(43 days)
Not Found
No
The provided 510(k) summary describes a surgical drill system and does not contain any mention of AI, ML, image processing, or data sets typically associated with AI/ML device descriptions.
No.
Explanation: The device is intended for cutting, drilling, and manipulation of tissue and bone during surgical procedures, which are considered mechanical actions rather than therapeutic actions aimed at treating a disease or disorder.
No
The ConMed Linvatec Osprey™ Drill System is described as a surgical tool intended for cutting, drilling, and manipulation of tissue and bone, which are therapeutic actions, not diagnostic ones. Its "Intended Use" focuses on performing procedures, not on identifying conditions or diseases.
No
The device is described as a "Drill System" intended for cutting, drilling, and manipulation of tissue and bone, which inherently implies a hardware component (the drill itself). The predicate devices listed are also handpiece and motor systems, further supporting that this is a hardware device.
Based on the provided information, the ConMed Linvatec Osprey™ Drill System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, drilling, and manipulation of soft tissue and bone" in various surgical applications. This describes a surgical tool used directly on a patient's body, not a device used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents or test kits.
- Use in a laboratory setting for diagnostic purposes.
The device is a surgical drill, which falls under the category of medical devices used for surgical procedures.
N/A
Intended Use / Indications for Use
The ConMed Linvatec Osprey™ Drill System is intended for cutting, drilling, and manipulation of soft tissue and bone in the following applications: orthopedic, neurosurgical, spinal, cranial, otolaryngological, oral/maxillofacial, reconstructive, and plastic.
Product codes (comma separated list FDA assigned to the subject device)
HBC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and bone
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)
Not Found
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.
K072706, K053526, K014060, K011444, K781979
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
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically 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
K08044
510(k) SUMMARY ConMed Linvatec Osprey™ Drill System
APR - 2 2008
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 the 510(k) Number
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
Company Contact B.
Sue F. Dauterman Regulatory Affairs Specialist (727) 399-5321 Telephone (727) 399-5264 FAX
C. Device Name
| Trade Name: | ConMed Linvatec Osprey™ Drill System |
|---|---|
| Common Name: | Electric Surgical System |
| Classification Name: | Electric Cranial Drill Motor, 882.4360 |
| Proposed Class/Device: | Class II |
| Product Code: | HBC |
D. Predicate/Legally Marketed Devices
| MicroPower Handpiece System | 510(k) # K072706 | ConMed Linvatec |
|---|---|---|
| Microspeed Uni Motor System | 510(k) # K053526 | Aesculap, Inc. |
| MicroAire 1000E System | 510(k) # K014060 | MicroAire Surgical Instruments |
| Anspach eMax Drill | 510(k) # K011444 | The Anspach Effort, Inc. |
| Hall® UltraPower® Drill | 510(k) # K781979 | Linvatec Corporation (acquired |
| from AMSCO/Hall® Surgical) |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has a ribbon-like design flowing from its beak.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConMed Linvatec % Ms. Sue Dauterman Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773
APR - 2 2008
Re: K080444
Trade/Device Name: ConMed Linvatec Osprey™ Drill System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: HBC Dated: February 13, 2008 Received: February 19, 2008
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 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.
2
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K 0804444
Device Name: ConMed Linvatec Osprey™ Drill System
Indications for Use:
The ConMed Linvatec Osprey™ Drill System is intended for cutting, drilling, and manipulation of soft tissue and bone in the following applications: orthopedic, neurosurgical, spinal, cranial, otolaryngological, oral/maxillofacial, reconstructive, and plastic.
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)
NitRL. Sglm
(Division Sign-Off) for mxm
Division of General, Restorative, and Neurological Devices
510(k) Number K080444