(147 days)
Not Found
No
The document describes a powered surgical system for tissue removal and drilling, focusing on mechanical components and controls. There is no mention of AI, ML, image processing, or data-driven decision-making within the device description or performance studies.
No.
Explanation: The device is used for surgical incision, cutting, removal, and drilling of tissue and bone. These are operative functions, not therapeutic ones, as they do not treat a disease or condition directly but facilitate a surgical procedure.
No.
The Intended Use / Indications for Use states the device is for "incision/cutting, removal and drilling of soft and hard tissue and bone," and the Device Description characterizes it as a "powered microdebrider and drill system that removes soft tissue, hard tissue and bone during surgical procedures." These functions are therapeutic/surgical, not diagnostic.
No
The device description clearly outlines hardware components such as a power control console, foot control unit, hand-pieces, and an integrated irrigation pump, indicating it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for cutting, removing, and drilling tissue and bone during surgical procedures. This is a therapeutic/surgical function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a powered surgical system with hand-pieces, burs, blades, drills, and an irrigation pump. These are all tools used for physical manipulation of tissue during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient's body during surgery.
N/A
Intended Use / Indications for Use
The XPS Nexus™ System is indicated for the incision/cutting, removal and drilling of soft and hard tissue and bone in head and neck/ENT, oral/maxillofacial and plastic/reconstructive/aesthetic surgical procedures.
Product codes
ERL
Device Description
The XPS Nexus™ System is a powered microdebrider and drill system that removes soft tissue, hard tissue and bone during surgical procedures. The system consists of a power control console, a foot control unit and assorted hand-pieces to drive various burs, blades, drills, rasps and cannulas. Hand-piece options include the StraightShot® M2 Microdebrider, the StraightShot® M4 Microdebrider and the Indigo® Otology Drill.
The power control console also includes integrated irrigation pump for irrigation of blades and burs.
Optional accessories include an IV pole to hold a bag(s) of irrigation solution as well as a carrying case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head and neck/ENT, oral/maxillofacial
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
No clinical testing was deemed necessary for this Premarket Notification.
Key Metrics
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2015
Medtronic Xomed, Inc. Ms. Gabriela Anchondo Principal Regulatory Affairs Specialist 6743 Southpoint Dr. North Jacksonville, FL 32216
Re: K150728
Trade/Device Name: XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL Dated: July 7, 2015 Received: July 9, 2015
Dear Ms. Anchondo:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Y. Alexander -A
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150728
Device Name XPS Nexus™ System
Indications for Use (Describe)
The XPS Nexus™ System is indicated for the incision/cutting, removal and drilling of soft and hard tissue and bone in head and neck/ENT, oral/maxillofacial and plastic/reconstructive/aesthetic surgical procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Section 5.0 510(k) Summary
| A. 510(k) Owner | Medtronic Xomed, Inc
6743 Southpoint Drive North
Jacksonville, Florida 32216-0980 USA
904-296-9600
904-296-2386 (FAX) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| B. Contact Information | Gabriela Anchondo
Regulatory Affairs Manager
Medtronic Xomed, Inc
gabriela.anchondo@medtronic.com |
| C. Date Summary Prepared | March 19, 2015 |
| D. Proprietary Name | XPS Nexus™ System |
| E. Device Name | |
| Trade name: | XPS Nexus™ |
|---|---|
| Common/Usual Name: | Drill, Surgical, ENT (electric or pneumatic) including |
| hand piece (ERL) | |
| Classification Name: | Ear, nose and throat electric or pneumatic surgical drill |
| (21 CFR 874.4250, Product Code: ERL, Class II) |
F. Predicate Devices:
| Trade Name: | XPS 3000 System |
|---|---|
| Common/Usual Name: | Drill, Surgical, ENT (electric or pneumatic) including |
| hand piece (ERL) | |
| Classification Name: | Ear, nose and throat electric or pneumatic surgical drill |
| (21 CFR 874.4250, Product Code: ERL, Class II) | |
| Premarket Notification: | K041413 |
| Trade Name: | IPC® Integrated Power Console |
| Common/Usual Name: | Drill, Surgical, ENT (electric or pneumatic) including |
| hand piece (ERL) | |
| Classification Name: | Ear, nose and throat electric or pneumatic surgical drill |
| (21 CFR 874.4250, Product Code: ERL, Class II) | |
| Premarket Notification: | K081277 |
G. Device Description
The XPS Nexus™ System is a powered microdebrider and drill system that removes soft tissue, hard tissue and bone during surgical procedures. The system consists of a power control console, a foot control unit and assorted hand-pieces to drive various
4
burs, blades, drills, rasps and cannulas. Hand-piece options include the StraightShot® M2 Microdebrider, the StraightShot® M4 Microdebrider and the Indigo® Otology Drill.
