(445 days)
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 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.
The provided document is a 510(k) summary for the Endoscopic Monopolar Instruments and Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria through detailed clinical studies typical of software or AI/ML devices.
Therefore, the information requested in the prompt, such as acceptance criteria, reported device performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone performance, is not applicable to this type of device and submission. The study presented here is a bench test, not a clinical trial.
However, I can extract information related to the comparison with the predicate device, which is the "acceptance criteria" for regulatory clearance in this context.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" in this context are demonstrating substantial equivalence in technological characteristics and indications for use compared to the predicate device. The "reported device performance" is the comparison outlined in the "Technological Characteristics" table.
| Feature | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Indications for Use | Used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation, and taking of biopsy samples, and to control bleeding by use of monopolar high-frequency electrical current. | Used in laparoscopic and other minimally invasive procedures for cutting, dissection, fixation, and taking of biopsy samples, and to control bleeding by use of monopolar high-frequency electrical current. (Determined to be equivalent) |
| Materials | Stainless steel, PPSU, Halar S, Nylon insulation (mentioning K033249 for modular handle instruments). | Stainless steel, PPSU, Halar S, Nylon. (Determined to be equivalent) |
| Sterility | Non-sterile | Non-sterile (Determined to be equivalent) |
| Reusability | Reusable | Reusable (Determined to be equivalent) |
| Sterilization Method | Steam | Steam (Determined to be equivalent) |
| Electrical Safety | IEC 60601-2-18 | IEC 60601-1, IEC 60601-2-2 (2006). Note: While different standards are cited, this difference did not prevent a substantial equivalence determination, implying the subject device met current safety standards deemed equivalent or superior. |
| Design | Two and Three-Piece Modular System, with single-piece instruments cleared under K930666. | Two and Three-Piece Modular System, Single-Piece Instruments. (Determined to be equivalent based on similar configurations and market clearance of components for electrosurgical cutting and coagulation). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for a "test set" in the context of device performance metrics. The study involved "bench testing" to characterize thermal spread and mechanical functions/robustness. The number of devices or components tested is not detailed.
- Data Provenance: Not applicable in the context of clinical data. The "bench testing" would have been conducted in a laboratory setting by the manufacturer (BEMA GmbH & Co. KG, Germany).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device does not involve expert-established ground truth in a clinical or imaging context. The evaluation is based on engineering and material specifications, and performance against defined physical properties.
4. Adjudication method for the test set:
- Not applicable. There is no expert adjudication process described for this type of bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth: For bench testing, the "ground truth" would be the established engineering standards, material properties, and functional requirements for electrosurgical instruments (e.g., thermal spread limits, mechanical strength, electrical insulation integrity). The document states "Bench testing was provided to characterize thermal spread and mechanical functions and robustness."
8. The sample size for the training set:
- Not applicable. No training set is mentioned as this is not a machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. No training set is mentioned.
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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 1278576 EmmingenGermany |
| 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:
.
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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 DeviceEndoscopic MonopolarInstruments andAccessories | Predicate DeviceEndoscopic Tube ShaftInstruments forMonopolar Coagulation |
|---|---|---|
| Indications for Use | Endoscopic MonopolarInstruments andAccessories are used inlaparoscopic and otherminimally invasiveprocedures for cutting,dissection, fixation andtaking of biopsy samples,depending on the designof the tip. They are alsointended to controlbleeding by use ofmonopolar high-frequency electricalcurrent. | These Endoscopic TubeShaft Instruments areused in laparoscopic andother minimally invasiveprocedures for cutting,dissection, fixation andthe taking of biopsysamples, depending onthe design of the workingtips. They are furtherintended to controlbleeding by use ofmonopolar high-frequency electricalcurrent. |
| Materials | Stainless steel, PPSU,Halar SNylon | Stainless steel, PPSU,Halar SNylon insulation for anelectrosurgical cuttingand coagulation modularcomponent has beencleared for marketing byK033249, Pajunk ModularHandle 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-PieceModular System◯ Single-PieceInstruments | ◯ Two and Three-PieceModular SystemSingle-Piece Instrumentsfor electrosurgicalcutting and coagulationhave been cleared formarketing by K930666,Reusable LaparoscopicInstruments w/Electrocautery |
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- 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
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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
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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
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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 ____________________________________________________________________________________________________________________________________________________________________
§ 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.