(26 days)
No
The description focuses on microprocessor control and pressure regulation, with no mention of AI or ML terms or functionalities.
No.
The device is used to regulate the flow of irrigation fluids during arthroscopic joint surgery to maintain pressure and clear visualization, which is a supportive function during a surgical procedure, not a direct therapeutic application treating a disease or condition.
No
The device is described as a "Fluid Management System" that controls the flow of irrigation fluids and maintains intra-articular pressure during surgery. Its primary function is to facilitate clear visualization of the surgical site, which is a supportive role during a procedure, not a diagnostic one.
No
The device description explicitly states it is a "microprocessor controlled arthroscopic fluid management system" and describes its function in controlling fluid flow and pressure, indicating it is a hardware device with embedded software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The Smith & Nephew 25 Fluid Management System is used during surgery to manage irrigation fluids within a joint. It does not analyze any biological samples taken from the patient.
- The intended use is for surgical support. The description clearly states its purpose is to regulate fluid flow and maintain pressure during arthroscopic surgery for visualization. This is a surgical device, not a diagnostic one.
- There is no mention of analyzing biological samples or providing diagnostic information. The device's function is purely mechanical and related to fluid management during a procedure.
N/A
Intended Use / Indications for Use
The Smith & Nephew 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.
Product codes
HRX
Device Description
The Smith & Nephew 25 Fluid Management System is a microprocessor controlled arthroscopic fluid management system that is designed for controlled delivery of irrigation fluids during intra-articular surgery. The system controls joint pressure independently of aspiration rate over a wide range of flow rates. The system will maintain control of intra-articular pressure regardless of varying outflow rates and may be used with any arthroscopic inflow cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip and small joints
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)
The performance testing and the software verification and validation conducted on the Smith & Nephew 25 Fluid Management System demonstrates substantial equivalence to the Smith & Nephew InteliJET™ HERMES-Ready, cleared in K031605 and the Smith & Nephew InteliJET™ Fluid Management System cleared in K050580. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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JUN 1 5 2005
We are
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SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew 25 Fluid Management System
Date Prepared: May 18, 2005
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Janice Haselton
Sr. Regulatory Affairs Specialist
Phone: (978) 749-1494
FAX: (978) 749-1443)
C. Device Name
| Trade Name: | Smith & Nephew 25 Fluid Management System |
|---|---|
| Common Name: | Arthroscopic Fluid Management System |
| Classification Name:Arthroscope |
D. Predicate Devices
The Smith & Nephew 25 Fluid Management System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew InteliJET™ HERMES-Ready (K031605) and Smith & Nephew InteliJET™ Fluid Management Systems (K050580).
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K05/326
Page 2 of 2
E. Description of Device
The Smith & Nephew 25 Fluid Management System is a microprocessor controlled arthroscopic fluid management system that is designed for controlled delivery of irrigation fluids during intra-articular surgery. The system controls joint pressure independently of aspiration rate over a wide range of flow rates. The system will maintain control of intra-articular pressure regardless of varying outflow rates and may be used with any arthroscopic inflow cannula.
F. Intended Use
The Smith & Nephew 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.
G. Comparison of Technological Characteristics
The Smith & Nephew 25 Fluid Management System is substantially equivalent in design, materials, function and intended use to the Smith & Nephew InteliJET™ HERMES-Ready, cleared in K031605 and the Smith & Nephew InteliJET™ Fluid Management System cleared in K050580. The proposed and the prodicate devices both have the same intended use and the same fundamental scientific technology.
H. Summary Performance Data
The performance testing and the software verification and validation conducted on the Smith & Nephew 25 Fluid Management System demonstrates substantial equivalence to the Smith & Nephew InteliJET™ HERMES-Ready, cleared in K031605 and the Smith & Nephew InteliJET™ Fluid Management System cleared in K050580. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure.
JUN 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janice Haselton Sr. Regulatory Affairs Specialist Endoscopy Division Smith & Nephew Incorporated 150 Minuteman Road Andover, Massachusetts 01810
Re: K051326
Trade/Device Name: Smith & Nephew 25 Fluid Management System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: June 8, 2005 Received: June 8, 2005
Dear Ms. Haselton:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(t) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1976, the enated with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Fee) that do not require act the general controls provisions of the Act. The Y ou may, therefore, market the device, public requirements for annual registration, listing of general Controls provisions of the fiest 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 and It may be subject to such additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Features concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase be advised that I Dri 3 issuanted or our device complies with other requirements of the Act that IDA has made a decommanding administered by other Federal agencies. You must of any I ederal statutes and regarations and limited to: registration and listing (21 Comply with an the Net 8 requirements, and manufacturing practice requirements as set CITY art 607), adomig (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Ms. Janice Haselton
This letter will allow you to begin marketing your device as described in your Section 510(k) rms reket 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Emm A. Th
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko5-1326
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew 25 Fluid Management System
Indications For Use:
The Smith & Nephew 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.
Prescription Use
(Per 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K051326
Smith & Nephew 25 Page 15 of 510