(80 days)
Not Found
No
The description focuses on mechanical and electrical components and standard surgical procedures. There is no mention of AI/ML terms, image processing, or data analysis that would indicate AI/ML technology.
Yes.
The device is used to perform "various diagnostic and therapeutic surgical procedures," indicating it has a therapeutic purpose.
No
The device is described as an accessory for surgical procedures, providing access and visualization for both diagnostic and therapeutic purposes, but it does not independently perform diagnostic functions. Its primary role is to assist in surgical interventions.
No
The device description explicitly details physical components (Laparoscopic Scissor Tips, Handle) made of medical grade stainless steel and mentions sterilization and electrosurgical use, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "providing access to and visualization of body cavities, organs and canals to perform various diagnostic and therapeutic surgical procedures." This describes a surgical instrument used in vivo (within the body) for direct intervention and visualization.
- Device Description: The description details a surgical tool (scissors and handle) used for electrical and non-electrosurgical procedures. This aligns with surgical instrumentation, not devices used to examine samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test samples of human origin (like blood, urine, tissue) to provide information about a physiological state, health, or disease. The device's function is mechanical and electrical manipulation of tissue during surgery.
IVD devices are specifically designed to perform tests on samples taken from the body to aid in diagnosis or monitoring. This device is a surgical tool used directly on the body during a procedure.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, organs and canals
Indicated Patient Age Range
Not Found
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)
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.
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.
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
§ 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.
0
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 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.
1
Page 2 of ②
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)
2
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.
3
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,
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K 10:3840
INDICATIONS FOR USE
510K #
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)
==============================================================================================================================================================================
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