(50 days)
The Dyonics® InteliJET™ Inflow/Outflow Cannula is 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.
The Dyonics InteliJET Inflow/Outflow Cannula is used to establish a portal to the surgical site during arthroscopic surgical procedures. The Dyonics InteliJET Inflow/Outflow Cannula is designed to work in conjunction with the InteliJET Fluid Management System to maintain intraarticular pressure for uniform distention and clear visualization of the surgical site.
This 510(k) summary describes a device, the Dyonics® InteliJET™ Inflow/Outflow Cannula, which is a hardware component. The provided text does not include any information about an AI/ML powered device, a study designed to prove the device meets acceptance criteria, or acceptance criteria itself. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, principle of operation, and intended use for regulatory clearance. It does not contain the type of performance evaluation details requested for AI/ML devices. Therefore, I cannot generate the requested table and answer the study-related questions.
{0}------------------------------------------------
981156
510(k) Summary Smith & Nephew, Inc., Endoscopy Division Dyonics® InteliJET™ Inflow/Outflow Cannula
Substantial Equivalence:
Endoscopy Division
mith & Nephew Inc Dascomb Road, Andover, MA 01810 U.S.A. lenhone: 978-749-1000
Smith = Nephew
The Dyonics InteliJET Inflow/Outflow Cannula is substantially equivalent to the 3M™ Inflow/Outflow Pressure Sensing Scope Sheath System in design, materials, principal of operation and intended use. Both cannulas work with their respective control units to maintain and optimize joint distention via a pressure sensing feedback mechanism.
Furthermore, the InteliJET Inflow/Outflow Cannula is substantially equivalent in materials, function and intended use to currently offered InteliJET Reusable Cannulas.
Predicate Device:
The predicate devices for this submission are the currently marketed Dyonics InteliJET Reusable Cannulas and the 3M™ Inflow/Outflow Pressure Sensing Scope Sheath System.
Summary of Device Function:
The Dyonics InteliJET Inflow/Outflow Cannula is used to establish a portal to the surgical site during arthroscopic surgical procedures. The Dyonics InteliJET Inflow/Outflow Cannula is designed to work in conjunction with the InteliJET Fluid Management System to maintain intraarticular pressure for uniform distention and clear visualization of the surgical site.
Intended Use of Device:
The Dyonics InteliJET Inflow/Outflow Cannula is indicated for use with the InteliJET Fluid Management System during arthroscopic surgical procedures of the knee, shoulder and small ioints 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 Dyonics InteliJET Inflow/Outflow Cannula is substantially equivalent to technologies, design and function found in the current InteliJET Reusable Cannulas and the 3M Inflow/Outflow Pressure Sensing Scope Sheath System. The minor differences between these devices raise no new issues of safety and effectiveness.
Deborah J. Currin
Deborah J. Connors Senior Regulatory Affairs Specialist
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Ms. Deborah J. Connors ·Senior Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Incorporated 160 Dascomb Road Andover, Massachusetts 01810
K981156 Re: Dyonics® InteliJET™ Inflow/Outflow Cannula Trade Name: Regulatory Class: II Product Code: HRX Dated: March 30, 1998 Received: March 31, 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ರ್ಕೆ 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 In addition, FDA may publish further announcements action. 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 lat for daminge under the Float work on
{2}------------------------------------------------
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 requlation (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,
Colin M. Whitten, Ph.D., M.
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
{3}------------------------------------------------
510(k) Number : K 9 8 // 5 b
Device Name : Dyonics® InteliJET™ Inflow/Outflow Cannula
Indications for Use :
. ・
(
7
The Dyonics® InteliJET™ Inflow/Outflow Cannula is 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)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: K991186
| Prescription Use _(Per 21 CFR 801.109) | OR | Over-the-Counter _(Optional Format 1-2-96) |
|---|---|---|
| ---------------------------------------- | ---- | -------------------------------------------- |
§ 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.