medical imaging AI.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to legally marketed devices.

Based on the provided text, here's a breakdown in relation to your questions:

1. A table of acceptance criteria and the reported device performance

For a 510(k) focusing on substantial equivalence, the "acceptance criteria" are not performance metrics like sensitivity/specificity for a diagnostic device. Instead, the acceptance criteria are met by demonstrating that the new device is as safe and effective as predicate devices. The "reported device performance" is essentially that the new device shares similar technological characteristics and indications for use with the predicate devices.

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

There is no "test set" in the context of an AI/diagnostic device study. This 510(k) is for a medical instrument (Vertebral Access System). Device performance is demonstrated through comparison of specifications and design features, not clinical data from a "test set" analyzing patient outcomes in the way a diagnostic AI would.

• Sample size: Not applicable in this context.
• Data provenance: Not applicable.

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

Not applicable. "Ground truth" in the context of AI refers to expert-labeled data. For a hardware medical device submission like this, there isn't a "ground truth" to establish for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication process for clinical outcomes described in this 510(k) summary.

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 device. No MRMC study was performed or required for this type of medical instrument submission.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices based on their prior FDA clearances. The new device demonstrates substantial equivalence to these predicates. This is a technical comparison of specifications and intended use, not an evaluation against a clinical ground truth for diagnostic accuracy or outcomes.

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

In summary: The provided document is a 510(k) premarket notification for a medical instrument, not a diagnostic AI system. Therefore, the questions related to acceptance criteria, test sets, ground truth, experts, and AI performance metrics are not relevant to this specific regulatory submission type. The "study" proving the device meets its "acceptance criteria" is the detailed comparison of its technological characteristics and indications for use against legally marketed predicate devices, which led to the FDA's finding of "substantial equivalence."

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The OnControl™ Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy.

The OnControl™ Bone Marrow Biopsy System consists of a reusable battery powered driver (similar to the one cleared for bone marrow aspiration in adults via K062833) connected to a disposable bone marrow biopsy needle set. The 11 gauge, 152mm cannula is identical in gauge and length to the predicate InterV® TrapLok, cleared via K043523. The BioAccess Bone Marrow Harvest System is an FDAcleared powered biopsy device (K953064), which has a battery power source similar to Vidacare's product. Upon activation, the driver assists the clinician to insert a biopsy needle set through the cortex of the bone. The driver is then separated from the hub of the biopsy needle set by retracting the collar on the driver - coupler. The trocar/stylet is then removed from the needle set leaving な an 11-gauge biopsy cannula firmly seated in the bone. A standard Luer lock (part of the 11 gauge cannula) then permits attachment of a standard syringe for aspiration of bone marrow. The driver/coupler is then reattached to the biopsy cannula and the power driver is activated. The biopsy cannula is advanced to the desired depth in the medullary cavity for capturing adequate bone marrow biopsy samples. The entire needle assembly is then withdrawn from the patient using power to facilitate removal. At this point the driver is separated from the biopsy needle assembly; the specimen is removed from the biopsy cannula by attaching an alignment guide to the cutting end of the biopsy cannula and pushing out the bone specimen with an ejector rod. The cannula length is 152mm (6"), which is identical to the predicate InterV® TrapLok, K043523.

The provided text is a 510(k) summary for the OnControl™ Bone Marrow Biopsy System. It describes the device, its intended use, and its equivalence to predicate devices. However, it does not contain information about acceptance criteria or a specific study that proves the device meets those criteria.

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific clinical study in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot provide the requested information from the given text.

The document states:

• "The predicates and the OnControl™ Bone Marrow Biopsy System were compared in the following areas and found to have similar technological characteristics and to be equivalent."
• "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..."

This indicates that the review focused on demonstrating equivalence in design, indications for use, and technological characteristics to existing devices, not on meeting new, specified performance criteria through a dedicated study.

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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:
  • K062833: Powered EZ-IO® Bone Marrow Aspiration System (Vidacare Corp.)
  • K051506: MIELO-CAN® (Sterylab)
  • K032885: VidaPort Intraosseous Infusion System (Powered Adult IO) (Vidacare Corp.)
  • K51992: Powered Pediatric IO (PD-IO) (Vidacare Corp.)

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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Sternal IO access is indicated for adult patients when rapid fluid or pharmacological resuscitation is required in emergencies

The EZ-MIO Sternal is very similar to the EZ-MIO, manual driver, previously cleared under 510(k) K052195. The two minor differences between the devices are in the driver and addition of a collar to the needle set. The predicate EZ-MIO consists of a proprietary pentagon shaft permanently attached to an ergonomically designed reusable driver. The EZ-MIO Sternal is single use and has a smaller driver permanently attached to the needle set. The second difference is the EZ-MIO Sternal has a permanently attached collar added to the same needle set used by the EZ-MIO. The collar is used to control depth of penetration. Both products utilize the same needle set and are designed to allow the user to manually insert a needle set consisting of a stylet and catheter through the cortex of a bone to a desired depth within the bone marrow to facilitate the infusion of desired fluids. After insertion of the needle set, both systems function identically by allowing the user to remove a stylet 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 needle set size used in the sternum is the identical needle set used by the predicate EZ-MIO (15G X 25mm). The EZ-MIO system is approved for use in the proximal tibia under 510(k) K052195. This submission requests an indication for use of the EZ-MIO Sternal in the sternum location already established by the predicate device Pyng F.A.S.T.1 (K970380).

This Premarket Notification [510(k)] for the Vidacare EZ-MIO Sternal device does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) summary submitted to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not include:

• Acceptance criteria: Specific performance metrics with defined thresholds.
• Study details: Information about a clinical or other performance study designed to demonstrate the device meets acceptance criteria.
• Sample sizes (test, training): There's no mention of a test set or training set.
• Data provenance, ground truth establishment, expert qualifications, adjudication methods: These are all related to performance studies, which are not described here.
• MRMC comparative effectiveness study or standalone algorithm performance: These concepts are relevant to AI/algorithm-driven devices, which the EZ-MIO Sternal (an intraosseous infusion system) is not.

The document states: "The EZ-MIO Sternal has the exact same technology as the EZ-MIO cleared under 510(k) K052195. There have been no major changes to the design or components and therefore the comparison of technological characteristics such as target population, needle design, technique, sterility, biocompatibility and where it is used is identical."

This indicates that the submission relies on the established safety and effectiveness of the predicate devices rather than new performance studies specifically for the EZ-MIO Sternal. The primary purpose of this 510(k) is to extend the indications for use of an existing device concept to a new anatomical location (sternum) based on equivalence to another device already cleared for that location (PYNG Medical Corp. F.A.S.T. 1).

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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.

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).

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.

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.

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