(264 days)
Not Found
No
The description focuses on the mechanical and electrical functions of the device (water jet, ESU, electrode) and does not mention any AI or ML capabilities.
Yes
The device is described as an ERBE Hybrid Knife™ used to cut and dissect soft tissue and provide monopolar cutting and coagulation as part of surgical procedures, directly applying a therapy (cutting/coagulating tissue) to a patient.
No
Explanation: The device is described as a surgical instrument used to cut and dissect soft tissue, and for monopolar cutting and coagulation. Its function is to perform surgical procedures, not to diagnose conditions or diseases.
No
The device description clearly outlines physical components such as tubing, a cable, a handle, probe tubing, and an electrode, indicating it is a hardware device.
Based on the provided information, the ERBE Hybrid Knife™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "cut and dissect soft tissue" and "provide monopolar cutting and coagulation of the target tissue." These are surgical procedures performed directly on the patient's body.
- Device Description: The description details how the device physically interacts with tissue using a water jet and an electrode for cutting and coagulation. This is a direct intervention on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. The provided text does not mention any analysis of samples or diagnostic purposes.
The ERBE Hybrid Knife™ is a surgical instrument used for therapeutic purposes (cutting and coagulating tissue) during surgical procedures.
N/A
Intended Use / Indications for Use
The ERBE Hybrid Knife™ is intended to be used in combination with the Water Jet System/ERBEJET 2 and an ERBE ESU VIO Model to cut and dissect soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) via the Water Jet System as well as to provide monopolar cutting and coagulation of the target tissue by the ESU in open and as well as endoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
FQH and GEI
Device Description
The ERBE Hybrid Knife™ is used with the Water Jet Model ERBEJET® 2 and an ERBE ElectroSurgical Unit (ESU), VIO Model. The Water Jet delivers pressurized sterile normal saline through the Hybrid Knife to cut and dissect soft tissue. The ESU supplies High Frequency (HF) energy through a retractable electrode of the Hybrid Knife for the cutting and coagulation of tissue. The ERBE Hybrid Knife™ consists of tubing to the Water Jet, a cable to the ESU, a handle, probe tubing, and an electrode. Clinicians would assemble the device and attach it respectively to the Water Jet and ESU. For endoscopic procedures, the Hybrid Knife is placed down the channel of an endoscope that has a working channel greater than 2.8 mm. Upon the set up of the Water Jet and ESU, the Hybrid Knife is ready for use. The pedal of the ERBEJET 2 Footswitch activates its water-jet cutting capabilities. To activate cautery, the recessed electrode is extended out its tip (up to 5 mm) and the ESU's Footswitch is depressed. The ERBE Hybrid Knife™ is provided sterile and is single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians, open and as well as endoscopic surgery.
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)
Performance testing demonstrated the functionality of the Hybrid Knife.
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
Ko836.08
ERBE USA Incorporated Traditional 510(k): ERBE Hybrid Knife™
Page 1 of 2
510(k) SUMMARY
AUG 2 6 2009
ERBE USA, Inc. Submitted By: 2225 Northwest Parkway Marietta, GA 30067 Tel: 770-955-4400 Fax: 770-955-2577
John Tartal Contact Person: QA/RA Manager
February 26, 2008 Date Prepared:
Water Cutter/Dissector with Electrosurgical Cutting and Common Name: Coagulation Capabilities
ERBE Hybrid Knife™ Trade/Proprietary Name:
Jet Lavage (21 CFR Part 880.5475) and Electrosurgical Classification Name: cutting and coagulation device and accessories (21 CFR 878.4400)
FQH and GEI Product Code:
Legally Marketed Predicate Device:
ERBE Monopolar Attachment for Helix Hydro-Jet 510(k) Number: K062712 and ERBE ERBEJET 2 System (Includes Applicator) 510(k) Number: K072404
Device Description:
The ERBE Hybrid Knife™ is used with the Water Jet Model ERBEJET® 2 and an ERBE ElectroSurgical Unit (ESU), VIO Model. The Water Jet delivers pressurized sterile normal saline through the Hybrid Knife to cut and dissect soft tissue. The ESU supplies High Frequency (HF) energy through a retractable electrode of the Hybrid Knife for the cutting and coaqulation of tissue. The ERBE Hybrid Knife™ consists of tubing to the Water Jet, a cable to the ESU, a handle, probe tubing, and an electrode. Clinicians would assemble the device and attach it respectively to the Water Jet and ESU. For endoscopic procedures, the Hybrid Knife is placed down the channel of an endoscope that has a working channel greater than 2.8 mm. Upon the set up of the Water Jet and ESU, the Hybrid Knife is ready for use. The pedal of the ERBEJET 2 Footswitch activates its water-jet cutting capabilities. To activate cautery, the recessed electrode is extended out its tip (up to 5 mm) and the ESU's Footswitch is depressed. The ERBE Hybrid Knife™ is provided sterile and is single use.
