(181 days)
Not Found
No
The description focuses on the mechanical and electrical function of a surgical instrument and does not mention any AI/ML components or capabilities.
Yes
The device is used to cut, dissect, and cauterize soft tissue during surgical procedures, which are therapeutic actions.
No
The device is described as a surgical instrument for cutting, dissecting, and cauterizing tissue, not for diagnosing conditions.
No
The device description clearly outlines a physical, electrosurgical instrument with mechanical components (flexible wire cable, hook knife electrode, handle control knobs) and electrical functionality (delivering monopolar electrical current). It is not solely software.
No, 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 for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Device Function: The Rotating Hook Knife is a surgical instrument used inside the body (in vivo) during endoscopic procedures. Its function is to cut, dissect, and cauterize soft tissue directly within the patient.
- Intended Use: The intended use clearly states it's for "cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures." This is a surgical intervention, not a diagnostic test performed on a specimen.
The device description and intended use clearly indicate it's a surgical tool used directly on the patient's tissue, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Ethicon Endo Surgery® (EES) Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The device consists of a flexible wire cable and hook knife electrode, which can be extended and rotated from the flexible outer shaft using two handle control knobs. When connected to an electrosurgical generator and activated, the hook knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 2.8 mm or larger working channel. This device is supplied sterile for single-patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Bench testing was performed to demonstrate that the EES device performs as intended. The patient contact portions of the device have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1. The device was tested to demonstrate compliance with the following standards:
- Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment, IEC 60601-2-2, 2006/07/01
- Medical Electrical Equipment - Part 2-18: Particular Requirements for the Safety of Endoscopic Equipment, IEC 60601-2-18, 1996/08/01
- Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility, IEC 60601-1-2 (2004)
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.
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
Image /page/0/Picture/1 description: The image shows a handwritten string of numbers. The numbers are '1091290'. The numbers are written in black ink on a white background. The handwriting is somewhat messy and difficult to read.
510(k) Summary
Company Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242
Contact Tom Bosticco QSRA Principal Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-8935 Fax: (513) 337-2935 Email: tbosticc@its.jnj.com
OCT 2 9 2009
Date Prepared October 27, 2009
New Device Name
Trade Name: Ethicon Endo Surgery® Rotating Hook Knife Common or Usual Name: Electrosurgical Hook Electrodes Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Product Code GEI)
Predicate Device
Ethicon Endo Surgery® Articulating Hook Knife (K082955)
Device Description The Ethicon Endo Surgery® (EES) Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The device consists of a flexible wire cable and hook knife electrode, which can be extended and rotated from the flexible outer shaft using two handle control knobs. When connected to an electrosurgical generator and activated, the hook knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 2.8 mm or larger working channel. This device is supplied sterile for single-patient use.
Indications for Use The Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
Technological Characteristics The EES Rotating Hook Knife device is very similar to the EES Articulating Hook Knife (K082955). Both devices consist of an electrode, an elongated flexible wire shaft and a handle. The handle allows for the manipulation of the electrode via the control knobs. In both devices, the metal electrode tip is used to deliver monopolar energy to the surgical site. Both devices are designed to be connected to electrosurgical generators, and utilize RF monopolar energy for operation. The "L" hook shape of the electrode in the Rotating Hook Knife is the same as in the EES Articulating
1
Hook Knife. Both devices feature rotation of the electrode. The Rotating Hook Knife does not contain the articulating feature present in the Articulating Hook Knife.
Performance Data. Bench testing was performed to demonstrate that the EES device performs as intended. The patient contact portions of the device have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1. The device was tested to demonstrate compliance with the following standards:
-
Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
-
Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment, IEC 60601-2-2, 2006/07/01
-
Medical Electrical Equipment - Part 2-18: Particular Requirements for the Safety of Endoscopic Equipment, IEC 60601-2-18, 1996/08/01
-
Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility, IEC 60601-1-2 (2004)
2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, Inc. % Ms. Glenda Marsh QS/RA Project Manager 4545 Creek Road Cincinnati, Ohio 45242
OCT 2 9 2009
Re: K091290
Trade Name: Ethicon Endo-Surgery® Rotating Hook Knife Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulation Class: II Product Code: GEI Dated: October 15, 2009 Received: October 19, 2009
Dear Ms. Marsh:
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 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 mav 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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Page 2 – Ms. Glenda Marsh
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Mathews
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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:
Ethicon Endo Surgery® Rotating Hook Knife
Indications for Use:
The Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
FOR M. MELKERSON
(Division Sign (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091290
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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