HANS HERMANN LAPAROSCOPES AND ACCESSORIES

K051610 · Hans Hermann GmbH · GCJ · Jul 29, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051610
• Device Name: HANS HERMANN LAPAROSCOPES AND ACCESSORIES
• Applicant: Hans Hermann GmbH
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The Laparosopes and accessories are intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures. The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow. The bipolar electrodes are use to coagulate and to remove or destroy tissue by the use of bipolar HF current.

Device Story

Device suite includes surgical instruments, bipolar/monopolar electrodes, Verres needles, suction/irrigation systems, endoscopes (laparoscope, arthroscope, cystoscope), and light cables. Used by surgeons in clinical/OR settings for minimally invasive surgery. Electrodes utilize bipolar high-frequency (HF) current for tissue coagulation, removal, or destruction. Visualization provided via endoscopes and light cables. Provides access to body cavities/organs for diagnostic/therapeutic procedures. Benefits include minimally invasive access, reducing surgical trauma compared to open procedures.

Clinical Evidence

Bench testing only. Devices conform to IEC 60601-2-2 and European Device Directive 93/42/EEC.

Technological Characteristics

Materials: stainless steel, PTFE, PEEK, silicon, brass, and various coatings. Components: surgical instruments, electrodes, endoscopes, light cables. Energy: bipolar HF current. Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for patients requiring minimally invasive diagnostic or therapeutic surgical procedures involving access to/visualization of body cavities, organs, and canals. Arthroscope indicated for joint examinations, biopsies, and diagnosis of joint disease in knee, shoulder, wrist (carpal tunnel syndrome), TMJ, ankle, and elbow. Bipolar electrodes indicated for tissue coagulation, removal, or destruction via bipolar HF current.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Reference Devices

• Ackermann
• ASAF
• Richard Wolf
• Sticles

Submission Summary (Full Text)

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K051610
.JUL 29 2005

1/2

Hermann Medizintechnik GmbH Württemberger Str. 26 D-78567 Fridingen Germany

# 510(k) Summery of Safety and Effectiveness

# Titel: Laparoscopes and accessories

April 08, 2005

| Submitted by | Ing.-Büro Jung<br>Unterer Winkel 3<br>D-78573 Wurmlingen |
|--------------------------------------|-------------------------------------------------------------------|
| Contact Person | Harald Jung<br>Telefon [phone]<br>FAX [phone] |
| Trade Name | Laparoscopes and accessories |
| Common Name | Laparoscopes |
| Product Code and Classification Name | GCJ, Laparoscope, General & Plastic Surgery |
| Product Classification | 21 CFR § 876.1500 |

#### Device Description

The Hans Hermann Laparoscopes and accessories consists of

- uls Hermann Daparoped surgical instruments with and without monopolar ﺖ high frequency connection
- bipolar electrodes and accessories -
- monopolar electrodes and accessories -
- monopolar cicchrodos and accessories, Verres needles and suction-/irrigation systems,
- several Endoscopes (Laparoscope, Arthroscope, Cystoscope) -
- and a light cable -

The body contact portions of the Laparoscopes and accessories are composed of The body comace stainless steel, PTFE, PEEK, several coatings, silicon and brass surgical grade stamicss stock, in medical devices for a wide range of chiromutin placer which is commonly of biocompatibility for human use at short term contact.

### Intended Use

The Laparosopes and accessories are intended for use in providing access to and I he Laparosopos and accessorsegans, and canals to perform various diagnostic and therapeutic surgical procedures.

The arthroscope is indicated for illumination during joint examinations, arthroscopies, The artiff oscope is minimally invasive in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow. silouder, whist (ourpar tamies by the organiate and to remove or destroy tissue by the use of bipolar HF current.

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K051610 2/2

## Substantial Equivalence

Substantial Equivalente
The Laparoscopes and accessories are substantial equivalent to the predicate and I he Laparoscopes and accessories and others, since the basic features, design and Ackermann, ASAF, Nichard Wolf and Sticles, ces between the Laparoscopes and intended uses are the same. The mator assess of safety and effectiveness, as as accessories and the predicate devices raise no now as function or intended use of the devices.

## Performance Data

I criormance Data.
The devices conform to IEC 60601-2-2 and to the relevant provisions of European Device Directive 93/42/EEC.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around the perimeter of the circle. The text is in all capital letters.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 9 2005

Hans Herman GmbH c/o Mr. Stefan Preiss TÜV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112

Re: K051610

Trade/Device Name: Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, GCJ Dated: July 20, 2005 Received: July 26, 2005

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) the article the arredicate devices marketed in interstate for use stated in the encrosule) to regally manced producal Device Americal Device Ameral Food. Drug commerce prior to May 28, 1970, the enactified in accordance with the provisions of the Federal Food, Drug, devices that have been reciassince in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the Act . Th and Cosmetic Act (Act) that to hot require approval controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general controls pro You may, merelore, market the devices, sayes to the go
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Feet merclass required.
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 If your device is classified (see above) into ensier as a consider of the subject can be may be subject to such additional controller controls. Extransmily on one In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to B.B. be found in the Code of Peachar Regerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuates of a succession in the requirements of the Act
that FDA has made a determination that your device complies with on your must that FDA has made a decermination administered by other Federal agencies. You must or any Federal statures and regulations daminding, but not limited to: registration and isting (21 l comply with an the Act 3 requirements, me, good manufacturing practice requiremes as set CFR Part 807), labeling (21 CFR Part 801), good and if applicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 - Mr. Stefan Preiss

This letter will allow you to begin marketing your device as described in your Section 510(k)
The start of the support of any of a lot stick spivalence of your device to a le This letter will allow you to begin marketing your article of your device of your device to a legally
premarket notification. The FDA finding of substantial equivale and thu premarket notification. The PDA inding of substantial equively of your device ﻴﻦ ﻣﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the may be and any and 10, 276 0115 - Also, massa note the regulation en If you desire specific advice for your uevice on our nooming the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulation contact the Office of Complialice at (240) 270 - 197 Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarkst nothleading the Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638-200 other general intornation on your responsive Assistance at its toll-free number [phone] or Manufacturers, International and Consulter Assistance at to to to to to to to consideration of the more of index.html.

Sincerely yours,
Stupt Rurda

Mark N. Melkerson Acting 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

510(k) Number (if known):

Right
Left

#### Laparoscopic instruments Device Name:

Indications For Use:

Indications For Use:
The Laparosopes and accessories are intended for use in providing access to and visualization of The Laparosopes and accessories are interious for assumes and therapeutic surgical procedures.

procedures.
The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and The arthroscope is indicated on indimlation uning John oxantinables, and the knee, shoulder, wrist (capal
diagnosis of joint disease in minilly invasive only one olbow draghosis of joint disodoo ill mandibular joint, ankle and elbow.
tunnel syndrome), temporal mandibular joint, ankle remove on

tunnel syndrome), temporal mandibular joint, ankle and elser.
The bipolar electrodes are use to coagulate and to remove or destroy tissue by the use of bipolar HF current.

Prescription Use yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hyt Rueda

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

510(k) Number K051610

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