(137 days)
Not Found
No
The summary describes a physical attachment for existing electrosurgical and hydro-jet systems. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The device's function is purely mechanical and electrical energy delivery.
Yes
The device is used for "coagulation and cutting of tissue" by delivering "High Frequency (HF) energy through the electrode tip," which are therapeutic actions.
No
Explanation: The device description states its use for "monopolar coagulation and cutting" and "to cut and dissect soft tissue," indicating it is a therapeutic or surgical device, not one for diagnosis.
No
The device description clearly states that the ERBE Monopolar Attachment is a physical component made of stainless steel and plastic insulation, designed to be used with other hardware (Helix Hydro-Jet™ and ERBE Electrosurgical Generator). It is a reusable, non-sterile hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is used in conjunction with a hydraulic pressure system and an electrosurgical unit to cut and coagulate soft tissue directly within the body. This is an in vivo procedure, not an in vitro test.
- Intended Use: The intended use is for surgical procedures involving soft tissue, not for analyzing samples outside the body.
Therefore, the ERBE Monopolar Attachment is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Monopolar Attachment combines the use of the Helix Hydro-Jet™ Applicator with suction (Part Number 20139-074) with the use of monopolar coagulation and cutting (option drip irrigation is also available) when used in conjunction with an ERBE ESU (ICC or VIO Models).
The Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie Note: receptacle. The use of ERBE ESU ICC and VIO Models are recommended. Compatibility and settings should be demonstrated/established prior to using a different Generator in the clinical environment.
Product codes (comma separated list FDA assigned to the subject device)
FQH, GEI
Device Description
The ERBE Monopolar Attachment [P/N 20139-094] is used with the Helix Hydro-Jet™ and the ERBE Electrosurgical Generator (ESU) Systems (ICC or VIO Mc rels), The Helix Hydro-Jet™ is a hydraulic pressure delivery system that uses physiological same to cut and dissect soft tissue. The ERBE Electrosurgical Generator (ESU) Systems (IC or VIO Models) deliver High Frequency (HF) energy through the electrode tip of the ERBE Monopolar Attachment for coagulation and cutting of tissue. The ERBE Monopolar Attachment for Helix Hydro-Jet™ is made of stainless steel with plastic insulation except at the electrode to ribers isolates the HF energy to only the tip surface). The ERBE Monopolar Attachment has a channel and ring where the Helix Hydro-Jet™ Applicator slides into the Monopolar Attachment and is held in place for the Physician. The Monopolar Attachment is provided non-sterile and is reusable. (Note: The cleaning and sterilization processes are provided in the proposed draft labeling, "Notes on Use" - ERBE Monopolar Attachment, )
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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.
K033590, K953738, K953159, K935815, K933002, K933157, K060484, K936304
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
510K SUMMARY
| Submitted By: | ERBE USA, Inc.
2225 Northwest Parkway
Marietta, GA 30067
Tel: 770-955-4400 Fax: 770-955-2577 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Tartal
QA/RA Manager |
| 510(k) Number: | |
| Date Prepared: | September 7, 2006 |
| Common Name: | Monopolar Attachment for Water Jet Dissector |
| Trade/Proprietary Name: | ERBE Monopolar Attachment for Helix Hydro-Jet™ |
| Classification Name: | Jet Lavage (21 CFR Part 880.5475) and Electrosurgical cutting
and coagulation device and accessories (21 CFR 878.4400) |
| Product Code: | FQH and GEI |
| Legally Marketed
Predicate Devices: | ERBE Helix Hydro-Jet™ System, 510(k) Number: K033590
ERBE ESU (ICC or VIO Models) Systems, 510(k) Numbers:
K953738; K953159; K935815; K933002; K933157; K060484
ERBE Disposable Push Button Pencil, 510(k) Number: K936304 |
JÁN 26 2007### Device Description:
General Description. The ERBE Monopolar Attachment [P/N 20139-094] is used with the Helix Hydro-Jet™ and the ERBE Electrosurgical Generator (ESU) Systems (ICC or VIO Mc rels), The Helix Hydro-Jet™ is a hydraulic pressure delivery system that uses physiological same to cut and dissect soft tissue. The ERBE Electrosurgical Generator (ESU) Systems (IC or VIO Models) deliver High Frequency (HF) energy through the electrode tip of the ERBE Monopolar Attachment for coagulation and cutting of tissue. The ERBE Monopolar Attachment for Helix Hydro-Jet™ is made of stainless steel with plastic insulation except at the electrode to ribers isolates the HF energy to only the tip surface). The ERBE Monopolar Attachment has a channel and ring where the Helix Hydro-Jet™ Applicator slides into the Monopolar Attachment and is held in place for the Physician. The Monopolar Attachment is provided non-sterile and is reusable. (Note: The cleaning and sterilization processes are provided in the proposed draft labeling, "Notes on Use" - ERBE Monopolar Attachment, )
Intended Use:
The Monopolar Attachment combines the use of the Helix Hydro-Jet™ Applicator with suction (Part Number 20139-074) with the use of monopolar coagulation and cutting (option drip irrigation is also available) when used in conjunction with an ERBE ESU (ICC or VIO Models).
The Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie Note: receptacle. The use of ERBE ESU ICC and VIO Models are recommended. Compatibility and settings should be demonstrated/established prior to using a different Generator in the clinical environment.
1
510K SUMMARY
Similarities and Differences of the Proposed Devices to the Predicate Devices Comparison/Substantial Equivalence):
Similarities
The ERBE Monopolar Attachment allows the physician to combine the use of the ERBE Helix Hydro-Jet™ for water jet dissection with the ERBE Electrosurgical Generator (ESUL Systems (ICC or VIO Models) for monopolar coagulation and cutting, The use of the ERRE Monopolar Attachment does not change the way the Physician uses the ERBE Helix Hydro-Jet™ System and Applicators or the ERBE Electrosurgical Generator (ESU) Systems (ICC or VIO Models). The ERBE Monopolar Attachment for Helix Hydro-Jet™ has the same intended use as the ERBE Helix Hydro-Jet™ System with the combined ability of the intended use of the ERBE ESU. While the energy sources are still used separately, the Monopolar Attachment combines their instrumentation parts into one handhed piece.
Differences
The ERBE Monopolar Attachment is different from the use of the ERBE Helix Hydro-Jet™ for water jet dissection with the ERBE Electrosurgical Generator (ESU) Systems (ICC over Models) for Monopolar coagulation/cutting in that the predicate method was for the Physician to pick up each instrument separately, use the instrument, then pick up the "the next instrument. Again while the energy sources are still used separately, the Monopolar Attachment combines their instrumentation parts into one handheld piece.
All the instrument design changes have been verified or validated in design control by ERBE Elektromedizin GmbH.
Conclusion:
The ERBE Monopolar Attachment for Helix Hydro-Jet™ has the same intended use, principles of operation, and technological characteristics as the predicate devices that were previously cleared for market in a 510(k).
The ERBE Monopolar Attachment differs only in that it allows the Physician to combine the instrumentation parts of the ERBE Helix™ Hydro-Jet for water jet dissection with the ERBE Electrosurgical Generator (ESU) Systems (ICC or VIO Models) for monopolar coagulation and cutting into one handheld piece.
In conclusion, there are no issues with the ERBE Monopolar Attachment for Helix Hydro-Jet™ that would raise additional safety or efficacy issues when compared to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 26 2007
ERBE USA, Inc. % Mr. John Tartal QA/RA Manager 2225 Northwest Parkway Marietta, Georgia 30067
Re: K062712
Trade/Device Name: ERBE Monopolar Attachment for Helix Hydro-Jet Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 18, 2007 Received: January 19, 2007
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 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. John Tartal
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Dohm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: ERBE Monopolar Attachment for Helix Hydro-JetTM
Indications For Use:
The Monopolar Attachment combines the use of the Helix Hydro-Jet™ Applicator with suction (Part Number 20139-074) with the use of monopolar coagulation and cutting (optional drip irrigation is also available) when used in conjunction with an ERBE ESU (ICC or VIO Models).
The Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie Note: receptacle. The use of ERBE ESU ICC and VIO Models are recommended. Compatibility and settings should be demonstrated/established prior to using a different Generator in the clinical environment.
Prescription Use (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) Division Sign-
Division of General, Restorative, and Neurological Devices
510(k) Number K062212
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