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The multiFlux 130 and 160 filters are intended for single use only for extracorporeal blood purification during continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVHD), and continuous veno-venous hemodiafiltration (CVVHDF) using pre-, post- or mixed-dilution modes for patients suffering from acute kidney injury.

The multiFlux 130 and 160 hemofilters are high-flux, single-use, steam-sterilized filters. The hemofilters are provided blood pathway sterile and non-pyrogenic. The hemofilters allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.

The multiFlux 130 and 160 hemofilters are high-flux, sterile devices designed for single-use acute hemodialysis. The hemofilters are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the hemofilters. The hemofilters contain semi-permeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Hemofilters utilize a counter-current flow in which dialysate and blood flow in opposite directions in the hemofilter. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

The multiFlux 130 and 160 hemofilters' components are composed of the following materials:
Housing: Polypropylene
Potting Resin: Polyurethane
Fiber Bundle: Polysulfone-polyvinylpyrrolidone blend, alpha-tocopherol (vitamin E)
Sealing Ring: Silicone
Flange: Polypropylene
Blood Port Cap(s): Polypropylene
Dialysate Port Cap(s): Styrol-Ethylen-Butylen-Styrol, Polypropylene

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Multi-Unit DAS System is intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

Compatible Implant Systems

All digitally designed custom abutments for use with Multi-Unit DAS System are to be sent to a Talladium validated milling center for manufacture.

Multi-Unit DAS System abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration

Multi-Unit DAS system abutments are designed for retention of multi-unit or single-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For all compatible OEM implant lines, the multi-unit abutment components are provided with gingival heights ranging from 1 mm to 4 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm.

This submission includes one (1) abutment level Ti-Base (coping) Engaging Interface for use with the subject multi-unit abutments. The subject Ti-Base (coping) Engaging Interface is a straight prepable design with an additional gingival height of 1.5 mm and a prepable 10.5 mm prosthetic post. This Ti-Base (coping) Engaging Interface has an engaging interface to the multi-unit abutments and is to be used to fabricate a straight final abutment and a straight final restoration. The subject device is identical to the previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559), except the current subject device has an engaging interface. The previously cleared abutment level Ti-base (Part 35.312.209.21-2, K231559) is to be used to fabricate a straight final abutment and a straight final restoration.

The subject device multi-unit abutments may be used with the following components, all previously cleared in K231559: Straight Ti-base, non-engaging, part number 35.312.209.21-2; DAS Multi-Unit Engaging Dynamic Ti-Base, part number 31.312.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.01-2; DAS Multi-Unit Non-Engaging Dynamic Ti-Base, part number 31.322.209.21-2; DAS Multi-Unit Healing Cap Regular, part number 40.320.003.88-2; DAS Multi-Unit Healing Cap Wide, part number 40.320.003.89-2; DAS Multi-Unit Dynamic Screw 3.0, part number 41.320.040.01-2; DAS Multi-Unit Provisional Dynamic Screw, part number 41.320.050.02-2; and DAS Multi-Unit Straight Screw, part number 40.320.003.06-2.

No new DAS Multi-Unit Dynamic Ti-Bases are included in this submission. The previously cleared DAS Multi-Unit Dynamic Ti-Base (coping) components (K231599), part numbers 31.312.209.01-2, 31.322.209.01-2, and 31.322.209.21-2 may be used with the subject device Angled Multi-Unit abutments to fabricate a final angled abutment.

A summary of the subject device Multi-Unit DAS System abutment compatibilities with the OEM implants is provided in the following Table 1 Summary of Compatibilities.

Table 1 Summary of Compatibilities

All zirconia superstructures for use with the subject device Multi-Unit DAS system will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The design parameters for the CAD-CAM zirconia superstructure for the subject Multi-Unit DAS Dynamic Ti-base are:

• Minimum wall thickness – 0.25 mm
• Minimum post height for single-unit restorations – 4.0 mm
  (post height measured above the gingival height of the final patient-matched design)
• Maximum gingival height – 4.90 mm
• Minimum gingival height – 3.89 mm
• Maximum angulation – 15°

The design parameters for the CAD-CAM zirconia superstructure for the subject device Multi-Unit DAS Ti-Base (coping) Engaging Interface are:

• Minimum wall thickness – 0.25 mm
• Minimum post height for single-unit restorations – 4.0 mm
  (post height measured above the gingival height of the final patient-matched design)
• Maximum gingival height – 4.90 mm
• Minimum gingival height – 3.89 mm
• Maximum angulation – 0°

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Multichem ID-G: Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

Multichem ID-GNeg: Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

Multichem ID-G and Multichem ID-GNeg are each supplied as single level controls. These products are prepared from human plasma. Multichem ID-G contains Hepatitis B Surface Antigen (HBsAg), and lgG antibodies to HIV-1 (Human Immunodeficiency Virus Type 1), HCV (Hepatitis C Virus), HBc (Hepatitis B Core Antigen) and Treponema pallidum. Multichem ID-GNeg does not contain analytes for HBsAg, anti-HIV-1 lgG, anti-HCV lgG, anti-HBc lgG, and anti-Treponema pallidum lgG. These controls are provided in liquid form for convenience. Each control is available as either 1 or 4 vials x 4 ml/vial.

