(45 days)
The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.
Otology / neurotology indications include aural atresia, cholesteatoma, cochleostomy, development of a suture tunnel for cochlear implant fixation, drainage of petrous apex cyst from endaural and middle-fossa approach, endolymphatic hydrops, extosis lesion removal, facial nerve decompression, mastoidectomy, mastoidotomy, ossicular chain reconstruction (OCR), otosclerosis, removal of ear tumors including acoustic neuroma, tympanoplasty, and vestibular neurectomy.
Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectorny/sphenoethmoidectorny, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-spheniodal procedures.
Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillectomy.
Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.
The XPS 3000 system using the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.
The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.
The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is required. These include spinal and large joint arthroscopic procedures.
The XPS 3000 system consists of a power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, and rasps.
The provided document is a 510(k) summary for the Medtronic XPS 3000 System, dated June 4, 2004. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study data for new acceptance criteria.
Therefore, the document does not contain the acceptance criteria or a study proving the device meets new acceptance criteria for the following reasons:
- 510(k) Submissions for Substantial Equivalence: The primary objective of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and safety/effectiveness data to the predicate device, not necessarily defining and meeting new, specific quantitative performance acceptance criteria through clinical trials.
- Focus on Expanded Indications: In this specific 510(k), Medtronic Xomed is seeking clearance for expanded indications for use for the XPS 3000 system. The comparison table directly addresses the expanded indications against the previously cleared XPS 3000 (K002224) by showing that the "operating principle, technology, overall design, function, and materials" are similar, and that "Clinical evaluation and risk analysis reveal no new safety or efficacy issues in the expanded indications for use." This implies a comparison of the new indications' safety and efficacy to existing knowledge/data related to the predicate and current device, not a new study with defined performance metrics.
- Lack of Quantitative Performance Data: The document provides specifications like RPMs for different handpieces and blade sizes, but it does not present quantifiable performance metrics (e.g., tissue removal rate, precision of cut, etc.) with corresponding acceptance criteria and study results.
Therefore, I cannot populate the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the provided 510(k) summary.
The summary states: "Clinical evaluation and risk analysis reveal no new safety or efficacy issues in the expanded indications for use." This suggests that the substantial equivalence argument relies on prior knowledge, risk assessment, and possibly non-clinical testing supporting no new issues, rather than a new comparative effectiveness study or standalone performance study against pre-defined acceptance criteria.
If this were a PMA (Premarket Approval) application or a more complex 510(k) that required clinical studies to demonstrate new performance claims, these details would be included. However, for an expanded indications 510(k) demonstrating substantial equivalence, such detailed performance studies with dedicated acceptance criteria are often not required or presented in the summary.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.