(89 days)
The Microline Flexible Ligating Shears are intended for simultaneous cutting and cauterization of soft tissue during minimally invasive abdominal laparoscopic surgery. The device may also be used for cutting natural, non-metallic sutures during surgery.
The Microline Flexible Ligating Shears system consists of the following: Microline Flexible Ligating Shears Microline Universal Power Supply Single or multiple access port device such as the TransEnterix SPIDER Single Port. The Microline Flexible Ligating Shears are designed to provide thermal ligation and division during minimally invasive abdominal laparoscopic surgery. The Microline Flexible Ligating Shears consist of a sterile single patient use handpiece. The device has heating elements at the distal tip which are activated by a finger switch located on the handpiece of the device. The Microline Universal Power Supply is designed to allow the surgeon control of the heating element power of the device in order to accommodate for individual patient anatomy. An instrument cord is attached to the handpiece and is plugged into the dedicated Microline Universal Power Supply. The Microline Flexible Ligating Shears are designed to be used with an Introducer such as the SPIDER Single Port Device. The Microline Flexible Ligating Shears are supplied sterile in a Tyvek/Mylar sterilization pouch on a mounting card and thermoformed tray, placed in a fiberboard carton. The device is intended to be used by a trained physician for a single patient use during minimally invasive abdominal laparoscopic surgery. The Microline Flexible Ligating Shears power cable is attached to the instrument handpiece and connects to the Microline Universal Power Supply. The Universal Power Supply is supplied nonsterile for reusable use outside the sterile field. The Microline Flexible Ligating Shears incorporates Hi and Low heating modes that are used to cauterize and cut soft tissue. The heating elements in the tip are activated by a physician controlled finger switch located on the handpiece of the device. The Microline Flexible Ligating Shears is intended to provide general purpose cauterization, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.
The provided document is a 510(k) summary for a medical device, the Microline Flexible Ligating Shears. It describes the device, its intended use, and comparative testing against predicate devices to establish substantial equivalence. However, this document does not describe a study involving an AI/algorithmic device or a comparative effectiveness study with human readers.
The device described is a surgical instrument. The performance testing mentioned is for the physical functionality, sterilization, biocompatibility, and electrical safety of the surgical shears themselves, not for an artificial intelligence or algorithmic system that processes data or assists human interpretation.
Therefore, many of the requested criteria (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this document as it's not about an AI-powered device.
Here's an attempt to address the applicable points based on the provided text, while explicitly noting where information is not present or not relevant to an AI context:
Device Name: Microline Flexible Ligating Shears
This document describes the 510(k) clearance process for a surgical instrument, not an AI or algorithmic device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance (e.g., accuracy, sensitivity, specificity of an algorithm) does not apply here. The "acceptance criteria" are related to the device's physical functionality, safety, and equivalence to predicate devices.
The "studies" conducted are verification and validation tests to ensure the device performs its intended mechanical/electrical functions and meets safety standards, rather than evaluating an algorithm's performance on a dataset.
1. A table of acceptance criteria and the reported device performance
The document focuses on establishing substantial equivalence to predicate devices, which implies that the device must meet similar performance and safety standards. Explicit quantitative "acceptance criteria" for performance metrics like "sensitivity" or "specificity" (common in AI device evaluation) are not defined in the context of this mechanical device. Instead, the "performance" demonstrated is that the device functions as intended and is safe.
