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, mastoidotomy, and acoustic neuroma.

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, 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.

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 Xomed XPS 3000 System, which describes an electrical surgical shaver and microresector. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel performance claims.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not explicitly present in this document because they are generally not required for a 510(k) submission of this nature. The document highlights functional equivalence to a previously cleared device (K002224).

Here's an attempt to answer your request based on the provided text, while also noting where information is not available:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device performance

The submission demonstrates substantial equivalence to a predicate device (K002224) by comparing key functional characteristics. The "acceptance criteria" here are implied to be the performance specifications of the predicate device, which the new device matches or exceeds.

Characteristic	Acceptance Criteria (Predicate Device: XPS 3000 K002224)	Reported Device Performance (XPS 3000 Expanded Indications)
Intended Use / Indications for use	Cutting soft tissue and bone (See page 6)	Cutting soft tissue and bone (See page 7)
Magnum / Straightshot Microresector FWD/REV (Default)	6,000 RPM	6,000 RPM
Magnum / Straightshot Microresector FWD/REV (Max)	6,000 RPM	6,000 RPM
Magnum / Straightshot Microresector Oscillation Speed (Default)	3,000 RPM	3,000 RPM
Magnum / Straightshot Microresector Oscillation Speed (Max)	3,000 RPM	3,000 RPM
Magnum II / M4 Microresector FWD/REV (Default)	6,000 RPM	6,000 RPM
Magnum II / M4 Microresector FWD/REV (Max)	15,000 RPM	15,000 RPM
Magnum II / M4 Microresector Oscillation Speed (Default)	3,000 RPM	3,000 RPM
Magnum II / M4 Microresector Oscillation Speed (Max)	5,000 RPM	5,000 RPM
Steam autoclavable handpieces	Yes	Yes
Blade sizes (O.D.)	2.0 mm - 6mm	2.0 mm - 6mm
Direct patient contacting materials (Burs / Blades)	Stainless Steel and medical polymer	Stainless Steel and medical polymer
Blades / burs biocompatible	Yes	Yes
Peristaltic pumps	Not explicitly stated/compared for predicate	2 pumps, 1 for irrigation and 1 optional for handpiece cooling

Note: The "acceptance criteria" for the new device are inherently benchmarked against the predicate device's performance to establish substantial equivalence. New product features (like the second optional pump) are provided but their specific "acceptance criteria" related to a performance study are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a performance study with a "test set" sample size in the context of clinical data. The comparison is based on device specifications and indications for use. No data provenance (country, retrospective/prospective) is applicable here as clinical data is not presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission does not involve clinical data requiring expert review for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This submission does not involve a test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical instrument, not an AI-powered diagnostic tool. MRMC studies are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission are the established technical specifications and performance characteristics of the predicate device, which the new device is shown to match for substantial equivalence regarding safety and effectiveness.

8. The sample size for the training set

Not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set described.

Summary

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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 (904) 279-7586

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.

{1}------------------------------------------------

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).

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.

{2}------------------------------------------------

Characteristic	XPS 3000Expanded Indications	XPS 3000(K002224)
Intended Use /Indications for use	Cutting soft tissue and bone(See page 7)	Cutting soft tissue and bone(See page 6)
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 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.

{4}------------------------------------------------

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. 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

{5}------------------------------------------------

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.

(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

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.