K073255 · Medtronic Xomed, Inc. · ERL · Mar 24, 2008 · Ear, Nose, Throat
Device Facts
Record ID
K073255
Device Name
XPS 3000 SYSTEM
Applicant
Medtronic Xomed, Inc.
Product Code
ERL · Ear, Nose, Throat
Decision Date
Mar 24, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 874.4250
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The XPS® 3000 System is intended for the incision and removal of soft and hard tissue or bone in various surgical procedures, general otorhinolaryngology, head and neck and otoneurological surgery. 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 surgerv. 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, 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. Nasopharvngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions. Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bonv pvramid). 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. Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired. 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.
Device Story
XPS 3000 System comprises power control console, footswitches, cables, and various handpieces; drives burs, blades, drills, rasps, and cannulae. Used in OR by surgeons for tissue/bone resection and aspiration. Integral pumps provide irrigation and handpiece cooling. System enables precise tissue removal in ENT, neurosurgical, and orthopedic contexts. Output is mechanical cutting/shaving of target tissue; surgeon visualizes site directly or endoscopically. Device facilitates surgical access and tumor debulking; benefits include improved procedural efficiency and tissue management.
Clinical Evidence
No clinical data provided; substantial equivalence based on design, intended use, and technological characteristics compared to predicate devices.
Technological Characteristics
Electrically powered surgical drill/shaver system. Components: control console, footswitches, handpieces, cutting accessories. Features integral irrigation and cooling pumps. Connectivity: wired handpiece/footswitch interface. Sterilization: compatible with standard surgical instrument sterilization protocols.
Indications for Use
Indicated for patients requiring incision, removal, or aspiration of soft/hard tissue or bone in otorhinolaryngology, head/neck, otoneurological, neurosurgical, general surgical, and orthopedic procedures. Includes tumor removal (e.g., meningiomas, craniopharyngiomas, astrocytomas), sinus surgery, airway procedures, rhinoplasty, lipoplasty, and joint arthroscopy.
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.
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K073255
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# 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR XPS® 3000 System (with expanded indication)
MAR 2 4 2008
Medtronic Xomed, Inc 510(k) Owner 6743 Southpoint Drive North Jacksonville. Florida 32216-0980 USA 904-296-9600 904-296-2386 (FAX)
#### Contact Name David Guzek Senior Regulatory Affairs Specialist Medtronic Xomed, Inc
Date Summary Prepared March 20, 2008
XPS® 3000 System Proprietary Name
Common Name Electrical surgical shavers, electrical microresectors, mastoid drills, microdrill, ENT drills, handpieces and cutting blades, rasps and burs
Drill, Surgical, ENT (Electric or pneumatic) Classification Name including handpiece (21 CFR 874.4250 and 874.4140, Product Codes 77ERL and 77EQJ. Class II and I)
### Marketed device claiming equivalence to
Medtronic Xomed XPS® System, 510(k), K041523 Medtronic Xomed XPS® System, 510(k), K041413 Medtronic Xomed XPS® System, 510(k), K002224
#### Device Description
The XPS® 3000 System consists of power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps and cannulae.
This submission expands the device's indications for use in brain tumor removal from the current acoustic neuroma, tympanoplasty and vestibular neurectomy to include such tumors as meningiomas, craniopharyngiomas, pilocytic astrocytomas, some oligodendrogliomas and gangliogliomas, colloid cysts, choroid plexus papillomas, hemangioblastomas and some pineal region tumors such as teratomas, pinealocytomas.
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K073255
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## Intended Use
The XPS® 3000 System is intended for the incision and removal of soft and hard tissue or bone in various surgical procedures, general otorhinolaryngology, head and neck and otoneurological surgery.
#### 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 surgerv.
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, 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.
Nasopharvngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions.
Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bonv pvramid). 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.
Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired.
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K073255
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# INDICATIONS FOR USE (con't)
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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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 depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2008
Medtronic, Inc. % Mr. David Guzek Senior Regulatory Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216
Re: K073255
Trade/Device Name: XPS® 3000 System (with expanded indication) Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: II Product Code: ERL, EQJ Dated: February 19, 2008 Received: February 20, 2008
Dear Mr. Guzek:
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 – Mr. David Guzek
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE KOJ 325
510(k) Number (if known): K073255
Device Name: XPS® 3000 System (with expanded indication)
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, 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, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions.
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.
Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired.
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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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Souther
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
**510(k) Number***K073255*
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
