(147 days)
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 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.
The provided document is a 510(k) summary for the Medtronic Xomed, Inc. XPS Nexus System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the device is not an AI/ML powered device, and the information requested (acceptance criteria, study details, sample sizes, expert involvement, etc., in the context of an AI/ML device) is not directly applicable or available in this document.
However, I can extract the types of testing performed and the standards met, which serve as "acceptance criteria" for this conventional medical device's safety and performance in the context of a 510(k) submission.
Here's a breakdown of the available information, reframed to address the spirit of your request where possible, but highlighting that this is not an AI/ML device study:
1. A table of acceptance criteria and the reported device performance
For a conventional medical device like the XPS Nexus System, "acceptance criteria" typically refer to compliance with recognized standards for safety and fundamental performance. The reported "device performance" in a 510(k) for such a device is demonstrated by meeting these standards and showing equivalence to predicate devices.
| Acceptance Criteria Category | Specific Standard/Guidance | Reported Device Performance |
|---|---|---|
| Electrical Safety | AAMI ANSI ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | "Test results indicated that XPS Nexus System complies with the applicable standards." |
| Electromagnetic Comp. | IEC 60601-1-2 Edition 3: 2007-03 | "Test results indicated that XPS Nexus System complies with the applicable standards." |
| Software Testing | FDA Guidance: "The content of premarket submissions for software..." (May 11, 2005) | "Test results indicated that XPS Nexus System complies with the applicable standards." |
| FDA Guidance: "General principles of software validation..." (Jan 11, 2002) | (Implied compliance with guidance, not a pass/fail test) | |
| IEC 60601-1-4:1996 + Am. 1:1999 | "Test results indicated that XPS Nexus System complies with the applicable standards." | |
| IEC 62304: 2006-05 (Medical device software - Software life cycle processes) | "Test results indicated that XPS Nexus System complies with the applicable standards." | |
| Performance Testing | IEC 60601-1-6 Edition 3.0: 2010-01 (Usability) | "Test results indicated that XPS Nexus System complies with the applicable standards." |
| AAMI ANSI IEC 62366:2007/(R)2013 (Application of usability engineering) | "Test results indicated that XPS Nexus System complies with the applicable standards." | |
| General performance verification and validation testing to verify performance and output. | "General performance verification and validation testing... was also performed to verify the performance and output characteristics." (Implied successful verification within safety limits) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes engineering and regulatory compliance testing rather than clinical or AI/ML performance testing involving patient data. For electrical, EMC, software, and general performance testing, a "sample size" of patient data is not applicable. The samples would be the device units tested, but the number is not specified.
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)
This information is not applicable and not provided. "Ground truth" established by experts is relevant for AI/ML diagnostic or prognostic devices that interpret medical data. This device is a surgical drill system; its "ground truth" relates to its mechanical and electrical function as per engineering specifications, not expert interpretation of medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 are typically used in clinical studies or AI/ML evaluations where there's disagreement among human readers or between AI and human readers. This document details engineering compliance testing.
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
This information is not applicable and not provided. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical drill and does not involve "human readers" interpreting data with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical surgical tool and does not involve a standalone algorithm for performance evaluation in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, the "ground truth" would be established by engineering specifications, validated test methods (e.g., measuring power output, torque, temperature, electrical leakage), and compliance with the recognized consensus standards listed (e.g., IEC 60601 series). It's a functional "ground truth" based on physics and engineering, not medical interpretation or pathology.
8. The sample size for the training set
This information is not applicable and not provided. Training sets are used for machine learning models. This is a conventional medical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
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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.
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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
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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)
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Section 5.0 510(k) Summary
| A. 510(k) Owner | Medtronic Xomed, Inc6743 Southpoint Drive NorthJacksonville, Florida 32216-0980 USA904-296-9600904-296-2386 (FAX) |
|---|---|
| B. Contact Information | Gabriela AnchondoRegulatory Affairs ManagerMedtronic Xomed, Incgabriela.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) includinghand 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) includinghand 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) includinghand 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
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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.