1
ERBE USA Incorporated Traditional 510(k): ERBE Hybrid Knife™
Intended Use:
The ERBE Hybrid Knife™ is intended to be used in combination with the Water Jet System/ERBEJET 2 and an ERBE ESU VIO Model to cut and dissect soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) via the Water Jet System as well as to provide monopolar cutting and coagulation of the target tissue by the ESU in open and as well as endoscopic surgery.
Similarities and Differences of the Proposed Device to the Current Devices (Predicate Comparison/Substantial Equivalence):
Similarities
The ERBE Hybrid Knife™ has the same basic intended use as the predicate ERBE Monopolar Attachment for Helix Hydro-Jet. That is it combines water-jet cutting and dissection of soft tissue with the ability of providing cautery. It is similar to the other predicate, ERBEJET 2 Applicator, in that it works with the ERBEJET 2 Unit, functions upon the same operating principles as well as is sterilized via Ethylene Oxide, single use, and disposable. The ERBE Hybrid Knife is also manufactured by ERBE Elektromedizin GmbH.
Differences
The types of materials used for the ERBE Hybrid Knife™ are similar to the predicates but specific materials are slightly different. Therefore, biocompatibility of the specific materials for the Hybrid Knife was demonstrated. See Biocompatibility Study, III-18 to III-27. One of the other differences is that the electrode is retractable for the Hybrid Knife as opposed to being just at the end of the tip of the predicate ERBE Monopolar Attachment for Helix Hydro-Jet. Structurally and dimensionally the Hybrid Knife is different than the predicate ERBEJET 2 Applicator, in that its tip is internally different and its Outer Diameter is much smaller (2 mm versus 5 mm) with a much longer length 2200 mm versus 336 mm). The size was altered for use in 2.8 mm or larger working channels of endoscopic scopes. With a specifically designed software version of the ERBEJET 2 Unit, performance testing demonstrated the functionality of the Hybrid Knife. See Performance Testing, III-28 to III-31.
Conclusion:
The ERBE Hybrid Knife™ has the same basic intended use, principles of operation, and technological characteristics as the predicate devices in the previously cleared 510(k)s. The modifications involve having a device that connects to the Water Jet Model ERBEJET 2 and an ESU VIO Model, has a smaller outer diameter and longer working length for endoscopic use if desired, as well as retractable electrode. In conclusion, all the changes were verified or validated. As a result, the changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles a stylized bird or a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
ERBE USA, Inc. % Mr. John Tartal QA/RA Manager 2225 Northwest Parkway Marietta, Georgia 30067
AUG 2 6 2009
Re: K083608
Trade/Device Name: ERBE USA, Inc.'s ERBE Hybrid Knife" Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FQH and GEI Dated: August 19, 2009 Received: August 20, 2009
Dear Mr. Tartal:
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 1 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. John Tartal
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.
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
for
Mark N. Melkerson
Mark N. Melkerson Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
6083608
Indications for Use
510(k) Number (if known):
Device Name: ERBE USA, Inc.'s ERBE Hybrid Knife™
Indications For Use:
The ERBE Hybrid Knife™ is intended to be used in combination with the Water Jet System/ERBEJET 2 and an ERBE ESU VIO Model to cut and dissect soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) via the Water Jet System as well as to provide monopolar cutting and coagulation of the target tissue by the ESU in open and as well as endoscopic surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Pth
Jassion Sign-Off) ion of Surgical, Orthopedic, Restorative Devices
510(k) Number K083608
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