(27 days)
No
The summary describes a mechanical surgical system and instruments, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
No.
The device is used for surgical procedures involving cutting, drilling, and removal of tissue and bone, as well as working with screws, posts, and rods, but it does not treat or alleviate a disease or condition itself.
No
Explanation: The device is indicated for surgical procedures involving cutting, drilling, and removal of tissue and bone, and for placement or cutting of screws, posts, and rods. These are all therapeutic and operative functions, not diagnostic ones.
No
The device description clearly states it is a system of reusable instruments made from materials used in orthopedic procedures, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures involving the cutting, removal, drilling, and sawing of tissue and bone within the body. IVDs are used to examine specimens outside the body to provide information about a patient's health.
- Device Description: The description details surgical instruments used in orthopedic procedures, not devices for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
The device is a surgical system used for performing procedures directly on the patient's body.
N/A
Intended Use / Indications for Use
IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranifacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC™ POWEREASE™ System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
Product codes (comma separated list FDA assigned to the subject device)
HBE, HBG
Device Description
Medtronic Reusable Instruments compatible with Medtronic's IPC™ The POWEREASE™ System are spine preparation instruments manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The instruments may be connected to the POWEREASE™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
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)
The subject working ends for use with the POWEREASE™ System are limited contact (
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2018
Medtronic Sofamor Danek USA, Inc. Ankit Shah Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K182436
Trade/Device Name: POWEREASE System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE Dated: September 6, 2018 Received: September 7, 2018
Dear Ankit Shah:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Matthew C. Krueger -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name POWEREASETM System
Indications for Use (Describe)
IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC™ POWEREASE™ System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY MEDTRONIC Sofamor Danek POWEREASE™ System September 2018
| I. Submitter | Medtronic Sofamor Danek, USA Inc. |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901)396-3133 | |
| Fax: (901) 346-9738 | |
| Contact: | Ankit K. Shah |
| Principal Regulatory Affairs Specialist | |
| Phone: (901) 344-1272 | |
| Date Prepared: | September 4, 2018 |
| II. Device | |
| Name of Device: | POWEREASE™ System |
| Classification Names: | Powered simple cranial drills, burrs, trephines, and their accessories (21 CFR 882.4310) |
| Manual cranial drills, burrs, trephines, and their accessories (21 CFR 882.4300) | |
| Class: | Class II |
| Product Code: | HBE, HBG |
| III. Predicate Devices: | |
| Primary Predicate: | |
| • IPC™ POWEREASE™ SYSTEM, K111520 (S.E. 10/26/2011) | |
| Reference Device: | |
| • CD HORIZON™ Spinal System, K162379 (S.E. 11/16/2016) |
The predicates have not been subject to a design related recall.
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IV. Description:
Medtronic Reusable Instruments compatible with Medtronic's IPC™ The POWEREASE™ System are spine preparation instruments manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The instruments may be connected to the POWEREASE™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.
Indications for Use: V.
IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC™ POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
Comparison of Technological Characteristics with the Predicate Devices: VI.
The subject working ends for use with the POWEREASE™ System have the same indications, intended use, fundamental scientific technology, materials, and sterilization method as the previously FDA cleared predicate IPC™ POWEREASE™ SYSTEM, K111520 (S.E. 10/26/2011).
VII. Performance Data:
The following information is provided in support of substantial equivalence.
Biocompatibility
The subject working ends for use with the POWEREASE™ System are limited contact (