MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM

K132232 · Minilap Technologies · OCW · Dec 4, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K132232
• Device Name: MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
• Applicant: Minilap Technologies
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Dec 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MiNS grasping 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.

Device Story

MiNS Needlescopic Resposable Laparoscopic device system consists of a reusable autoclavable handle and a sterile, disposable, single-use needle/cannula shaft housing a retractable grasper (NLU). The device is used by surgeons during general laparoscopic procedures. The instrument shaft is introduced percutaneously to the surgical site without a traditional insertion conduit. Once at the site, the working portion is deployed to approximate, grasp, and manipulate soft tissue or hernia mesh. The system provides a minimally invasive means to access internal anatomy. The device benefits patients by allowing for needlescopic access, potentially reducing trauma compared to larger diameter instruments.

Clinical Evidence

Bench testing only. The device underwent mechanical and attribute evaluations. Biocompatibility was established based on identical materials to the predicate device (K070686), which previously passed ISO 10993 testing.

Technological Characteristics

Materials: Medical grade stainless steel (17-7 SS, 300 SS, 475 SS) and polyester. Dimensions: 2.4mm ± 0.1mm diameter, 300mm length. Principle: Manual mechanical grasping/manipulation. Sterilization: Handle is autoclavable (moist heat, ISO 17665); disposable NLU is gamma-irradiated (ISO 11137). Connectivity: None. Software: None.

Indications for Use

Indicated for use in minimally invasive laparoscopic procedures to penetrate soft tissue, grasp, hold, and manipulate internal tissues and hernia mesh.

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.

Predicate Devices

• Mini Lap Instruments (K070686)
• Snowden-Pencer-Resposable Laparoscopic Scissors (K113407)
• Aesculap Needlescopic Instrument System (K982623)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Mini Lap Technologies Inc. The logo includes the words "MINI LAP" in a stylized font, along with a graphic of an atom. The text "Mini Lap Technologies Inc." is printed to the right of the logo. The text "K132232" is printed below the company name.

510(k) Summary (as specified by 21 CFR 807.92) Prepared July 11, 2013. Modified December 3, 2013

DEC 04 2013

Device Name: MiNS Needlescopic Resposable Laparoscopic device system

#### Intended Use

The MiNS grasping 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.

#### No Previous NSE Decision

This device has not been the subject of a previous NSE decision nor has there been other submissions or communication to the FDA regarding this device ..

#### Establishment Registration Number

Regulatory Contact Allan Alward 145 Palisade Street Dobbs Ferry, NY 10522

#### Sponsor/Manufacturer

Mini Lap Technologies Inc. 145 Palisade Street Dobbs Ferry, NY 10522 Contact: Dr. S. Ravikumar Tel: [phone]

FDA Establishment Registration Number is 3007123990

#### Device Trade or Proprietary Names

The device trade names are: MiNS Needlescopic Resposable Laparoscopic device system

#### Device Common, Usual or Classification Names

Laparoscopic Instruments, Graspers, Cannula, Trocar, Manual Surgical Instruments.

#### Classification Panel

Classification of this device falls under the responsibility of the General & Plastic Surgery panel.

#### Class

Class 2 device under the following product codes/regulations:

OCW, 21 CFR 876.1500, Endoscope and accessories ■

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Image /page/1/Picture/0 description: The image shows the logo for Mini Lap Technologies Inc. The logo includes the text "MINI LAP" in a stylized font, with a graphic of an atom-like structure. To the right of the graphic is the text "Mini Lap Technologies Inc." in a bold, sans-serif font.

## Applicable Standards

## Compliance with Section 514 of the Food, Drug and Cosmetic Act

None. Section 514 has not established performance standards for this device.

#### Device Description

#### Summary of the function of the device and its major components:

The MiNS devices are a family of disposable and re-useable devices. Consisting of an integrated, insulated needle/cannula shaft that houses a retractable grasper (NLU) which are inserted into a reusable Handle. The disposable NLU's when inserted into a reusable Handles are used for mobilization and manipulation of soft tissue during general laparoscopic procedures. The system has the ability to directly penetrate soft tissue to access certain areas of the human anatomy without the need for a traditional insertion conduit. The shaft of the instrument can be introduced percutaneously to the surgical site, after which the working portion of the instrument can be deployed to approximate, grasp and manipulate soft tissue.

#### Patient Contact Materials

The device is composed of biocompatible materials that have been used in medical devices for many years. The patient contact materials are biocompatible and are identical to the predicate Minilap device (K070686) which passed testing to ISO 10993.

