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Hair Regrowth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The Hair Regrowth Cap (HRC) is a wearable device designed to treat androgenetic alopecia in both men and women. The cap utilizes LED light phototherapy to stimulate hair regrowth through a daily treatment session of approximately 10 minutes.

The system consists of a soft, comfortable textile cap embedded with LEDs, powered by a rechargeable battery. It includes driver electronics and is easily operated via a built-in switch button located on the cap. Hair Regrowth Cap device cannot operate while charging. The device has no communication function.

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The Healgen® URS Test Strips are for the qualitative detection of leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a urinary tract infection (UTI). It is intended for over-the-counter home use only.

The Healgen® URS Test Strips are in vitro diagnostic test devices for the qualitative detection of leukocytes and nitrites in urine. The device is composed of two color pads aligned on a strip. One pad is employed for testing leukocytes and the other for nitrites by visually reading the color change of the applicable pad and comparing with the corresponding blocks on a color chart.

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The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH, Norfentanyl and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The single or multi-test panels can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

The Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs in human urine at the cutoff concentrations of table below.

This is not a screening device to monitor prescription medication.

This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.

This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.

Healgen Accurate Home Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a dip card format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

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HEDRON C™ Spacers and HEDRON IC™ Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

HEDRON C™ Spacers and HEDRON IC™ Spacers are intended to be used with supplemental fixation, such as an anterior cervical plate or posterior cervical fixation.

When the HEDRON IC™ Spacer is used with the COALITION AGX™ Plate, the plate-spacer assembly (HEDRON IC™ Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implant. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws.

HEDRON C-MIS™ Spacer is an integrated interbody fusion device indicated for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are intended to be used with or without two screws and/or anchors which accompany the implants. When used with two screws, these devices are intended for stand-alone use at one or two levels. When used with one or more anchors, these devices are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation, such as an anterior cervical plate or posterior cervical screw fixation. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws or anchors.

HEDRON™ Cervical Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by the FDA for use in intervertebral body fusion to facilitate fusion.

HEDRON™ Cervical Spacers (HEDRON C™, HEDRON IC™, and HEDRON C-MIS™) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRON IC™ Spacer may be assembled to the COALITION AGX™ Plate to create the HEDRON IC™ Plate-Spacer, a stand-alone cervical interbody fusion device. HEDRON C-MIS™ Spacer is a cervical interbody fusion device that may be used with screws and/or anchors. HEDRON C-MIS™ is a stand-alone device when used with screws only. HEDRON™ Cervical Spacers are additively manufactured from titanium alloy powder. The mating screws and anchors are manufactured from titanium alloy.

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The Stryker Hoffmann LRF System is indicated in pediatric (2 through 21 years of age) and adult patients for the treatment and fixation of:

• Open and Closed Fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures of the distal radius
• Bone transport

The Hoffmann LRF System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Lisfranc dislocations

The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient. The system components are manufactured from aluminum, carbon fiber, stainless steel, and various polymers. The system also encompasses a web application and mobile application.

Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System. Use of these components does not confer MRI compatibility to the Hoffmann LRF System.

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HemoSphere Alta™ Advanced Monitoring Platform with Swan-Ganz™ Technology

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere Alta Swan-Ganz™ Patient Cable and Swan-Ganz™ Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Swan-Ganz™ Catheter and Swan-Ganz Jr™ Catheter indications for use statement for information on target patient population specific to the catheter being used.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz™ Catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

When used in combination with a Swan-Ganz™ Catheter connected to a pressure cable and pressure transducer, the Smart Wedge™ Algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressure measurement. The Smart Wedge™ Algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge™ Algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge™ Algorithm parameters.

HemoSphere Alta™ Advanced Monitoring Platform with HemoSphere™ Oximetry Cable

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere™ Oximetry Cable and oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.

HemoSphere Alta™ Advanced Monitoring Platform with HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor - Pressure Cable

The HemoSphere Alta™ Advanced Monitor when used with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the FloTrac™ Sensor, FloTrac Jr™ Sensor, Acumen IQ™ Sensor, and TruWave™ Disposable Pressure Transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used.

The Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI™ Feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI™ Feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index™ Parameter.

