(89 days)
No
The description focuses on the mechanical and electrical components of the laparoscopic instruments and their intended use in surgical procedures, with no mention of AI or ML capabilities.
No
The device is described as an instrument for cutting, grasping, and dissecting various abdominal tissue during endoscopic surgical procedures, not for treating a disease or condition.
No
Explanation: The device is described as a surgical instrument (forceps and scissors) used for cutting, grasping, and dissecting tissue during endoscopic procedures, and also for enabling surgical procedures and biopsies during a laparoscopy. It does not mention any function related to diagnosing conditions or diseases.
No
The device description clearly details physical components like handles, shafts, connection rods, and single-use tips, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Cutting, Grasping and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparosopic) Surgical Procedures." This describes a surgical instrument used during a procedure on a patient's body.
- Device Description: The description details surgical instruments (forceps and scissors) designed for use in laparoscopic surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on specimens. It is a tool used directly on the patient's tissue during surgery.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cutting, Grasping and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparosopic) Surigcal Procedures.
Product codes
GEI
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal Tissue / abdominal cavity and the organs contained therein (liver, gall bladder, spleen, uterus, etc.)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Performed Biocompatibility testing according to ISO 10993-1, Electrical Safety testing according to EN 60601-1 and EN 60601-2-2, and Sterilization and Shelf-Life validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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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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1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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)
| XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
3
| DATE OF APPLICATION: | 22.05.2017 |
|---|---|
| ---------------------- | ------------ |
APPLICANT:
Getsch + Hiller Medizintechnik GmbH Sattlerstraße 20 78532 Tuttlingen Germany Tel: + 49 (0) 7461 - 130510 Fax: +49 (0) 7461 - 1305150 E-Mail: info@getsch-hiller.de
CONTACT PERSON:
Werner Hiller CEO Tel.: +49 (0) 7461 - 130512 E-Mail: werner.hiller@getsch-hiller.de
4
Image /page/4/Picture/2 description: The image shows the logo for GETSCH+HILLER MEDIZINTECHNIK. The logo consists of a blue circle with a plus sign inside, followed by the company name in gray and blue text. The word "GETSCH+HILLER" is in gray, and the word "MEDIZINTECHNIK" is in blue.
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
Description | Regulation
Medical
Specialty | Review
Panel | Product
Code | Regulation
Number | Device
Classification |
|---------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------|---------------------------------|-----------------|----------------------|--------------------------|
| Electrosurgical,
Cutting &
Coagulation &
Accessories | Electrosurgical
cutting and
coagulation
device and
accessories | General &
Plastic
Surgery | General &
Plastic
Surgery | GEI | 878.4400 | 2 |
3. Predicate Device / Reference Device
| Device | Predicate Device | Reference Device | 510(k)
Number | 510(k) Holder |
|-----------------------------------------------------|--------------------------------------------------|------------------------------|------------------|----------------------------|
| Monopolar Single Use
Laparoscopic
Instruments | ReNew V Handpiece
Laparoscopic
Instruments | - | K160706 | Microline Surgical
Inc. |
| | - | Disposable Re-New
Forceps | K974066 | Microline Pentax,
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
5
Image /page/5/Picture/2 description: The image shows the logo for GETSCH+HILLER MEDIZINTECHNIK. The logo consists of a blue circle with a plus sign inside, followed by the company name in gray and blue text. The words "GETSCH+HILLER" are in gray, and the word "MEDIZINTECHNIK" is in blue.
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
Medizintechnik
GmbH
(New Device) | Microline Surgical
Inc.
(Predicate Device) | Microline Pentax,
Inc.
(Reference Device) | Result |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | Monopolar Single Use
Laparoscopic
Instruments | ReNew V Handpiece
Laparoscopic
Instruments | Disposable Re-New
Forceps | - |
| Regulation Number | 878.4400 | 878.4400 | 878.4400 | Substantially
Equivalent |
| Class | II | II | II | Substantially
Equivalent |
| Code | GEI | GEI | GEI | Substantially
Equivalent |
| 510(k) number | - | K160706 | K981389 | - |
| Indication for Use | Cutting, Grasping and
Dissecting Various
Abdominal Tissue
during Endoscopic
(inclusive of
laparoscopic) Surgical
Procedures | Cutting and
Dissecting Various
Abdominal Tissue
during Endoscopic
(inclusive of
laparoscopic) Surgical
Procedures | Cutting, Grasping and
Dissection Various
Abdominal Tissue
during Endoscopic
(inclusive of
laparoscopic) Surgical
Procedures | Substantially
Equivalent |
| Prescription / OTC | Prescription | Prescription | Prescription | Substantially
Equivalent |
| Device Design | Reusable handle and
disposable tip | Reusable handle and
disposable tips and
reusable tips | Reusable handle and
disposable tips and
reusable tips | Substantially
Equivalent |
| Handle Design | Non-ratcheted | Non-ratcheted/
ratcheted | Non-ratcheted/
ratcheted | Substantially
Equivalent |
| Tip Design | scissors or graspers | scissors tips | Graspers/
Fenestrated forceps/
"Dolphin Nose"
Dissector/
"Babock"/
"Maryland" Dissector | Substantially
Equivalent |
| Shaft Diameter
[mm] | 5 | 5 | 5 | Substantially
Equivalent |
6.1. Device characteristics table
6
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
Medizintechnik
GmbH
(New Device) | Microline Surgical
Inc.
(Predicate Device) | Microline Pentax,
Inc.
(Reference Device) | Result |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Working Length
[mm] | 330 / 450 | 250 / 340 / 420 | 250 / 340 / 420 | Substantially
Equivalent |
| Tip Length [mm] | 10.0 - 22.5 | 11.2 - 19.3 | 18.8 -22.6 | Substantially
Equivalent |
| HF-mode | monopolar | monopolar | monopolar | Substantially
Equivalent |
| Generators | U.S. FDA cleared
Electrosurgical High-
Frequency (HF)
Generator which
complies with the IEC
60601-1-2 EMC
(Electromagnetic
Compatibility) testing
requirements | U.S. FDA cleared
Electrosurgical High-
Frequency (HF)
Generator which
complies with the IEC
60601-1-2 EMC
(Electromagnetic
Compatibility) testing
requirements | - | Substantially
Equivalent |
| Rated Voltage | max. 2kVp | 800 Vp - 2,65 kVp | 800 Vp - 2,65 kVp | Substantial
Equivalent |
| Single Use | Tips | Tips | Tips | Substantial
Equivalent |
| Reusable | Handle, insulated
shaft, connection rod | Tips, handle | Tips, handle | Substantial
Equivalent |
| Delivered Condition | Reusable handle is
delivered in unsterile
condition.
Disposable tips are
delivered in sterile
condition. | Reusable handle and
reusable tips are
delivered in non-
sterile condition.
Disposable tips are
delivered in sterile
condition. | Reusable handle and
reusable tips are
delivered in non-
sterile condition.
Disposable tips are
delivered in sterile
condition. | Substantial
Equivalent |
| Sterilization
Method | EO | EO | EO | Substantial
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.
7
Image /page/7/Picture/2 description: The image contains the logo for GETSCH+HILLER MEDIZINTECHNIK. The logo consists of a blue circle with a plus sign inside on the left. To the right of the circle, the text "GETSCH+HILLER" is written in gray, and below that, "MEDIZINTECHNIK" is written in blue.
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.