MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · Teleflexmedical, Inc. · OCW · Feb 12, 2018 · Gastroenterology, Urology
Device Facts
Record ID
K172775
Device Name
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
Applicant
Teleflexmedical, Inc.
Product Code
OCW · Gastroenterology, Urology
Decision Date
Feb 12, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
MiniLap instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues, as well as items such as hernia mesh, during pediatric and adult surgery. The MiniPolar Instruments are used to cut and cauterize soft tissue during pediatric and adult surgery. The MiniLap System with MiniGrip Handles grasping instruments have applications in a variety of general, thoracic, gynecologic, urologic, laparoscopic procedures for manipulation of tissue, as well as items such as hernia mesh, during pediatric and adult surgery. Bipolar Grasper instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic procedures for manipulation and coagulation of tissue and for manipulation of items such as hernia mesh during pediatric and adult surgery. The male bipolar connection is located at the back of the handle and may be utilized for bipolar applications when attached to standard two plus bipolar cables and their generators (a male connection is provided as an integral part of the instrument).
Device Story
Teleflex MiniLap System comprises percutaneous surgical instruments for minimally invasive access; includes ThumbGrip (needle/cannula shaft with retractable working tip) and MiniGrip (pistol-grip handle with rotating jaws) families. Devices penetrate soft tissue directly without trocars; used for grasping, holding, manipulating tissue/hernia mesh, or electrosurgical cutting/coagulation. Electrosurgical variants connect to standard ESUs (e.g., Valleylab Force FX) via monopolar or bipolar cables. Operated by surgeons in clinical settings; provides reduced trauma by eliminating trocar sites and incision closure. Output is mechanical tissue manipulation or thermal cautery effect. Benefits include reduced surgical trauma and improved access. Single-use, sterile, disposable.
Clinical Evidence
Bench testing only. Verification and validation testing confirmed device performance against intended use. Electrosurgical components tested to IEC 60601-1. Packaging/sterility validated per ISO 11607-1. Stability testing supported shelf-life extension.
Technological Characteristics
Disposable manual percutaneous instruments; 2.3mm-2.4mm shaft diameters. Materials compliant with ISO 10993-1. Energy: Monopolar (banana plug) or Bipolar (standard two-plug cable). Features: Retractable working tips, stabilizing pivot disk, pistol-grip handle with ratchet/rotation hub. Sterilization: Terminally sterilized. Connectivity: Standard ESU cable interface.
Indications for Use
Indicated for pediatric and adult patients undergoing general, thoracic, gynecologic, urologic, or laparoscopic surgery requiring soft tissue manipulation, grasping, holding, or cauterization (monopolar/bipolar). Contraindications: laparoscopic/endoscopic techniques generally contraindicated; blind insertion; not for female sterilization.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 12, 2018
Teleflex Medical, Inc. Holly Hallock Regulatory Affairs Manager 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
## Re: K172775
Trade/Device Name: Teleflex MiniLap System with ThumbGrip Handle, Teleflex MiniLap System with ThumbGrip MiniPolar Handle, Teleflex MiniLap System with MiniGrip Handle, Teleflex MiniLap System with MiniGrip BiPolar Handle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OCW, GEI Dated: September 12, 2017 Received: September 14, 2017
Dear Holly Hallock:
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 Aments, 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, 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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
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#### K172775 - Page 1 of 4
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known)
#### K172775
Device Name
Teleflex MiniLap® System with ThumbGrip Handle
#### Indications for Use (Describe)
Minil ap instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp. hold, and manipulate other soft internal tissues, as well as items such as hernia mesh, during pediatric and adult surgery.
Type of Use (Select one or both, as applicable)
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *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:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
Device Name
Teleflex MiniLap® System with ThumbGrip MiniPolar® Handle
Indications for Use (Describe)
The MiniPolar Instruments are used to cut and cauterize soft tissue during pediatric and adult surgery.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *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:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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 See PRA Statement below.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
510(k) Number (if known)
Device Name
Teleflex MiniLap® System with MiniGrip® Handle
Indications for Use (Describe)
The MiniLap System with MiniGrip Handles grasping instruments have applications in a variety of general, thoracic, gynecologic, urologic, laparoscopic procedures for manipulation of tissue, as well as items such as hernia mesh, during pediatric and adult surgery.
