(86 days)
Not Found
No
The description focuses on mechanical components, power systems, and software upgrades for compatibility, with no mention of AI or ML functionalities.
No
The device is described as a powered instrument system for cutting soft tissue and bone, which is a surgical tool, not a device intended for therapy or treatment of a disease or condition in itself.
No
Explanation: The device is described as a powered instrument system for cutting soft tissue and bone, used in various surgical procedures. Its function is to perform cutting, not to diagnose.
No
The device description explicitly lists hardware components such as a drive console, handpiece cord, motorized handpieces, shavers, blades, burrs, drills, routers, and a foot switch. While there is a software modification mentioned, the device is clearly a system of both hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone." This describes a surgical tool used directly on a patient during a procedure.
- Device Description: The description details components like a drive console, handpieces, blades, burrs, drills, routers, and a foot switch. These are all physical instruments used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Universal Drive System does not involve any such activities.
The device is a surgical instrument system, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Universal Drive System functions as a powered instrument The onload brills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of include: Orthopedic, Arthroscopic, application Otolaryngological, Oral/Maxillofacial, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Universal Drive System is a combination of the entire MicroChoice® System and component Linvatec handpieces/blades/burrs of the Apex® Universal Drive System. Both systems and their intended uses are cleared by MicroChoice 510(k) #K942660 and Apex Universal Drive System 510(k)'s #K944476 & #K964548.
The Universal Drive System consists of a AC powered drive console, a sterilizable handpiece cord, various motorized handpieces, various shavers, blades, burrs, drills, routers, and a foot switch.
The modification will take place within the MicroChoice drive console power unit software. A computer chip will be upgraded to allow additional motorized handpieces from the Apex Universal Drive system for orthopedic and arthroscopic type procedures.
Three handpieces from the Apex Universal Drive System will be modified with a detachable handpiece cord. The detachable handpiece cord will allow the "Apex style" handpieces to run on the same console as the MicroChoice original handpieces. All new handpieces will perform as described in the previous 510(k) submissions.
The accessories including shavers, blades, burrs, drills, and routers from the Apex Universal Drive System will be used in addition to the MicroChoice System accessories. The shavers will have diameters of 2.0-6.0mm and lengths of 75-200mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, 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)
Testing has been done to prove safety and effectiveness of the devices.
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.
Not Found
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.
MicroChoice 510(k) #K942660, Apex Universal Drive System 510(k)'s #K944476 & #K964548
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.
0
Image /page/0/Picture/0 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three angled lines inside.
JUN 18 1997
11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax 813 399-5264
Carol A. Weideman, Ph.D.
Manager, Regulatory and Clincal Allans
971059
March 21, 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Universal Drive System, 510(k) Number
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Carol A. Weideman, Ph.D. Manager, Regulatory and Clinical Affairs
Device Name C.
| Trade Name: | Universal Drive System |
|---|---|
| Common Name: | Drive System |
| Classification Name: | Instrument, Surgical, |
| Orthopedic, AC Powered Motor | |
| and accessory/Attachment | |
| 878.4820 |
Predicate/Legally Marketed Devices D.
Hall MicroChoice® Electric Powered System Linvatec Corporation
Apex® Universal Drive System Linvatec Corporation
TPS Total Performance System Stryker Endoscopy
Adapteur Power System™ Arthrex Inc.
Image /page/0/Picture/20 description: The image contains a single digit, specifically the number 4. The number is written in a simple, sans-serif font. The digit is slightly blurred, suggesting it may be a close-up or a low-resolution image.
Image /page/0/Picture/21 description: The image shows the logo for Bristol-Myers Squibb Company. On the left is a geometric design that looks like a stylized flower or star. To the right of the design is the text "A Bristol-Myers Squibb Company" in a serif font.
1
Summary of Safety and Effectiveness Universal Drive System 510(k) # March 21, 1997 Page 2 of 4
Device Description E.
The Universal Drive System is a combination of the entire MicroChoice® System and component Linvatec handpieces/blades/burrs of the Apex® Universal Drive System. Both systems and their intended uses are cleared by MicroChoice 510(k) #K942660 and Apex Universal Drive System 510(k)'s #K944476 & #K964548.
The Universal Drive System consists of a AC powered drive console, a sterilizable handpiece cord, various motorized handpieces, various shavers, blades, burrs, drills, routers, and a foot switch.
The modification will take place within the MicroChoice drive console power unit software. A computer chip will be upgraded to allow additional motorized handpieces from the Apex Universal Drive system for orthopedic and arthroscopic type procedures.
Three handpieces from the Apex Universal Drive System will be modified with a detachable handpiece cord. The detachable handpiece cord will allow the "Apex style" handpieces to run on the same console as the MicroChoice original handpieces. All new handpieces will perform as described in the previous 510(k) submissions.
The accessories including shavers, blades, burrs, drills, and routers from the Apex Universal Drive System will be used in addition to the MicroChoice System accessories. The shavers will have diameters of 2.0-6.0mm and lengths of 75-200mm.
F. Intended Use
Drive System functions as a Universal powered The instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Otolaryngological, Oral/Maxillofacial, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.
2
Summary of Safety and Effectiveness Universal Drive System 510 (k) # March 21, 1997 Page 3 of 4
G. Substantial Equivalence
The Universal Drive System is substantially equivalent in design, function and intended use to the Hall MicroChoice Electric Powered System (Linvatec Corporation), Apex Universal Drive System (Linvatec Corporation), TPS Total Performance System (Stryker Endoscopy), and Adapteur Power System™ (Arthrex Inc.).
Testing has been done to prove safety and effectiveness of the devices.
The similarities/dissimilarities to the predicates are shown in the attached table.
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" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 18 1997
Carol A. Weideman, Ph.D. Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Re: K971059 Trade Name: Universal Drive System Regulatory Class: II Product Code: HRX Dated: March 21, 1997 Received: March 24, 1997
Dear Dr. Weideman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Carol A. Weideman, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
fo selle
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
March 21, 1997 ---------------------------------------------------------------------------------------------------------------------------------------------------------------
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rest of the program and the provinsity of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of th
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|--|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
- Device Name: Universal Drive System__
Indications for Use:
The Universal Drive System functions as a powered instrument The onload brills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of include: Orthopedic, Arthroscopic, application Otolaryngological, Oral/Maxillofacial, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Om
Division of General Restorative Devices K9 71059
510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
Over-the-Counter Use_
(Optional Format 1-2-96)
LINVATEC/HALL SURGICAL HWATECHPACE COMMON PORMATION PROPEMETION PROPERTIC
This information is exempt from This information is extemptions 3 and 4 disclosure under Exemption Act isclosure under Exempliation Act.
of the Freedom of Information Act.