When used in combination with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable connected to a compatible Swan-Ganz™ Catheter, the Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Right Ventricular Pressure (RVP) parameters.

When used in combination with the HemoSphere™ Pressure Cable or HemoSphere Alta™ Monitor – Pressure Cable connected to a compatible Swan-Ganz™ Catheter, the Right Ventricular Cardiac Output (RVCO) feature provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVCO algorithm is intended for use in surgical or non-surgical patients over 18 years of age that require advanced hemodynamic monitoring. The Right Ventricular Cardiac Output provides a continuous cardiac output and derived parameters.

The Cerebral Autoregulation Index (CAI) algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere™ Pressure Cable and StO2 is acquired by the ForeSight™ Oximeter Cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Autoregulation Index (CAI) algorithm.

HemoSphere Alta Advanced Monitoring Platform with ForeSight™ Oximeter Cable

The non-invasive ForeSight™ Oximeter Cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The ForeSight™ Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight™ Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere Alta™ Advanced Monitoring Platform.

• When used with large sensors, the ForeSight™ Oximeter Cable is indicated for use on adults and transitional adolescents ≥40 kg.
• When used with medium sensors, the ForeSight™ Oximeter Cable is indicated for use on pediatric subjects ≥3 kg.
• When used with small sensors, the ForeSight™ Oximeter Cable is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.

The algorithm for measurement of blood hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight™ Oximeter Cable and noninvasive ForeSight IQ™ Sensors in cerebral locations.

HemoSphere Alta™ Advanced Monitoring Platform with Non-invasive technology

The HemoSphere Alta™ Monitor when used with the pressure controller and a compatible finger cuff are indicated for adult and pediatric patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the non-invasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere Alta™ Advanced Monitor and compatible finger cuffs non-invasively measures blood pressure and associated hemodynamic parameters. Refer to the non-invasive finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.

The Acumen Hypotension Prediction Index™ Software Feature (HPI™ Parameter) provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI™ Feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI™ Feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index™ Parameter.

HemoSphere Alta Advanced Monitoring Platform with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor

The Acumen assisted fluid management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the assisted fluid management suggestions.

The HemoSphere Alta Advanced Monitoring Platform is the next-generation platform that provides a means to interact with and visualize hemodynamic and volumetric data on a screen. It incorporates a comprehensive view of patient hemodynamic parameters with an intuitive and easy user interface. The HemoSphere Alta Advanced Monitoring Platform is designed to provide monitoring of cardiac flow with various core technologies coupled with other technologies-based features such as Algorithms and Interactions. It integrates existing hemodynamic monitoring technologies into a unified platform.

The HemoSphere Alta Advanced Monitoring Platform's FDA 510(k) clearance letter and associated 510(k) summary (K252533) primarily focus on software modifications and the integration of previously cleared hardware components to an existing platform (K242451). The document states that no new clinical testing was performed in support of the subject 510(k). Therefore, the information provided mainly pertains to performance verification studies rather than standalone clinical performance studies involving ground truth establishment by experts for a novel algorithm.

However, based on the provided text, we can infer the acceptance criteria and study information as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several verification activities without providing specific numerical acceptance criteria for each, except implicitly stating "All tests passed" or "All acceptance criteria were met."

2. Sample Size Used for the Test Set and Data Provenance

• For Usability Study: The document mentions "the intended users." It does not specify the numerical sample size of users or the provenance of the data (e.g., retrospective or prospective, country of origin).
• For Non-Clinical Performance (Bench Simulation): "Measured and derived parameters were tested using a bench simulation." No sample size in terms of patient data or data provenance is applicable here, as it's a bench test.
• For Software Verification: "Extensive software verification testing was conducted." No specific sample size of test cases or data provenance is provided.
• For Clinical Performance: "No new clinical testing was performed in support of the subject 510(k)." This indicates no patient-level test set data was used for this specific submission. The algorithms within the device (e.g., GHI, Smart Wedge, HPI, CAI, RVP, RVCO, AFM) likely had clinical performance studies for their initial clearances, but those details are not provided in this 510(k) for the HemoSphere Alta platform updates.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• As "no new clinical testing was performed" for this 510(k) submission, there is no mention of experts establishing ground truth for a new clinical test set.
• For the Usability Study, "intended users" participated, implying clinical professionals, but their specific qualifications or their role in establishing "ground truth" (beyond identifying usability issues) are not detailed.

