XPS 3000 SYSTEM

K041523 · Medtronic Xomed, Inc. · ERL · Jul 23, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K041523
• Device Name: XPS 3000 SYSTEM
• Applicant: Medtronic Xomed, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, 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 úsing 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.

Device Story

XPS 3000 system is an electrosurgical power console with footswitches, cables, and handpieces (e.g., PowerSculpt) driving burs, blades, drills, and rasps. Used in OR by surgeons for tissue/bone resection. System includes integral peristaltic pumps for irrigation and handpiece cooling. Operates by mechanical cutting/shaving of tissue; suction cannula removes soft tissue and fluid. Provides surgeons with precise control over cutting speed (RPM) and oscillation. Benefits include efficient tissue removal across diverse surgical specialties, including otology, sinus, laryngeal, and orthopedic procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing, design analysis, and risk assessment.

Technological Characteristics

Power console with peristaltic pumps for irrigation/cooling; handpieces drive burs/blades/rasps. Materials: stainless steel and medical polymer. Steam autoclavable. Connectivity: footswitch/cable interface. Performance: 3,000–15,000 RPM depending on handpiece model.

Indications for Use

Indicated for patients requiring incision/removal of soft/hard tissue or bone in ENT, head and neck, otoneurological, and orthopedic surgical procedures, including spinal and joint arthroscopy, and aesthetic body contouring (lipoplasty).

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

• XPS system (K002224)

Submission Summary (Full Text)

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JUL 2 3 2004

# 510(k) Summary

### 1.0 Date Prepared

June 4, 2004

### Submitter (Contact) 2.0

Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL [phone]

### 3.0 Device Name

| Proprietary Name: | XPS 3000 System. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name(s): | Electrical surgical shavers, electrical microresectors, mastoid drills,<br>microdrill, ENT drills, handpieces and cutting blades, rasps and burs. |
| Classification Name(s): | Drill, Surgical, ENT (Electric or pneumatic) including handpiece. |

#### Device Classification 4.0

| Classification Name: Drill, Surgical, ENT (Electric or pneumatic) including handpiec | | | |
|--------------------------------------------------------------------------------------|-------|----------|-------------------|
| Procode | 77ERL | Class II | 21 CFR § 874.4250 |
| Procode | 77EQJ | Class I | 21 CFR § 874.4140 |

### 5.0 Device Description

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

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# 510(k) Summary (continued)

#### 6.0 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 middlefossa 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 neurectorny.

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 small and large joint arthroscopic procedures.

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## 510(k) Summary (continued)

### 7.0 Substantial Equivalence

The proposed XPS 3000 system is substantially equivalent in operating principle, technology, overall design, function, and materials to the XPS system described in K002224. Clinical evaluation and risk analysis reveal no new safety or efficacy issues in the expanded indications for use.

| Characteristic | XPS 3000<br>Expanded Indications | XPS 3000<br>(K002224) |
|----------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Intended Use /<br>Indications for use | Cutting soft tissue and bone | Cutting soft tissue and bone |
| Magnum / Straightshot<br>Microresector FWD / REV | Default: 6,000 RPM<br>Max: 6,000 RPM | Default: 6,000 RPM<br>Max: 6,000 RPM |
| Magnum / Straightshot<br>Microresector Oscillation Speed | Default: 3,000 RPM<br>Max: 3,000 RPM | Default: 3,000 RPM<br>Max: 3,000 RPM |
| Magnum II / M4 Microresector<br>FWD/REV | Default: 6,000 RPM<br>Max: 15,000 RPM | Default: 6,000 RPM<br>Max: 15,000 RPM |
| Magnum II / M4 Microresector<br>Oscillation Speed | Default: 3,000 RPM<br>Max: 5,000 RPM | Default: 3,000 RPM<br>Max: 5,000 RPM |
| Steam autoclavable<br>handpieces | Yes | Yes |
| Blade sizes (O.D.) | 2.0 mm - 6mm | 2.0 mm - 6mm |
| Direct patient contacting<br>materials (Burs / Blades) | Stainless Steel and<br>medical polymer | Stainless Steel and<br>medical polymer |
| Blades / burs biocompatible | Yes | Yes |
| Perastaltic pumps | 2 pumps, 1 for irrigation and 1<br>optional pump for handpiece<br>cooling | 2 pumps, 1 for irrigation and 1<br>optional pump for handpiece<br>cooling |

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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 eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Medtronic Xomed, Inc. c/o Martin D. Sargent Regulatory Affairs Manager 6743 Southpoint Dr. N. Jacksonville, FL 32216

Re: K041523

> Trade/Device Name: XPS 3000 System Regulation Number: 21 CFR 874.4250 Regulation Name: ENT electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: June 4, 2004 Received: June 8, 2004

Dear Mr. Sargent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encount of the enactment date of the Medical Device Amendments, or to conniner or ria) 2011-12-12) 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 I va may , ates , serovisions 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 If your do ho such additional controls. Existing major regulations affecting your device can may or defore to deen 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 - Martin D. Sargent

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

A. kelp L. Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): Device Name: XPS 3000 System 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, 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 úsing 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.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrency

(Division Sion-Off) Division of Ophthalmic Ear, Nose and Throat Devises

KO4 1523 510(k) Number _

> Prescription Use (Per 21 CFR 801.109)

Or

Over-the-Counter Use

(Optional Format 1-2-96)