Monopolar Single Use Laparoscopic Instrument

K171523 · Getsch+Hiller Medizintechnik GmbH · GEI · Aug 22, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171523
• Device Name: Monopolar Single Use Laparoscopic Instrument
• Applicant: Getsch+Hiller Medizintechnik GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cutting, Grasping and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparosopic) Surgical Procedures

Device Story

Monopolar single-use laparoscopic instruments consist of reusable handles and shafts with disposable tips; available in 2-part or 4-part configurations. Device connects to FDA-cleared monopolar electrosurgical HF-generators. Operated by surgeons in clinical/OR settings during endoscopic procedures. Instrument tip performs mechanical cutting, grasping, or dissection while delivering monopolar HF energy for coagulation. Output is physical tissue manipulation and thermal coagulation. Benefits include precise tissue management during minimally invasive surgery.

Clinical Evidence

Bench testing only. No clinical data presented. Evidence includes biocompatibility testing (ISO 10993-1: cytotoxicity, sensitization, irritation), electrical safety testing (EN 60601-1, EN 60601-2-2), and sterilization validation (EO for tips, steam for reusable parts) per ISO 10993-7.

Technological Characteristics

Manual surgical instruments; 5mm shaft diameter; 330mm/450mm working lengths. Monopolar HF energy delivery; max rated voltage 2kVp. Reusable handle/shaft/rod; single-use tips. Sterilization: EO for tips, steam for reusable components. Complies with IEC 60601-1-2 EMC requirements.

Indications for Use

Indicated for cutting, grasping, and dissecting abdominal tissue during endoscopic (including laparoscopic) surgical procedures.

Regulatory Classification

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.

Predicate Devices

• ReNew V Handpiece Laparoscopic Instruments (K160706)

Reference Devices

• Disposable Re-New Forceps (K974066)
• Disposable Re-New Forceps (K981389)

Submission Summary (Full Text)

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August 22, 2017

Getsch + Hiller Medizintechnik GmbH Werner Hiller CEO Sattlerstraße 20 Tuttlingen, 78532 Germany

Re: K171523

Trade/Device Name: Monopolar Single Use Laparoscopic Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 22, 2017 Received: May 25, 2017

Dear Werner Hiller:

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 Actinclude 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 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-

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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known)

K171523

Device Name

Monopolar Single Use Laparoscopic Instruments

Indications for Use (Describe)

Cutting, Grasping and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparosopic) Surigcal Procedures

Type of Use (*Select one or both, as applicable*)

| | <span style="padding-right: 20px;"> <span style="border: 1px solid black; padding: 0px; margin-right: 5px;"><b>X</b></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="border: 1px solid black; padding: 0px; margin-right: 5px;"></span>Over-The-Counter </span> |
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Use (21 CFR 801 Subpart C)

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Expiration Date: January 31, 2017

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| DATE OF APPLICATION: | 22.05.2017 |
|----------------------|------------|
|----------------------|------------|

APPLICANT:

Getsch + Hiller Medizintechnik GmbH Sattlerstraße 20 78532 Tuttlingen Germany Tel: + 49 (0) 7461 - 130510 Fax: [phone] E-Mail: [e-mail]

#### CONTACT PERSON:

Werner Hiller CEO Tel.: [phone] - 130512 E-Mail: [e-mail]

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## 1. Device Name

| Trade Name: | Monopolar Single Use Laparoscopic Instruments |
|-----------------------------|------------------------------------------------------|
| Common Name: | Manual Detachable Surgical Instruments |
| Device Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |

# 2. Classification / Product Code

Monopolar Single Use Laparoscopic Instruments can be classified according to following device name and product code:

| Device | Regulation<br>Description | Regulation<br>Medical<br>Specialty | Review<br>Panel | Product<br>Code | Regulation<br>Number | Device<br>Classification |
|---------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------|---------------------------------|-----------------|----------------------|--------------------------|
| Electrosurgical,<br>Cutting &<br>Coagulation &<br>Accessories | Electrosurgical<br>cutting and<br>coagulation<br>device and<br>accessories | General &<br>Plastic<br>Surgery | General &<br>Plastic<br>Surgery | GEI | 878.4400 | 2 |

# 3. Predicate Device / Reference Device

| Device | Predicate Device | Reference Device | 510(k)<br>Number | 510(k) Holder |
|-----------------------------------------------------|--------------------------------------------------|------------------------------|------------------|----------------------------|
| Monopolar Single Use<br>Laparoscopic<br>Instruments | ReNew V Handpiece<br>Laparoscopic<br>Instruments | - | K160706 | Microline Surgical<br>Inc. |
| | - | Disposable Re-New<br>Forceps | K974066 | Microline Pentax,<br>Inc. |

## 4. Device Description

The Monopolar Sinqle Use Laparoscopic Instruments of Getsch + Hiller is available in two different designs. It is available as system consisting of two parts and as a system consisting of four parts.

