(27 days)
Not Found
Not Found
No
The description focuses on a microprocessor-based system with an electronic pressure control loop and voice/pendant control, without mentioning AI or ML.
Yes
The device is used to maintain intra-articular pressure during arthroscopic joint surgery, which directly contributes to the medical procedure and patient care.
No
Explanation: The device is described as a fluid management system used to regulate irrigation fluid flow and maintain intra-articular pressure during surgery for visualization. It does not perform any diagnostic functions or analyze patient conditions to determine the nature of a disease.
No
The device description explicitly states it is a "microprocessor-based system" with a "control unit" and "tube cassette," indicating the presence of hardware components beyond just 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 for regulating irrigation fluid flow during arthroscopic joint surgery to maintain pressure and visualization. This is a direct intervention and support for a surgical procedure, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a system for controlled delivery of fluid during surgery, focusing on pressure control and integration with surgical control systems. This aligns with a surgical support device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are designed 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 Smith & Nephew InteliJET™ Fluid Management System (FMS) is indicated for use during arthroscopic joint surgery 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
HRX
Device Description
The Smith & Nephew InteliJETTM Fluid Management System Hermes-Ready™ is a microprocessor-based system designed for controlled delivery of irrigation fluid during intra-articular surgery. This controlled delivery is accomplished via an electronic pressure control loop between the control unit and the tube cassette. The addition of the Hermes Ready™ feature will enable voice and pendant control of the pressure, mode, suction, and on/off functions when used in conjunction with a Hermes™ Digital O.R. Center.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joint (intra-articular)
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)
All verification and validation data demonstrates that the device is safe and effective and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith & Nephew InteliJETTM Fluid Management System.
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.
0
031605
JUN 1 8 2003
Smith & Nephew, Inc. 150 Minuteman Road, Andover, MA 01810-1031 U.S.A. Telephone: 978-749-1000 Fax: 978-749-1599
Smith = Nephew
Endoscopy Division
Exhibit C
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.
InteliJETTM Fluid Management System Hermes-Ready™
Date Prepared: May 21, 2003
A. Submitter's Name:
Smith & Nephew. Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Janice Haselton Regulatory Affairs Specialist II Phone: (978) 749-1494 Fax: (978) 749-1443
C. Device Name
| Trade Name: | InteliJETT™ Fluid Management System Hermes-Ready™ |
|---|---|
| Common Name: | Arthroscopic Fluid Management System |
| Classification Name: | Arthroscopes |
D. Predicate Devices
The Smith & Nephew InteliJET™ Fluid Management System Hermes-Ready™ is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew InteliJETTM Fluid Management System.
E. Description of Device
The Smith & Nephew InteliJETTM Fluid Management System Hermes-Ready™ is a microprocessor-based system designed for controlled delivery of irrigation fluid during intra-articular surgery. This controlled delivery is accomplished via an electronic pressure control loop between the control unit and the tube casssette. The addition of the Hermes Ready™ feature will enable voice and pendant
1
control of the pressure, mode, suction, and on/off functions when used in conjunction with a Hermes™ Digital O.R. Center.
Intended Use r.
The Smith & Nephew InteliJET™ Fluid Management System (FMS) is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids through the ioint to maintain intra-articular pressure for uniform distention and clear visualization of the surgical site.
G. Comparison of Technological Characteristics
The Smith & Nephew InteliJET™ Fluid Management System Hermes-Ready™ has the same technological characteristics and intended use as the predicate device, the Smith & Nephew InteliJET™ Fluid Management System. The addition of a communication interface for voice activation with the Hermes™ Control Center offers the surgeon direct communications without changing the intended use or features of the Smith & Nephew InteliJET™ Fluid Management System.
H. Summary Performance Data
All verification and validation data demonstrates that the device is safe and effective and performs as intended.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JUN 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janice Haselton Regulatory Affairs Specialist II Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K031605
Trade/Device Name: InteliJET™ Fluid Management System Hermes-Ready™ Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 21, 2003 Received: May 22, 2003
Dear Ms. Haselton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to Muy 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) that do not require approval of a premarket approval application (PMA). 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 (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. Janice Haselton
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 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 (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,
Mark A Milliken
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
Indications for Use
| 510(k) Number (if known): | K031605 |
|---|---|
| --------------------------- | --------- |
Device Name: __ InteliJET™ Fluid Management System Hermes-Ready™
Indications For Use:
The Smith & Nephew InteliJET™ Fluid Management System (FMS) is indicated for use during arthroscopic joint surgery 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)
Prescription Use
(Per 21 CFR 801.109) √
OR
(Division Sign-Off)
Division of General Restorative
Over-The-Counter Use __
Division of General, Restorative and Neurological Dev
510(k) Number
InteliJet TM Fluid Management System HERMES - Ready TM Page 14 of 8