XPS 3000 SYSTEM

K073255 · Medtronic Xomed, Inc. · ERL · Mar 24, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K073255
• Device Name: XPS 3000 SYSTEM
• Applicant: Medtronic Xomed, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Mar 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The XPS® 3000 System is intended for the incision and removal of soft and hard tissue or bone in various surgical procedures, general otorhinolaryngology, head and neck and otoneurological surgery. 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 surgerv. 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, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy. Nasopharvngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions. Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bonv pvramid). 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. Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired. 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 small and large joint arthroscopic procedures.

Device Story

XPS 3000 System comprises power control console, footswitches, cables, and various handpieces; drives burs, blades, drills, rasps, and cannulae. Used in OR by surgeons for tissue/bone resection and aspiration. Integral pumps provide irrigation and handpiece cooling. System enables precise tissue removal in ENT, neurosurgical, and orthopedic contexts. Output is mechanical cutting/shaving of target tissue; surgeon visualizes site directly or endoscopically. Device facilitates surgical access and tumor debulking; benefits include improved procedural efficiency and tissue management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, intended use, and technological characteristics compared to predicate devices.

Technological Characteristics

Electrically powered surgical drill/shaver system. Components: control console, footswitches, handpieces, cutting accessories. Features integral irrigation and cooling pumps. Connectivity: wired handpiece/footswitch interface. Sterilization: compatible with standard surgical instrument sterilization protocols.

Indications for Use

Indicated for patients requiring incision, removal, or aspiration of soft/hard tissue or bone in otorhinolaryngology, head/neck, otoneurological, neurosurgical, general surgical, and orthopedic procedures. Includes tumor removal (e.g., meningiomas, craniopharyngiomas, astrocytomas), sinus surgery, airway procedures, rhinoplasty, lipoplasty, and joint arthroscopy.

Regulatory Classification

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.

Predicate Devices

• Medtronic Xomed XPS® System (K041523)
• Medtronic Xomed XPS® System (K041413)
• Medtronic Xomed XPS® System (K002224)

Submission Summary (Full Text)

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K073255

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# 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR XPS® 3000 System (with expanded indication)

MAR 2 4 2008

Medtronic Xomed, Inc 510(k) Owner 6743 Southpoint Drive North Jacksonville. Florida 32216-0980 USA 904-296-9600 904-296-2386 (FAX)

#### Contact Name David Guzek Senior Regulatory Affairs Specialist Medtronic Xomed, Inc

Date Summary Prepared March 20, 2008

XPS® 3000 System Proprietary Name

Common Name Electrical surgical shavers, electrical microresectors, mastoid drills, microdrill, ENT drills, handpieces and cutting blades, rasps and burs

Drill, Surgical, ENT (Electric or pneumatic) Classification Name including handpiece (21 CFR 874.4250 and 874.4140, Product Codes 77ERL and 77EQJ. Class II and I)

### Marketed device claiming equivalence to

Medtronic Xomed XPS® System, 510(k), K041523 Medtronic Xomed XPS® System, 510(k), K041413 Medtronic Xomed XPS® System, 510(k), K002224

#### Device Description

The XPS® 3000 System consists of power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps and cannulae.

This submission expands the device's indications for use in brain tumor removal from the current acoustic neuroma, tympanoplasty and vestibular neurectomy to include such tumors as meningiomas, craniopharyngiomas, pilocytic astrocytomas, some oligodendrogliomas and gangliogliomas, colloid cysts, choroid plexus papillomas, hemangioblastomas and some pineal region tumors such as teratomas, pinealocytomas.

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K073255

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## Intended Use

The XPS® 3000 System is intended for the incision and removal of soft and hard tissue or bone in various surgical procedures, general otorhinolaryngology, head and neck and otoneurological surgery.

#### Indications for Use

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 surgerv.

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, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharvngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions.

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bonv pvramid). 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.

Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired.

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K073255

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# INDICATIONS FOR USE (con't)

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 small and large joint arthroscopic procedures.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2008

Medtronic, Inc. % Mr. David Guzek Senior Regulatory Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K073255

Trade/Device Name: XPS® 3000 System (with expanded indication) Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: II Product Code: ERL, EQJ Dated: February 19, 2008 Received: February 20, 2008

Dear Mr. Guzek:

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 – Mr. David Guzek

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millman

- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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INDICATIONS FOR USE KOJ 325

510(k) Number (if known): K073255

Device Name: XPS® 3000 System (with expanded indication)

Indications for Use:

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, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions.

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.

Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired.

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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 small and large joint arthroscopic procedures.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Souther
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

**510(k) Number***K073255*