(172 days)
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.
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.
The provided text refers to a premarket notification for a medical device (K151044), specifically the "CLICKLINE Scissors Insert for Single Use." This document, often referred to as a 510(k) summary, focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving performance against specific acceptance criteria for a new AI/software system.
Therefore, many of the requested categories related to AI/software performance studies do not apply directly to this document. The document describes bench testing for the physical device, not an AI or software component.
Here's a breakdown of the information available and unavailable based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria with corresponding performance values in the way you might expect for an AI/software study (e.g., sensitivity, specificity thresholds). Instead, it states:
"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."
And further:
"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."
The "acceptance criteria" are implied to be "meeting all design specifications" and demonstrating "substantial equivalence" to the predicate device based on bench testing. The specific quantitative results of these tests (e.g., exact measured force, temperature, etc.) are referred to as being in "section 021_Performance Testing," which is not included in the provided text extract.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is "bench testing," which typically involves physical specimens of the device rather than a "test set" of patient data as implied by your question.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the device is a physical surgical instrument, not an AI system relying on medical imaging or diagnostic interpretation. Ground truth for its performance would be established through engineering and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device bench test.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a surgical instrument, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical device, the "ground truth" for proving its performance would be established through physical measurements and engineering standards, as indicated by compliance with standards like ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18, and specific bench tests like "Charring Test," "Thermal Spread Test," "Pulling Test," and "Dropping Test."
8. The sample size for the training set
Not applicable. There is no AI/software training set for this physical device.
9. How the ground truth for the training set was established
Not applicable. There is no AI/software training set for this physical device.
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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, Inc2151 E. Grand AvenueEI Segundo, CA 90245 |
|---|---|
| Contact: | Winkie WongRegulatory Affairs Specialist424-218-8379424-218-8519 |
| Date of Preparation: | September 2, 2015 |
| Device Identification: | Trade Name: CLICKLINE Scissors Insert for Single UseCommon Name: Electrosurgical, Cutting & CoagulationClassification 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 availablein two models, 34310MA-D and 34310MS-D. The two modelshave the same diameters of 4.9mm with different workinglengths of 41.17 cm and 40.7cm, respectively. The jaws of thescissors are made from AISI grade 420 surgical stainless steel.The shafts of the working lengths are manufactured from AISIgrade 303 and 304 stainless steel. The tubing and colorant onouter sheath on the working length are made from Apex MTEMedical Grade Polyolefin Tubing and Mevopur-Black,respectively. |
| Indications For Use: | The CLICKLINE Scissor Insert for Single Use is used incombination with a reusable CLICKLINE handle (K954122)for cutting tissue. Instruments with HF connection can also beused for the monopolar coagulation of tissue or the coagulationof small hemorrhages. |
| TechnologicalCharacteristics: | The predicate and subject devices are both Scissor inserts thatare intended to be attached to a handle for monopolarcoagulations. There is one minor difference in the physicalcharacteristics in the shaft diameter, 4.9mm vs. 2.35mm. Thisdifference does not raise new question of safety andeffectiveness because:The difference in diameter is due to the predicate device'sattachment is inserted to a patient-contacting mechanical pencilthat has a greater diameter whereas the subject device isattached to the handle that is not patient-contacting. Theoverall insertion diameters of both the predicate and subjectdevices are similar (based on predicate literature, one of theball electrode has a diameter of 5mm.The bench test data for the CLICKLINE Scissor Insert forSingle Use demonstrates that the design characteristics used asto achieve its intended use have been met. The results showthat the subject device has met all its specifications. Theperformance validation test report is provided in section021_Performance Testing of this submission.The minor difference in specifications of the CLICKLINEScissor Insert for Single Use when compared to the predicatedevice, ACE Monopolar Attachment by BioEconeer, Inc, donot raise new issues of safety and effectiveness and the devicesare substantially equivalent for monopolar coagulation of tissue |
| Non-ClinicalPerformance Data: | CLICKLINE Scissor Insert for Single Use is tested accordingto 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 andvalidation purposes: | |
| • Charring Test• Thermal Spread Test• Pulling Test• Dropping Test | |
| The bench testing performed verified and validated that theCLICKLINE Scissor Insert for Single Use has met all itsdesign specification and is substantially equivalent to thepredicate device, ACE Monopolar Attachment, for monopolarcoagulation of tissue. | |
| ClinicalPerformance Data: | No clinical information is required for this submission |
| Conclusion: | The Karl Storz's CLICKLINE Scissor Insert for Single Use issubstantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe andeffective as the legally marketed devices. |
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§ 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.