Type of Use (Select one or both, as applicable)
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *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:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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 See PRA Statement below.
{5}------------------------------------------------
#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known)
Device Name
Teleflex MiniLap® System with MiniGrip® BiPolar Handle
#### Indications for Use (Describe)
Bipolar Grasper instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic procedures for manipulation and coagulation of tissue and for manipulation of items such as hernia mesh during pediatric and adult surgery.
The male bipolar connection is located at the back of the handle and may be utilized for birolar applications when attached to standard two plus bipolar cables and their generators (a male connection is provided as an integral part of the instrument).
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *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:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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 See PRA Statement below.
{6}------------------------------------------------
# 510(k) SUMMARY
# MiniLap® Percutaneous Surgical System: ThumbGrip Instruments and MiniGrip® Graspers
# A. Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560
Phone: 919-433-4918 919-433-4996 Fax:
## B. Contact Person
Holly Hallock Regulatory Affairs Manager
# C. Date Prepared
February 9, 2018
## D. Device Name
| Trade Name | Teleflex MiniLap® System with ThumbGrip Handle |
|------------------------|----------------------------------------------------------------|
| Common Name | Endoscopic Tissue Approximation Device |
| Classification<br>Name | Endoscopic and accessories |
| Trade Name | Teleflex MiniLap® System with ThumbGrip MiniPolar®<br>Handle |
| Common Name | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification<br>Name | Electrosurgical cutting and coagulation device and accessories |
| Trade Name | Teleflex MiniLap® System with MiniGrip® Handle |
| Common Name | Endoscopic Tissue Approximation Device |
| Classification<br>Name | Endoscopic and accessories |
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| Trade Name | Teleflex MiniLap® System with MiniGrip® BiPolar Handle |
|---------------------|----------------------------------------------------------------|
| Common Name | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Name | Electrosurgical cutting and coagulation device and accessories |
## E. Device Description
The Teleflex MiniLap® Percutaneous Surgical System is a family of minimally invasive surgical devices that provide a surgeon with the means to penetrate soft tissue to access certain areas of the human anatomy, then grasp, hold and manipulate other soft internal tissue within the body that are related to the surgical procedure.
Please note that this is a bundled submission: the MiniLap Percutaneous Surgical System has two families presented in this 510(k). The first is the MiniLap ThumbGrip Instruments, which have a thumb grip handle to control the instrument tips. These instruments are available in electrosurgical and non-electrosurgical configurations. The second product family discussed in this 510(k) is the MiniLap MiniGrip Graspers, which have a pistol grip handle that allows single handed device operation to control the jaws. While these graspers are currently only cleared for electrosurgical configurations (K113597), the intent of this 510(k) is to support non-electrosurgical configurations of the MiniGrip Graspers as well.
ThumbGrip Instruments and MiniGrip Graspers are disposable manual instruments designed for direct introduction to the surgical site without the need for a traditional insertion conduit. These instruments are used for grasping, holding and manipulating soft internal tissues. These percutaneous instruments provide the benefit of reduced trauma due to no surgical incision closure and the elimination of one or more trocars.
# ThumbGrip Instruments
MiniLap ThumbGrip Instruments consist of an integrated needle/cannula shaft that houses a retractable working instrument. The shaft can be introduced percutaneously to the surgical site, after which the working instrument can be deployed for grasping and manipulating or cauterizing tissue. The ThumbGrip Instruments are available in electrosurgical and nonelectrosurgical configurations, with shaft diameters of 2.4mm and 2.3mm, respectively. A stabilizing pivot disk is available on the non-electrosurgical configurations that can be stuck to the skin of the patient to provide entry-depth control, and a banana plug is available on the electrosurgical configurations for monopolar energy. The working instrument is controlled through the thumb handle and a locking mechanism on the proximal end of the device.
