(110 days)
Not Found
No
The summary describes a mechanical and electrical surgical instrument with modifications to the handle and jaws. There is no mention of AI, ML, image processing, or data-driven decision making. The performance studies focus on mechanical, electrical, and tissue interaction properties.
Yes.
Explanation: The device is used for electrosurgical coagulation, mechanical cutting, and grasping of tissue during surgical procedures, which are therapeutic interventions.
No
Explanation: The device is described as surgical forceps used for electrosurgical coagulation, mechanical cutting, and grasping of tissue, which are therapeutic actions rather than diagnostic ones. There is no mention of it being used to detect, identify, or monitor medical conditions.
No
The device description explicitly states it is a "single use, sterile accessory" and describes physical components like a handle, jaws, and shaft, indicating it is a hardware device. The performance studies also focus on non-clinical (electrical, mechanical, functional) and preclinical (bench, ex-vivo tissue) testing of these physical components.
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 "electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures." This describes a surgical instrument used on the patient's tissue, not a device used to test samples from the body in a laboratory setting.
- Device Description: The description reinforces its use as a "single use, sterile accessory" for surgical procedures, used in conjunction with an electrosurgical workstation.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue samples, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing. The performance studies focus on the device's mechanical, electrical, and functional performance on tissue, not on the accuracy of diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the general purpose ESG-400 workstation.
Product codes
GEI
Device Description
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the general purpose ESG-400 workstation. The device is a single use, sterile accessory, to be used in conjunction with the bipolar outputs of the Olympus workstation with PK software (ESG-400).
The proposed device is a modification of the Gyrus HALO PKS Cutting Forceps and includes an improved handle and improved jaw performance. The device handle has been redesigned with internal changes to improve ease of use. The jaws are identical as those found on the predicate Gyrus HALO PKS Cutting Forceps except that coatings have been added, and a mechanical bridge has been added inside the shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance tests were executed to ensure that the device functions as intended and meets design specifications.
Evidence of safety and effectiveness was obtained from two primary areas:
-
- non-clinical (electrical, mechanical, functional, stability) performance testing
-
- preclinical (bench, ex-vivo tissue) evaluations and testing
Non-clinical: Basic safety and performance testing was performed in accordance with IEC 60601-1 and IEC 60601-2-2. In addition, verification and comparison bench studies were conducted to evaluate the mechanical and functional performance. Testing included: system testing, torque strength, endurance, force testing, reliability, ship testing, baseline performance testing, age testing, environmental conditioning, durability, dimensional verification, ergonomics, system compatibility, grasping, thermal margin, cutting, rotation, coagulation, and basic functionality.
Stability: Samples were subjected to accelerated aging to confirm that the device maintains functionality and continues to meet specifications over time. The results of the accelerated age testing demonstrate that the device will be stable for the stated shelf-life. In addition, real time age testing will be carried out to confirm the results of the accelerated age testing. Samples were also subjected to environmental conditioning and ship testing.
Preclinical: Evidence obtained from preclinical bench tissue (ex vivo) demonstrates that the device performs substantially equivalent to the predicate devices in relevant aspects associated with usability, cutting, coagulation, and tissue grasping. For bench testing, the selected tissue medium was confirmed to be appropriate for testing based on clinical experience with the predicate.
Bench tissue - evaluated ex vivo using bovine and porcine tissue:
- Thermal margin -
- Visual comparison of coagulation
Testing demonstrated that the device performs as well as or better than the predicate device. Non-clinical bench testing and preclinical performance testing shows that the device performance is substantially equivalent to the predicate, and that the modifications raise no new issues of safety and effectiveness.
No clinical testing was conducted. The use of Electrosurgical Cutting and Coagulation Devices has been documented in published literature and indicates safe and effective use for the target indications and expected patient populations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2015
Gyrus ACMI Incorporated Mr. Dolan Mills Sr. Specialist, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772
Re: K142759
Trade/Device Name: PK Cutting Forceps for ESG-400 workstation Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 4, 2014 Received: December 8, 2014
Dear Mr. Mills:
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 (reporting of medical
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
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)
Device Name PK Cutting Forceps for ESG-400 workstation K142759
Indications for Use (Describe)
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the general purpose ESG-400 workstation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary Gyrus ACMI, Inc. PK Cutting Forceps for ESG-400 Workstation
General Information
| Manufacturer: | Gyrus ACMI, Inc., an Olympus company
136 Turnpike Road
Southborough, MA 01772-2104
Phone: 1-800-262-3540
Fax: 1-901-373-0260 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Dolan Mills
Senior Specialist, Regulatory Affairs |
| Date Prepared: | September 24, 2014 |
Device Description
| Classification Name: | Electrosurgical Cutting & Coagulation
Device and Accessories |
|----------------------|-------------------------------------------------------------------|
| Regulatory Class | Class 2 |
| Regulation Number | 21 CFR 878.4400 |
| Review Panel | General and Restorative Surgery Panel |
| Product Code | GEI |
| Trade Name(s): | PK Cutting Forceps, ESG PK Cutting
Forceps, ESG PK CF |
| Generic/Common Name: | Electrosurgical cutting and coagulation
device and accessories |
Predicate Device
Gyrus ACMI Inc. HALO PKS Cutting Forceps: K100896 This predicate has not been subject to a design-related recall.
Product Description
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the general purpose ESG-400 workstation. The device is a single use, sterile accessory, to be used in
4
conjunction with the bipolar outputs of the Olympus workstation with PK software (ESG-400).
The proposed device is a modification of the Gyrus HALO PKS Cutting Forceps and includes an improved handle and improved jaw performance. The device handle has been redesigned with internal changes to improve ease of use. The jaws are identical as those found on the predicate Gyrus HALO PKS Cutting Forceps except that coatings have been added, and a mechanical bridge has been added inside the shaft.
Technological Characteristics
The Gyrus ACMI PK Cutting Forceps is a single use, sterile accessory for use with the ESG-400 Generator with updated PK software only, and is intended to provide the same performance as the predicate Gyrus HALO PKS Cutting Forceps. The modified device and the currently marketed device share intended use and the same operating principle, similar patient contacting materials, and the same processes of packaging and sterilization. Other than the coating, the distal jaws are identical as those found on the predicate Gyrus HALO PKS Cutting Forceps. The device may be activated via the handpiece coagulation switch or footswitch.
Material
The device uses similar patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI.
The patient contacting items are classified in accordance with ISO 10993-1, as an external communicating, tissue/bone/dentin device for limited exposure (