(46 days)
Not Found
No
The document describes a surgical power system with various handpieces and cutting tools, focusing on mechanical tissue removal. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities.
Yes
The device is used for the incision and removal of tissue and bone in surgical procedures, which is a therapeutic intervention.
No
The text describes the XPS 3000 as a surgical system used for the incision and removal of soft and hard tissue or bone. Its listed indications are all related to surgical procedures, not the diagnosis of conditions.
No
The device description explicitly lists hardware components such as a power control console, footswitches, connection cables, and handpieces, indicating it is not software-only.
Based on the provided information, the XPS 3000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- XPS 3000 Intended Use: The intended use of the XPS 3000 is for the incision and removal of soft and hard tissue or bone during surgical procedures. This is a direct surgical intervention on the patient's body, not the analysis of specimens outside the body.
- Device Description: The device description confirms it's a system with a power control console, footswitches, cables, and handpieces to drive surgical tools like burs, blades, drills, and rasps. These are tools for physical manipulation of tissue and bone during surgery.
The XPS 3000 is a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
77ERL, 77EQJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general otorhinolaryngology, head and neck, otoneurological, Otology / neurotology (mastoid, acoustic neuroma), Sinus (septoplasty, septal spurs, polypectomy, antrostomy, ethmoidectorny/sphenoethmoidectorny, frontal sinus, DCR, trans-spheniodal, maxillary sinus, choanal atresia, sphenoidotomy), Nasopharyngeal / laryngeal (adenoidectomy, tracheal, laryngeal, tonsillar, endobronchial lesions, recurrent respiratory papillomatosis (RRP)), Head and neck (ENT) (soft tissue, rhinoplasty, bony vault, bony pyramid, adipose tissue in maxillary and mandibular regions of the face, acoustic neuroma), orthopedic (spinal and large joint arthroscopic)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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).
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.
2
| Characteristic | XPS 3000
Expanded 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 / Straightshot
Microresector FWD/REV | Default: 6,000 RPM
Max: 6,000 RPM | Default: 6,000 RPM
Max: 6,000 RPM |
| Magnum / Straightshot
Microresector Oscillation Speed | Default: 3,000 RPM
Max: 3,000 RPM | Default: 3,000 RPM
Max: 3,000 RPM |
| Magnum II / M4 Microresector
FWD/REV | Default: 6,000 RPM
Max: 15,000 RPM | Default: 6,000 RPM
Max: 15,000 RPM |
| Magnum II/ M4 Microresector
Oscillation Speed | Default: 3,000 RPM
Max: 5,000 RPM | Default: 3,000 RPM
Max: 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 |
| Perastaltic pumps | 2 pumps, 1 for irrigation and 1
optional pump for handpiece cooling | |
Table 1
3
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.
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