(129 days)
No
The description focuses on a pneumatically powered surgical drill system and its mechanical components. There is no mention of AI, ML, or any software-driven analytical capabilities.
No
The device is a surgical instrument used for cutting, drilling, and sawing tissue and bone, which are direct surgical actions, not therapeutic interventions aimed at treating a disease or disorder through non-invasive means or by restoring function.
No.
The device is described as a surgical instrument system used for cutting, drilling, and sawing various tissues and bones during surgical procedures; it does not mention any diagnostic functions.
No
The device description explicitly states it is a "pneumatically powered high-speed drill system consisting of a choice of various Pneumatic Handpieces... equipped with a foot or finger controller, Pneumatic Foot Control Unit, Surgical Dissecting Tools, System Accessories, and where applicable, Attachments". This clearly describes a hardware-based surgical instrument system, not a software-only device.
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 instrument system used for cutting, drilling, and sawing tissue and bone during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device description details a pneumatically powered drill system with handpieces, controllers, and surgical tools. These are all components of a surgical instrument.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens.
The device is a surgical tool used in vivo (within the body) during surgical procedures.
N/A
Intended Use / Indications for Use
The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Additionally, the Pneumatic Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
- Lumbar Microdiscectomy
- Lumbar Stenosis Decompression
- Posterior Lumbar Interbody Fusion (PLIF)
- Transforaminal Lumbar Interbody Fusion (TLIF)
- Anterior Lumbar Interbody Fusion (ALIF)
- Direct Lateral Interbody Fusion (DLIF)
Product codes (comma separated list FDA assigned to the subject device)
HBB, KFK, ERL, EQJ, HSZ, GET, HBE, DWH
Device Description
The Pneumatic Drill System is a pneumatically powered high-speed drill system consisting of a choice of various Pneumatic Handpieces (comprising of a High Pressure and Exhaust Hose, and Handpiece) equipped with a foot or finger controller, Pneumatic Foot Control Unit, Surgical Dissecting Tools, System Accessories, and where applicable, Attachments to support various Surgical Dissecting Tools, and System Accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
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)
Clinical Literature Review: A comprehensive clinical literature search was conducted and reviewed regarding the safe and effective use of the Drill System for the expanded indications for use, which is the subject of this submission. Result: The cadaver validation study, and review of supporting literature, supports the use of the Medtronic Drill System in LM, PLIF, TLIF, LSD, ALIF, and DLIF spinal surgical procedures, as well as any variations of these procedures.
Cadaveric Testing: Users evaluated the acceptability of the subject drill system to its intended use on a variety of procedures using cadavers. Result: The Medtronic Pneumatic Drill System is acceptable for its intended use in various surgical procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2017
Medtronic Powered Surgical Solutions Deep Pal Regulatory Affairs Manager 4620 North Beach Street Fox Worth, TX 76177
Re: K163182
Trade/Device Name: Medtronic Legend Pneumatic: MR7 Pneumatic: Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic Cranial Drill Motor Regulatory Class: Class II Product Code: HBB, KFK, ERL, EQJ, HSZ, GET, HBE, DWH Dated: December 22, 2016 Received: December 23, 2016
Dear Mr. Pal:
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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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.
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163182
Device Name
Medtronic Legend Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
Indications for Use (Describe)
The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Additionally, the Pneumatic Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
- Lumbar Microdiscectomy
- Lumbar Stenosis Decompression
- Posterior Lumbar Interbody Fusion (PLIF)
- Transforaminal Lumbar Interbody Fusion (TLIF)
- Anterior Lumbar Interbody Fusion (ALIF)
- Direct Lateral Interbody Fusion (DLIF)
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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3
SECTION 9: 510(k) SUMMARY
This summary is submitted in accordance with the requirements of 21CFR807.92.
9.1 DATE PREPARED
November 10, 2016
9.2 NAME AND ADDRESS OF MANUFACTURER
Table 4: Manufacturer information
| Establishment Name | Establishment Registration Number |
|---|---|
| Medtronic Powered Surgical Solutions | |
| 4620 North Beach Street | |
| Fort Worth, TX 76137 USA | 1625507 |
| Medtronic Xomed, Inc. | |
| 6743 Southpoint Drive North | |
| Jacksonville, FL 33216 USA | 1045254 |
9.3 CONTACT PERSON
Deep Pal Regulatory Affairs Manager Telephone: 817.788.6685 Facsimile: 817.788.6222 E-Mail: deep.pal@medtronic.com
9.4 PROPRIETARY NAME
Medtronic Legend Pneumatic, MR7 Pneumatic, Triton Pneumatic Drill System incorporating various Pneumatic Handpieces, Attachments, Surgical Dissecting Tools and System Accessories
9.5 COMMON/USUAL NAME
Surgical Drill Motors and Accessories
9.6 DEVICE CLASSIFICATION NAME
Table 5: FDA device classification information
| Description | FDA Code | Regulation Number |
|---|---|---|
| Saw, pneumatically powered | KFK | 21CFR878.4820 |
| Motor, drill, pneumatic | HBB | 21CFR882.4370 |
