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510(k) Data Aggregation
(135 days)
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(256 days)
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(30 days)
The Infinity™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3. These devices are to be used with autograft and/or allograft.
- Traumatic spinal fractures and/or traumatic dislocations.
- Instability or deformity.
- Failed previous fusions (e.g. pseudarthrosis).
- Tumors involving the cervical spine.
- Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System, and PASS OCT Spinal System package inserts for a list of the indications of use.
Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
Note: Segmental fixation is recommended for these constructs.
Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Stealth™ Spine Clamps
When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:
- The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
- The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
- The Stealth™ spine clamps are indicated for skeletally mature patients.
Infinity™ OCT System
The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.
The Infinity™ OCT System is fabricated from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together. Never use titanium alloy and/or cobalt chromium with stainless steel in the same construct. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
To achieve best results, do not use any of the Infinity™ OCT System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another Medtronic document. As with all orthopedic and neurosurgical implants, Infinity™ OCT System components should never be reused under any circumstances.
Medtronic Navigated Referencing Devices
Medtronic navigated referencing devices provide rigid fixation to patient anatomy and enables the assembly of a patient reference frame. Various types of instruments are available including spine referencing clamps and associated connections to maintain compatibility with current spine reference frames.
Medtronic navigated referencing devices are compatible with various Medtronic spinal implant systems including Medtronic computer assisted surgery systems, including, but not not limited to, StealthStation™ and/or Mazor™ systems, and Medtronic navigation reusable instruments. These instruments are also compatible with Medtronic's IPC™ Powerease™ System when connected to the Powerease™ Driver.
Medtronic navigated referencing devices are supplied as non-sterile reusable instruments. All devices should be cleaned and sterilized before use.
Medtronic navigated referencing devices are manufactured from a variety of materials commonly used in orthopedic and neurological procedures, which meet applicable national and/or international standards. These instruments may be shipped in accessories. Accessories include cases, trays, lids, caddies, and modules fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic and neurological reusable instruments.
Medtronic Reusable Instruments and Accessories
Reusable instruments are manufactured from a variety of materials commonly used in orthopedic and neurological procedures, which meet applicable national and/or international standards. These instruments may be shipped in Medtronic Transportation/ Sterilization Cassettes. The Medtronic Transportation/Sterilization Cassettes are designed to be used in conjunction with a legally marketed, validated, and FDA-cleared sterilization wrap to allow steam sterilization of non-sterile devices.
Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.
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(39 days)
The device is indicated for temporary use during the creation of anastomosis for medical conditions requiring beating heart coronary artery bypass procedures.
The disposable intracoronary shunts consist of a flexible tube. Both ends of the tube feature a teardrop shaped tip made from radiopaque material with 14 mm between the ends. Tip diameters range from 1.00 mm to 3.00 mm. A tether with a tag made of radiopaque material is permanently attached to the shunts. These devices are sterile, nonpyrogenic, disposable and intended for single use only. They are sterilized using ethylene oxide and are categorized as external communicating devices, with limited contact (<=24 hours) circulating blood contact.
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(205 days)
The Sprinter Legend RX and OTW 1.25mm Balloon Dilatation Catheter is indicated as a pre dilatation catheter for enlarging coronary luminal diameters during PCI procedures.
The Sprinter Legend RX 1.5-4.0mm balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.25 mm - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is a percutaneous transluminal coronary angioplasty (PTCA) device. The proximal end comprises of a luer hub, strain relief and a hypotube and stiffening wire subassembly (proximal shaft assembly). The distal end comprises of an inflatable balloon, dual lumen tip (guidewire lumen and the inflation lumen) and radiopaque marker bands. The distal shaft includes a hydrophilic coating to aid in device advancement to the target lesion. The guidewire lumen at the distal end enables the use of a 0.014" guidewire to position the device during use. Radiopaque balloon markers enable accurate placement at the target lesion. Exit markers on the proximal shaft indicate the exit of the balloon tip out of the guide catheter for brachial and femoral approaches.
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(224 days)
The Affinity® Pediatric Arterial Blood Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
The Affinity Pixie™ Pediatric Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
The Affinity Pixie™ Arterial Filter with Balance™ Biosurface and Affinity® Pediatric Arterial Blood Filter are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size, from the circuit for periods up to six (6) hours, during cardiopulmonary bypass surgery. The Affinity Pixie™ Arterial Filter with Balance™ Biosurface device is coated with a non-leaching biocompatible surface to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. The Affinity® Pediatric Arterial Blood Filter is uncoated. The models listed above will be referred to as Affinity Pixie™ Arterial Filter throughout the submission.
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(216 days)
Cardiopulmonary Bypass (CPB):
Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.
Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS):
The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral-access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
The Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including cardiopulmonary bypass (CPB), Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in), with and without additional side holes may be used as either drainage or reinfusion catheters.
These devices are sterile, nonpyrogenic, disposable, intended for single use only. Do not store the product above 25°C (77°F).
Extracorporeal membrane oxygenation (ECMO): Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability.
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(97 days)
The MiniMed 780G insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The MiniMed 780G insulin pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The MiniMed 780G insulin pump contains a bolus calculator that calculates an insulin dose based on user-entered data.
The MiniMed 780G insulin pump is indicated for use in individuals 7 years of age and older.
The MiniMed 780G insulin pump is intended for single patient use and requires a prescription.
The MiniMed 780G insulin pump ("780G ACE Pump") is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The pump is intended to be used both alone and in conjunction with compatible, digitally connected medical devices for the purpose of drug delivery.
The 780G insulin pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump that contains pump software and houses electronics, a pumping mechanism, a user interface, and a medication reservoir within the same physical device. The pump also contains a bolus calculator that calculates an insulin dose based on user-entered data. It is comprised of several discrete external and internal components including a pump case made of a polycarbonate blend, an electronic printed circuit board assembly stacks and a drive motor system.
The 780G Pump is an interoperable device that can communicate via a Bluetooth Low Energy (BLE) wireless electronic interface with digitally connected devices. The 780G pump is a host device for the iAGC and integrates iAGC algorithm into the pump firmware. The pump is then able to receive, execute, and confirm commands from an iAGC to adjust delivery of insulin. The pump receives sensor glucose (SG) data via BLE interface from a compatible iCGM or a compatible interoperable Medtronic CGM and transmits these CGM data to the embedded iAGCs.
The 780G pump can operate in one of two modes: Manual Mode or Auto Mode (also referred to as "SmartGuard Mode"). The pump provides the user with keypad pump controls, as well as a data screen for configuring therapy settings and viewing continuous real-time glucose values, glucose trends, alerts, alarms, and other information. The user interface and alerts provide the user with the ability to interact with the pump delivery system and digitally connected devices.
The provided FDA 510(k) clearance letter and summary for the MiniMed 780G Insulin Pump (K253470) do not contain the detailed information required to fill out all requested sections of the acceptance criteria and study design. This document focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements, rather than providing a detailed clinical study report suitable for assessing device performance against specific, quantifiable acceptance criteria in the manner requested.
However, based on the provided text, I can extract and infer some information, and note where specific details are missing.
Here's an attempt to answer your request based on the provided text:
Acceptance Criteria and Device Performance for MiniMed 780G Insulin Pump
The provided FDA 510(k) summary extensively references compliance with regulatory standards and performance compared to predicate devices, particularly for "Delivery Volume Accuracy" and "Bolus Delivery Accuracy" which specify numerical criteria. Other performance aspects are described more qualitatively as meeting requirements or demonstrating safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (as reported or inferred) | Reported Device Performance |
|---|---|---|
| ACE Pump (QFG) - Delivery Volume Accuracy (Basal) | ±5% (Intermediate basal delivery (1 UPH) must meet ±5% of expected) (per 60601-2-24) | Per K251032 (predicate device), implied to meet the same ±5% criteria. |
| ACE Pump (QFG) - Bolus Delivery Accuracy | ±5% (for bolus volumes ≥ 0.1 unit) (per 60601-2-24) | Per K251032 (predicate device), implied to meet the same ±5% criteria. |
| ACE Pump (QFG) - Catheter Occlusion Detection | No pump malfunctions or infusion set occlusions. | "The test results confirmed that there were no pump malfunctions or infusion set occlusions" with Humalog, NovoLog, Admelog, Fiasp, and Lyumjev U-100 insulins. (Data for Humalog, NovoLog, Admelog insulins found in K251032). |
| ACE Pump (QFG) - Drug Stability and Compatibility | Pump does not adversely affect insulins; insulins do not adversely affect the pump. | "The test results demonstrated that the 780G insulin pump does not adversely affect the insulins being delivered, and that the insulin types do not adversely affect the pump." (Data for Humalog, NovoLog, Admelog insulins found in K251032). |
| ACE Pump (QFG) - Data Logging | Logging or recording timestamped critical events as required by ACE pump special controls. | "The 780G insulin pump has been tested and verified for logging or recording timestamped critical events as required by the ACE pump special controls." |
| ACE Pump (QFG) - Cybersecurity | All cybersecurity risks with potential to impact safety were mitigated. | "All cybersecurity risks with potential to impact safety were mitigated." |
| ACE Pump (QFG) - Human Factors Validation | Device is safe and effective for intended users, uses, tasks, and environments. | "Results of the human factors validation testing demonstrated that the device is safe and effective for the intended users, intended uses and expected tasks, and intended use environments." |
| ACE Pump (QFG) - Labeling | Sufficient and satisfies applicable requirements of 21 CFR 801. | "The 780G Insulin Pump's device labeling for users and healthcare practitioners is sufficient and satisfies applicable requirements of 21 CFR 801." |
| ACE Pump (QFG) - Risk Management | All risks reduced as far as possible; overall residual risk acceptable; benefits outweigh risks. | "All risks have been reduced as far as possible. The benefit risk analysis has determined that the benefits of using the device outweighs the residual risk, and the overall residual risk is acceptable." |
| ACE Pump (QFG) - Interoperability | Compliance with FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (September 2017)" and ACE special controls 21 CFR 880.5730(b)(3)-(5). | Documentation provided outlining strategy and approach, and demonstrating compliance. |
| General Performance (All) | All tests passed and met acceptance criteria. | "All tests passed and met the acceptance criteria. The test results demonstrate that the device met the specified requirements." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The document refers to various "testing" and "verification activities" but does not detail the sample sizes for these tests (e.g., number of pumps, number of test cycles, number of patients, etc.).
