(172 days)
No
The device description and performance studies focus on the mechanical and electrical properties of a surgical scissor insert, with no mention of AI or ML.
Yes
The device is used for cutting tissue and for monopolar coagulation of tissue or small hemorrhages, which are therapeutic actions.
No
The device is described as a scissor insert used for cutting tissue and monopolar coagulation, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines physical components made of stainless steel and polyolefin tubing, 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 tissue" and "monopolar coagulation of tissue or the coagulation of small hemorrhages." This describes a surgical instrument used on the body, not a device used to test samples from the body (like blood, urine, or tissue samples) to diagnose a condition.
- Device Description: The description details a surgical scissor insert made of stainless steel and polyolefin tubing. This aligns with the description of a surgical instrument, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting specific analytes (proteins, DNA, etc.)
- Providing diagnostic information about a patient's health status.
Therefore, the CLICKLINE Scissor Insert for Single Use is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GEI
Device Description
The CLICKLINE Scissors Inserts for Single Use are available in two models, 34310MA-D and 34310MS-D. The two models have the same diameters of 4.9mm with different working lengths of 41.17 cm and 40.7cm, respectively. The jaws of the scissors are made from AISI grade 420 surgical stainless steel. The shafts of the working lengths are manufactured from AISI grade 303 and 304 stainless steel. The tubing and colorant on outer sheath on the working length are made from Apex MTE Medical Grade Polyolefin Tubing and Mevopur-Black, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Performance Data: CLICKLINE Scissor Insert for Single Use is tested according to the following standard: 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 validation purposes: • Charring Test • Thermal Spread Test • Pulling Test • Dropping Test The bench testing performed verified and validated that the CLICKLINE Scissor Insert for Single Use has met all its design specification and is substantially equivalent to the predicate device, ACE Monopolar Attachment, for monopolar coagulation of tissue.
Clinical Performance Data: No clinical information is required for this submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACE Monopolar Attachment (K123061)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | 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
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Regulatory Affairs Specialist
424-218-8379
424-218-8519 |
| Date of Preparation: | September 2, 2015 |
| Device Identification: | Trade Name: CLICKLINE Scissors Insert for Single Use
Common Name: Electrosurgical, Cutting & Coagulation
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
in two models, 34310MA-D and 34310MS-D. The two models
have the same diameters of 4.9mm with different working
lengths of 41.17 cm and 40.7cm, respectively. The jaws of the
scissors are made from AISI grade 420 surgical stainless steel.
The shafts of the working lengths are manufactured from AISI
grade 303 and 304 stainless steel. The tubing and colorant on
outer sheath on the working length are made from Apex MTE
Medical Grade Polyolefin Tubing and Mevopur-Black,
respectively. |
| | |
| Indications For Use: | The CLICKLINE Scissor Insert for Single Use is used in
combination with a reusable CLICKLINE handle (K954122)
for cutting tissue. Instruments with HF connection can also be
used for the monopolar coagulation of tissue or the coagulation
of small hemorrhages. |
| Technological
Characteristics: | The predicate and subject devices are both Scissor inserts that
are intended to be attached to a handle for monopolar
coagulations. There is one minor difference in the physical
characteristics in the shaft diameter, 4.9mm vs. 2.35mm. This
difference does not raise new question of safety and
effectiveness because:
The difference in diameter is due to the predicate device's
attachment is inserted to a patient-contacting mechanical pencil
that has a greater diameter whereas the subject device is
attached to the handle that is not patient-contacting. The
overall insertion diameters of both the predicate and subject
devices are similar (based on predicate literature, one of the
ball electrode has a diameter of 5mm.
The bench test data for the CLICKLINE Scissor Insert for
Single Use demonstrates that the design characteristics used as
to achieve its intended use have been met. The results show
that the subject device has met all its specifications. The
performance validation test report is provided in section
021_Performance Testing of this submission.
The minor difference in specifications of the CLICKLINE
Scissor Insert for Single Use when compared to the predicate
device, ACE Monopolar Attachment by BioEconeer, Inc, do
not raise new issues of safety and effectiveness and the devices
are substantially equivalent for monopolar coagulation of tissue |
| Non-Clinical
Performance Data: | CLICKLINE Scissor Insert for Single Use is tested according
to the following standard:
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
validation purposes: |
| | • Charring Test
• Thermal Spread Test
• Pulling Test
• Dropping Test |
| | The bench testing performed verified and validated that the
CLICKLINE Scissor Insert for Single Use has met all its
design specification and is substantially equivalent to the
predicate device, ACE Monopolar Attachment, for monopolar
coagulation of tissue. |
| Clinical
Performance Data: | No clinical information is required for this submission |
| Conclusion: | The Karl Storz's CLICKLINE Scissor Insert for Single Use is
substantially equivalent to its predicate devices. The non-
clinical testing demonstrates that the device is as safe and
effective as the legally marketed devices. |
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