4. Adjudication Method for the Test Set

• Since no new clinical test set data with expert adjudication is described in this submission, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• The document does not mention any MRMC comparative effectiveness study comparing human readers with and without AI assistance for this 510(k) submission.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)

• While the device contains various algorithms (e.g., GHI, HPI, Smart Wedge, CAI, RVP, RVCO, AFM), this 510(k) primarily addresses software updates and hardware integration to an existing platform. It doesn't detail standalone performance studies for these specific algorithms within this document. The description of these algorithms (e.g., "additional information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions") implies a non-standalone, assistive role, but explicit standalone performance studies are not part of this submission's provided information.

7. Type of Ground Truth Used

• "No new clinical testing was performed." Therefore, for this specific 510(k) submission, no new patient-level ground truth (expert consensus, pathology, outcomes data, etc.) was established for performance evaluation of new algorithms or features. The verification activities relied on bench simulations and usability testing, not clinical ground truth.

8. Sample Size for the Training Set

• The document pertains to the clearance of a device (HemoSphere Alta Advanced Monitoring Platform) with software modifications and hardware integration, not the development or training of new AI algorithms. Therefore, no information on the sample size of a training set is provided. The algorithms included in the HemoSphere Alta system (e.g., GHI, HPI, CAI) would have been developed and trained using data sets prior to their initial clearance. This current 510(k) does not detail those previous training sets.

9. How the Ground Truth for the Training Set Was Established

• Similar to the training set sample size, this information is not provided in this 510(k) document, as it focuses on software updates and hardware integration to an already cleared platform, not the initial development and training of novel algorithms.

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The Hēlo Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature.
• The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels.

The Hēlo Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism.

The Hēlo Audible Flow Indicator is intended for use exclusively with the Hēlo Thrombectomy System and provides audible feedback of rapid flow through the device during a thrombectomy procedure.

The Hēlo Thrombectomy System (Hēlo System) is a minimally invasive aspiration system designed for the removal of thromboembolic material from the pulmonary arteries. It can be initially introduced with a 16 Fr introducer sheath and expands to 8 mm at the distal portion once inside the vasculature. The Hēlo System allows for engagement with the targeted clot, aspiration of the targeted clot, and transportation of aspirated clot out of the body. The Hēlo System is supplied sterile using Ethylene Oxide gas and is intended for single-use only. The Hēlo System is comprised of the following components:

• Aspiration Catheter: The Aspiration Catheter includes a funnel, an outer sleeve, and an integrated handle with controls. The handle also features a side port for the purposes of fluid injection, flushing of the inner lumen of the Aspiration Catheter, and for measurement of intravascular pressure using a standard pressure line setup, if needed. A second side port is used to purge air from the outer sleeve prior to use. The Aspiration Catheter is compatible with a 0.035" or 0.038" guidewire. It connects to a commercially available vacuum pump.

• Agitator: The Agitator is intended to be inserted in the inner lumen of the Aspiration Catheter. It includes a drive unit that connects to the proximal end of the Aspiration Catheter. The Agitator is designed to mechanically disrupt emboli within the distal region of the Aspiration Catheter during aspiration. The Agitator may be disconnected, removed, and reintroduced through the Aspiration Catheter during use.

• Rotating Hemostatic Valve (RHV): The RHV is an accessory that can be attached to the proximal end of the Aspiration Catheter when the Agitator is removed from the Aspiration Catheter. The RHV includes a Tuohy Borst valve to enable compatibility and sealing on ancillary devices, such as guidewires.

• 9F Dilator: The 9F diameter, Dilator is an accessory that is compatible with 0.035" or 0.038" guidewires and can be used to facilitate navigation through the heart.

• Audible Flow Indicator (AFI): The AFI is an optional accessory that connects between the suction port of the aspiration handle and the suction canister and provides audible feedback to the operator when actuation of the Suction/Agitator Control Button results in full flow through the device. A clot catcher made up of a coarse filter attaches to the suction canister and provides visualization of the clot.

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