Multichem ID-G is manufactured by adding the required analytes to the negative delipidated human serum base matrix, described above. Human disease state plasma that has tested positive for the required analyte using an FDA-cleared/approved assay is used to spike the base matrix to each target specification and within the ranges set for the Roche Immunoassay systems (Tables 1 and 2).

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Multi-functional Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial stimulation through MC(micro-current) mode.

The Multi-functional Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

The device is only home environment use, which has some massage heads, and LED light mode (Red and /or Blue lights are output independently) to provides following functions.

a. Micro-current stimulation function.
b. Red LED irradiation function. (Cleared under K252142).
c. Blue LED irradiation.(Cleared under K252142).
d. Hot compress and vibration function.(The vibration is classified as class I and not need for 510K, and the hot compress(39℃±0.5℃) is not for medical purpose).
e. Hot compress function.(The hot compress(35.5℃～38.5±0.5℃) is not for medical purpose).
f. Vibration function(motor vibration).(The vibration is classified as class I and not need for 510K).

Each mode of the device is independent from all other modes of the Multi-functional Facial Beauty Device.

The Multi-functional Facial Beauty Device consists of a main unit, USB charging cable, components shown as following illustration: (Here takes model SKB-2109 and model SKB-2129 as examples)

SKB-2109:

• Intensity indicator
• Mode indicator
• Intensity button
• OFF/ON& Mode switch button
• Massage head
• LED light
• Massage head
• USB charging cable

SKB-2129:

• LEDs (Red)
• Massage head
• Power/Mode/Intensity Button
• RED LIGHT Indicator
• MC Indicator
• Intensity Indicator
• USB charging cable

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The N10, N12, N15, N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, Heart Rate (HR) and Heart-Rate-Variability(HRV)), interpretations of resting 12-lead ECG, Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2). The N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are also intended for monitoring, displaying, reviewing, storing, alarming and transferring of physiological parameters including Masimo Rainbow SpO2, Anesthesia gas (AG), oxygen (O2) respiratory gas monitoring, Bispectral Index (BIS), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). All the parameters can be monitored on single adult, pediatric, and neonatal patient except for the following:

• Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
• NIBP measurement continual mode is not applicable to neonates.
• When using COMEN SpO2, the monitor is intended to be used on adult patient only.
• PAWP is intended for adult and pediatric patients only.
• C.O. measurement is intended for adult patients only.
• BIS monitoring is intended for adult patients only.
• RM is intended for adult and pediatric patients only.
• NMT monitoring is intended for adult and pediatric patients only.

The monitors are to be used in healthcare facilities by healthcare professionals or under their guidance.

The Multi-parameter Patient monitors are not intended for emergency and transport use, aircraft environment or home use.

The monitors are not intend for use as apnea monitors.

The monitors are not intended for use in MRI or CT environments.

The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

There are six (6) models under evaluation, namely N10, N12, N15, N10MPro, N12MPro, N15MPro. All models share the same intended condition of use, the same intended patient population and operator profile, biological safety characteristic and principle of operation. All these models are the same on electric and electrical circuit and components, mechanical construction, software and alarm system. The only difference lies on the screen and configuration of with/without plug-in module slot and the number of battery packs.

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Multi-functional Facial Beauty Device (model: SKB-1909):

• Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
• Red light is intended for the treatment of facial wrinkles.

Multi-functional Facial Beauty Device (model: SKB-1703):

• Blue light is intended for the treatment of facial mild to moderate inflammatory acne.

Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB-2209):

• Red light is intended for the treatment of facial wrinkles.

The Multi-functional Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

The device is only home environment use, which has some massage heads, and LED light mode (Red and /or Blue lights are output independently) to provides following functions.

a. Micro-current stimulation function.
b. Red LED irradiation function.
c. Blue LED irradiation.
d. Hot compress and vibration function.(The vibration is classified as class I and not need for 510K, and the hot compress (39℃±0.5℃) is not for medical purpose).
e. Hot compress function.(The hot compress (35.5℃～38.5±0.5℃) is not for medical purpose).
f. Vibration function.(The vibration is classified as class I and not need for 510K).

Each mode of the Multi-functional Facial Beauty Device is independent from all other modes of the device.