| ThumbGrip Instruments | | |
|-----------------------|-----------------------------|---------------------|
| Model Number | Name | Configuration |
| GBC250 | ThumbGrip Alligator Grasper | |
| CLC250 | ThumbGrip Clutch Grasper | Non-electrosurgical |
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| BCK250 | ThumbGrip Babcock Grasper | |
|---------|-----------------------------------|-----------------------------------------------------|
| BLC250 | ThumbGrip Bowel Grasper | |
| GBC200 | ThumbGrip Alligator Grasper Short | |
| ECMC300 | ThumbGrip Curved Spatula Probe | Electrosurgical with monopolar energy (“MiniPolar”) |
| ECMS300 | ThumbGrip Straight Spatula Probe | |
| ECMH300 | ThumbGrip Hook Probe | |
| ECMP300 | ThumbGrip Conical Probe | |
# MiniGrip Graspers
The MiniLap MiniGrip Graspers consist of an integrated 2.4mm needle/cannula shaft that houses a retractable grasper. The shaft, which is insulated for electrosurgical configurations, can be introduced percutaneously to the surgical site, after which the working portion of the instrument can be deployed to approximate and grasp soft tissue.
The grasper jaws are controlled by a pistol-grip handle. The orientation of the jaws relative to the handle can be adjusted by the rotation hub. The ratchet function of the handle locks the position of the jaws in a closed or free mode. The "ON" position locks the jaws together for insertion and removal of the jaws. The "OFF" position of the ratchet allows for free motion of the jaws. The arming button allows the surgeon to arm the device (insertion needle out). A red indication will be visible under the arming button when the needle is exposed.
| MiniGrip Graspers | | |
|-------------------|----------------------------------|----------------------------------------|
| Model Number | Name | Configuration |
| BPS300 | MiniGrip BiPolar Grasper | Electrosurgical with bipolar<br>energy |
| PGAC300 | MiniGrip Alligator Grasper | |
| PGCC300 | MiniGrip Clutch Grasper | |
| PGBK300 | MiniGrip Babcock Grasper | Non-electrosurgical |
| PGBC300 | MiniGrip Tong Grasper | |
| PGAC200 | MiniGrip Alligator Grasper Short | |
The ThumbGrip MiniPolar Instruments connect to most electrosurgical units (ESUs) via a standard monopolar cable, as they provide monopolar energy. The MiniGrip BiPolar Graspers connect to most ESUs via a standard bipolar cable, as they provide bipolar energy. An example of an ESU that may be used with both of these products families is Valleylab Force FX.
# F. Indications for Use and Contraindications
# ThumbGrip Instruments
Indications:
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MiniLap instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues, as well as items such as hernia mesh, during pediatric and adult surgery.
#### Contraindications:
The device is not for use when laparoscopic techniques generally are contradicted.
## ThumbGrip MiniPolar Instruments
#### Indications:
The MiniPolar Instruments are used to cut and cauterize soft tissue during pediatric and adult surgery.
#### Contraindications:
The device is not intended for use when endoscopic techniques are generally contraindicated.
Do not resterilize. The device is provided sterile and is intended for use in a single procedure. Discard after use.
The MiniPolar instruments with monopolar cautery are not intended for contraceptive coagulation of fallopian tissue, but may be used to achieve hemostasis following transection of the fallopian tube.
## MiniGrip Graspers
#### Indications:
The MiniLap System with MiniGrip Handles grasping instruments have applications in a variety of general, thoracic, gynecologic, urologic, laparoscopic and endoscopic procedures for manipulation of tissue, as well as items such as hernia mesh, during pediatric and adult surgery.
#### Contraindications:
Blind insertion in laparoscopic surgery.
The device is provided STERILE and it is intended for use in a SINGLE procedure. DISCARD AFTER USE. DO NOT RE-STERILIZE.
## MiniGrip BiPolar Graspers
#### Indications:
Bipolar Grasper instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic, and endoscopic procedures for manipulation and coagulation of tissue and for manipulation of items such as hernia mesh during pediatric and adult surgery.
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The male bipolar connection is located at the back of the handle and may be utilized for bipolar applications when attached to standard two plug bipolar cables and their generators (a male connection is provided as an integral part of the instrument).
