(146 days)
No
The document describes a powered surgical instrument system with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
No.
The device description indicates it is a powered instrument system (drills, saws) for cutting tissue and bone, which are surgical tools, not therapeutic devices.
No
The device is described as a powered instrument system for cutting soft tissue and bone during surgical procedures, not for diagnosing conditions.
No
The device description explicitly lists numerous hardware components including a console, power cord, footswitch, handpieces, shavers, blades, burs, etc., indicating it is a hardware system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used for "cutting of soft tissue and bone" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a system of powered instruments (drills, saws, handpieces) used for surgical cutting.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
The E9000 System is a surgical instrument system used during surgery, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The E9000 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, Medial Sternotomy, Spinal and Plastic/Reconstructive surgical procedures.
Product codes
HRX
Device Description
The E9000 System is a combination drive system and irrigation console, which consists of an AC powered drive/pump console, a power cord, a footswitch, a sterilizable handpiece cord, various motorized handpieces, associated shavers, blades, burs, bur guards, routers, irrigation tubing sets, and bur tips.
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 has been done to prove safety and effectiveness of the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K990254, K981636 & K981637, K971059
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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" in bold, black letters on the right. The geometric shape is a square with three smaller squares inside, each rotated 45 degrees relative to the outer square. The word "Linvatec" is written in a sans-serif font.
Largo, FL 33773-4908 727-392-6464 11311 Concent Boule
JUL 15 1999
June 28, 1999
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 E9000 System, 510(k) Number K990524.
Submitter A.
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Laura Seneff Manager, Regulatory Affairs
Device Name c.
| Trade Name: | : | E9000 System |
|---|---|---|
| Common Name | : | Integrated Drive/Pump System |
| Classification Name | : | Surgical, ENT (electric or |
| pneumatic), including | ||
| handpiece - 874.4250 | ||
| Electric cranial drill motor - | ||
| 882.4360 | ||
| Infusion Pump - 880.5725 | ||
| Surgical instrument motors and | ||
| accessories/attachments - 878.4820 | ||
| Bone cutting instrument and | ||
| accessories - 872.4120 |
1
Summary of Safety and Effectiveness E9000 System 510(K)# K990524 June 28, 1999 Page 2 of 4
D. Predicate/Legally Marketed Devices
Integrated Drive/Pump System (Hall E9000 System) Linvatec Corporation
Universal Drive System (MicroChoice System) Linvatec Corporation
Hall Sternum Saw Linvatec/Hall Surgical
E. Device Description
The E9000 System is a combination drive system and irrigation console, which consists of an AC powered drive/pump console, a power cord, a footswitch, a sterilizable handpiece cord, various motorized handpieces, associated shavers, blades, burs, bur guards, routers, irrigation tubing sets, and bur tips.
F. Intended Use
The E9000 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, Medial Sternotomy, Spinal and Plastic/Reconstructive surgical procedures.
2
Summary of Safety and Effectiveness E9000 System 510(K)# K990524 June 28, 1999 Page 3 of 4
Substantial Equivalence G.
The E9000 System is substantially equivalent in design, function and intended use to the Hall E9000 Integrated Drive/Pump System (Linvatec Corporation), the MicroChoice Universal Drive System (Linvatec Corporation) and the Hall Sternum Saw (Linvatec/Hall Surgical).
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
Summary of Safety and Effectiveness E9000 System 510 (K) # K990524 June 28, 1999 Page 4 of 4
HALLE 9000 SYSTEM DEVICE E9000 SYSTICM MIGROGHOIGE दिसम्मान आमिश्रम्बद्धा देतु (ENTERMARASEN) IDEADHD Crassiste SA STICIM INTENDED Resection of tissue and bone during Resection of soft tissue and Resection of soft tissue and bone Cutting of bone beginning USE arthroscopic, orthopedic, bone during orthopedic, cutting during arthroscopic, the suprasternal notch or t otolaryngological, otololaryngological, orthopedic, oral/maxillofacial, xiphoid process during a oral/maxillofacial, hand, foot, neurological and spinal medial sternotomy. otoloaryngological, hand, foot, neurological, spinal, surgical procedures. neurological and plastic/reconstructive and medial plastic/reconstructive surgical sternotomy surgical procedures. procedures. K990254 510(K) K981636 & K981637 K971059 K862474 NUMBER ACCESSORIES Blades, Burs, Routers, Attachments, Blades, Burs, Routers, Blades, Battery Pack Blades, Burs, Attachments, Foot Bur Guards, Bur Tips, Irrigation Attachments, Bur Guards, Bur Control Tubing Sets, Foot Control, Shaver Tips, Irrigation Tubing Sets, Adapter, Universal Cord Foot Control, Shaver Adapter, Universal Cord Drive/Pump Console, High DEVICE Drive/Pump Console, Cranial Universal Drive Console, Micro Handpiece COMPONENT Perforator, High Speed Drill Speed Shaver Handpiece, High Joint Handpiece, Standard Medium Speed Drill, Reciprocating Speed Drill, Cranial Handpiece, Full-Function Saw, Oscillating Saw, Low Speed Perforator, Micro Handpiece, Handpiece, Low Speed Drill, Drill, Modular Handpiece, Sagittal Saw Medium Speed Drill, High Speed Wiredriver, Large Shaver Drill, Oscillating Saw, Sagittal Handpiece, Full-Function Saw, Reciprocating Saw, Handpiece, Small Shaver Wiredriver Handpiece, Micro Handpiece MATERIAL Aluminum, Stainless Steel Aluminum, Stainless Steel Aluminum, Stainless Steel Stainless Steel
CHART OF SIMILARITIES AND DISSIMILARITIES
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Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three horizontal lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1999
Ms. Laura Seneff Manager Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K990524 Trade Name: E9000 System Regulatory Class: II Product Code: HRX Dated: May 27, 1999 Received: May 28, 1999
Dear Ms. Seneff:
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 (QS) 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.
5
Page 2 - Ms. Laura Seneff
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) 594-4659. 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,
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
6
June 28, 1999
Page 1 of 1
510(k) Number (if known): K990524
Device Name: E9000 System
Indications for Use:
The E9000 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, Medial Sternotomy, Spinal and Plastic/Reconstructive surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ L
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices K990524
510(k) Number __