The 2-part system is available with reusable handle assembled with a completely insulated shaft on which only a single use tip has to be fixed by the user. This has a working length of 330 mm.

The 4-part system consists of a reusable handle and a reusable shaft insulated, a connection rod with easy snap lock and a single use tip. The system has to be assembled by the user. The 4-part system is available with a working length of 330 mm and 450 mm.

Different types of single use tips are offered for both systems, Maryland grasping forceps, Endoclinch grasping forceps, Aggressive grasping forceps and Johan grasping forceps. Furthermore Metzenbaum scissors in different sizes, straight or curved, are available.

The systems are intended to be used in laparoscopy is an optical examination and diagnostic procedure in which the abdominal cavity and the organs contained therein (liver, gall bladder, spleen, uterus, etc.) are mirrored with an endoscope. During a

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laparoscopy, in addition to the diagnosis, surgical procedures and biopsies are also made possible whereby surgical micro-instruments are utilized. The Monopolar Single Use Laparoscopic Instruments have to be used in combination with a monopolar HF connector.

The Monopolar Single Use Laparoscopic Instruments can be connected to U.S. FDA cleared Electrosurgical HF-Generator (e.g. K02464, K053290, K94519 and other FDA cleared HFgenerators) which complies with the IEC 60601-1-2 EMC (Electromagnetic Compatibility) testing requirements.

## 5. Indication for Use

Cutting, Grasping and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparosopic) Surgical Procedures.

## 6. Technological Characteristics

The technological characteristics of our Monopolar Single Use Laparoscopic Instruments are the same as the technological characteristics of the predicate device.

| Company | Getsch + Hiller<br>Medizintechnik<br>GmbH<br>(New Device) | Microline Surgical<br>Inc.<br>(Predicate Device) | Microline Pentax,<br>Inc.<br>(Reference Device) | Result |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | Monopolar Single Use<br>Laparoscopic<br>Instruments | ReNew V Handpiece<br>Laparoscopic<br>Instruments | Disposable Re-New<br>Forceps | - |
| Regulation Number | 878.4400 | 878.4400 | 878.4400 | Substantially<br>Equivalent |
| Class | II | II | II | Substantially<br>Equivalent |
| Code | GEI | GEI | GEI | Substantially<br>Equivalent |
| 510(k) number | - | K160706 | K981389 | - |
| Indication for Use | Cutting, Grasping and<br>Dissecting Various<br>Abdominal Tissue<br>during Endoscopic<br>(inclusive of<br>laparoscopic) Surgical<br>Procedures | Cutting and<br>Dissecting Various<br>Abdominal Tissue<br>during Endoscopic<br>(inclusive of<br>laparoscopic) Surgical<br>Procedures | Cutting, Grasping and<br>Dissection Various<br>Abdominal Tissue<br>during Endoscopic<br>(inclusive of<br>laparoscopic) Surgical<br>Procedures | Substantially<br>Equivalent |
| Prescription / OTC | Prescription | Prescription | Prescription | Substantially<br>Equivalent |
| Device Design | Reusable handle and<br>disposable tip | Reusable handle and<br>disposable tips and<br>reusable tips | Reusable handle and<br>disposable tips and<br>reusable tips | Substantially<br>Equivalent |
| Handle Design | Non-ratcheted | Non-ratcheted/<br>ratcheted | Non-ratcheted/<br>ratcheted | Substantially<br>Equivalent |
| Tip Design | scissors or graspers | scissors tips | Graspers/<br>Fenestrated forceps/<br>"Dolphin Nose"<br>Dissector/<br>"Babock"/<br>"Maryland" Dissector | Substantially<br>Equivalent |
| Shaft Diameter<br>[mm] | 5 | 5 | 5 | Substantially<br>Equivalent |

