(151 days)
Not Found
No
The summary describes manual surgical instruments for grasping, holding, manipulating, cutting, and cauterizing tissue. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is a surgical instrument used to grasp, hold, manipulate, cut, and cauterize tissues during surgery, not to treat a disease or condition itself.
No
Explanation: The provided text describes the device as surgical instruments used for grasping, holding, manipulating, cutting, and cauterizing soft tissue during surgery. There is no mention of the device being used to identify or analyze diseases or conditions.
No
The device description clearly outlines physical instruments (ThumbGrip Instruments and MiniGrip Graspers) used for surgical procedures, including penetration, grasping, holding, and manipulating tissue. It also mentions electrosurgical configurations and testing to hardware standards (IEC 60601-1). There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the devices as being used for surgical procedures to grasp, hold, manipulate, cut, and cauterize soft tissue and other items within the human body. This is an in vivo (within a living organism) application, not an in vitro (outside the body, typically on samples) diagnostic test.
- Device Description: The description reinforces the surgical nature of the devices, detailing their use for penetrating soft tissue and manipulating internal tissues during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue biopsies), detecting biomarkers, or providing diagnostic information. The devices are purely surgical tools for manipulation and treatment.
Therefore, the MiniLap instruments are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
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, and endoscopic 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 plug bipolar cables and their generators (a male connection is provided as an integral part of the instrument).
Product codes (comma separated list FDA assigned to the subject device)
OCW, GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, human anatomy.
Indicated Patient Age Range
Pediatric and adult.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K070686, K070352, K083754, K113597
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
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
1
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).
Image /page/1/Picture/5 description: The image shows a signature block with the word "Sincerely" at the top. Below that is the name "Jennifer R. Stevenson -S3" in a larger font. The text appears to be part of a formal document or letter.
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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."
3
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.
4
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)
| 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.
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 | |
| Name | Endoscopic and accessories |
| Trade Name | Teleflex MiniLap® System with ThumbGrip MiniPolar® |
| Handle | |
| Common Name | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification | |
| Name | Electrosurgical cutting and coagulation device and accessories |
| Trade Name | Teleflex MiniLap® System with MiniGrip® Handle |
| Common Name | Endoscopic Tissue Approximation Device |
| Classification | |
| Name | Endoscopic and accessories |
7
| 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 |
8
| 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 |
| 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:
9
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.
10
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 | |||
| Instruments with Medusa | |||
| 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 | |||
| Instruments | Teleflex | K083754 | November 30, 2009 |
| MINI LAP Pediatric | |||
| Instruments with Medusa | |||
| 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 | |||
| ELECTROCAUTERY | |||
| DEVICES | Mini-Lap Technologies | K113597 | June 03, 2012 |
| MINI LAP Pediatric | |||
| Instruments with Medusa | |||
| Clamping System | Mini-Lap Technologies | K070352 | April 05, 2007 |
11
The proposed MiniLap MiniGrip BiPolar Graspers are substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| MINI-LAP BIPOLAR | |||
| ELECTROCAUTERY | |||
| DEVICES | Mini-Lap Technologies | K113597 | June 03, 2012 |
| MINI LAP Pediatric | |||
| Instruments with Medusa | |||
| 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.