(193 days)
Not Found
No
The description focuses on mechanical and electrical components for tissue resection and hemostasis, with no mention of AI or ML capabilities.
Yes
The device is used in arthroscopic surgical procedures for resection and excision of tissues and hemostasis of bleeding vessels, which are therapeutic actions.
No
Explanation: The device is indicated for resection and excision of soft and osseous tissues, and hemostasis of bleeding vessels during arthroscopic surgical procedures. This describes a treatment function rather than a diagnostic function.
No
The device description clearly outlines a physical medical device that combines rotary cutting technology with electrosurgical capabilities, requiring connection to a generator and shaver system. It is not solely software.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The DYONICS ElectroBlade Resector is a surgical tool used during arthroscopic procedures to cut and remove tissue and control bleeding within the body. It operates directly on the patient's tissues.
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient, not the analysis of samples taken from the patient.
Therefore, the DYONICS ElectroBlade Resector falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DYONICS Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The DYONICS Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.
The DYONICS Electroblade Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The DYONICS EletroBlade Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The DYONICS ElectroBlade Resector combines the rotary cutting technology of Dyonics Arthroscopic Surgery Blades with the electrosurgical capabilities of a bipolar electrosurgery probe. The inner rotational blade is electrified by connection to a standard generator. Insulation on the outer blade isolates the electrical energy to the inner tube where it is exposed to tissue at the cutting window of the blade. The DYONICS ElectroBlade Resector operates in conjunction with the standard Dyonics shaver system and standard electrosurgical generator systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large and small articular cavities
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DYONICS ElectroBlade (K994365)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
510(k) Summary DYONICS ElectroBlade Resector™ Date Prepared: July 20, 2001
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
FEB 0 1 2002
Submitter A.
Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810
B. Company Contact
Tim Crabtree Regulatory Affairs Specialist
C. Device Name
Trade Name: DYONICS EletroBlade Resector Common Name: Arthroscopic Surgery Blade / Electrosurgical Probe Classification Name: Electrosurgical Probe
D. Predicate Devices
DYONICS ElectroBlade (K994365)
E. Description of Device
The DYONICS ElectroBlade Resector combines the rotary cutting technology of Dyonics Arthroscopic Surgery Blades with the electrosurgical capabilities of a bipolar electrosurgery probe. The inner rotational blade is electrified by connection to a standard generator. Insulation on the outer blade isolates the electrical energy to the inner tube where it is exposed to tissue at the cutting window of the blade. The DYONICS ElectroBlade Resector operates in conjunction with the standard Dyonics shaver system and standard electrosurgical generator systems.
D. Intended Use
్ట్రాల్యాల్లో ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ఆరోగ్య కేంద్రం, ప్రాథమిక ఆరోగ్య కేంద్రం, ప్రాథమిక ఆరోగ్య కేంద్రం, ప్రాథమిక ఆరోగ్య కేంద్
The DYONICS Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The DYONICS Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.
1
Comparison of Technological Characteristics E.
The DYONICS Electroblade Resector is a combination of both bipolar RF and mechanical resector technologies. The design reflects this combination of these technologies. The resection and coagulation capabilities are features that are also found in the DYONICS Electroblade. The modified DYONICS Electroblade Resector is substantially equivalent to the DYONICS Electroblade in intended use, materials and method of operation.
Tim Licht
ాజ్యాల్లో
Tim Crabtree Regulatory Affairs Specialist
:
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are simple and abstract, and they are arranged in a way that suggests movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 01 2002
Mr. Tim Crabtree Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover. Massachusetts 01810
Re: K012314
Trade/Device Name: DYONICS Electroblade Resector™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulating device and accessories Regulatory Class: II Product Code: GEI Dated: November 2, 2001 Received: November 5, 2001
Dear Mr. Crabtree:
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 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) 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 - Mr. Tim Crabtree
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Muriam 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
4
510(k) Number : KO123/4
Device Name: DYONICS Electroblade Resector™
Indications for Use:
The DYONICS Electroblade Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The DYONICS EletroBlade Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use سك (Per 21 CFR 801.109)
OR
Over-the-Counter ------
(Optional Format 1-2-96)
Miriam C. Provost
on of General, Restorative and Neurological Devices
510(k) Number K012314
Smith & Nephew Electroblade Resector Page 18 of 57