(44 days)
The Smith & Nephew InteliJET™ 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.
The Smith & Nephew InteliJET™ Fluid Management System-HERMES Ready 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.
The Smith & Nephew InteliJETTM Fluid Management Systems are microprocessor-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 provided text is a 510(k) summary for the Smith & Nephew InteliJET™ Fluid Management Systems. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria.
The document states: "All verification and validation data demonstrate that the devices are safe and effective and performs as intended." However, it does not provide any specifics on what these data are, what the acceptance criteria were, or the results of any such studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided text.
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Endoscopy Smith & Nephew, Inc 150 Minuteman Road Andover, MA 01810
078 749 1599 Fax
Page 1 of 2
We are smith&nephew
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as
APR 2 0 2005
510(K) SUMMAN I OF SHEET PARTE LE 1 11.12 LE LEFR 807.92 upon
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 InteliJET™ Fluid Management Systems
Date Prepared: March 2, 2005
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover, MA 01810
B. Company Contact
Kathleen Burns Regulatory Affairs Associate Phone: (978) 474-6301 Fax: (978) 749-1443
C. Device Name
Smith & Nephew InteliJET™ Fluid Management Systems Trade Name: Arthroscopic Fluid Management System Common Name: Classification Name: Arthroscopes
D. Predicate Devices
The Smith & Nephew InteliJET™ Fluid Management Systems are substantially I he offinal ce replied intental Scientific Technology to the following legally marketed devices in commercial distribution: K002040: FMS SOLO, Future Medical Systems K033927: Arthroscopic Pump A115, World of Medicine K041824: NeXtra™ Arthroscopic Pump and Shaver System
Description of Device E.
The Smith & Nephew InteliJETTM Fluid Management Systems are microprocessor-I he Shiftil to replied for controlled delivery of irrigation fluid during intra-
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articular surgery. This controlled delivery is accomplished via an electronic pressure control loop between the control unit and the tube cassette.
Intended Use F.
The Smith & Nephew InteliJET™ Fluid Management Systems are indicated for use I he Simul to Nephon int 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 InteliJET™ Fluid Management Systems have the same The Smith & Nophen Internation as the predicate devices, the Arthroscopic Pump A115, FMS SOLO, and NeXtra™ Arthroscopic Pump and Shaver System. In addition, 1 MB SOLO; and Neritew InteliJET™ Fluid Management System and predicate device are intended for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints.
H. Summary Performance Data
All verification and validation data demonstrate that the devices are safe and effective and performs as intended.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three wavy lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2005
Ms. Kathleen Burns Regulatory Affairs Associate Smith and Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K050580
KU30580
Trade/Device Name: Smith and Nephew InteliJET™ Fluid Management System Smith and Nephew InteliJETTM Fluid Management System-HERMES
Ready Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: March 4, 2005 Received: March 7, 2005
Dear Ms. Burns:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) pe me substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosule) to regally names of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuired in assee approval of a premarket approval application (PMA). and Cosment Act (71ct) that ac not requent of the general controls provisions of the Act. The 1 ou may, merciole, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is elassified (660 are 2) trols. Existing major regulations affecting your device (100 it may be subject to sach additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of counts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean F lease of advised that I Dri of issually of our device complies with other requirements of the Act that IDA has made a decemmants in as administered by other Federal agencies. You must of any I cochal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Her S requirements, we spective requirements as set CFR Part 807), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Kathleen Burns
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin halfieling of substantial equivalence of your device to a legally prematket notification. "The I Drivinanig sification 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 If you desire specific advice for your act (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Compullies as (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octisahttp://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
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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Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew InteliJET™ Fluid Management System
Indications For Use:
The Smith & Nephew InteliJET™ Fluid Management System is indicated for use during I he Smill & Nepliew michs D - - 1 This wof irrigation fluids in the knee, shoulder, hip arthroscopic joint surgery to regalation in pressure for uniform distension and clear visualization of the surgical site.
Device Name: Smith & Nephew InteliJET™ Fluid Management System-HERMES Ready
Indications For Use:
The Smith & Nephew InteliJET™ Fluid Management System-HERMES Ready is The Smith & Neptlew meets 21 - 1 int surgery to regulate flow of irrigation fluids in multated for use daring artist over por to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
rative 341000
Smith & Nephew, Inc.
InteliJET™ F M S
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§ 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.