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I. Substantial Equivalence
Summary of Technological Characteristics
| Subject Device | Predicate Device(s) | ||
|---|---|---|---|
| Device name | XPS Nexus™ System | IPC® Integrated Power ConsoleK081277 | XPS 3000 SystemK041413 |
| Indications for Use | The XPS Nexus™ System is indicated for theincision/cutting, removal and drilling of softand hard tissue and bone in head and neck /ENT, oral / maxillofacial and plastic /reconstructive / aesthetic surgical procedures. | The Electric Drill System is indicatedfor the incision / cutting, removal,drilling, and sawing of soft and hardtissue and bone in Head & Neck / ENT(Otologic, Neurologic, Neurotologic,Sinus, Rhinologic, Nasopharyngeal /Laryngeal), Oral / Maxillofacial, andPlastic / Reconstructive / AestheticSurgical Procedures. | The XPS 3000 is intended for the incision and removal of soft and hardtissue or bone in general otorhinolaryngology, head and neck, andotoneurological surgery.Otology/ neurotology indications include mastoidectomy, mastoidotomy,and acoustic neuroma.Sinus indications include septoplasty, removal of septal spurs,polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontalsinus trephination and irrigation, frontal sinus drill out, endoscopic DCR,trans-spheniodal procedures, maxillary sinus polypectomy, circumferentialmaxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral,and posterior frontal sinusotomyNasopharyngeal / laryngeal indications include adenoidectomy, trachealprocedures, laryngeal polypectomy, laryngeal lesion debulking,tonsillectomy, tonsillotomy for obstructive tonsillar disease, removal ofendobronchial lesions, and the surgical management of recurrentrespiratory papillomatosis (RRP).Head and neck (ENT) indications include soft tissue shaving, rhinoplasty(narrowing of the bony vault and revision of the bony pyramid), removaland shaping of bone during rhinoplasty procedures, removal of adiposetissue (lipo debridement) in the maxillary and mandibular regions of theface, removal of acoustic neuroma, and incision and removal of soft tissueduring plastic, reconstructive, and/or aesthetic surgery.The XPS 3000 system using the PowerSculpt handpiece and reciprocatingcutting blades / rasps is indicated to cut hard and soft tissue or bone inotorhinolaryngology and head and neck surgery.The XPS 3000 system with reciprocating adapter and suction cannula isintended for the removal of soft tissue and fluid during general surgicalprocedures including suction lipoplasty for aesthetic body contouring.The XPS 3000 system is indicated for use in orthopedic surgicalprocedures where the cutting and removal of soft and hard tissue or bone isrequired. These include spinal and small and large joint arthroscopicprocedures.An integral pump is provided for irrigation, and a second integral pumpmaybe provided for handpiece cooling. |
| MicrodebridersStraightShot® Magnum IIStraightShot® M4 | YesYes | YesYes | YesYes |
| DrillsIndigo™Visao® | YesNo | -YesYes | -NoYes |
| Basic Features | Hand piece w/suctionControl unit w/Footswitch1 Irrigation Pump | Hand piece w/suctionControl unit w/Footswitch2 Irrigation Pumps | Hand piece w/suctionControl unit w/Footswitch1 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 ConsoleK081277 | XPS 3000 SystemK041413 | |
| 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 contactingmaterials | Stainless steel and medical polymer | Stainless steel and medical polymer | Stainless steel and medical polymer |
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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:
| FDARecognitionNumber | StandardDevelopingOrganization | RecognitionList Number | StandardDesignationNumber andDate | Title of Standard | EffectiveDate | Category |
|---|---|---|---|---|---|---|
| 19-4 | AAMI ANSI | 036 | ES 60601-1:2005/(R)2012and A1:2012, | C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text)Medical electricalequipment - Part 1:General requirementsfor basic safety andessential 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:
| FDARecognitionNumber | StandardDevelopingOrganization | RecognitionList Number | StandardDesignationNumber andDate | Title of Standard | FRPublicationDate | Category |
|---|---|---|---|---|---|---|
| 19-1 | IEC | 037 | 60601-1-2Edition 3:2007-03 | Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessential performance -Collateral standard:Electromagneticcompatibility -Requirements and tests | 10/17/2014 | General II(ES/EMC) |
Test results indicated that XPS Nexus System complies with the applicable standards.
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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)
| FDARecognitionNumber | StandardDevelopingOrganization | RecognitionList Number | StandardDesignationNumber andDate | Title of Standard | FRPublicationDate | Category |
|---|---|---|---|---|---|---|
| 13-8 | IEC | 029 | 62304: 2006-05 | Medical devicesoftware - Software lifecycle processes | 08/20/2012 | (Software/Informaticss) |
Test results indicated that XPS Nexus System complies with the applicable standards.
Performance Testing
Performance testing was performed in compliance with the following standards:
| FDARecognitionNumber | StandardDevelopingOrganization | RecognitionList Number | StandardDesignationNumber andDate | Title of Standard | FRPublicationDate | Category |
|---|---|---|---|---|---|---|
| 5-85 | IEC | 036 | 60601-1-6Edition 3.02010-01 | Medical electricalequipment -- Part 1-6:General requirementsfor basic safety andessential performance —Collaterial Standard:Usability | 07/09/2014 | (General I(QS/RM) |
| 5-67 | AAMI ANSIIEC | 036 | 62366:2007/(R)2013 | Medical devices -Application of usabilityengineering to medicaldevices | 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.
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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.
§ 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.