## 6.1. Device characteristics table

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Monopolar Single Use Laparoscopic Instruments 510(k) Premarket Notification

Image /page/6/Picture/3 description: The image shows the logo for GETSCH+HILLER MEDIZINTECHNIK. The logo consists of a blue circle with a plus sign inside on the left, followed by the company name in gray and blue text on the right. The word "GETSCH+HILLER" is in gray, and the word "MEDIZINTECHNIK" is in blue.

| Company | Getsch + Hiller<br>Medizintechnik<br>GmbH<br>(New Device) | Microline Surgical<br>Inc.<br>(Predicate Device) | Microline Pentax,<br>Inc.<br>(Reference Device) | Result |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Working Length<br>[mm] | 330 / 450 | 250 / 340 / 420 | 250 / 340 / 420 | Substantially<br>Equivalent |
| Tip Length [mm] | 10.0 - 22.5 | 11.2 - 19.3 | 18.8 -22.6 | Substantially<br>Equivalent |
| HF-mode | monopolar | monopolar | monopolar | Substantially<br>Equivalent |
| Generators | U.S. FDA cleared<br>Electrosurgical High-<br>Frequency (HF)<br>Generator which<br>complies with the IEC<br>60601-1-2 EMC<br>(Electromagnetic<br>Compatibility) testing<br>requirements | U.S. FDA cleared<br>Electrosurgical High-<br>Frequency (HF)<br>Generator which<br>complies with the IEC<br>60601-1-2 EMC<br>(Electromagnetic<br>Compatibility) testing<br>requirements | - | Substantially<br>Equivalent |
| Rated Voltage | max. 2kVp | 800 Vp - 2,65 kVp | 800 Vp - 2,65 kVp | Substantial<br>Equivalent |
| Single Use | Tips | Tips | Tips | Substantial<br>Equivalent |
| Reusable | Handle, insulated<br>shaft, connection rod | Tips, handle | Tips, handle | Substantial<br>Equivalent |
| Delivered Condition | Reusable handle is<br>delivered in unsterile<br>condition.<br>Disposable tips are<br>delivered in sterile<br>condition. | Reusable handle and<br>reusable tips are<br>delivered in non-<br>sterile condition.<br>Disposable tips are<br>delivered in sterile<br>condition. | Reusable handle and<br>reusable tips are<br>delivered in non-<br>sterile condition.<br>Disposable tips are<br>delivered in sterile<br>condition. | Substantial<br>Equivalent |
| Sterilization<br>Method | EO | EO | EO | Substantial<br>Equivalent |

# 7. Summary of technological characteristics

The proposed devices are similar in terms of design, operating principles and intended use and have similar technological characteristics as the predicate devices. The materials used on these devices are also used in the legally marketed predicate devices.

## 8. Performance Data

Verification and validation results demonstrate that the device performs as intended and that the Monopolar Single Use Laoaroscopic Instruments are substantially equivalent to the Predicate Device K160706.

## 8.1. Biocompatibility

The device has been evaluated for its biological safety according to ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process". Following endpoints have been assessed during the evaluation:

- Cytotoxicity .
- . Sensitization
- . Irritation or Intracutaneous Reactivity

The evaluation proofs the biological safety of the device.

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## 8.2. Electrical Safety

To proof safety and effectiveness the device has been tested according to the requirements of EN 60601-1 and EN 60601-2-2

#### 8.3. Sterilization and Shelf-Life

The reusable parts can be reprocessed using a validated cleaning and disinfection procedure. Steam sterilization of the reusable parts has been validated.

Disposable tips are delivered in sterile condition. EO-sterilization is used for the sterilization of the disposable tips. A sterilization validation has been conducted. Furthermore a test for Ethylene oxide sterilization residuals has been conducted. The devices passed the limits of ISO 10993-7. Sterile packaging has been tested for its peel ability of the seal, seal strength and leakage of the seal. All tests were passed by the used packaging.

## 9. Substantial Equivalence Summary / Conclusions

Based on available 510(k) information provided herein, our Monopolar Single Use Laparoscopic Instruments are considered to be substantially equivalent to the predicate device ReNew V Handpiece Laparoscopic Instruments and the Reference Device Disposable Re-New Forceps in terms of indication for use, materials and technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness.