(69 days)
No
The 510(k) summary describes a surgical instrument combining electrosurgical and shaver technology and an adaptor. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on electrical safety and sterilization standards, not algorithmic performance.
Yes.
The device is used in arthroscopic surgical procedures for "resection and excision of soft tissue" and "hemostasis of bleeding vessels," which are therapeutic interventions.
No
Explanation: The device is described as a surgical tool used for resection and excision of soft tissue, combining electrosurgical and shaver technology. Its intended use is in "arthroscopic surgical procedures," which are interventional rather than diagnostic.
No
The device description clearly states it is a "transformer that converts the power output of the generator into a higher current / lower voltage output," indicating it is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft tissue." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as combining "electrosurgical and shaver technology" and an "adaptor that converts the power output of the generator." This aligns with a surgical instrument, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used during a procedure.
N/A
Intended Use / Indications for Use
The Smith & Nephew ElectroBlade Adaptor, when used in conjunction with The Smith & Nephew ElectroBlade® Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft tissue. The Smith & Nephew ElectroBlade® 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
GEI, HRX
Device Description
The Smith & Nephew ElectroBlade® Resector combines electrosurgical and shaver technology to provide hemostasis and mechanical cutting in a single instrument. The Smith & Nephew ElectroBlade® Adaptor is a transformer that converts the power output of the generator into a higher current / lower voltage output.
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)
The proposed device combination will perform as well as the predicate device combination to the following standards at the time of commercialization:
- . ANSI/AAMI HF18-1993 for Electrosurgical Devices
- IEC 601-1(A1 + A2) Medical Electrical Equipment: Part 1 General Requirements . for Safety
- IEC 601-1-2 Medical electrical equipment Part1: General Requirements for . Safety and Part 2; Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC60601-2-2:1998 for Medical Electrical Equipment (Part2-2): Particular . Requirements for the Safety of High Frequency Surgical Equipment.
The Smith & Nephew ElectroBlade® Resector referenced in this submission is the same as the resector cleared in K012314. This resector is in compliance with the following standards:
- ANSI/AAMI ISO 10993-1 for Biological evaluation of medical devices Par11: . Guidance on selection of tests
- ANSI/AAMI ISO 11135 Validation and Routine control of Ethylene Oxide . Sterilization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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978-749-1000 978-749-1599 Fax www.similly neelshavion
Page 1 of 3
SECTION IN
K 041328
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.
Date Prepared: May 19, 2004
A. Submitter's Name:
.
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact:
Karen Provencher Regulatory Affairs Specialist Phone: 978-749-1365 Fax: 978-749-1443
C. Device Name
| Trade Name: | Smith & Nephew ElectroBlade® Resector
Smith & Nephew ElectroBlade® Adaptor |
|----------------------|-------------------------------------------------------------------------------|
| Common Name: | Arthroscopic Surgery Blade and Electrosurgical Probe |
| Classification Name: | Electrosurgical cutting and coagulation device |
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D. Predicate Devices
Page 2 of 3
The Smith & Nephew Smith & Nephew ElectroBlade® Resector and Smith & Nephew ElectroBlade® Adaptor combination is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution: Smith & Nephew ElectroBlade® Resector and ERBE ICC 350. The predicate device combination was cleared in K031675 on June 20, 2003.
Description of Device ய்
The Smith & Nephew ElectroBlade® Resector combines electrosurgical and shaver technology to provide hemostasis and mechanical cutting in a single instrument. The Smith & Nephew ElectroBlade® Adaptor is a transformer that converts the power output of the generator into a higher current / lower voltage output.
Intended Use F.
The Smith & Nephew ElectroBlade Adaptor, when used in conjunction with the Smith & Nephew ElectroBlade® Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft tissue. The Smith & Nephew ElectroBlade® 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 videoassisted fiber-optic visualization.
G. Comparison of Technological Characteristics
The Smith & Nephew Smith & Nephew ElectroBlade® Resector and Smith & Nephew ElectroBlade° Adaptor combination is substantially equivalent in design, materials, function and intended use to the following legally marketed devices in commercial distribution: Smith & Nephew ElectroBlade® Resector and ERBE ICC 350. The predicate device combination was cleared in K031675 on June 20, 2003.
Summary Performance Data H.
The proposed device combination will perform as well as the predicate device combination to the following standards at the time of commercialization:
- . ANSI/AAMI HF18-1993 for Electrosurgical Devices
- IEC 601-1(A1 + A2) Medical Electrical Equipment: Part 1 General Requirements . for Safety
2
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Page ③ of 3
- IEC 601-1-2 Medical electrical equipment Part1: General Requirements for . Safety and Part 2; Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC60601-2-2:1998 for Medical Electrical Equipment (Part2-2): Particular . Requirements for the Safety of High Frequency Surgical Equipment.
The Smith & Nephew ElectroBlade® Resector referenced in this submission is the same as the resector cleared in K012314. This resector is in compliance with the following standards:
- ANSI/AAMI ISO 10993-1 for Biological evaluation of medical devices Par11: . Guidance on selection of tests
- ANSI/AAMI ISO 11135 Validation and Routine control of Ethylene Oxide . Sterilization
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like extensions.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2004
Ms. Karen Provencher Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K041328
Trade/Device Name: Smith & Nephew ElectroBlade™ Resector Smith & Nephew ElectroBlade™ Adaptor Regulation Number: 21 CFR 878.4400, 21 CFR 888.1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Arthroscope Regulatory Class: II Product Code: GEI, HRX Dated: May 19, 2004 Received: May 19, 2004
Dear Ms. Provencher:
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.
4
Page 2 - Ms. Karen Provencher
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. 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/dsma/dsmamain.html
Sincerely yours,
Miriam 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
5
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew ElectroBlade® Resector and Smith & Nephew ElectroBlade® Adaptor
Indications For Use:
The Smith & Nephew ElectroBlade Adaptor, when used in conjunction with The Smith & Nephew ElectroBlade® Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft tissue. The Smith & Nephew ElectroBlade® 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.
Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW T NOTHER PAGE IF NEEDED) Evaluation (ODE) Division of General, Restorative.
510(k) Number K641326
S&N ElectroBlade® Resector & Adaptor Page 14 of 69