(30 days)
Not Found
No
The description focuses on the mechanical function of powered surgical instruments and does not mention any AI/ML capabilities or related concepts like image processing, data analysis, or learning algorithms.
No.
The device is described as a powered instrument system (drills, saws) used for cutting soft tissue and bone, which is a surgical tool rather than a device intended to treat or resolve a medical condition.
No.
The device descriptions indicate that these systems are powered instruments for cutting soft tissue and bone during surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it is an "electric pencil grip handheld" and is used in conjunction with "controllers," indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems are powered surgical instruments used for cutting soft tissue and bone during various surgical procedures.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples or providing diagnostic information about a patient's health status. The device's function is purely mechanical and surgical.
Therefore, this device falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MicroPower® Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.
The MicroPower® OralMax Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.
The MicroChoice® Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, otolaryngological, oral/maxillofacial, hand, foot, neuro, and plastic/reconstructive surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRX, HBC, DZI
Device Description
The MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems are electric pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A cord connects the handpiece to the controller that supplies power to the device. The handpieces have a lever or footswitch that is used to actuate the device. The drills use a wide variety of attachments, including bur guards, drill bits and burs. The saws use a wide variety of blades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Testing conducted prior to product release assures that the new devices do not raise any new issues of safety and efficacy.
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.
K971059, K060198, K060260, K060270
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.
Not Found
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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OCT 2 4 2007
510(k) SUMMARY
MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number __ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Sue F. Dauterman Regulatory Affairs Specialist (727) 399-5321 Telephone (727) 399-5264 FAX
C. Device Name
Common Name: Surgical Drill System
Proposed Class/Device: Class II
| Trade Name | Classification
Panel | Classification Name | Product
Code |
|-------------------------------------------|-------------------------|------------------------------------------------------|-----------------|
| MicroChoice Drills
and Saws | Orthopedic | Arthroscope, 888.1100 | HRX |
| MicroPower Drills
and Saws | Neurology | Electric cranial drill motor,
882.4360 | HBC |
| MicroPower
OralMax High
Speed Drill | Dental | Bone cutting instrument and
accessories, 872.4120 | DZI |
1
510(k) Summarv
MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems
D. Predicate/Legally Marketed Devices
| 510(k) Name | 510(k) # | Owner |
|---|---|---|
| Universal Drive System | K971059 | Linvatec |
| Corporation | ||
| MicroPower Hand Piece: Medium Speed | ||
| Drill, Sagittal Saw, Reciprocating Saw, and | ||
| Oscillating Saw | K060198 | Linvatec |
| Corporation | ||
| MicroPower Hand Piece:High Speed Drill | K060260 | Linvatec |
| Corporation | ||
| MicroPower Hand Piece:Oral Max High | ||
| Speed Drill | K060270 | Linvatec |
| Corporation |
E. Device Description
The MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems are electric pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A cord connects the handpiece to the controller that supplies power to the device. The handpieces have a lever or footswitch that is used to actuate the device. The drills use a wide variety of attachments, including bur guards, drill bits and burs. The saws use a wide variety of blades.
F. Intended Use
| Name | Intended Use |
|---|---|
| MicroPower® | |
| Handpiece | |
| System | The MicroPower® Handpiece System functions as a |
| powered instrument system consisting of drills, saws | |
| and associated handpieces to perform cutting of soft | |
| tissue and bone. The fields of application include: | |
| orthopedic, arthroscopic, neurosurgical, | |
| otolaryngological, plastic/reconstructive, and | |
| oral/maxillofacial procedures. |
2
| Name | Intended Use |
|---|---|
| MicroPower® | |
| OralMax | |
| Handpiece | |
| System | The MicroPower® OralMax Handpiece System |
| functions as a powered instrument system consisting | |
| of drills, saws and associated handpieces to perform | |
| cutting of soft tissue and bone. The field of application | |
| includes only oral/maxillofacial. | |
| MicroChoice® | |
| Handpiece | |
| System | The MicroChoice® Handpiece System functions as a |
| powered instrument system consisting of drills, saws | |
| and associated handpieces to perform cutting of soft | |
| tissue and bone. The fields of application include: | |
| orthopedic, arthroscopic, otolaryngological, | |
| oral/maxillofacial, hand, foot, neuro, and | |
| plastic/reconstructive surgical procedures. |
G. Technological Characteristics
The MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece Systems are identical to the predicate devices cleared in the original submissions except for an update to the handpiece identification mechanism as detailed in Section 9 of this submission. These modifications do not affect the device's intended use or performance specifications in a manner that raises any new issues regarding safety and effectiveness.
H. Substantial Equivalence
The MicroPower®, MicroPower® OralMax, and MicroChoice® Handpiece · Systems are substantially equivalent in intended use, design and technological characteristics to the below listed systems.
| Proposed Name | Predicate 510(k) Name | 510(k) # |
|---|---|---|
| MicroChoice® Handpiece | ||
| System | Universal Drive System | K971059 |
| MicroPower® Handpiece | ||
| System | MicroPower Hand Piece: Medium | |
| Speed Drill, Sagittal Saw, | ||
| Reciprocating Saw, and | ||
| Oscillating Saw | K060198 | |
| MicroPower Hand Piece:High | ||
| Speed Drill | K060260 | |
| MicroPower® OralMax | ||
| Handpiece System | MicroPower Hand Piece:Oral Max | |
| High Speed Drill | K060270 |
Testing conducted prior to product release assures that the new devices do not raise any new issues of safety and efficacy.
3
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, featuring four parallel lines that curve and taper towards the right side of the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2007
ConMed Livatec % Ms. Sue F. Dauterman Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K072706
Trade/Device Name: MicroPower® Handpiece System MicroPower® OralMax Handpiece System MicroChoice® Handpiece System
Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: September 21, 2007 Received: September 24, 2007
Dear Ms. Dauterman:
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
4
Page 2 - Ms. Sue F. Dauterman
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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K072700 510(k) Number (if known):
Device Name: MicroPower® Handpiece System
Indications for Use:
The MicroPower® Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.
Prescription Use_X__ AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
of (Division Sign-Off)
(Division Degand Neurological Devices
510(k) Number 16072706
6
KO72706 510(k) Number (if known):
Device Name: MicroPower® OralMax Handpiece System
Indications for Use:
i
The MicroPower® OralMax Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.
Prescription Use_X__ AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
7
510(k) Number (if known): K072706
Device Name: MicroChoice® Handpiece System
Indications for Use:
The MicroChoice® Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, otolaryngological, oral/maxillofacial, hand, foot, neuro, and plastic/reconstructive surgical procedures.
Prescription Use_X____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Number