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• Direct restorations in all cavity classes (I-V)
• Base / liner under direct restoration
• Veneering of discolored anterior teeth
• Splinting of mobile teeth
• Extended pit and fissure sealing in molars and premolars
• Repair of composite/ceramic veneers
• Retention of thermoplastic aligners

The addition of anti-microbial particles to MultiMatch Flow Chameleon AntiMicrobial Composite reduces demineralization and the total amount of bacteria at the material surface, which is part of the caries-formation process.

Premier's MultiMatch Flow Chameleon AntiMicrobial Composite is a low viscosity, light-cured, radiopaque, flowable nano-hybrid composite. It is for use in direct Class I-V restorations as a base liner, indirect restorations, and for retention of clear aligners. The restorative has an antimicrobial additive which reduces demineralization and total amount of bacteria at the material surface. The restorative is available in one chameleon shade to fit a variety of tooth-colored shades.

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MultiPulse TFL Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

• Urethral Strictures
• Bladder Neck Incisions (BNI)
• Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BPH)
• Transurethral incision of the prostate (TUIP)
• Laser Resection of the Prostate Laser Enucleation of the Prostate
• Laser Ablation of the Prostate
• Condyloma
• Lesions of external genitalia
• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• Treatment of distal impacted fragments remaining in the ureters following lithotripsy
• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitis, Hemorrhoids, Cholecystectomy, Benign and Malignant Neoplasma, Angiodysplasia, Colorectal cancer, Telangiectasia, Telangiectasia of the Osler-WeberRenu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions.

Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) including: Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy, Foraminoplasty, Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasive spinal surgery.

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue: Intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septum by incision, excision, ablation and/or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix.

ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: Endonasal/sinus Surgery, Partial turbinectomy, Polypectomy, Dacryocystorhinostomy, Frontal Sinusotomy, Ethmoidectomy, Maxillary antrostomy, Functional endoscopic sinus surgery, Lesions or tumors (oral, nasal, glossal, pharyngeal and laryngeal), Tonsillectomy, Adenoidectomy.

General surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy, Lysis of adhesion, Appendectomy, Biopsy, Skin incision, Tissue dissection, Excision of external tumors and lesions, Complete or partial resection of internal organs, tumors and lesions, Mastectomy, Hepatectomy, Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Tonsillectomy, Lymphadenectomy, Partial Nephrectomy, Pilonidal Cystectomy, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer.

The MultiPulse TFL laser system and its fiber optic delivery system is a laser Class IV, operating in CW or pulsed mode at a wavelength of 1940 nm. The laser power up to 200W is transmitted through different optical fibers. Besides of the optical bench the device consists of a power supply, a water cooling unit and a control electronic. The device is operated by a touch screen and a foot switch.

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The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.

The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reuseable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs).

The Multi4 System consists of the following components:
• Multi4 Pump (with Integrated Fluid Control)
o Footswitch
• Multi4 B
o Resectoscope & Needle
o Simple4tainer (For collection of gross resected tissue pieces for pathology)

The provided FDA 510(k) clearance letter and summary for the Multi4 System primarily focuses on demonstrating substantial equivalence to predicate devices through design similarity, material composition, intended use, and technological characteristics. The document details extensive non-clinical testing performed to ensure safety and effectiveness.

However, the provided text does not contain details about acceptance criteria, the study design, or performance metrics in a way that allows for the construction of a table comparing acceptance criteria with reported data, nor does it provide information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document does mention:

• Non-Clinical Testing: Software Verification and Validation Testing, Sterility Testing, Packaging Testing, Shelf-life Testing, Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity), Electrical Safety & EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-2), Integrity Testing, Functional Testing (Cut and coagulation, aspiration, irrigation, injection), Dimensional Inspection and Testing, Simulated Use Testing.
• Lack of Clinical Study: The "SUMMARY OF NON-CLINICAL TESTING" section and the overall context strongly suggest that the clearance was based on non-clinical data demonstrating equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against acceptance criteria for a new AI/algorithm. There is no mention of "ground truth" as it would apply to an AI study (e.g., expert consensus, pathology, outcomes data).

Therefore, I must state that the requested information regarding acceptance criteria, study data for AI performance, sample sizes for AI test/training sets, expert roles, adjudication, and MRMC studies is not present in the provided text. The document focuses on demonstrating substantial equivalence via engineering and bench testing, not clinical performance or AI/algorithm validation with a test set and ground truth in the manner typically required for AI-driven devices.

Without this specific information from the provided text, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-driven device with performance metrics.

If this were an AI device, the missing information would be crucial for understanding its validation. For this specific device and the information provided, the "acceptance criteria" were met by demonstrating that the Multi4 System performs as safely and effectively as its predicate devices through rigorous non-clinical testing.

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