(182 days)
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Not Found
No
The description focuses on mechanical operation and control by the surgeon, with no mention of AI/ML terms or functionalities.
No
The device, Dyonics Disposable Endoscopic Surgery Blades, is used for resection of tissues during surgery, which is an interventional procedure, not a therapeutic one. It facilitates the removal of tissue but does not directly treat a disease or condition itself.
No
The device description indicates that the Dyonics Disposable Endoscopic Surgery Blades are used for "resection of soft and osseous tissues," meaning they cut and remove tissue. This is a therapeutic or surgical function, not a diagnostic one. Diagnostic devices are used to identify a disease or condition.
No
The device description explicitly states it is a "Disposable Endoscopic Surgery Blade" and is used "in conjunction with a control console, motor drive unit, footswitch and suction". This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Dyonics Disposable Endoscopic Surgery Blades are used directly within the body during surgical procedures to resect (cut and remove) tissue. They are surgical tools, not diagnostic tests performed on specimens.
- Intended Use: The intended use clearly states resection of soft and osseous tissues in specific anatomical locations. This is a surgical function, not a diagnostic one.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Dyonics Disposable Endoscopic Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
Product codes
HRX
Device Description
Curved Small Joint Disposable Endoscopic Surgery Blades are utilized in conjunction with a control console, motor drive unit, footswitch and suction to resect soft and osseous tissues as per indications. The blades can be operated in forward, reverse and oscillate modes and at variable speeds controlled by the surgeon. The rotary action coupled with suction draws tissue into the window of the blade where rotation of the inner blade cleanly excises and evacuates the resected material. Irrigation aids in evacuation of resected materials through the blade.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker Endoscopy's Curved Small Joint/ENT Disposable Blades, Linvatec Melin Disposable Arthroscopic Surgery Blade
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.
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AUG 12 1997 K970511
510(k) Summary Smith & Nephew, Inc. Endoscopy Division Dyonics Curved Small Joint Disposable Endoscopic Surgery Blades
Substantial Equivalence:
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: 508-749-1000 Telefax: 508-749-1599
Smith - Nephew
The Smith & Nephew, Inc., Endoscopy Division Dyonics Curved Small Joint Disposable Endoscopic Surgery Blades are substantially equivalent in intended use, materials, design and function to small joint/ENT curved blades offered by Stryker Endoscopy for use with the Hummer and Hummer II Systems. Dyonics Curved Small Joint Disposable Endoscopic Surgery Blades are also substantially equivalent in intended use, materials, design and function to the Linvatec Merlin line of bendable blades which are intended for use in arthroscopy and FESS procedures. Smith & Nephew, Inc., Endoscopy Division, Stryker Endoscopy and Linvatec provide blunt tip arthroscopic surgery blades in curved configurations. All blades have lateral cutting windows, in various diameters, lengths, and cutting window configurations. All blades are designed to run in conjunction with a control console, motor drive unit, footswitch, and a suction system under endoscopic video visualization.
Predicate Device:
The predicate devices for this submission are Stryker Endoscopy's Curved Small Joint/ENT Disposable Blades and the Linvatec Melin Disposable Arthroscopic Surgery Blade.
Summary of Device Function:
Curved Small Joint Disposable Endoscopic Surgery Blades are utilized in conjunction with a control console, motor drive unit, footswitch and suction to resect soft and osseous tissues as per indications. The blades can be operated in forward, reverse and oscillate modes and at variable speeds controlled by the surgeon. The rotary action coupled with suction draws tissue into the window of the blade where rotation of the inner blade cleanly excises and evacuates the resected material. Irrigation aids in evacuation of resected materials through the blade.
Intended Use of Device:
The Dyonics Disposable Endoscopic Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS indication is limited to those small blades which are appropriate for the procedure.
Comparison of Technological Characteristics of Predicate Device:
The basic design and function of the Dyonics line of Curved Small Joint Disposable Endoscopic Surgery Blades is consistent with the Dyonics curved blades designs as described in previous submissions. These designs, function and intended use are substantially equivalent to those for curved small joint/ENT blades marketed by Stryker Endoscopy and the Linvatec Merlin "bendable" arthroscopy blade. The addition of the features defined in this premarket notification submission present no new safety or effectiveness concerns for the device.
Delmer J. Conner
Deborah J. Connors Regulatory Affairs
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Deborah J. Connors Regulatory Affairs Specialist Smith & Nephew, Inc., Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810
AUG 1 2 1997
Re: K970511
Trade Name: Dyonics Disposable Endoscopic Surgery Blades Regulatory Class: II Product Code: HRX Dated: May 21, 1997 Received: May 22, 1997
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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Deborah J. 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 regulation (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,
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
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Indications for Use: Dyonics Disposable Endoscopic Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.
Contraindications: The 2.0mm and 2.9mm TurboWhisker® and 2.9mm Cutter are contraindicated for FESS applications.
(Division Sign-Off)
હતું.
Division of General Restorative Devices 510(k) Number .
Prescription Use
(Per 21 CFR 801.109) X