(23 days)
Not Found
Not Found
No
The summary describes reusable cannulas used with a fluid management system to regulate pressure and flow. There is no mention of AI or ML in the intended use, device description, or any of the other sections. The focus is on mechanical components and fluid dynamics.
No
The device is used to establish portals and regulate fluid flow during surgery, helping visualization for the surgeon, but it does not directly treat a disease or condition.
No
The device is described as cannulas used to establish portals and regulate fluid flow during arthroscopic procedures, which aids in visualization and distention, not in diagnosing medical conditions.
No
The device description clearly states it is a "Reusable Cannula," which is a physical, hardware component used in surgical procedures. It is not solely 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 regulate fluid flow and maintain pressure for visualization. This is a surgical tool used directly on the patient's body, not for testing samples in vitro (outside the body).
- 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 (blood, urine, tissue, etc.), detecting diseases or conditions based on sample analysis, or providing diagnostic information from in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on facilitating a surgical procedure.
N/A
Intended Use / 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.
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
the currently cleared Dyonics InteliJET Reusable Cannulas.
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
APR 1 7 2002
Exhibit D
510(k) Summary Dvonics InteliJET Reusable Cannulas Date Prepared: March 21, 2002
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: 978-749-1000 Telefax: 978-749-1599
Smith - Nephew
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
A. Submitter
Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810 USA
B. Company Contact
Deborah Connors Regulatory Affairs Manager
C. Device Name
Dvonics InteliJET™ Reusable Cannulas Trade Name: cannula for arthroscopy pump Common Name: Classification Name: Infusion Pump
D. Predicate Devices
The predicate device for this submission are the currently cleared Dyonics InteliJET Reusable Cannulas.
E. Description of Device
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.
F. Intended Use
The Dyonics InteliJET Reusable Cannulas are indicated for use with the Intel.JET 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.
রে. Comparison of Technological Characteristics
The basic technologies, design and function of the Dyonics InteliJET Reusable Cannulas is not changed by the material modification described in this Premarket Notification Submission. The new material has been demonstrated to meet the requirements for biocompatibility established in ISO 10993-1: 1997. This change raises no new issues of safety and effectiveness.
Duinh (Sinn)
Deborah Connors Regulatory Affairs Manager
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2002
Smith & Nephew, Inc. Endoscopy Division Ms. Deborah Connors Regulatory Affairs Manager 160 Dascomb Road Andover, Massachusetts 01810
Re: K020947
Trade Name: Dyonics InteliJET™ Reusable Cannulas Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 22, 2002 Received: March 25, 2002
Dear Ms. Connors:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave renewed your 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 May 20, 1970, the chargence 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, (Ave) that do flor require sphiect to the general controls provisions of the Act. The general thereols, maintons of the Act include requirements for annual registration, listing of devices, controlly provisions or actice, 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 11 your device 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.
2
Page 2 – Ms. Deborah Connors
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematicated 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 If you desire specific ad 1.00 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 859. Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1609 - 115ce of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general informational 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
3
Indications for Use Statement
ﺗ
| 510(k) Number
| (if known) | KO20947 |
|---|---|
| Device Name | 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 NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Miriam C. Provost | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K020947 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
|---|---|
| --------------------------------------------------- | ------------------------------------- |