| Criterion/Characteristic | Acceptance Standard (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Functionality | Simultaneous cutting and cauterization of soft tissue, cutting non-metallic sutures, general purpose cauterization, spreading, and grasping. | "The Microline Flexible Ligating Shears have been tested for functionality and they have found to perform their intended functions for minimally invasive abdominal laparoscopic procedures. Additionally, testing has proven that they perform their ligating functions." |
| System Compatibility | Compatible with the SPIDER® device. | "The device has also been tested with the SPIDER® device and pasted all required testing for system compatibility." |
| Sterilization | Sterilized to a Sterility Assurance Level (SAL) of 1x10⁻⁶ via gamma irradiation per ISO 11137-2. Sterile barrier maintains sterility for shelf life. | "The Microline Thermal Ligating Shears have been sterilized to a SAL of 1x10⁻⁶ using gamma irradiation. The gamma sterilization process was validated... Sterile barrier testing has been performed and it has been shown that the sterile barrier has the capability of maintaining sterility during the required shelf life, and that the device itself maintains its performance requirements." |
| Biocompatibility | All patient contact materials meet biocompatibility testing per ANSI/AAMI/ISO 10993-1 for an external communicating device. | "Biocompatibility testing was successfully conducted on the Microline Flexible Ligating Shears in accordance with ANSI/AAMI/ISO 10993-1... the appropriate tests were performed as described in Table A.1 in Annex A of ANSI/AAMI/ISO 10993-1." |
| Electrical Safety | Compliant with IEC 60601-1:1988 + A1:1999 + A2:1995 (general requirements for basic safety) including US, CAN National Differences. | "The Microline Flexible Ligating Shears were evaluated by an independent testing laboratory and found compliant to IEC 60601-1:1988 + A1:1999 + A2:1995 general requirements for basic safety, including all US, CAN National Differences." |
| Substantial Equivalence | No significant technological differences affecting safety and efficacy compared to predicate devices (Thermal Ligating Shears K062257, Spider Flexible Monopolar Surgical Instruments K122299). Minor design/material differences present no new safety/effectiveness issues. | Stated that "verification and validation test results are sufficient to demonstrate safety and effectiveness when compared to the predicate devices. The minor design or material differences... have been evaluated and tested and found to present no new issues of safety and effectiveness." FDA confirmed substantial equivalence. |
2. Sample sizes used for the test set and the data provenance
This document discusses physical and electrical tests performed on the device itself, not performance on a data test set for an algorithm. Therefore, "sample size" in the context of data points or images is not relevant. The "test set" would refer to the number of physical devices or components subjected to a particular test (e.g., sterilization validation might use multiple samples, but the exact number isn't specified in this summary). There's no data provenance mentioned as it's a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI, refers to expert-labeled data. For this physical surgical device, "ground truth" is established by engineering specifications, safety standards, and functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This refers to adjudication of discordant expert readings for AI evaluation.
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. This is not an AI-assisted device. The document explicitly states, "clinical data was not necessary for evaluation of substantial equivalence." This means a clinical study, which an MRMC study would be, was not performed or deemed necessary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a human-operated surgical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the AI sense. For this device, "ground truth" for its performance is derived from:
- Engineering specifications and design: The device is designed to perform specific mechanical and electrical functions.
- International and national standards: Compliance with standards like ISO 11137-2 (sterilization), ANSI/AAMI/ISO 10993-1 (biocompatibility), and IEC 60601-1 (electrical safety).
- Functional testing: Direct observation and measurement of the device's ability to cut, cauterize, grasp, and connect to power.
- Comparison to predicate devices: The "ground truth" for substantial equivalence is that the device is as safe and effective as previously cleared devices.
8. The sample size for the training set
Not applicable. There is no AI model or algorithm being "trained" for this device.
9. How the ground truth for the training set was established
Not applicable. As there's no training set for an AI model, there's no ground truth establishment process for it.
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800 Cummings Center, Suite 166T Beverly, MA 01915, USA Tel: 978.922.9810 Fax: 978.922.9209 Web: www.microlinesurgical.com
510(k) Summary
MAR 2 7 2013
| Submitted By: | Microline Surgical |
|---|---|
| Contact Person: | Bill McCallum |
| Date Prepared: | February 19, 2013 |
| Proprietary Name: | Microline Flexible Ligating Shears |
| Classification Name: | Electrosurgical Cutting and Coagulation and Accessories21 CFR § 878.440079 GEI |
| Predicate Devices: | This product is similar in design, composition, to and function to the:Thermal Ligating Shears (K062257) cleared on October 10, 2006 and theSpider Flexible Monopolar Surgical Instruments (K122299) cleared onOctober 25, 2012. |
Device Description and Technological Characteristics:
The Microline Flexible Ligating Shears system consists of the following:
Microline Flexible Ligating Shears Microline Universal Power Supply Single or multiple access port device such as the TransEnterix SPIDER Single Port.
The Microline Flexible Ligating Shears are designed to provide thermal ligation and division during minimally invasive abdominal laparoscopic surgery. The Microline Flexible Ligating Shears consist of a sterile single patient use handpiece. The device has heating elements at the distal tip which are activated by a finger switch located on the handpiece of the device. The Microline Universal Power Supply is designed to allow the surgeon control of the heating element power of the device in order to accommodate for individual patient anatomy. An instrument cord is attached to the handpiece and is plugged into the dedicated Microline Universal Power Supply.
The Microline Flexible Ligating Shears are designed to be used with an Introducer such as the SPIDER Single Port Device.
