CLICKLINE Scissor Insert for Single Use

K151044 · Karl Storz Endoscopy America, Inc. · GEI · Oct 9, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K151044
• Device Name: CLICKLINE Scissor Insert for Single Use
• Applicant: Karl Storz Endoscopy America, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CLICKLINE Scissor Insert for Single Use is used in combination with a reusable CLICKLINE handle for cutting tissue. Instruments with HF connection can also be used for the monopolar coagulation of tissue or the coagulation of small hemorrhages.

Device Story

Single-use surgical scissor insert; attaches to reusable CLICKLINE handle; used for tissue cutting and monopolar coagulation. Input: manual mechanical force from surgeon via handle; electrical energy for coagulation. Output: mechanical cutting action; electrosurgical coagulation. Used in clinical/surgical settings by physicians. Benefits: provides sharp, sterile cutting and coagulation capability while utilizing reusable handle infrastructure.

Clinical Evidence

No clinical data. Bench testing only: charring, thermal spread, pulling, and dropping tests. Compliance with ISO 10993-1, -5, -10; IEC 60601-1, -2-2, and -2-18.

Technological Characteristics

Materials: AISI 420 stainless steel (jaws), AISI 303/304 stainless steel (shafts), Apex MTE Medical Grade Polyolefin (tubing), Mevopur-Black (colorant). Dimensions: 4.9mm diameter, 41.17cm/40.7cm lengths. Energy: Monopolar electrosurgical. Connectivity: Mechanical attachment to reusable handle. Standards: ISO 10993, IEC 60601 series.

Indications for Use

Indicated for cutting tissue and monopolar coagulation of tissue or small hemorrhages during surgical procedures when used with a compatible reusable CLICKLINE handle.

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

• ACE Monopolar Attachment (K123061)

Reference Devices

• CLICKLINE handle (K954122)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

KARL STORZ Endoscopy America Incorporated Ms. Winkie Wong Regulatory Affairs Specialist 2151 East Grand Avenue El Segundo, California 90245

October 9, 2015

Re: K151044

Trade/Device Name: CLICKLINE Scissors Insert for Single Use Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 9, 2015 Received: September 10, 2015

Dear Ms. Wong:

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 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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); 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)

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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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

Joshua C. Nipper -S

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

Enclosure

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## Indications for Use

510(k) Number (if known) K151044

Device Name

CLICKLINE Scissors Insert for Single Use

Indications for Use (Describe)

The CLICKLINE Scissor Insert for Single Use is used in combination with a reusable CLICKLINE handle for cutting tissue. Instruments with HF connection can also be used for the monopolar coagulation of tissue or the coagulation of small hemorrhages.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in a smaller, sans-serif font.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy-America, Inc<br>2151 E. Grand Avenue<br>EI Segundo, CA 90245 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong<br>Regulatory Affairs Specialist<br>424-218-8379<br>424-218-8519 |
| Date of Preparation: | September 2, 2015 |
| Device Identification: | Trade Name: CLICKLINE Scissors Insert for Single Use<br>Common Name: Electrosurgical, Cutting & Coagulation<br>Classification Name: Electrosurgical, Cutting & Coagulation & Accessories |
| Product Code: | GEI |
| Regulation: | CFR 878.4400 |
| 510(k) Type: | Traditional |
| Predicate Device(s): | ACE Monopolar Attachment (K123061) |
| Device Description: | The CLICKLINE Scissors Inserts for Single Use are available<br>in two models, 34310MA-D and 34310MS-D. The two models<br>have the same diameters of 4.9mm with different working<br>lengths of 41.17 cm and 40.7cm, respectively. The jaws of the<br>scissors are made from AISI grade 420 surgical stainless steel.<br>The shafts of the working lengths are manufactured from AISI<br>grade 303 and 304 stainless steel. The tubing and colorant on<br>outer sheath on the working length are made from Apex MTE<br>Medical Grade Polyolefin Tubing and Mevopur-Black,<br>respectively. |
| | |
| Indications For Use: | The CLICKLINE Scissor Insert for Single Use is used in<br>combination with a reusable CLICKLINE handle (K954122)<br>for cutting tissue. Instruments with HF connection can also be<br>used for the monopolar coagulation of tissue or the coagulation<br>of small hemorrhages. |
| Technological<br>Characteristics: | The predicate and subject devices are both Scissor inserts that<br>are intended to be attached to a handle for monopolar<br>coagulations. There is one minor difference in the physical<br>characteristics in the shaft diameter, 4.9mm vs. 2.35mm. This<br>difference does not raise new question of safety and<br>effectiveness because:<br><br>The difference in diameter is due to the predicate device's<br>attachment is inserted to a patient-contacting mechanical pencil<br>that has a greater diameter whereas the subject device is<br>attached to the handle that is not patient-contacting. The<br>overall insertion diameters of both the predicate and subject<br>devices are similar (based on predicate literature, one of the<br>ball electrode has a diameter of 5mm.<br><br>The bench test data for the CLICKLINE Scissor Insert for<br>Single Use demonstrates that the design characteristics used as<br>to achieve its intended use have been met. The results show<br>that the subject device has met all its specifications. The<br>performance validation test report is provided in section<br>021_Performance Testing of this submission.<br><br>The minor difference in specifications of the CLICKLINE<br>Scissor Insert for Single Use when compared to the predicate<br>device, ACE Monopolar Attachment by BioEconeer, Inc, do<br>not raise new issues of safety and effectiveness and the devices<br>are substantially equivalent for monopolar coagulation of tissue |
| Non-Clinical<br>Performance Data: | CLICKLINE Scissor Insert for Single Use is tested according<br>to the following standard:<br>ISO 10993-1 ISO 10993-5 ISO 10993-10 IEC 60601-1 IEC 60601-2-2 |
| | • IEC 60601-2-18 |
| | Additional bench testing for performance verification and<br>validation purposes: |
| | • Charring Test<br>• Thermal Spread Test<br>• Pulling Test<br>• Dropping Test |
| | The bench testing performed verified and validated that the<br>CLICKLINE Scissor Insert for Single Use has met all its<br>design specification and is substantially equivalent to the<br>predicate device, ACE Monopolar Attachment, for monopolar<br>coagulation of tissue. |
| Clinical<br>Performance Data: | No clinical information is required for this submission |
| Conclusion: | The Karl Storz's CLICKLINE Scissor Insert for Single Use is<br>substantially equivalent to its predicate devices. The non-<br>clinical testing demonstrates that the device is as safe and<br>effective as the legally marketed devices. |

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