## Cleaning, Disinfection, Sterilization and Pyrogenicity

The MiNS Needlescopic Resposable Laparoscopic device NLU's are a family of sterile disposable single patient packaged in a pet blister tray and sealed with a tyvek lid for the sterile barrier use ends that attaches to an autoclavable reusable handle.

The MiNS Needlescopic Resposable Laparoscopic device Handle is a reusable autoclavable portion of the MiNS system which has separate cleaning and sterilization techniques located in the information booklet and is packed as a non sterile device in a separate package..

The Handle portion is designed for moist heat sterilization, validated in production to an SAL of 10th per ISO 17665:2006 utilizing a half cvcle overkill method to meet the requirements of ISO17665-1:2006, Steam sterilization of medical devices.

The disposable NLU's are sterilized using gamma radiation, validated in production to a SAL of 10° per ISO 11137:2006. Method 1. in order to reduce gamma exposure/aging. When applicable, the VDmax provisions of 1137:2006 will be used to substantiate the standard 25-to-40 kGy dose.

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Image /page/2/Picture/0 description: The image shows the logo for Mini Lap Technologies Inc. The logo includes the text "Mini Lap Technologies Inc." in a bold, sans-serif font. To the left of the text is a stylized graphic that includes the words "MINI" and "LAP" with a circular design.

## Software

The subject device does not include software.

## 510(k) Summary of Safety and Effectiveness

We have compared various characteristics of the MiNS Needlescopic Resposable device system to existing technologies that would have an adverse affect upon the safety and efficacy of the system and have found that the Mini Lap MiNS Needlescopic Resposable device system does not present any new risks to the patient and therefore, we believe that it is substantially equivalent to other devices and technologies cleared by the FDA.

## Technological Characteristics

Mini Lap Technologies, Inc. believes that the subject device is substantially equivalent to other devices that have previously received FDA 510(k) clearance including the predicate devices.

## Predicate Device

The following devices have been identified as predicate devices:

- · Mini Lap Instruments K070686
- · Snowden-Pencer-Resposable Laparoscopic Scissors- K113407
- · Aesculap Needlescopic Instrument System- K982623

## Predicate Device Comparison

The Mini Lap MiNS Needlescopic Resposable device systems are, in principal and function, identical to existing technologies. A variety of reusable laparoscopic instruments are already widely manufactured and used in surgical procedures and have many similarities to the MiNS Needlescopic Resposable device svstem.

Discussion on Comparison:

## Mini Lap Instruments

The Mini Lap Instruments (K070686) were included as part of the comparison because the needle design and jaw design dimensions as well as the patient contact materials are identical to the subject device along with sterilization method.

- The main differences between the Mini Lap Instruments and the MiNS Needlescopic Resposable ● device system are the a) handle design which is reusable , b) the grasper shaft assembly attaches to a reusable handle .
Snowden-Pencer Resposable Laparoscopic Scissors (K113407) were included as predicates because they are a family of products with a reusable handle and sterile disposable tips indicated for mechanically cutting soft tissue in laparoscopic procedures.

- The two sets of devices share similar handle design, composed of Medical Grade stainless steel and . plastic components.
- The main difference between the MiNS Needlescopic Resposable device system and the Snowden-. Pencer Resposable Laparoscopic device is the outer diameter of the subject device is 2.4mm and the predicate is a 5mm.

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Image /page/3/Picture/0 description: The image contains the logo for Mini Lap Technologies Inc. The logo includes the text "MINI LAP" in a stylized font, accompanied by a geometric design resembling intersecting ellipses. To the right of the logo is the company name, "Mini Lap Technologies Inc.", written in a bold, sans-serif font.

A esculap Needlescopic Instrument System (K 982623) were included as predicates because they are a family of products with a reusable handles and attachable Shafts/tips indicated for use in endoscopic and laparoscopic procedures.

- The main difference between the MiNS Needlescopic Resposable device system and the Aesculap . Needlescopic Instrument System is the Aesculap system is reusable.
In the following section, we compare various characteristics of the MiNS Needlescopic Resposable device system to existing technologies. The Mini Lap MiNS Needlescopic Resposable device system does not present any new risks to the patient and therefore, we believe that it is substantially equivalent to other devices and technologies cleared by the FDA.

