CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE

K103840 · Flexbar Machine Corp. · GEI · Feb 28, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103840
• Device Name: CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
• Applicant: Flexbar Machine Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The disposable accessory Laparoscopic Scissor Tips and Handle are used for electrical and nonelectrosurgical procedures intended for providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures.

Device Story

The Edge System consists of disposable stainless steel laparoscopic scissor tips (Curved/Straight/Mini Metzenbaum, Hook, Maryland Dissector) and a reusable insulated monopolar surgical handle. Used in laparoscopic surgery, the device connects to a standard electrosurgical generator for cutting and coagulation. The handle is reusable and requires cleaning/sterilization between uses, while tips are single-use. The system provides surgeons with mechanical cutting and electrosurgical capabilities to perform diagnostic and therapeutic procedures within body cavities. The device is operated by a surgeon in a clinical/OR setting.

Clinical Evidence

Bench testing only. Verification procedures confirmed design specifications, including tip retention, grasping, insulation performance, and cutting performance. Compliance with IEC60601-1, IEC60601-1-2, and IEC60601-2-2 standards for safety, HF dielectric, and leakage was demonstrated.

Technological Characteristics

Medical grade stainless steel tips; insulated monopolar handle; compatible with standard electrosurgical generators. Standards: IEC60601-1 (safety), IEC60601-1-2 (EMC), IEC60601-2-2 (HF surgical equipment), EN550 (sterilization).

Indications for Use

Indicated for patients undergoing diagnostic and therapeutic surgical procedures requiring access to and visualization of body cavities, organs, and canals via electrical or non-electrosurgical laparoscopic techniques.

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

• Ackermann Instrumente - Laparoscope Scissor Tips and Handle (K974382)

Submission Summary (Full Text)

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K 103840

FFB 28 2011

510(K) SUMMARY K103840 January 7, 2011

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## SUBMITTER INFORMATION: (2424366)

Flexbar Machine Corp. d/b/a Mediflex Surgical Products 250 Gibbs Road Islandia. New York 11749 Tel: [phone] Fax: [phone] Contact: Mr. Larry Derrig

# APPLICANT/FDA AGENT/CORRESPONDING OFFICIAL INFORMATION:

North American Technical Services (NATS) Corp. 30 Northport Rd Sound Beach, NY 11789 Tel: [phone] Fax: [phone] Email: [e-mail] Contact: Stephen T. Micoch

## DEVICE NAME:

Common Name: Disposable Laparoscopic Scissor Tips and reusable Handle Proprietary Model: Disposable Scissor Tips: 91710, 91720, 91730, 91740, 91750 Handle: The Edge System

Classification: 2

Classification Code: GCJ, 21CFR 876.1500 Laparoscope, General & Plastic Surgery GEI, 21CFR 878.4400 Electrosurgical, Cutting & Coagulation & Accessories

## PREDICATE DEVICE:

Ackermann Instrumente - K974382; Laparoscope Scissor Tips and Handle

# DESCRIPTION:

The Laparoscopic Scissor Tips are accessory disposable components that attach to the reusable Laparoscopic Surgical Handle. Laparoscopic Scissor Tips are assembled from medical grade stainless steel and sterilized for single use with the reusable surgical handle that must be cleaned and sterile before use. The Edge System is used with a standard electrosurgical generator and is a monopolar system. The handle is a standard insulated monopolar type with an insulated shaft.

The Laparoscopic Scissor Tips and Handle are substantially equivalent in safety and effectiveness to the legally marketed Scissor. Tips and Handle per 510(K) Number K974382. The use, indications and operation are the same for electro and non-electro surgical handles and tips of this type. The 5 tip types identified are for established medical procedures identified as Curved Metzenbaum 91710, Straight Metzenbaum 91720, Mini Metzenbaum 91730, Hook 91740, and Maryland Dissector 91750.

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# INTENDED USE:

The disposable accessory Laparoscopic Scissor Tips and Handle are used for electrical and nonelectrosurgical procedures intended for providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures.

# SUMMARY OF NONCLINICAL TESTS AND DESIGN CONTROL ACTIVITIES:

The Laparoscopic Scissor Tips and Handle comply with the standards below and are therefore safe for the intended use. The device has been tested, validated and has verification procedures in place to confirm design specifications. Compliance with the following mandatory and voluntary standards has been made:

- IEC60601-1, IEC60601-1-2, IEC60601-2-2 are applicable for safety, HF Dielectric and . Leakage.
- . EN550 Sterilization of Tips by contract sterilizer.
- . GMP/ISO13485 Quality System Certification Factory procedures are established for production and assembly. Flexbar performs additional QC procedures to confirm design characteristics and performance criteria.

The control activity shows that there are no new questions of safety and effectiveness for the Laparoscopic Scissor Tips and Handle made by Flexbar. The design analysis and predicate comparison confirm the functional characteristics are the same to the predicate device and raise no other safety or effectiveness issues. Inspection verification procedures assure retention of tips, grasping, insulation performance with analyzer and cutting performance are compliant to Flexbar specifications.

#### CONCLUSION:

The Flexbar Laparoscopic Scissor Tips and Handle are substantially equivalent to the Ackerman Scissor Tips and Handle. They have same intended use and are capable of electrical and nonelectrosurgical medical procedure uses.

Note key comparison and equivalence items here:

- Same tip materials. -
- . Same type handle construction.
- The scissor tips are sterilized and packaged for single use. -
- Handle is reusable per product instructions. -
- Intended use is the same. +

(medi/0033fm)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Flexbar Machine Corp. % North American Technical Services (NATS) Corp. Mr. Stephen T. Mlcoch 30 Northport Road Sound Beach, New York 11789

FEB 28 2011

Re: K103840

Trade/Device Name: Disposable Laparoscopic Scissor Tips and Reusable Handle: The Edge System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 25, 2010 Received: January 04, 2011

## Dear Mr. Mr. Mlcoch:

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.

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Page 2 - Mr. Stephen T. Mlcoch

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 10:3840

INDICATIONS FOR USE

510K #

K103840

Device Name:

Accessory Disposable Laparoscopic Scissor Tips and Reuseable Handle, The Edge System

Indications for Use:

The disposable Laparoscopic Scissor Tips and reuseable Handle are used in electrical and non-electrosurgical procedures intended for providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Jaden for nkm
Official Sign Off

Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number K103840