(445 days)
Not Found
No
The summary describes standard electrosurgical instruments and accessories without mentioning any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is used for cutting, dissection, fixation, taking of biopsy samples, and controlling bleeding during surgical procedures, which are all therapeutic actions.
No
The device is described as an instrument used in surgical procedures for cutting, dissection, fixation, taking biopsy samples, and controlling bleeding using monopolar high-frequency electrical current. Its function is interventional/surgical, not diagnostic.
No
The device description clearly outlines physical components (handle, shaft, tip) and their use in surgical procedures involving electrical current, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in surgical procedures (cutting, dissection, fixation, biopsy, bleeding control) using mechanical action and electrical current. This is a direct interaction with the patient's body during surgery.
- Device Description: The description details the physical components and how they are used in surgical settings.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
Endoscopic Monopolar Instruments and Accessories are used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monopolar high-frequency electrical current.
Product codes
GEI
Device Description
Endoscopic Monopolar Instruments and Accessories comprises three systems: Modular Three-Piece System, Modular Two-Piece System and Eco-Line. The respective components (handle, shaft and tip) of the Three-Piece and Two-Piece Systems can be used interchangeably, while Eco-Line consists of an assortment of insulated, single-piece instruments. All shafts and several modular handles are insulated and may be used with appropriate tip inserts to control bleeding in monopolar electrosurgical procedures. Additional insulated and non-insulated modular handles are intended for general manual (non-electrical) surgical use according to the design of the chosen tip.
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
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
Bench testing was provided to characterize thermal spread and mechanical functions and robustness of the Endoscopic Monopolar Instruments and Accessories included in this submission.
Key Metrics
Not Found
Predicate Device(s)
K010192, K033249, K970541, K003717
Reference Device(s)
Not Found
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
DEC 2 0 2011
K102921
pg 1 of 3
ND EFFECTIVENESS
510(k) Summary of Safety and effective
| Date: | December 12, 2011 |
|---|---|
| Submitter: | |
| Name: | BEMA GmbH & Co. KG |
| Address: | Rudolf-Diesel-Strasse 12 |
| 78576 Emmingen | |
| Germany | |
| Contact Person: | Thomas Becker |
| Telephone: | +49.7465.92990 |
| Fax: | +49.7465.929929 |
| Product: | |
| Trade Name: | Endoscopic Monopolar Instruments and Accessories |
| Common Name: | Electrosurgical Instruments and Accessories |
| Classification Name: | Electrosurgical Cutting & Coagulation Device & Accessories |
| Predicate Device: | K010192 - Endoscopic Tube Shaft Instruments for Monopolar CoagulationK033249 - Pajunk Modular Handle InstrumentsK970541 - Aesculap Modular Monopolar ElectrodesK003717 - Tekno Medical Instruments for Laparoscopy |
| Device Description: | Endoscopic Monopolar Instruments and Accessories comprises three systems: Modular Three-Piece System, Modular Two-Piece System and Eco-Line. The respective components (handle, shaft and tip) of the Three-Piece and Two-Piece Systems can be used interchangeably, while Eco-Line consists of an assortment of insulated, single-piece instruments. All shafts and several modular handles are insulated and may be used with appropriate tip inserts to control bleeding in monopolar electrosurgical procedures. Additional insulated and non-insulated modular handles are intended for general manual (non-electrical) surgical use according to the design of the chosen tip. |
| Indications for Use: | Endoscopic Monopolar Instruments and Accessories are used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monopolar high-frequency electrical current. |
ENDOSCOPIC INSTRUMENTS AND ACCESSORIES:
.
1
K102921- pg 2 of 3
Technological Characteristics
Bench testing was provided to characterize thermal spread and mechanical functions and robustness of the Endoscopic Monopolar Instruments and Accessories included in this submission. The device has similar technological and performance characteristics as the predicate device cleared under 510(k) K010192, as shown by the following summary:
| Feature | Subject Device
Endoscopic Monopolar
Instruments and
Accessories | Predicate Device
Endoscopic Tube Shaft
Instruments for
Monopolar Coagulation |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Endoscopic Monopolar
Instruments and
Accessories are used in
laparoscopic and other
minimally invasive
procedures for cutting,
dissection, fixation and
taking of biopsy samples,
depending on the design
of the tip. They are also
intended to control
bleeding by use of
monopolar high-
frequency electrical
current. | These Endoscopic Tube
Shaft Instruments are
used in laparoscopic and
other minimally invasive
procedures for cutting,
dissection, fixation and
the taking of biopsy
samples, depending on
the design of the working
tips. They are further
intended to control
bleeding by use of
monopolar high-
frequency electrical
current. |
| Materials | Stainless steel, PPSU,
Halar S
Nylon | Stainless steel, PPSU,
Halar S
Nylon insulation for an
electrosurgical cutting
and coagulation modular
component has been
cleared for marketing by
K033249, Pajunk Modular
Handle Instruments. |
| Sterility | Non-sterile | Non-sterile |
| Reusability | Reusable | Reusable |
| Sterilization Method | Steam | Steam |
| Electrical Safety | IEC 60601-1, IEC 60601-2-
2 (2006) | IEC 60601-2-18 |
| Design | ◯ Two and Three-Piece
Modular System
◯ Single-Piece
Instruments | ◯ Two and Three-Piece
Modular System
Single-Piece Instruments
for electrosurgical
cutting and coagulation
have been cleared for
marketing by K930666,
Reusable Laparoscopic
Instruments w/
Electrocautery |
2
- pg 3.83
Conclusion:
The information provided in this 510(k) submission provides reasonable assurance that the subject device Endoscopic Monopolar Instruments and Accessories is safe and effective and that it is substantially equivalent to the predicate device with respect to intended use and technological characteristics.
ENDOSCOPIC INSTRUMENTS AND ACCESSORIES Section 6 - 510(k) Summary Submission Applicant: BEMA GmbH & Co. KG
3
Image /page/3/Picture/12 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 20 2011
Bema-GmbH & Co. Kg % Business Support International Ms. Angelika Scherp Amstel 320-1 Amsterdam, Noord-Holland Netherlands 1017AP
Re: K102921
Trade/Device Name: Endoscopic Monopolar Instruments and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 09, 2011 Received: December 13, 2011
Dear Ms. Scherp:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Ms. Angelika Scherp
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. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely your
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the text "K102921" above a line. Below the line, the text "Pg 1 of 1" is circled. The text and circle are handwritten in black ink.
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES
Indications for Use:
Endoscopic Monopolar Instruments and Accessories are used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monopolar high-frequency electrical current.
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)
Signature Of
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102921
Page 1 of ____________________________________________________________________________________________________________________________________________________________________