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.

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.

AI/ML Overview

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.

Summary

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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 (904) 279-7586

3.0 Device Name

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.

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.

Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillectomy.

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 3000Expanded Indications	XPS 3000(K002224)
Intended Use /Indications for use	Cutting soft tissue and bone	Cutting soft tissue and bone
Magnum / StraightshotMicroresector FWD / REV	Default: 6,000 RPMMax: 6,000 RPM	Default: 6,000 RPMMax: 6,000 RPM
Magnum / StraightshotMicroresector Oscillation Speed	Default: 3,000 RPMMax: 3,000 RPM	Default: 3,000 RPMMax: 3,000 RPM
Magnum II / M4 MicroresectorFWD/REV	Default: 6,000 RPMMax: 15,000 RPM	Default: 6,000 RPMMax: 15,000 RPM
Magnum II / M4 MicroresectorOscillation Speed	Default: 3,000 RPMMax: 5,000 RPM	Default: 3,000 RPMMax: 5,000 RPM
Steam autoclavablehandpieces	Yes	Yes
Blade sizes (O.D.)	2.0 mm - 6mm	2.0 mm - 6mm
Direct patient contactingmaterials (Burs / Blades)	Stainless Steel andmedical polymer	Stainless Steel andmedical polymer
Blades / burs biocompatible	Yes	Yes
Perastaltic pumps	2 pumps, 1 for irrigation and 1optional pump for handpiececooling	2 pumps, 1 for irrigation and 1optional pump for handpiececooling

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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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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.

Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillectomy.

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.

(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)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.