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 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.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial or algorithm validation.

Therefore, the requested information elements related to specific performance metrics, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not present in this document because it's a regulatory submission emphasizing design and functional equivalence to an existing device, not a novel device requiring extensive de novo performance validation.

However, I can extract the relevant information pertaining to the "acceptance criteria" as implied by a 510(k) submission and how the device "meets" them, based on the principle of substantial equivalence and compliance with relevant standards.

Here's the closest interpretation of an "acceptance criteria" table and study information based on the provided text:

Acceptance Criteria and Device Performance (Interpreted from 510(k) Submission)

Acceptance Criteria Category	Description	Reported Device Performance
Intended Use	Must be identical or substantially equivalent to predicate device.	The device (Disposable Laparoscopic Scissor Tips and Reusable Handle, The Edge System) has the same intended use as the predicate device (Ackermann Instrumente - K974382; Laparoscope Scissor Tips and Handle): "used for 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."
Technological Characteristics	Materials, fundamental scientific technology, and principles of operation must be identical or substantially equivalent to predicate device.	Key Equivalence Items Reported:- Same tip materials.- Same type handle construction.- The scissor tips are sterilized and packaged for single use.- Handle is reusable per product instructions.- The design analysis and predicate comparison confirm the functional characteristics are the same. Device Description: "Laparoscopic Scissor Tips are assembled from medical grade stainless steel... 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."
Performance Standards Compliance	Must comply with relevant mandatory and voluntary standards to ensure safety and effectiveness.	Compliance with the following standards has been made:- IEC60601-1 (Safety for medical electrical equipment)- IEC60601-1-2 (Electromagnetic compatibility)- IEC60601-2-2 (Particular requirements for the safety of high frequency surgical equipment)- EN550 (Sterilization of Tips)- GMP/ISO13485 (Quality System Certification)
Functional Performance (Verification)	Specific functional aspects (e.g., retention, grasping, insulation, cutting) must meet established specifications.	"Inspection verification procedures assure retention of tips, grasping, insulation performance with analyzer and cutting performance are compliant to Flexbar specifications." (Specific quantitative "Flexbar specifications" are not detailed in this document but implied to be met).
Safety and Effectiveness	The device must not raise new questions of safety and effectiveness compared to the predicate device.	"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."
Sterilization & Reusability Procedures	Clear procedures for sterilization of disposable components and cleaning/sterilization of reusable components must be established and validated.	"Laparoscopic Scissor Tips are... sterilized for single use... The handle is reusable per product instructions." "EN550 Sterilization of Tips by contract sterilizer."

Study Information (as derived from the 510(k) submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No specific "test set" in the context of clinical or performance data is mentioned. The submission relies on design control activities and verification procedures for the manufactured device. The "sample size" would refer to the units tested during manufacturing quality control and design verification, but no numbers are provided.
- Data Provenance: Not specified as clinical data is not the primary basis of this submission for substantial equivalence. It's an internal validation of manufacturing and design.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is not a study requiring expert-established ground truth for diagnostic or clinical performance. "Ground truth" in this context refers to engineering specifications and regulatory standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical or diagnostic test set requiring adjudication is mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a surgical instrument, not an AI-driven diagnostic or assistive device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a surgical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" implicitly used is compliance with established engineering specifications, recognized industry standards (IEC, EN, ISO), and the functional and material characteristics of the legally marketed predicate device.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K 103840

FFB 28 2011

510(K) SUMMARY K103840 January 7, 2011

Page 1 of 2

SUBMITTER INFORMATION: (2424366)

Flexbar Machine Corp. d/b/a Mediflex Surgical Products 250 Gibbs Road Islandia. New York 11749 Tel: 631-582-8440 Fax: 631-582-8487 Contact: Mr. Larry Derrig

APPLICANT/FDA AGENT/CORRESPONDING OFFICIAL INFORMATION:

North American Technical Services (NATS) Corp. 30 Northport Rd Sound Beach, NY 11789 Tel: 631-744-0059 Fax: 631-744-0192 Email: natscorp@aol.com 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 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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Page 2 of ②

INTENDED USE:

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.