The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general surgery, laparoscopic, gynecologic, urological, and thoracic procedures where fusion of vessels or tissues is desired. The devices can be used on vessels up to 7 mm and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument.

The ERBE BiClamp™ Open and Laparoscopic Instruments are designed for use with an ERBE VIO Electrosurgical Generator (ESU) System having an Optional Bipolar Mode/ BiClamp™ upgrade and the multi-function receptacle. Not recommended for use with other manufacturer's generators.

The indications for use with Open Instruments include: general surgery, gynecologic, urological, and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.

The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.

CAUTION: Vessel fusion can be affected by patient factors such as age, elasticity of vessels, thickness of vessel walls, etc.; therefore, the physician should review each vessel fusion for seal integrity. This device is not effective for use in tubal sterilization/tubal coagulation for sterilization purposes.

Device Description

The ERBE BiClamp™ Open and Laparoscopic Instruments are used with an ERBE VIO Electrosurgical Generator (ESU) System having the Optional Bipolar Mode, BiClamp. High Frequency (HF) energy from the ESU is delivered through the jaws of the ERBE BiClamp" Instruments to coagulate/desiccate tissue. The ERBE BiClamp™ Open Instruments are made of stainless steel with plastic insulation except at the jaw surfaces (which isolates the energy to only the jaw surfaces). The ERBE BiClamp'™ Laparoscopic Instruments are made of metals and plastics with the electrical energy isolated to the jaws. They have various jaw types, which are standard in the industry. The ERBE BiClamp™ Open Instruments range in size from 200 mm (7.9 inches) to 270 mm (10.6 inches) in length with bent jaws that have a smooth surface. The ERBE BiClamp™ Laparoscopic Instruments have a 5 mm outside diameter (O.D.) and a 340 mm (13.4 inches) working length. The Instruments are provided non-sterile and are reusable (Note: The cleaning and sterilization processes have been validated and are provided in the Notes on Use to the customer.).

AI/ML Overview

This document is a 510(k) summary for the ERBE BiClamp™ Open and Laparoscopic Instruments. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results with acceptance criteria.

Therefore, the requested information regarding acceptance criteria and performance studies cannot be fully extracted from the provided text for this specific device. The document mostly discusses similarities and differences with a predicate device and states that "all the instrument designs have been verified or validated in design control by ERBE Elektromedizin GmbH." This suggests that design control activities were performed, but the details of those validations are not included in this summary.

Based on the information provided in the K033421 510(k) Summary, here's what can be gathered, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria or reported device performance metrics (e.g., success rates, failure rates, or specific measurements) are provided in this document. The submission relies on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data against defined criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The document does not describe a clinical test set in the way a clinical trial would. It refers to design verification and validation, but details on sample size, country of origin, or retrospective/prospective nature are not included for a specific performance evaluation test set within this summary.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable. The document does not describe a process for establishing ground truth using experts for device performance evaluation. The "truth" in this context is based on the predicate device's established safety and efficacy.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned or implied. This device is an electrosurgical instrument, not an AI-based diagnostic tool, so such a study would not be relevant.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a medical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate device (Valleylab Inc. LigaSure™ Open and Laparoscopic Instruments K981916). The submission argues that the ERBE BiClamp™ is substantially equivalent to this predicate.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a training set in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary of what is available and missing:

Available:
- Device Description: Detailed information about the ERBE BiClamp™ instruments, their materials, sizes, and compatibility with the ERBE VIO Electrosurgical Generator.
- Intended Use and Indications for Use: Clear statements on how and where the device is intended to be used, including specific surgical procedures and vessel sizes.
- Predicate Device: Clearly identifies the legally marketed predicate device (Valleylab Inc. LigaSure™ Open and Laparoscopic Instruments, K981916).
- Similarities and Differences to Predicate: Highlights shared characteristics (physical, dimensional, technological, intended use) and differences (reusability, lack of closure mechanism).
- Verification/Validation Statement: It states that "all the instrument designs have been verified or validated in design control by ERBE Elektromedizin GmbH." This implies that internal testing was conducted to ensure the device met its design specifications and user needs.
Missing from this document (and typically not found in a 510(k) summary unless the device is novel or has substantial differences requiring new clinical data):
- Specific quantitative acceptance criteria (e.g., tensile strength of seals, burst pressure, seal integrity rates).
- Detailed results of the design verification and validation studies (e.g., number of vessels tested, types of tissue, success rates).
- Any clinical trial data with specific sample sizes, ground truth establishment, or expert reviews.
- Any comparative effectiveness data against the predicate device in a clinical setting.