The power control console also includes integrated irrigation pump for irrigation of blades and burs.
Optional accessories include an IV pole to hold a bag(s) of irrigation solution as well as a carrying case.
H. Intended Use/Indications for Use:
The XPS Nexus™ System is indicated for the incision/cutting, removal and drilling of soft and hard tissue and bone in head and neck / ENT, oral / maxillofacial and plastic / reconstructive / aesthetic surgical procedures.
5
I. Substantial Equivalence
Summary of Technological Characteristics
| Subject Device | Predicate Device(s) | ||
|---|---|---|---|
| Device name | XPS Nexus™ System | IPC® Integrated Power Console | |
| K081277 | XPS 3000 System | ||
| K041413 | |||
| Indications for Use | The XPS Nexus™ System is indicated for the | ||
| incision/cutting, removal and drilling of soft | |||
| and hard tissue and bone in head and neck / | |||
| ENT, oral / maxillofacial and plastic / | |||
| reconstructive / aesthetic surgical procedures. | The Electric Drill System is indicated | ||
| for the incision / cutting, removal, | |||
| drilling, and sawing of soft and hard | |||
| tissue and bone in Head & Neck / ENT | |||
| (Otologic, Neurologic, Neurotologic, | |||
| Sinus, Rhinologic, Nasopharyngeal / | |||
| Laryngeal), Oral / Maxillofacial, and | |||
| Plastic / Reconstructive / Aesthetic | |||
| Surgical Procedures. | 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-spheniodal 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, | |||
| tonsillectomy, tonsillotomy for obstructive tonsillar disease, removal of | |||
| endobronchial lesions, and the surgical management of recurrent | |||
| 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 small and large joint arthroscopic | |||
| procedures. | |||
| An integral pump is provided for irrigation, and a second integral pump | |||
| maybe provided for handpiece cooling. | |||
| Microdebriders | |||
| StraightShot® Magnum II | |||
| StraightShot® M4 | Yes | ||
| Yes | Yes | ||
| Yes | Yes | ||
| Yes | |||
| Drills | |||
| Indigo™ | |||
| Visao® | Yes | ||
| No | - | ||
| Yes | |||
| Yes | - | ||
| No | |||
| Yes | |||
| Basic Features | Hand piece w/suction | ||
| Control unit w/Footswitch | |||
| 1 Irrigation Pump | Hand piece w/suction | ||
| Control unit w/Footswitch | |||
| 2 Irrigation Pumps | Hand piece w/suction | ||
| Control unit w/Footswitch | |||
| 1 Irrigation Pumps, 1 optional handpiece cooling pump | |||
| User interface | Touch pad | Touch screen | Control buttons, displays |
| Device name | Subject Device | Predicate Device(s) | |
| XPS Nexus™ System | IPC® Integrated Power Console | ||
| K081277 | XPS 3000 System | ||
| K041413 | |||
| Provided sterile | - | - | - |
| Console/handpiece | No | No | No |
| Foot Control | No | No | No |
| Blade/bur/drill bit | Yes | Yes | Yes |
| Tubing sets | Yes | Yes | Yes |
| Patient contact | - | - | - |
| Console/handpiece | No | No | No |
| Foot control | No | No | No |
| Tubing set (fluid path) | Yes | Yes | Yes |
| Blade/bur/drill bit | Yes | Yes | Yes |
| Body contacting | |||
| materials | Stainless steel and medical polymer | Stainless steel and medical polymer | Stainless steel and medical polymer |
6
7
J. Testing
The verification and validation testing of the XPS Nexus™ System included the following testing:
Electrical Safety Testing
Electrical Safety compliance is demonstrated through testing in accordance with:
| FDA
Recognition
Number | Standard
Developing
Organization | Recognition
List Number | Standard
Designation
Number and
Date | Title of Standard | Effective
Date | Category |
|------------------------------|----------------------------------------|----------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------|
| 19-4 | AAMI ANSI | 036 | ES 60601-1:
2005/(R)2012
and A1:2012, | C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text)
Medical electrical
equipment - Part 1:
General requirements
for basic safety and
essential performance
(IEC 60601-1:2005,
MOD) | 07/09/2014 | General II
(ES/EMC) |
Test results indicated that XPS Nexus System complies with the applicable standards.
