Snowden-Pencer MicroLap 3mm Laparoscopic Instruments

K163615 · Carefusion 2200, Inc. · GEI · May 4, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163615
• Device Name: Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
• Applicant: Carefusion 2200, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments are indicated to be used in laparoscopic and other minimally invasive procedures for cutting, clamping, grasping, suturing and dissecting and to allow high frequency monopolar cutting and coagulation.

Device Story

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments are reusable, two-piece modular surgical tools consisting of a handle and an insert assembly (shaft and end-effector). Designed for use in laparoscopic and minimally invasive procedures, these instruments are operated by surgeons to perform tissue manipulation and electrosurgical tasks. The device connects to an external electrosurgical generator to deliver monopolar energy for cutting and coagulation. Available in various lengths, handle styles (ring, pistol-grip, in-line), and jaw patterns (scissors, clamps, graspers, dissectors, needle holders), the instruments provide tactile feedback and mechanical control during surgery. By enabling precise tissue interaction and energy delivery, the device assists in surgical dissection and hemostasis, potentially reducing trauma and improving procedural efficiency compared to manual methods.

Clinical Evidence

No clinical tests were conducted for this submission. Substantial equivalence is supported by non-clinical bench testing, including mechanical strength, pneumoperitoneum maintenance, electrosurgical safety, cleaning/sterilization validation, and biocompatibility.

Technological Characteristics

Reusable two-piece modular system; 3mm diameter. Materials: Stainless steel, Radel (PPSU), Tungsten Carbide, Silver braze, 3M DP490, Marabu Tampapur TPU 970, Loctite, Santoprene, EPDM rubber, Kraton. Energy: Monopolar electrosurgical (1.5 kVp). Sterilization: Pre-vacuum steam. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, ISO 10993, AAMI TIR12/30, ANSI AAMI ST79/ST81.

Indications for Use

Indicated for patients undergoing laparoscopic or minimally invasive surgical procedures requiring cutting, clamping, grasping, suturing, dissecting, or monopolar electrosurgical cutting and coagulation.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• BEMA Endoscopic Monopolar Instruments and Accessories (K102921)

Submission Summary (Full Text)

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

May 4, 2017

CareFusion 2200 Inc. Ms. Jane Weber Regulatory Affairs Manager 75 North Fairway Drive Vernon Hills, Illinois 60061

Re: K163615

Trade/Device Name: Snowden-Pencer MicroLap 3mm Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 28, 2017 Received: May 2, 2017

Dear Ms.Weber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [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" (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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R. Stevenson -S 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K163615

#### Device Name

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments

#### Indications for Use (Describe)

The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments are indicated to be used in laparoscopic and other minimally invasive procedures for cutting, clamping, suturing and dissecting and to allow high frequency monopolar cutting and coagulation.

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)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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# 510(k) SUMMARY – K163615

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

| SUBMITTER INFORMATION | |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | CareFusion 2200 Inc. |
| Address | 75 North Fairway Drive<br>Vernon Hills, IL 60061 |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment Registration<br>Number | 1423507 |
| Name of contact person | Jane Weber |
| Date prepared | 28-APR-2016 |
| DEVICE INFORMATION | |
| Trade or proprietary name | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments |
| Common or usual name | Reusable Laparoscopic Instruments |
| Classification name | Electrosurgical Cutting and Coagulation and Accessories |
| Classification panel | 79 General and Plastic Surgery |
| Regulation | Class II per 21CFR 878.4400, Product code GEI |
| Product Code(s) | Multiple devices |
| Legally marketed device(s) to<br>which equivalence is claimed | BEMA Endoscopic Monopolar Instruments and Accessories -<br>K102921, GEI |
| Reason for 510(k) submission | Launch new 3mm product line |
| Device description | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments<br>consists of a handle and insert assembly. The insert assembly<br>contains a shaft and end-effector (jaw pattern). There are several<br>device models that encompass various lengths, diameters and jaw<br>patterns based on the surgeon's needs. |
| Intended use of the device | To be used in laparoscopic and other minimally invasive<br>procedures |
| Indications for use | The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments<br>are indicated to be used in laparoscopic and other minimally<br>invasive procedures for cutting, clamping, grasping, suturing and<br>dissecting and to allow high frequency monopolar cutting and<br>coagulation. |

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## SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| COMPARED TO THE PREDICATE DEVICE | | |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate Device | New Device |
| Type of Device | Reusable | Reusable |
| Intended for direct patient<br>contact? | Yes | Yes |
| Intended for extended<br>use? (more than 24 hrs) | No | No |
| Active component | Monopolar | Monopolar |
| Length | 18cm, 21cm, 33cm | 24cm and 36cm |
| Diameter | 3mm | 3mm |
| Overall device design | Two-Piece Modular System | Two-Piece Modular System |
| Handle design | Ring and In-Line | Ring, Pistol-Grip and In-Line |
| Insert Assembly End<br>Effectors (jaw patterns) | Scissors<br>Graspers<br>Dissectors<br>Needle Holders | Scissors<br>Clamps<br>Graspers<br>Dissectors<br>Needle Holders |
| Rated Voltage | 2 kVp in cutting/coagulation<br>3 kVp in spray | 1.5 kVp in all modes |
| Materials | Stainless Steel (SS)<br>Raydel (Poylphenlsufone – PPSU)<br>Tungsten Carbide<br>Silver Braze<br>3M DP490<br>Halar S<br>Nylon | Stainless Steel<br>Radel (Poylphenlsufone – PPSU)<br>Tungsten Carbide<br>Silver braze<br>3M DP490<br>Marabu Tampapur TPU 970 –<br>White<br>Loctite<br>Santoprene<br>EPDM Rubber<br>Kraton |
| How Supplied | Non-Sterile | Non-Sterile |
| Sterilization Modalities | Pre-vacuum Steam | Pre-Vacuum Steam |

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# PERFORMANCE DATA

# SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

### Performance Test Summary - New Device

| Characteristic | Standard / Test / FDA Guidance | Results Summary | | |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------|--|--|
| Instrument strength | Strength Tests | PASS | | |
| Device must be reusable | Cleaning and Sterilization Tests | PASS | | |
| Device must maintain<br>pneumoperitoneum | Pneumoperitoneum Test | PASS | | |
| Device to meet required<br>electrosurgical safety standards | IEC 60601-1, IEC 60601-2, IEC 60601-2-2,<br>IEC 60601-2-18 | PASS | | |
| Device is able to be cleaned and<br>sterilized | AAMI TIR12, AAMI TIR30, ANSI AAMI<br>ST79, ANSI AAMI ST81, ISO 11138, ISO<br>17664, ISO 17665 | PASS | | |
| Device materials are<br>biocompatible | ISO 10993 | PASS | | |

## SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

N/A - No clinical tests were conducted for this submission.

## CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of the non-clinical tests demonstrate the Snowden-Pencer MicroLap 3mm Laparoscopic Instruments meet all performance requirements, and are substantially equivalent to the predicate devices.