| Characteristic | Mini Lap<br>Technologies<br>MiniLap Resposable<br>Devices | Aesculap<br>Needlescopic<br>instruments | Mini Lap<br>Technologies<br>MINI LAP<br>Instruments | Snowden-Pencer<br>Resposable<br>Laparoscopic<br>Scissors |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K132232 | K982623 | K070686 | K113407 |
| Use | The MiNS grasping<br>instruments are a family<br>of minimally invasive<br>devices with the means<br>to penetrate soft tissue<br>to access certain areas<br>of the human anatomy.<br>The devices are used<br>to grasp, hold, and<br>manipulate other soft<br>internal tissues as well<br>as items such as hernia<br>mesh. | The Aesculap<br>Needlescopic<br>instrument set is<br>indicated for use in<br>adult and pediatric<br>diagnostics and<br>therapeutic general<br>endoscopy and<br>laparoscopy surgery. | The Minilap<br>instruments are a<br>family of<br>minimally invasive<br>devices with the<br>means to<br>penetrate soft<br>tissue to access<br>certain areas of the<br>human anatomy.<br>The devices are<br>used to grasp,<br>hold, and<br>manipulate other<br>soft internal tissues<br>as well as items<br>such as hernia<br>mesh. | The Snowden<br>Pencer<br>Laparoscopic<br>Ergonomic<br>Resposable Scissors<br>is a monopolar<br>electrosurgical<br>instrument<br>indicated to be used<br>in general<br>laparoscopic and<br>gynecologic<br>procedures to allow<br>high frequency<br>monopolar cutting<br>and coagulation.<br>The Resposable<br>scissors are<br>indicated to<br>mechanical cut<br>tissue and suture. |
| Needle diameter | 2.4mm ± .1mm | 2.5 mm | 2.4mm ± .1mm | 5mm |
| Device length | 300 mm | Various | 300 mm | 24CM,36CM,45CM |
| Material<br>Composition | Medical Grade Stainless<br>Steel<br>17-7 SS, 300 SS, | Medical Grade<br>Stainless Steel | Medical Grade<br>Stainless Steel<br>Polyester | Medical Grade<br>Stainless Steel<br>MT500 Polyolefin |

Predicate Comparison Chart

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Image /page/4/Picture/0 description: The image contains the logo for Mini Lap Technologies Inc. The logo includes the text "MINI" and "LAP" stacked vertically and connected by a stylized atom symbol. To the right of the logo is the text "Mini Lap Technologies Inc."

| | 475SS, Polyester | | | |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------|
| Sterilization | Autoclavable, non<br>sterile, reusable handles<br>with attachable<br>disposable sterile,<br>single use shaft tip<br>combinations. | Non sterile, reusable<br>detachable ends | Sterile, single use | Autoclavable, non<br>sterile reusable<br>handle Single use<br>sterile disposable<br>shaft and scissors<br>tip |

## Table of Contents

A table of content is included at the beginning of this submission. The pages referred to in the contents correspond to the sequentially numbered pages of this premarket notification.

## Truthful and Accurate Statement

A "truthful and accurate" statement regarding all information provided in this premarket notification is present on page .

#### Confidentiality

Mini Lap Technologies Inc. considers certain in this premarket notification to be confidential business information, and has taken measures to protect the release of this information. Mini Lap Technologies Inc. requests the FDA respect the confidentiality of this information to the extent possible under law. We expect the FDA will consult with Mini Lap Technologies Inc. prior to the release of any information in this premarket notification (outside the 510(k) summary) for any reason, including requests under the Freedom of Information Act.

## Performance Data |21 CFR 807.92(b)(1)|

The subject device has been subjected to and passed a variety of bench tests for mechanical and attribute evaluations. Additionally, the device is composed of biocompatible materials with a history of usage in the medical device industry and share common design components with K070686.

## Conclusion 121 CFR 807.92(b)(3)]

We believe the changes are minimal and conclude that the subject device is as safe and effective as the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Arenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 4, 2013

MiniLap Technologies, Inc. Mr. Allan Alward Vice President, Research and Development 145 Palisade Street Dobbs Ferry. New York 10522

Re: K132232

Trade/Device Name: MiNS Needlescopic Resposable device system Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCW Dated: October 29, 2013 Received: November 5, 2013

Dear Mr. Alward:

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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA `s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Allan Alward

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/7/Picture/0 description: The image shows the logo for Mini Lap Technologies Inc. The logo consists of the words "Mini Lap Technologies Inc." in a simple, sans-serif font. To the left of the text is a stylized graphic of what appears to be a molecule or atom, with the words "MINI LAP" incorporated into the design.

## Indications for Use

510(k) Number: K132232

Device Name: MiNS Needlescopic Resposable device system

Indications for Use:

ﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

The MiNS grasping 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHIER PAGE OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

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Long H. Chen -A

DN CUS, O-U.S. Government ou-HHS.
OU=FDA, Our People, chotong H. Chen-A
0.9.2342.19200300 100 1,1-1300369056
Date, 2013 11 2207 36 160500

for BSA

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(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132232

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