Electromagnetic Compatibility Testing
Electromagnetic Compatibility compliance is demonstrated through testing in accordance with:
| FDA
Recognition
Number | Standard
Developing
Organization | Recognition
List Number | Standard
Designation
Number and
Date | Title of Standard | FR
Publication
Date | Category |
|------------------------------|----------------------------------------|----------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------|
| 19-1 | IEC | 037 | 60601-1-2
Edition 3:
2007-03 | Medical electrical
equipment - Part 1-2:
General requirements
for basic safety and
essential performance -
Collateral standard:
Electromagnetic
compatibility -
Requirements and tests | 10/17/2014 | General II
(ES/EMC) |
Test results indicated that XPS Nexus System complies with the applicable standards.
8
Software Testing
Software testing was performed in compliance with the following guidance and standards:
- FDA Guidance: The content of premarket submissions for software contained in medical devices, May 11, 2005
- FDA Guidance: General principles of software validation; Final guidance for industry ● and FDA staff, January 11, 2002
- IEC 60601-1-4 Medical Electrical Equipment, Part 1-4: Collateral Standard: ● Programmable Electrical Medical Systems; IEC 60601-1-4:1996 (First Ed.) + Am. 1:1999 (Consolidated 1.1 Ed.) for use with IEC 60601-1 (1988). Amts. 1 (1991) and 2 (1995)
| FDA
Recognition
Number | Standard
Developing
Organization | Recognition
List Number | Standard
Designation
Number and
Date | Title of Standard | FR
Publication
Date | Category |
|------------------------------|----------------------------------------|----------------------------|-----------------------------------------------|---------------------------------------------------------------|---------------------------|---------------------------------|
| 13-8 | IEC | 029 | 62304: 2006-
05 | Medical device
software - Software life
cycle processes | 08/20/2012 | (Software/
Informatics
s) |
Test results indicated that XPS Nexus System complies with the applicable standards.
Performance Testing
Performance testing was performed in compliance with the following standards:
| FDA
Recognition
Number | Standard
Developing
Organization | Recognition
List Number | Standard
Designation
Number and
Date | Title of Standard | FR
Publication
Date | Category |
|------------------------------|----------------------------------------|----------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------------------|
| 5-85 | IEC | 036 | 60601-1-6
Edition 3.0
2010-01 | Medical electrical
equipment -- Part 1-6:
General requirements
for basic safety and
essential performance —
Collaterial Standard:
Usability | 07/09/2014 | (General I
(QS/RM) |
| 5-67 | AAMI ANSI
IEC | 036 | 62366:2007/(R
)2013 | Medical devices -
Application of usability
engineering to medical
devices | 07/09/2014 | (General I
(QS/RM) |
Test results indicated that XPS Nexus System complies with the applicable standards.
General performance verification and validation testing of the subject XPS Nexus System was also performed to verify the performance and output characteristics.
No clinical testing was deemed necessary for this Premarket Notification.
9
K. Conclusion
The data presented in this Premarket Notification support that the subject device is safe and effective and performs in the same manner as the predicate device when used in accordance with the labeled directions for use and for the specified indication(s).
The risks of the subject device, as well as the benefits to the patient, are the same as those attributed to the use of the predicate devices. No new risks have been identified.
The scope of intended use of XPS Nexus™ System is limited as compared with predicate devices; it has the same conditions of use and the same key technological characteristics as predicate devices and does not raise new issues of safety or effectiveness. The XPS Nexus™ System is therefore substantially equivalent to the IPC® Integrated Power Console cleared by K081277 and XPS 3000 System cleared by K041413.