XPS 3000 SYSTEM

K041413 · Medtronic Xomed, Inc. · ERL · Jul 12, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K041413
• Device Name: XPS 3000 SYSTEM
• Applicant: Medtronic Xomed, Inc.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Jul 12, 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 mastoidectomy, and acoustic neuroma. Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectorny/sphenoethmoidectory, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-spheniodal procedures, maxillary sinus polypectorny, circumferential maxillary out, andootophe D or a sia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy. Nasopharyngeal / laryngeal indications include adenoidectorny, tracheal procedures, laryngeal I wasophia yingsal lesion debulking, tonsillectorny, tonsillotomy for obstructive tonsillar disease, removal porypoolony, in Jilgoan lend the surgical management of recurrent respiratory papillomatosis (RRP). Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony I 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. The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of The Art & 5000 byeten in ageneral 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 I hoft and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

Device Story

XPS 3000 system comprises power control console, footswitches, cables, and various handpieces (e.g., PowerSculpt) to drive burs, blades, drills, and rasps; includes integral irrigation and cooling pumps. Used in OR by surgeons for tissue/bone resection; provides mechanical cutting/shaving/drilling. Output is physical tissue removal; aids surgeon in precise resection during ENT, head/neck, and orthopedic procedures. Benefits include efficient tissue management and surgical access.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing comparisons to predicate.

Technological Characteristics

Electric surgical drill system; includes power console, footswitches, handpieces, burs, blades, rasps. Materials: stainless steel and medical polymer. Features: integral peristaltic pumps for irrigation and handpiece cooling. Connectivity: cable-connected handpieces. Sterilization: steam autoclavable. Operation: electric motor-driven rotation/oscillation.

Indications for Use

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

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 3000 (K002224)

Submission Summary (Full Text)

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K041413

JUL 1 2 2004

510(k) Summary

## 1.0 Date Prepared

May 26, 2004

#### 2.0 Submitter (Contact)

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

#### Device Name 3.0

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

## 4.0 Device Classification

| Classification Name: | Drill, Surgical, ENT (Electric or pneumatic) including handpiece | | |
|----------------------|------------------------------------------------------------------|----------|-------------------|
| 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 mastoidectorny, mastoidotomy, and acoustic neuroma.

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, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharyngeal / larmgeal indications include adenoidectomy, tracheal procedures, laryngeal polypectorny, laryngeal lesion debulking, tonsillotomy for obstructive tonsillar disease, removal of endobronchial lesions, and the surgical management respiratory papillomatosis (RRP).

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.

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.

An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

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| Characteristic | XPS 3000<br>Expanded Indications | XPS 3000<br>(K002224) |
|----------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------|
| Intended Use /<br>Indications for use | Cutting soft tissue and bone<br>(See page 7) | Cutting soft tissue and bone<br>(See page 6) |
| 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 cooling | |

# Table 1

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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 features a stylized depiction of an eagle or bird-like figure, composed of three curved lines, which is a common symbol associated with the department. 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 1 2 2004

Medtronic Xomed c/o Martin D. Sargent Regulatory Affairs Manager 6743 Southpointe Drive, N. Jacksonville, Florida 32216-0980

Re: K041413

Trade/Device Name: XPS 300 System Regulation Number: 21 CFR 874.4140 Regulation Name: Ear, nose and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: May 26, 2004 Received: May 27, 2004

Dear Mr. Sargent:

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 - 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. Ralph 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): K041413 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 mastoidectomy, and acoustic neuroma.

Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectorny/sphenoethmoidectory, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-spheniodal procedures, maxillary sinus polypectorny, circumferential maxillary out, andootophe D or a sia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharyngeal / laryngeal indications include adenoidectorny, tracheal procedures, laryngeal I wasophia yingsal lesion debulking, tonsillectorny, tonsillotomy for obstructive tonsillar disease, removal porypoolony, in Jilgoan lend the surgical management of recurrent respiratory papillomatosis (RRP).

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony I 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.

The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of The Art & 5000 byeten in ageneral 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 I hoft and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures.

An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

Or

(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

Kuen H. Baka

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

510(k) Number: Koyivi-

Over-the-Counter Use

(Optional Format 1-2-96)

(Amended) 219