Image /page/0/Picture/11 description: The image shows a circular design. The design is composed of four curved shapes that resemble petals or lenses, arranged symmetrically around a central point. The shapes are enclosed within a circle, creating a pattern that looks like a stylized flower or a geometric emblem.
Image /page/0/Picture/12 description: The image contains two logos. The logo on the left is a circle with a checkmark inside, and the text "TÜV SÜD, SRQ" is written around the circle. The logo on the right has a crown on top of a checkmark, and the text "UKAS Product Certification 026" is written below the checkmark. Both logos appear to be certification marks.
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The Microline Flexible Ligating Shears are supplied sterile in a Tyvek/Mylar sterilization pouch on a mounting card and thermoformed tray, placed in a fiberboard carton. The device is intended to be used by a trained physician for a single patient use during minimally invasive abdominal laparoscopic surgery.
The Microline Flexible Ligating Shears power cable is attached to the instrument handpiece and connects to the Microline Universal Power Supply. The Universal Power Supply is supplied nonsterile for reusable use outside the sterile field.
The Microline Flexible Ligating Shears incorporates Hi and Low heating modes that are used to cauterize and cut soft tissue. The heating elements in the tip are activated by a physician controlled finger switch located on the handpiece of the device. The Microline Flexible Ligating Shears is intended to provide general purpose cauterization, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.
Principle of Operation:
The Microline Flexible Ligating Shears provide a path of entry to the surgical target by the SPIDER device's flexible extended IDTs (Instrument Delivery Tube), also called the SPIDER Single Port Device. Two (2) flexible channels known as IDTs (Instrument Delivery Tubes) are positioned horizontally to the operative plane and include extended flexible lumens to facilitate manipulation of surgical instruments, enabling control over operator determined distances. The IDTs facilitate x, y, and z motion to allow for a multidirectional and triangulated approach within the surgical field. This mimics the approach of standard laparoscopic surgery using multiple incisions.
The flexible IDTs provide 360 degrees of freedom at the distal tips. The right hand controls the right instrument and the left hand controls the left instrument. Two (2) rigid channels positioned vertically to the operative field enable the use of an endoscope and any other surgical instruments.
Indications for Use:
The Microline Flexible Ligating Shears are intended for simultaneous cutting and cauterization of soft tissue during minimally invasive abdominal laparoscopic surgery. The device may also be used for cutting natural, non-metallic sutures during surgery.
Performance Testing:
The Microline Flexible Ligating Shears have been tested for functionality and they have found to perform their intended functions for minimally invasive abdominal laparoscopic procedures. Additionally, testing has proven that they perform their ligating functions. The device has also been tested with the SPIDER® device and pasted all required testing for system compatibility.
The Microline Thermal Ligating Shears have been sterilized to a SAL of 1x10* using gamma irradiation. The gamma sterilization process was validated to the following: - Clause 9, Method VDmax -Substantiation of 25 kGy or 15 kGy as the sterilization dose in ISO 11137-2. Sterile barrier testing has
Image /page/1/Picture/12 description: The image shows a circular design. The design is composed of four leaf-like shapes arranged symmetrically around a central point. The leaves are oriented so that their pointed ends face outward, creating a pattern that resembles a four-petal flower or a stylized compass rose.
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been performed and it has been shown that the sterile barrier has the capability of maintaining sterility during the required shelf life, and that the device itself maintains its performance requirements.
Biocompatibility testing was successfully conducted on the Microline Flexible Ligating Shears in accordance with ANSI/AAMI/ISO 10993-1. The Microline Flexible Ligating Shears falls into the category of external communicating device and the appropriate tests were performed as described in Table A.1 in Annex A of ANSI/AAMI/ISO 10993-1.
The Microline Flexible Ligating Shears were evaluated by an independent testing laboratory and found compliant to IEC 60601-1:1988 + A1:1999 + A2:1995 general requirements for basic safety, including all US, CAN National Differences.
