(104 days)
Integrated Drive/Pump System functions as a powered The instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and bone. The fields of application include: Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.
The Integrated Drive/Pump System is a combination of the Linvatec Universal Drive System and Hall® Irrigation System with the addition of three new handpieces used in Otolaryngology, Neurological Surgical, Orthopedic, and Spinal procedures.
The Integrated Drive/Pump System consists of an AC powered drive/pump console, a sterilizable handpiece cord, a high speed handpiece, high speed drill, cranial perforator, various blades, burs, bur guards, irrigation tubing sets, shaver adapter, and a footswitch.
The provided text describes the "Integrated Drive/Pump System" by Linvatec Corporation and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a study detailing device performance against such criteria.
The document states:
- "Testing has been done to prove safety and effectiveness of the devices." (Page 3 of 5, Section G)
But it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Details about experts, ground truth establishment, or adjudication methods.
- Information about MRMC or standalone studies.
- Training set details.
Therefore, I cannot provide the requested table and detailed study information based on the input text. The document is a 510(k) Summary of Safety and Effectiveness, which typically focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results with acceptance criteria.
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B. 9/16/26.
AUG 20 1998
Image /page/0/Picture/2 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 chevrons inside. The word "Linvatec" is in a bold, sans-serif font.
11311 Concept Boulevard Largo, Florida 33773-4908 813 392-6464
May 7, 1998
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device In accordance with CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for Submitting the 510(x) Summary on 510(k) Number 981636
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
B. Company Contact
Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs
Device Name C.
Trade Name: . Common Name . Classification Names ..
Integrated Drive/Pump System Integrated Drive/Pump System Surgical, ENT (electric or pneumatic), including handpiece Electric 874.4250 । cranial drill motor - 882.4360 Infusion Pump - 880.5725 Surgical instrument motors and accessories/attachments - 878.4820
Predicate/Legally Marketed Devices D .
Universal Drive System Linvatec Corporation
Hall® Irrigation System Linvatec Corporation
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Summary of Safety and Effectiveness Integrated Drive/Pump System 510 (k) # May 7, 1998 Page 3 of 5
Substantial Equivalence G.
Integrated Drive/Pump System is substantially The equivalent in design, function and intended use to the Universal Drive System (Linvatec Corporation) Hall® TPS Total Irrigation System (Linvatec Corporation), Performance System (Stryker Endoscopy), and Hummer 2® (Stryker Endoscopy) .
Testing has been done to prove safety and effectiveness of the devices.
The similarities/dissimilarities to the predicates are shown in the attached table.
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Summary of Safety and Effectiveness Integrated Drive/Pump System 510 (k) # May 7, 1998 Page 2 of 5
D. Predicate/Legally Marketed Devices (Con't)
TPS Total Performance System Stryker Endoscopy
Hummer 2® Stryker Endoscopy
Device Description E.
The Integrated Drive/Pump System is a combination of the Linvatec Universal Drive System and Hall® Irrigation System with the addition of three new handpieces used in Otolaryngology, Neurological Surgical, Orthopedic, and Spinal procedures.
The Integrated Drive/Pump System consists of an AC powered drive/pump console, a sterilizable handpiece cord, a high speed handpiece, high speed drill, cranial perforator, various blades, burs, bur guards, irrigation tubing sets, shaver adapter, and a footswitch.
F. Intended Use
The Integrated Drive/Pump System functions as a powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform The fields of resection of soft tissue and bone. application include: Surgical, Orthopedic, and Spinal surgical procedures.
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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 symbol that resembles a human figure in profile, with three overlapping heads or faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1998
Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs Linvatec Coporation 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K981636 Trade Name: Integrated Drive/Pump System Regulatory Class: II Product Code: HRX Dated: July 28, 1998 Received: July 29, 1998
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
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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.
$\alpha$
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices .... Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/5/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 made up of three nested chevrons, each with small circles at the corners. The word "Linvatec" is written in a bold, sans-serif font.
11311 Concept Roulevard - Largo, Florida 33773-4908 - 813-392-646-4
May 7, 1998
Page 1 of 1
510(k) Number (if known): 1598/636
Device Name: Integrated Drive/Pump System
Indications for Use:
Integrated Drive/Pump System functions as a powered The instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and bone. The fields of application include: Otolaryngology, Neurological Surgical, Orthopedic, and Spinal surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
Over-the-Counter Use
(Per 21 CFR 801.109)
Thatcher Rhodes
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices K98/656
510(k) Number
§ 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.