In essence, this 510(k) relies on the premise that because the ERBE BiClamp™ has very similar intended use, principles of operation, and technological characteristics to an already cleared device, and the identified differences (reusability, no closure mechanism) do not raise new safety or efficacy issues, it is substantially equivalent. The "study" referenced is the design control process, whose detailed reports are not part of this public summary.

Summary

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KO33421

510K SUMMARY - Revised August 6, 2004

Submitted By:	OCT 1 4 2004ERBE USA, Inc.2225 Northwest ParkwayMarietta, GA 30067Tel: 770-955-4400 Fax: 770-955-2577
Contact Person:	Julie Stephens, President/ConsultantRegulatory Resources Group, Inc.
510(k) Number:	K033421
Date Prepared:	August 6, 2004
Common Name:	Bipolar Electrosurgical Open and Laparoscopic Instruments
Trade/Proprietary Name:	ERBE BiClamp™ Open and Laparoscopic Instruments
Classification Name:	Electrosurgical cutting and coagulation device and accessories(21CFR878.4400) and Gynecologic electrocautery andaccessories (21 CFR Part 884.4120)
Product Code:	GEI and HGI
Legally MarketedPredicate Device:	Valleylab Inc. LigaSure™ Open and LaparoscopicInstruments 510(k) Number: K981916

Device Description:

Intended Use:

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K033421 (pg 2 of 2)

510K SUMMARY - Revised August 6, 2004

The indications for use with Open Instruments include: general surgery, gynecologic, urological. and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.

The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or tissue bundles is performed including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), faparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.

Similarities and Differences of the Proposed Devices to the Predicate Devices Comparison/Substantial Equivalence):

Similarities

The ERBE BiClamp™ Open and Laparoscopic Instruments have similar physical and dimensional characteristics as the predicate devices. They have the same basic technological characteristics and the intended use is the same.

Differences

The ERBE BiClamp™ Open and Laparoscopic Instruments are different in that all of the product line components or parts are provided non-sterile and reusable: where as. the electrodes of the predicate's Open Instruments and Laparoscopic Instruments are sterile, single use. The ERBE BiClamp Open and Laparoscopic Instruments do not have closure mechanisms to hold the instrument closed (or clamped), where as, the predicate devices have closure mechanisms.

All the instrument designs have been verified or validated in design control by ERBE Elektromedizin GmbH.

Conclusion:

The ERBE BiClamp™ Open and Laparoscopic Instruments have 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 BiClamp™ Open and Laparoscopic Instruments differ only in that all the instruments and their parts are reusable and they do not have a closure mechanism to hold the instruments closed.

In conclusion, there are no issues with the ERBE BiClamp™ Open and Laparoscopic Instruments that would raise additional safety or efficacy issues when compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

OCT 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ERBE USA, Inc. c/o Ms. Julie Stephens Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K033421

Trade/Device Name: ERBE BiClamp™ Open and Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23, 2004 Received: September 24, 2004

Dear Ms. Stephens:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o no ro ro ro row a your 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 for associated in the 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). and Cosmetic fore, market the device, subject to the general controls provisions of the Act. The r ou may, are every inions 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.

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Page 2 - Ms. Julie Stephens

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use - REVISED August 6, 2004

510(k) Number (if known): K033421

Device Name: ERBE BiClamp™ Open and Laparoscopic Instruments

Indications For Use:

The ERBE BiClamp™ Open and Laparoscopic Instruments are intended for use in general The ERDE Dronalip - Opecologic, urological, and thoracic procedures where fusion of vessels surgery, laparoscopies, griesers, and e used on vessels up to 7 mm and bundles as large as of this us is a donrod. The instrument. A vessel fusion is created by the application of bipolar will in in the juve of argy (coagulation) to the vessels placed between the jaws of the instrument.

The indications for use with Laparoscopic Instruments include: all laparoscopic procedures (including gynecologic, general, urological, and thoracic surgery) where fusion of vessels or (incrading gracess), bootegory book procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholecystectomies (gall bladder procedures), Nissen fundoplication, adhesiolysis (lysis of adhesions), oophorectomy, etc.

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)

uriam C. Phiorrst

Page 1 of 1

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number K63342/

Regulation Number and Section

§ 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.