(90 days)
No
The description mentions a "microprocessor controlled pump system" but does not include any terms or descriptions indicative of AI or ML, such as "AI," "ML," "deep learning," "neural network," or descriptions of training/test data sets.
No
The device is an irrigation system used to provide fluid distension and irrigation during surgical procedures, which is a supportive function rather than directly treating a medical condition.
No
Explanation: The device is described as an irrigation system that provides fluid distension and irrigation to the operative site during surgical procedures. Its function is to facilitate the surgical process, not to diagnose a condition or disease.
No
The device description explicitly states it is a "peristaltic, microprocessor controlled pump system," indicating it is a hardware device with software control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide controlled fluid distension and irrigation during surgical procedures (arthroscopic and laparoscopic). This is a therapeutic/surgical support function, not a diagnostic one.
- Device Description: The description confirms it's a pump system for delivering fluid during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient during a procedure and does not perform any such analysis.
N/A
Intended Use / Indications for Use
The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.
Product codes
HRX, GCJ
Device Description
The Linvatec 10k Irrigation System is a peristaltic, microprocessor controlled pump system designed to provide liquid distention and irrigation during arthroscopic and laparoscopic procedures. The pump is used in conjunction with specific tubing sets designed for either arthroscopic or laparoscopic procedures.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Apex Universal Irrigation System 510(K) # K961590, Hydro-Flex Li Laparoscopic Irrigation System: 510(K) # K961224
Reference Device(s)
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
§ 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
033573 1/2
FEB 1 1 2004
November 03, 2003
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 Linvatec 10k Irrigation System 510(k) Number _________________________________________________________________________________________________________________________________________________________
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
Company Contact B.
Laura D. Krejci, RAC Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
| Trade Name: | Linvatec 10k Irrigation System |
|---|---|
| Common Name: | Irrigation System |
| Classification Names: | Arthroscope, 888.1100 |
| Endoscope and Accessories, 876.1500 | |
| Proposed Class/Device: | |
| Product Code: | Class II |
| HRX, GCJ |
1
Summary of Safety and Effectiveness 10K Irrigation System 510(k) # _ November 03, 2003
Predicate/Legally Marketed Devices D.
Apex Universal Irrigation System 510(K) # K961590 Linvatec Corporation
Hydro-Flex Li Laparoscopic Irrigation System: 510(K) # K961224 Davol Incorporated
Device Description ய்
The Linvatec 10k Irrigation System is a peristaltic, microprocessor controlled pump system designed to provide liquid distention and irrigation during arthroscopic and laparoscopic procedures. The pump is used in conjunction with specific tubing sets designed for either arthroscopic or laparoscopic procedures.
F. Intended Use
The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.
G. Substantial Equivalence
The Linvatec 10k Irrigation System is similar in intended use, design and technological characteristics as the Apex® Universal Irrigation System (Linvatec Corporation) and Hydro-Flex Li Laparoscopic Irrigation System (Davol Incorporated). Testing has been conducted to assure the differences in the new device and the predicate devices do not raise any new issues of safety and efficacy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is the department's symbol, which is a stylized version of the Caduceus, a symbol often associated with medicine and healthcare. The symbol consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2004
Ms. Laura D. Krejci, RAC Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K033573
Tradc/Device Name: Linvatec 10k Irrigation System Regulation Number: 21 CFR 888.1100, 21 CFR 876.1500 Regulation Name: Arthroscope, Endoscope and accessories Regulatory Class: II Product Code: HRX, GCJ Dated: November 3. 2003 Received: November 13, 2003
Dear Ms. Krejci:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the enactment date of the Medical Device Amendments, or to econiner to 1125 2011-125 20:12:12 in accordance with the provisions of the Federal Food, Drug, de rioss that have tective approval of a premarket approval application (PMA). and coometry refore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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.
3
Page 2 – Ms. Laura D. Krejci, RAC
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 p arketed 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
November 03, 2003
510(k) Number (if known): KOBBS 73
Device Name: Linvatec 10k Irrigation System
Indications for Use:
The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.
(Please DO NOT WRITE BELOW THIS LINE - Continue on ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Use_ Prescription Use_ √ он (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Muriam C Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K033573