(132 days)
Not Found
No
The description focuses on the electrosurgical functionality and mechanical design, with no mention of AI or ML terms or capabilities.
No
The device is described as an electrosurgical tool for cutting, grasping, manipulating, and coagulating tissues, which are procedures rather than therapeutic in nature.
No
The device is intended for monopolar cutting and bipolar coagulation of selected soft tissues, which are therapeutic actions, not diagnostic.
No
The device description explicitly states it is comprised of a mixture of plastics, metals, heatshrink, and epoxy, indicating it is a physical hardware 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 "monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical instrument with a handle, buttons, a switch, and connections to a generator. This is consistent with a surgical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue samples) or providing diagnostic information based on such analysis. IVDs are used to examine specimens in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
Therefore, the PK AIM device is a surgical electrosurgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PK AIM device is intended for monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery. This device is not intended to be used for tubal ligation or female sterilization.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
This 2 in 1 device has a pencil type handle and combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy. The device has passed all applicable biocompatibility testing and additional information is provided within this submission for any patient contacting materials that contain colorants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
selected soft tissues
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 following performance tests were conducted on sterilized units. Items marked with an * were also performed post accelerated aging:
-
Dimensional Measurements
- Cord Length
- Tip Width, Length, Thickness
All devices tested met specification and were graded as Pass.
-
Expected Forces on the Device
- Bipolar Closing Force
- Button Force
- Slider Force
- Grasping Force
All devices tested met specification and were graded as Pass
-
Overall Design Testing
- Load Testing (Monopolar and Bipolar)
- Tensile*, Compressive, Vertical, Lateral
- Cable Tensile
- Device Symmetry
- Hand Switching
- Tip Orientation
- Grasping Force*
- Slider Force and Distance*
- Bipolar Gap*
- Slider Endurance
- Electrical Functionality*(device performs as intended)
All devices met specification and were graded as Pass
- Load Testing (Monopolar and Bipolar)
-
Biocompatibility Testing
- Cytotoxicity
- Intracutaneous Injection
- Irritation
- Pyrogenicity
All devices passed ISO 10993 acceptance criteria and were graded as Pass
-
Packaging Testing (ISTA 2A)
- Label/package visual inspection *
- Bubble Leak*
- Peel Strength*
- Electrical Functionality*(device performs as intended)
All devices met specification and were graded as Pass.
In addition ex-vivo bench top testing was performed comparing the proposed PK AIM device to the predicates. All ex-vivo results showed substantially equivalent results to the predicate devices in terms of cutting and coagulation performance.
- indicates test was also performed on 1 year accelerated aged units.
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
Image /page/0/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 image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Gyrus ACMI Incorporated Mr. Neil Kelly Senior Regulatory Affairs Specialist 136 Turnpike Road Southborough, Massachusetts 01772 December 17, 2015
Re: K152219
Trade/Device Name: PK AIM Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 16, 2015 Received: November 18, 2015
Dear Mr. Kelly:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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.
Sincerely yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known) TBD
152219
Device Name PK AIM
Indications for Use (Describe)
The PK AIM device is intended for monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery. This device is not intended to be used for tubal ligation or female sterilization.
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)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Traditional 510(k) Notification July 2015
510(k) Summary of Safety and Effectiveness
Gyrus ACMI, Inc.
Olympus PK AIM
General Information
Manufacturer:
Gyrus ACMI, Inc. 9600 Louisiana Ave North Brooklyn Park, MN 55445 Phone: 508-804-2690
Establishment Registration Number:
510(k) Submitter:
3011050570
Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification Name:
Regulation number Product code Regulatory class Review Panel
Trade Name:
Generic/Common Name:
3003790304
Neil Kelly Senior Regulatory Affairs Specialist 508-804-2690 Neil.kelly@olympus-osta.com
July 2015
Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400 GEI Class II General and Plastic Surgery
Olympus - PK AIM
Electrosurgical cutting and coagulation device
K152219 Page 1 of 5
4
Traditional 510(k) Notification July 2015
Predicate Devices
| K813071 | ValleyLab/Covidien Electrosurgical Pencil (monopolar pencil) |
|---|---|
| K093108 | Stryker Bipolar Forceps (bipolar forceps) |
| K063195 | ValleyLab LigaSure Advance (dual plugs) |
Comparison to Predicate Devices:
The Olympus - PK AIM has been compared to the above mentioned predicates with respect to intended use, design, and fundamental scientific technology. The comparisons and testing results presented in this 510(k) notification to the FDA show this device to be substantially equivalent to predicate devices and raises no new concerns or safety or effectiveness.
Product Description
This 2 in 1 device has a pencil type handle and combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy. The device has passed all applicable biocompatibility testing and additional information is provided within this submission for any patient contacting materials that contain colorants.
