(59 days)
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Not Found
No
The summary describes a reusable cannula used with a fluid management system to regulate fluid flow and pressure during arthroscopic surgery. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on biocompatibility and flow analysis, not algorithmic performance.
No
The device is described as a reusable cannula used to establish portals and regulate fluid flow during arthroscopic procedures for clear visualization, not to directly treat a disease or condition.
No
The device, Dyonics InteliJet Reusable Cannulas, is used to establish portals and regulate fluid flow during arthroscopic surgery for visualization and distention. Its purpose is to facilitate a surgical procedure, not to diagnose a condition or disease.
No
The device description clearly states it is a "Reusable Cannula," which is a physical, hardware component used in surgical procedures. It is designed to work with a fluid management system, but the cannula itself is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used during arthroscopic surgical procedures to manage irrigation fluid flow and maintain pressure for visualization. This is a surgical tool used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description reinforces its use in establishing surgical portals and working with a fluid management system during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Dyonics InteliJet Reusable Cannulas are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The Dyonics InteliJet Reusable Cannulas are indicated for use with the Dyonics InteliJet Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
Product codes
FRN
Device Description
The Dyonics InteliJet Reusable Cannulas are used to establish portals to the surgical site during arthroscopic surgical procedures. The Dyonics InteliJet Reusable Cannulas are designed to work in conjunction with the InteliJet Fluid Management System to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The material change defined in this premarket notification submission has no impact on the designed safety and efficacy of the Dyonics InteliJet Reusable Cannula. This conclusion is supported by the following testing: biocompatibility and flow curve analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The predicate device for this submission is the currently marketed Dyonics InteliJet Reusable Cannula.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
510(k) Summary Smith & Nephew, Inc., Endoscopy Division Dyonics InteliJet™ Reusable Cannula
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. elephone: 508-749-1000
Smiths = Nephew
Substantial Equivalence:
The material change defined in this premarket notification submission has no impact on the designed safety and efficacy of the Dyonics InteliJet Reusable Cannula. This conclusion is supported by the following testing: biocompatibility and flow curve analysis.
Predicate Device:
The predicate device for this submission is the currently marketed Dyonics InteliJet Reusable Cannula.
Summary of Device Function:
The Dyonics InteliJet Reusable Cannulas are used to establish portals to the surgical site during arthroscopic surgical procedures. The Dyonics InteliJet Reusable Cannulas are designed to work in conjunction with the InteliJet Fluid Management System to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
Intended Use of Device:
The Dyonics InteliJet Reusable Cannulas are indicated for use with the Dyonics InteliJet Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
Comparison of Technological Characteristics of Predicate Device:
The basic technologies, design and function of the Smith & Nephew Dyonics InteliJet Cannulas are not changed by the material modification described in this Premarket Notification Submission. The material modification defined in this submission raises no new issues of safety and effectiveness.
Subnah J. Connor
Deborah J. Connors Sr. Regulatory Affairs Specialist
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, rendered in black lines. The eagle is positioned within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1998
Ms. Deborah J. Connors Senior, Requlatory Affairs Specialist Endoscopy Division Smith & Nephew, Incorporated 160 Dascomb Road Andover, Massachusetts 01810
K980092 Re: Trade Name: Smith & Nephew Dyonics Intelijet Reusable Cannulas Requlatory Class: II Product Code: FRN Dated: January 8, 1998 Received: January 9, 1998
Dear Ms. Connors:
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, Druq, 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.
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Page 2 - Ms. Connors
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,
Celia M. Witten, Ph.D.
- 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
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K980092 510(k) Number :
Device Name : Smith & Nephew, Inc., Dyonics InteliJet™ Reusable Cannulas
Indications for Use :
The Dyonics InteliJet Reusable Cannulas are indicated for use with the InteliJet Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small joints to regulate flow of irrigation fluids through the joint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ion Sign Off
(Division General Restorative Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)