| Drill, surgical, ent (electric or pneumatic) including handpiece | ERL | 21CFR874.4250 |
| Bur, ear, nose and throat | EQJ | 21CFR874.4140 |
| Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment | HSZ | Pre-Amendment |
| Pneumatic motor for general surgery | GET | 21CFR878.4820 |
| Drills, burrs, trephines and accessories (simple, powered) | HBE | 21CFR882.4310 |
| Blades, saw, surgical cardiovascular | DWH | 21CFR878.4820 |
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9.7 PREDICATE DEVICE IDENTIFICATION
Table 6: Subject Devices that are in the scope of this Submission
| SUBJECT SYSTEM DESCRIPTION | PREDICATE | |
|---|---|---|
| SYSTEM DESCRIPTION | 510(k) NUMBER | |
| Triton Pneumatic Drill System | Oscillating and Reciprocating Saw Drill-Reamer | K870157 |
| - Pneumatic Handpiece | - Pneumatic Handpiece | K870157 |
| - Pneumatic Foot Control Unit | - Pneumatic Control Unit | K870157 |
| - Surgical Dissecting Tools | - Surgical Dissecting Tools | K870157 |
| - Attachments | - Attachments | K870157 |
| - System Accessories | - System Accessories | K870157 |
| Legend Pneumatic High Speed System | Legend Pneumatic High Speed System | K020069 |
| - Pneumatic Handpiece | - Pneumatic Handpiece | K020069 |
| - Pneumatic Foot Control Unit | - Pneumatic Control Unit | K020069 |
| - Surgical Dissecting Tools | - Surgical Dissecting Tools | K020069, K072315 |
| - Attachments | - Attachments | K020069 |
| - System Accessories | - System Accessories | K020069 |
| Midas Rex MR7 Pneumatic High Speed System | Midas Rex MR7 Pneumatic High Speed System | K090112 |
| - Pneumatic Handpiece | - Pneumatic Handpiece | K090112 |
| - Pneumatic Foot Control Unit | - Pneumatic Control Unit | K090112 |
| - Surgical Dissecting Tools | - Surgical Dissecting Tools | K020069, K072315 |
| - Attachments | - Attachments | K020069 |
| - System Accessories | - System Accessories | K090112 |
9.8 DEVICE DESCRIPTION
The Pneumatic Drill System is a pneumatically powered high-speed drill system consisting of a choice of various Pneumatic Handpieces (comprising of a High Pressure and Exhaust Hose, and Handpiece) equipped with a foot or finger controller, Pneumatic Foot Control Unit, Surgical Dissecting Tools, System Accessories, and where applicable, Attachments to support various Surgical Dissecting Tools, and System Accessories.
The device design, function, the intended use and the general operating principles, and conditions of use of the overall Medtronic Pneumatic Drill Systems remain similar to those cleared under K870157, K020069, K072315, and K090112.
INDICATIONS FOR USE 9.9
The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumaic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Additionally, the Pneumatic Drill System is incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
- Lumbar Microdiscectomy o
- o Lumbar Stenosis Decompression
- Posterior Lumbar Interbody Fusion (PLIF) o
- O Transforaminal Lumbar Interbody Fusion (TLIF)
- Anterior Lumbar Interbody Fusion (ALIF) O
- O Direct Lateral Interbody Fusion (DLIF)
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 9.10
The Pneumatically powered drill system, designed to remove soft and hard tissue, and bone, and biomaterials is the technological principle for both the subject and predicate systems.
The subject and predicate systems are based on the following same technological elements:
- A Pneumatic Drill System Application: Designed to remove soft and hard tissue, bone, and biomaterials during various surgical applications.
- A Operating Principle: The pneumatic energy is supplied to the Handpiece to provide power to operate interchangeable Surgical Dissecting Tools supported by Attachments and intended for use in various surgical procedures to remove soft and hard tissue, bone, and biomaterials.
In terms of the materials used in manufacturing of the patient contacting components of the subject Pneumatic Drill System, the subject Attachments and Surgical Dissecting Tools are similar to the predicate Medtronic Attachments and Surgical Dissecting Tools.
9.11 DISCUSSION OF THE PERFORMANCE TESTING
Testing was completed to ensure the functionality of the Medtronic Pneumatic Drill System for the expanded indications. The following table summarizes the testing completed:
| TEST | DESCRIPTION | RESULTS |
|---|---|---|
| Clinical | ||
| Literature | ||
| Review | A comprehensive clinical literature | |
| search was conducted and reviewed | ||
| regarding the safe and effective use | ||
| of the Drill System for the expanded | ||
| indications for use, which is the | ||
| subject of this submission. | The cadaver validation study, and | |
| review of supporting literature, | ||
| supports the use of the Medtronic | ||
| Drill System in LM, PLIF, TLIF, LSD, | ||
| ALIF, and DLIF spinal surgical | ||
| procedures, as well as any | ||
| variations of these procedures. | ||
| Cadaveric | ||
| Testing | Users evaluated the acceptability of | |
| the subject drill system to its | ||
| intended use on a variety of | ||
| procedures using cadavers. | The Medtronic Pneumatic Drill | |
| System is acceptable for its | ||
| intended use in various surgical | ||
| procedures. |
9.12 CONCLUSIONS
The subject Medtronic Penumatic Drill Systems when compared to the predicate Drill Systems have same intended use, where the subject and the predicate drill systems are intended for use in various surgical procedures to remove soft and hard tissue, and biomaterials. Results of cadaveric testing have demonstrated that the addition of the proposed indications do not present any new issues of safety or effectiveness, and the systems perform as intended during surgical use, similar to the use during various other surgical procedures on currently cleared indications.