Technological Characteristics
The proposed PK AIM uses monopolar energy in order to cut and bipolar energy in order to coagulate soft tissue in general surgical procedures. For safety and convenience the ESG-400 generator recognizes the proposed PK AIM when it is connected and limits generator settings to those dedicated for use with the proposed PK AIM device, which are called out in the IFU.
The PK AIM can be activated using buttons located on the device handle, or via a foot pedals which are sold separately. The hand activation allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. A sliding toggle switch located on the handle allows the user to switch between using the device as a pencil or forceps.
5
Traditional 510(k) Notification July 2015
Indications for Use
The PK AIM device is intended for monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery. This device is not intended to be used for tubal ligation or female sterilization.
Compliance to Voluntary Standards
The design of the proposed device complies with the following standards:
ISO 10993-1, 2009 ISO 10993-5. 2009 ISO 10993-7 2008 ISO 10993-10, 2010 ANSI/AAMI/ISO 11607-1, 2006 ANSI/AAMI/ISO 11135-1, 2007 ISO 14971, 2007 ISO 15223-1; 2012 IEC 60601-1: 2005 IEC 60601-2-2: 2009
Summary of Sterilization and Shelf Life Discussion
The PK AIM is delivered in a sterile state and is intended for single patient use only. The sterilization method used is ethylene oxide and has a shelf life of 1 year.
Summary of Performance Testing
The following performance tests were conducted on sterilized units. Items marked with an * were also performed post accelerated aging:
- . Dimensional Measurements
- o Cord Length
- Tip Width, Length, Thickness o
All devices tested met specification and were graded as Pass.
- Expected Forces on the Device ●
- o Bipolar Closing Force
- o Button Force
- Slider Force o
- Grasping Force o
All devices tested met specification and were graded as Pass
- . Overall Design Testing
- O Load Testing (Monopolar and Bipolar)
- Tensile*, Compressive, Vertical, Lateral .
- O Load Testing (Monopolar and Bipolar)
6
Traditional 510(k) Notification July 2015
- o Cable Tensile
- Device Symmetry o
- o Hand Switching
- Tip Orientation o
- o Grasping Force*
- Slider Force and Distance* ্ত
- o Bipolar Gap*
- Slider Endurance o
- O Electrical Functionality*(device performs as intended)
All devices met specification and were graded as Pass
- Biocompatibility Testing .
- o Cytotoxicity
- Intracutaneous Injection o
- o Irritation
- Pyrogenicity o
All devices passed ISO 10993 acceptance criteria and were graded as Pass
- Packaging Testing (ISTA 2A) .
- · Label/package visual inspection *
- Bubble Leak* o
- Peel Strength* o
- Electrical Functionality*(device performs as intended) o
All devices met specification and were graded as Pass.
In addition ex-vivo bench top testing was performed comparing the proposed PK AIM device to the predicates. All ex-vivo results showed substantially equivalent results to the predicate devices in terms of cutting and coagulation performance.
- indicates test was also performed on 1 year accelerated aged units.
Substantial Equivalence
The proposed PK AIM has the same intended use, design, and scientific technology as the predicate devices combined into one device. The proposed device is both a pencil and a forceps device with a dual cord. Each of the predicate devices includes these very same features. In addition the proposed and predicate devices were shown to perform substantially equivalent in bench testing. There were no new issues of safety or effectiveness with the proposed device. Please see Table 1 - Substantial Equivalence Table on the following page.
7
Traditional 510(k) Notification July 2015
Table 1 – Substantial Equivalence Table
| Design Feature | Proposed
Olympus PK AIM | Predicate
ValleyLab/Covi
dien
Electrosurgical
Pencil
(K813071) | Predicate
Stryker SilverGlide
Bipolar Forceps
(K093108) | Predicate
ValleyLab
LigaSure Advance
(K063195)* | Comments |
|------------------------|-----------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------|-------------|
| Function of
Device | Forceps/Pencil | Pencil | Forceps | N/A | Same |
| Tip Size | Forceps
1mm tip, 2mm base
Pencil
2mm | 2mm | 2mm | N/A | Same |
| Energy | Monopolar/Bipolar | Monopolar | Bipolar | Monopolar/
Bipolar | Same |
| Activation | Hand / Footpedal | Hand | Foot Pedal | N/A | Same |
| Plug | Dual (mono/bi) | Single | Single | Dual (mono/bi) | Same |
| Electrode
Materials | Stainless Steel | Stainless
Steel | Steel with
Silver coating | N/A | Same |
| Sterility | 10-6
EtO | 10-6
Irradiation | 10-6
Gravity,
Autoclave | N/A | Same (10-6) |
| Single Use | Yes | Yes | No | N/A | Same |
Conclusion:
In summary, the Olympus – PK AIM is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.