Contraindications: The device is not intended for use when endoscopic techniques are generally contraindicated.
Blind insertion in laparoscopic surgery.
The device is provided STERILE and is intended for use in a SINGLE procedure, DISCARD AFTER USE. DO NOT RESTERILIZE.
This device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.
# G. Substantial Equivalence
The proposed MiniLap ThumbGrip Instruments (non-electrosurgical) are substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|------------------------------------------------------------------|-----------------------|------------|----------------|
| MINI LAP Instruments | Teleflex | K070686 | April 05, 2007 |
| MINI LAP Pediatric<br>Instruments with Medusa<br>Clamping System | Mini-Lap Technologies | K070352 | April 05, 2007 |
The proposed MiniLap ThumbGrip MiniPolar Instruments are substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|------------------------------------------------------------------|-----------------------|------------|-------------------|
| MINI LAP Electrocautery<br>Instruments | Teleflex | K083754 | November 30, 2009 |
| MINI LAP Pediatric<br>Instruments with Medusa<br>Clamping System | Mini-Lap Technologies | K070352 | April 05, 2007 |
The proposed MiniLap MiniGrip Graspers (non-electrosurgical) are substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|------------------------------------------------------------------|-----------------------|------------|----------------|
| MINI-LAP BIPOLAR<br>ELECTROCAUTERY<br>DEVICES | Mini-Lap Technologies | K113597 | June 03, 2012 |
| MINI LAP Pediatric<br>Instruments with Medusa<br>Clamping System | Mini-Lap Technologies | K070352 | April 05, 2007 |
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The proposed MiniLap MiniGrip BiPolar Graspers are substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|------------------------------------------------------------------|-----------------------|------------|----------------|
| MINI-LAP BIPOLAR<br>ELECTROCAUTERY<br>DEVICES | Mini-Lap Technologies | K113597 | June 03, 2012 |
| MINI LAP Pediatric<br>Instruments with Medusa<br>Clamping System | Mini-Lap Technologies | K070352 | April 05, 2007 |
# H. Comparison To Predicate Devices
The proposed MiniLap Percutaneous Surgical System, including the ThumbGrip Instruments and MiniGrip Graspers, has the same technology and functional characteristics as the predicate devices.
Additionally, the devices included in this submission have been on the market for several years with no substantial modifications. The manufacturer of the devices included in this submission is the same manufacturer of the predicate devices referenced. (Note: Teleflex Medical previously acquired the assets of Mini-Lap Technologies.)
## I. Materials
The proposed MiniLap Percutaneous Surgical System, including the ThumbGrip Instruments and MiniGrip Graspers, has the same patient contacting materials as the predicate devices. All materials are in compliance with ISO 10993-1.
## J. Technological Characteristics
A comparison of the technological characteristics of the proposed MiniLap Percutaneous Surgical System, including the ThumbGrip Instruments and MiniGrip Graspers and their predicate devices, has been performed. The results of this comparison demonstrate that the ThumbGrip Instruments and MiniGrip Graspers are equivalent to the marketed predicate devices in technological and performance characteristics.
# K. Performance Data
Ship testing, which has been performed in accordance with ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems, demonstrates that the ThumbGrip Instruments and MiniGrip Graspers are substantially equivalent to their predicate devices.
Additionally, design verification and validation of the ThumbGrip Instruments and MiniGrip Graspers was conducted to document that the device performed to the intended use. All verification and validation results support substantial equivalence.
{12}------------------------------------------------
Electrosurgical devices have been tested to IEC 60601-1 Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance.
Please note that the predicate devices previously all had shelf lives of 2 years. However, recent stability testing supported extending the shelf life of the MiniGrip Graspers (nonelectrosurgical) and the ThumbGrip Instruments (electrosurgical) from 2 years.
## L. Conclusion
Based upon the discussions above comparing the materials, the technological characteristics, and the performance data, the proposed MiniLap Percutaneous Surgical System, including the ThumbGrip Instruments and MiniGrip Graspers, is substantially equivalent to the predicate devices cleared to market via 510(k)s K070352, K070686, K083754, and K113597.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