- Data Provenance: The studies appear to be pre-market, non-clinical bench testing conducted by the manufacturer, Medtronic MiniMed, Inc. There is no indication of clinical study data or geographical origin of patient data (e.g., country of origin) as this particular submission focuses on the device and not a clinical study of its use. Many tests refer back to the predicate device (K251032).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Specified. The document describes non-clinical performance and engineering validation tests (e.g., accuracy, stability, cybersecurity, human factors). These types of tests typically rely on objective measurements against engineering specifications or regulatory requirements, rather than expert-established ground truth in the context of diagnostic interpretation. Human Factors validation involved intended users but the details about "experts" to establish a ground truth in a diagnostic sense are not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / None Specified. This methodology (e.g., 2+1, 3+1 for clinical adjudication) is used for establishing ground truth in diagnostic studies, typically when evaluating algorithmic performance against human interpretation. The provided text describes engineering and regulatory compliance testing where such adjudication methods are not typically employed.
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
- No. The provided text does not describe an MRMC comparative effectiveness study. This device is an insulin pump, not a diagnostic imaging AI system assisting human readers. The human factors validation is a separate type of study focusing on device usability and safety, not diagnostic performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly for many aspects. Many of the tests described are standalone performance evaluations of the device, its firmware, and its capabilities without human intervention beyond setting up the test (e.g., Delivery Volume Accuracy, Catheter Occlusion Detection, Data Logging, Cybersecurity, Software Verification). The bolus calculator's operation within the pump would also be a standalone algorithmic function based on user input. The "Manual Mode" and "Auto Mode" imply different levels of automation, but the core technical tests are often standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The type of "ground truth" varies by the specific test and is generally based on objective engineering and regulatory standards and reference methods.
- Delivery Accuracy: Ground truth is the precisely measured or theoretical ideal insulin volume/rate against which the pump's actual delivery is compared.
- Occlusion Detection: Ground truth would be the presence or absence of an occlusion under controlled test conditions.
- Drug Stability/Compatibility: Ground truth is the chemical stability of insulin and the integrity of pump materials under test conditions.
- Data Logging: Ground truth is the expected logging behavior as per design specifications and regulatory requirements.
- Cybersecurity: Ground truth is the identified vulnerabilities and presence of effective mitigations.
- Human Factors: Ground truth is the identification of safety-critical tasks and demonstration of safe and effective completion by intended users, often against predefined success criteria.
8. The sample size for the training set
- Not Specified / Not Applicable. The document does not describe a machine learning algorithm that undergoes a "training phase" with a specific dataset in the context of the device's development or regulatory submission. While the device contains firmware and potentially algorithms (like the iAGC algorithm embedded in the pump), the text focuses on verification and validation of the device itself against engineering specifications and regulatory controls, not the training of a learning algorithm. The iAGC is described as an embedded algorithm, but its training data or methodology are not part of this 510(k) summary.
9. How the ground truth for the training set was established
- Not Applicable. As no training set is described for a machine learning algorithm, the method for establishing its ground truth is not relevant to this document.
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(70 days)
The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.
The Concerto Versa™ Detachable Coil is an embolization coil indicated for arterial and venous embolization in the peripheral vasculature. It consists of a platinum-tungsten embolization implant coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately. The Concerto Versa™ Detachable Coil is for single use and provided sterile.
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