(89 days)
The ConMed Linvatec 24k Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures and fluid irrigation during laparoscopic procedures.
The ConMed Linvatec 24k Irrigation System is a peristaltic pump system designed to automatically provide and control distention and irrigation of the operative site during arthroscopic procedures and fluid irrigation of the operative site during laparoscopic procedures using sterile fluids. The pump is used in conjunction with specific tubing sets designed for either arthroscopic or laparoscopic procedures.
The provided document, K063326 for the ConMed Linvatec 24k Irrigation System, is a 510(k) summary and associated FDA clearance letter. It focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, and technological characteristics.
As such, this document does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Medical device 510(k) submissions typically demonstrate substantial equivalence through comparisons with legally marketed predicate devices, often relying on performance testing (e.g., electrical safety, EMC, biocompatibility) to ensure the new device does not raise new questions of safety and effectiveness, rather than conducting extensive clinical studies with specified acceptance criteria and human expert evaluations like a diagnostic algorithm.
The document states:
- "Testing conducted prior to product release will assure the new device does not raise any new issues of safety and efficacy." (Page 3)
This general statement indicates that some form of internal testing was performed to verify the device's basic functionality and safety, but the details of these tests (e.g., specific acceptance criteria, test methodology, results) are not included in this summary.
Therefore, I cannot provide the requested table and detailed information based on the provided text.
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Image /page/0/Picture/1 description: The image shows the Conmed Linvatec logo. The logo consists of a stylized black and white graphic on the left, followed by the word "CONMED" in black capital letters. Below "CONMED" is the word "LINVATEC" in smaller black capital letters. There is a horizontal line above the word "LINVATEC" and below the word "CONMED".
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11311 Concept Boulevard • Largo, FL 33773-4908 • 727-392-6464 • www.llmvatec.com
January 4, 2007
510(k) SUMMARY ConMed Linvatec 24k Irrigation System
JAN 3 1 2007
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
B. Company Contact
Sue F. Dauterman Regulatory Affairs Specialist (727) 399-5321 Telephone (727) 399-5264 FAX
C. Device Name
Product Code:
| Trade Name: | ConMed Linvatec 24k Irrigation System |
|---|---|
| Common Name: | Irrigation System |
| Classification Name: | Arthroscope, 888.1100 |
| Proposed Class/Device: | Class II |
HRX
5-1
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2063326
Image /page/1/Picture/1 description: The image shows the logo for CONMED Linvatec. The logo features a stylized, abstract shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below "CONMED" is the word "LINVATEC", with a line above and below it.
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iinvatec.com
510(k) Summary 24k Irrigation System January 4, 2007
D. Predicate/Legally Marketed Devices
| 10k Irrigation SystemLinvatec Corporation | 510(k) # K033573 |
|---|---|
| 3M Fluid Irrigation SystemLinvatec Corporation (acquired from 3M Healthcare) | 510(k) #K941388 |
| Nextra Arthroscopic Pump and Shaver SystemFuture Medical Systems, Inc. | 510(k) #K954465 |
| Arthroscopy Pump, Model A107W.O.M. World of Medicine, AgMarketed by Stryker Endoscopy as FloControl | 510(k) #K030402 |
| Hall Irrigation SystemLinvatec Corporation (acquired from Hall Surgical) | 510(k) # K852143 |
| HydroFlex LI Laparoscopic Irrigation SystemDavol, Inc. | 510(k) # K961224 |
E. Device Description
The ConMed Linvatec 24k Irrigation System is a peristaltic pump system designed to automatically provide and control distention and irrigation of the operative site during arthroscopic procedures and fluid irrigation of the operative site during laparoscopic procedures using sterile fluids. The pump is used in conjunction with specific tubing sets designed for either arthroscopic or laparoscopic procedures.
F. Intended Use
The ConMed Linvatec 24k Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures and fluid irrigation during laparoscopic procedures.
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Image /page/2/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo consists of a black square with a white abstract shape inside, followed by the word "CONMED" in large, bold, black letters. Below "CONMED" is the word "LINVATEC" in smaller, black letters, with a horizontal line above and below the word.
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11311 Concept Boulevard . Largo, FL 33773-4908 .
510(k) Summary 24k Irrigation System January 4, 2007
G. Substantial Equivalence
The ConMed Linvatec 24k Irrigation System is substantially equivalent in intended use, design and technological characteristics to the 10k Irrigation System (Linvatec Corporation), 3M Fluid Irrigation System (Linvatec Corporation), Nextra Arthroscopic Pump and Shaver System (Future Medical Systems, Inc.), Arthroscopy Pump, Model A107 (W.O.M. World of Medicine, Ag), HydroFlex LI Laparoscopic Irrigation System (Davol, Inc.) and Hall Irrigation System (Linvatec Corporation). Testing conducted prior to product release will assure the new device does not raise any new issues of safety and efficacy.
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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 features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConMed Linvatec % Ms. Suc F. Dauterman Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773-4908
JAN $ 1 7007
Re: K063326
Trade/Device Name: ConMed Linvatec 24k Irrigation System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: January 4, 2007 Received: January 9, 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 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.
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Page 2 -- Ms. Sue F. Dauterman
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 Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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16.63326
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11311 Concept Boulevard • Largo, FL 33773-4908 • 727-392-6464 • www.linvatec.com
October 16, 2006
510(k) Number (if known):
Device Name: ConMed Linvatec 24k Irrigation System
Indications for Use:
The ConMed Linvatec 24k Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures and fluid irrigation during laparoscopic 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 Signal. Restorative, Division of Gen and Neurologica
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.