(26 days)
The Smith & Nephew 25 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 25 Fluid Management System is a microprocessor controlled arthroscopic fluid management system that is designed for controlled delivery of irrigation fluids during intra-articular surgery. The system controls joint pressure independently of aspiration rate over a wide range of flow rates. The system will maintain control of intra-articular pressure regardless of varying outflow rates and may be used with any arthroscopic inflow cannula.
The provided text describes a 510(k) premarket notification for the "Smith & Nephew 25 Fluid Management System." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this document.
Here's an analysis of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document implies the acceptance criterion is "substantial equivalence" to predicate devices without introducing new issues of safety or efficacy.
- Reported Device Performance: The document states that "performance testing and the software verification and validation conducted on the Smith & Nephew 25 Fluid Management System demonstrates substantial equivalence." However, it does not provide specific performance data (e.g., accuracy, precision, reliability figures) in a quantifiable manner against predefined acceptance criteria.
Therefore, a table cannot be fully constructed with specific acceptance criteria and performance numbers from this document.
2. Sample size used for the test set and the data provenance:
- The document mentions "performance testing" but does not specify any sample size for a test set (e.g., number of cases, images, or test runs), nor does it provide data provenance (country of origin, retrospective/prospective). This is typically a preclinical engineering test, not a clinical study with a "test set" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since a clinical "test set" with ground truth established by experts is not described, this information is not applicable and not present in the document.
4. Adjudication method for the test set:
- As no expert-established ground truth for a test set is described, an adjudication method is not applicable and not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a fluid management system, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that "performance testing and the software verification and validation" were conducted on the device itself. This would be considered "standalone" performance for the device, but it's not an "algorithm only" in the sense of a diagnostic AI. No specific performance metrics for this standalone testing are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of device (fluid management system), "ground truth" would likely be established through engineering specifications and measurements (e.g., fluid pressure accuracy, flow rate stability, software functionality against requirements). The document doesn't explicitly state the methodology for establishing this "ground truth."
8. The sample size for the training set:
- Training sets typically refer to data used for machine learning models. This device is described as a "microprocessor controlled arthroscopic fluid management system," not an AI/ML device in the modern sense. Therefore, a "training set" with a specified sample size is not applicable and not mentioned.
9. How the ground truth for the training set was established:
- As there is no described training set, this information is not applicable and not present.
Summary of what is available from the document:
- Device: Smith & Nephew 25 Fluid Management System
- Purpose of the study/testing: To demonstrate substantial equivalence to predicate devices (Smith & Nephew InteliJET™ HERMES-Ready (K031605) and Smith & Nephew InteliJET™ Fluid Management Systems (K050580)).
- Method of demonstrating equivalence: "Performance testing and the software verification and validation."
- Conclusion: The testing "demonstrates substantial equivalence" and that "the differences in the new device and the predicate device do not raise any new issues of safety and efficacy."
This document is a regulatory submission focused on comparing a new device to existing legally marketed predicate devices, not on proving de novo performance against a set of clinical acceptance criteria using a typical clinical study design with human readers or AI algorithms.
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JUN 1 5 2005
We are
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SECTION IV 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.
Smith & Nephew 25 Fluid Management System
Date Prepared: May 18, 2005
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Janice Haselton
Sr. Regulatory Affairs Specialist
Phone: (978) 749-1494
FAX: (978) 749-1443)
C. Device Name
| Trade Name: | Smith & Nephew 25 Fluid Management System |
|---|---|
| Common Name: | Arthroscopic Fluid Management System |
| Classification Name:Arthroscope |
D. Predicate Devices
The Smith & Nephew 25 Fluid Management System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew InteliJET™ HERMES-Ready (K031605) and Smith & Nephew InteliJET™ Fluid Management Systems (K050580).
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K05/326
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E. Description of Device
The Smith & Nephew 25 Fluid Management System is a microprocessor controlled arthroscopic fluid management system that is designed for controlled delivery of irrigation fluids during intra-articular surgery. The system controls joint pressure independently of aspiration rate over a wide range of flow rates. The system will maintain control of intra-articular pressure regardless of varying outflow rates and may be used with any arthroscopic inflow cannula.
F. Intended Use
The Smith & Nephew 25 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.
G. Comparison of Technological Characteristics
The Smith & Nephew 25 Fluid Management System is substantially equivalent in design, materials, function and intended use to the Smith & Nephew InteliJET™ HERMES-Ready, cleared in K031605 and the Smith & Nephew InteliJET™ Fluid Management System cleared in K050580. The proposed and the prodicate devices both have the same intended use and the same fundamental scientific technology.
H. Summary Performance Data
The performance testing and the software verification and validation conducted on the Smith & Nephew 25 Fluid Management System demonstrates substantial equivalence to the Smith & Nephew InteliJET™ HERMES-Ready, cleared in K031605 and the Smith & Nephew InteliJET™ Fluid Management System cleared in K050580. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure.
JUN 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janice Haselton Sr. Regulatory Affairs Specialist Endoscopy Division Smith & Nephew Incorporated 150 Minuteman Road Andover, Massachusetts 01810
Re: K051326
Trade/Device Name: Smith & Nephew 25 Fluid Management System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: June 8, 2005 Received: June 8, 2005
Dear Ms. Haselton:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(t) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1976, the enated with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Fee) that do not require act the general controls provisions of the Act. The Y ou may, therefore, market the device, public requirements for annual registration, listing of general Controls provisions of the fiest 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 and It may be subject to such additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Features concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase be advised that I Dri 3 issuanted or our device complies with other requirements of the Act that IDA has made a decommanding administered by other Federal agencies. You must of any I ederal statutes and regarations and limited to: registration and listing (21 Comply with an the Net 8 requirements, and manufacturing practice requirements as set CITY art 607), adomig (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Ms. Janice Haselton
This letter will allow you to begin marketing your device as described in your Section 510(k) rms reket 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 (240) 276-0115 . 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 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/industry/support/index.html.
Sincerely yours,
Emm A. Th
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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Ko5-1326
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew 25 Fluid Management System
Indications For Use:
The Smith & Nephew 25 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.
Prescription Use
(Per 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR
(21 CFR 807 Subpart C)
(PLEASE DO NOT 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 and Neurological Devices
510(k) Number K051326
Smith & Nephew 25 Page 15 of 510
§ 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.