As illustrated in the Predicate Comparison Table below, the Microline Flexible Ligating Shears do not incorporate any significant technological differences that effect safety and efficacy. Therefore clinical data was not necessary for evaluation of substantial equivalence. The verification and validation test results are sufficient to demonstrate safety and effectiveness when compared to the predicate devices. The minor design or material differences between The Microline Thermal Ligating Shears and the predicate devices have been evaluated and tested and found to present no new issues of safety and effectiveness.
| Characteristic | Starion InstrumentsCorporation TLS3Thermal Ligating Shears510(k) K062257 (Predicatedevice) | Microline Flexible LigatingShears (subject of thissubmission) | Transenterix Spider FlexibleMonopolar SurgicalInstruments K122299(Predicate device) |
|---|---|---|---|
| Indications forUse | For the simultaneouscutting and cauterization ofsoft tissue during surgery,and cutting of natural orsynthetic, non-metallicsutures during surgery. | The Microline FlexibleLigating Shears are intendedfor simultaneous cutting andcauterization of soft tissueduring minimally invasiveabdominal laparoscopicsurgery. The device may alsobe used for cutting natural,non-metallic sutures duringsurgery. | The Spider Surgical Instrumentsare intended for use onminimally invasive abdominallaparoscopic surgical proceduresfor grasping, mobilizing,dissecting, retracting, cutting,cauterizing, ligating,suction/irrigation and othermanipulation of tissues andvessels during laparoscopicsurgery. |
| Principle ofOperation | Heat is conducted to tissuecompressed within the jawsvia heating elements in theinstrument tip. | Same | Monopolar high frequencycurrent passes from active jawtips of instrument to cut acoagulate tissue at the immediatesurgical site, flowing through thepatient to an adhesive electrodereturn pad connected to themonopolar electrosurgicalgenerator. |
| Energy Source | Electrical current fromStarion InstrumentsUniversal Power Supply(UPS) | Same | Electrical high frequency currentand voltage from a third partymonopolar electrosurgical unit(ESU). |
Predicate Comparison Table:
Image /page/2/Picture/6 description: The image contains the text "Confidence, simply delivered." The text is written in a bold, sans-serif font. The text is black and is set against a white background. The text appears to be a slogan or tagline for a company or product.
Image /page/2/Picture/7 description: The image shows a circular design composed of four leaf-like shapes arranged symmetrically around a central point. Each leaf shape has a curved outline and tapers to a point at both ends. The overall impression is that of a stylized flower or a geometric pattern with organic elements. The image is in black and white.
Image /page/2/Picture/8 description: The image contains two logos. The logo on the left is a circle with a checkmark inside, and the letters "SGS" are written below. The logo on the right is a checkmark with Arabic text below. Both logos appear to be certification marks.
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| Method ofActuation | Finger switch | Same | Same |
|---|---|---|---|
| Sterility | Gamma radiation, sterilityassurance level (SAL) is $10^6$ | Same | Same |
| Cleaning and re-sterilization ofthe reusablehand piece | N/ASterile for single use only. | Same | Same |
| Primary SterileBarrier | Tyvek/Mylar pouch | Same | Same |
| Biocompatibility | All patient contactmaterials meetbiocompatibility test perISO 10993-1 | Same | Same |
| Energy Usedand/orDelivered | Maximum Output - 60W | Same | Monopolar high frequencyoutput. |
| Rigidity/Flexibility | Rigid, not flexible | Functions with theTransEnterix SPIDER SinglePort Device | Functions with the TransEnterixSPIDER Single Port Device |
Summary:
The information provided demonstrates that the Microline Flexible Ligating Shears is substantially equivalent to the Thermal Ligating Shears (K062257) and the Spider Flexible Monopolar Surgical Instruments (K122299) cleared on October 25, 2012, in function, intended use and indications for use.
Image /page/3/Picture/5 description: The image contains two certification logos. The logo on the left is the SGS certification mark, which features a stylized checkmark within a circular design. The logo on the right is the UKAS (United Kingdom Accreditation Service) certification mark, which includes a crown above a checkmark and the text "UKAS Accredited Management Systems 005".
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Microline, Surgical, Incorporated % Mr. Bill McCallum Regulatory Affairs Manager 800 Cummings Center, Suite 166T Beverly, Massachusetts 01915
March 27, 2013
Re: K124029 Trade/Device Name: Microline Flexible Ligating Shears Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 26, 2012 Received: December 28, 2012
Dear Mr. McCallum:
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.
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-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.
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Page 2 - Mr. Bill McCallum
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K124029
Indications for Use
Device Name: Microline Flexible Ligating Shears
Indications for Use:
The Microline Flexible Ligating Shears are intended for simultaneous cutting and cauterization of soft tissue during minimally invasive abdominal laparoscopic surgery. The device may also be used for cutting natural, non-metallic sutures during surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
For
(Division Sign-Off) Division of Surgical Devices 510(k) Number __K124029
Page 1 of 1
§ 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.