(11 days)
No
The description focuses on the electrosurgical functions and physical design of the device, with no mention of AI or ML capabilities.
No
The device is used for cutting and coagulation of tissue during electrosurgery, which are surgical procedures, not therapeutic treatments.
No
The device is described as being for "monopolar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels... during electrosurgery," which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is comprised of a mixture of plastics, metals, heatshrink, and epoxy, indicating it is a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical procedures involving cutting, coagulation, grasping, and vessel sealing of soft tissues. This is a direct interaction with the patient's body during surgery.
- Device Description: The description details a surgical instrument (pencil-type handle, forceps, buttons, switches) that connects to a generator for electrosurgery. 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 (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is therapeutic (cutting, coagulating, sealing).
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.
Product codes
GEI
Device Description
Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that 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 electrosurgical system. The instrument is to be used only with the Olympus ESG-400 Generator. As a result of the PK AIM cable modifications which are the subject of this submission, no modifications were required or made to the ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in the original PK AIM K152219 for any patient contacting materials that contain colorants. Except for the cable design modification that is being implemented to address a capacitive coupling concern, the subject Olympus PK AIM and predicate Olympus PK AIM are physically identical no other design or material changes.
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
Summary of bench, Performance Testing (no clinical testing was conducted)
All performance testing passed or met prescribed acceptance criteria
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them. The symbol is black, and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2016
Gyrus ACMI, Inc. Mr. Graham Baillie Regulatory Affairs Manager 136 Turnpike Road Southborough, Massachusetts 01772
Re: K163373
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 29, 2016 Received: December 1, 2016
Dear Mr. Baillie:
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 of medical devicerelated 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.
1
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" (21 CFR 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, Jennifer R. Stevenson -A For 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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Indications for Use
510(k) Number (if known) K163373
Device Name PK AIM
Indications for Use (Describe)
The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. 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) |
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510(k) Summary 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: 3011050570 510(k) Submitter Gyrus ACMI, Inc. 136 Turnpike Rd Southborough, MA 01772 Contact Person: Graham A. L. Baillie Manager, Regulatory Affairs 508-804-2738 Graham.baillie@olympus-osta.com Date Prepared: November 29, 2016 Device Description Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation number 21 CFR 878.4400 Product code GEI Regulatory Class Class II Trade Name: Olympus PK Aim Generic/Common Name: Electrosurgical cutting and coagulation device Predicate Device
Olympus PK AIM
Comparison to Predicate Device:
The Olympus PK AIM has been compared to the predicate Olympus PK AIM with respect to intended use, design and fundamental scientific technology. The comparisons and summary of testing results presented in this Special 510(k) Notification show this device to be substantially equivalent to the predicate PK AIM and raises no new concerns of safety or effectiveness.
Like the predicate PK AIM, the proposed PK AIM is intended for monopolar cutting and coagulation, grasping, bipolar coagulation of selected soft tissue, and like its predicate PK AIM the proposed device is also intended to seal vessels up to and including 3.0 mm in diameter during electrosurgery. Both predicate and proposed PK AIM devices are not intended to be used for tubal ligation or female sterilization.
4
Product Description
Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that 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 electrosurgical system. The instrument is to be used only with the Olympus ESG-400 Generator. As a result of the PK AIM cable modifications which are the subject of this submission, no modifications were required or made to the ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in the original PK AIM K152219 for any patient contacting materials that contain colorants. Except for the cable design modification that is being implemented to address a capacitive coupling concern, the subject Olympus PK AIM and predicate Olympus PK AIM are physically identical no other design or material changes.
Technological Characteristics
The proposed Olympus 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 Olympus PK AIM when it is connected and limits generator settings to those dedicated for use with the proposed Olympus PK AIM device. These settings are called out in the IFU.
The Olympus 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 monopolar pencil or bipolar forceps.
Material
No material or packaging changes were made to the predicate PK AIM cleared under K161825.
Indications for Use
The intended use of the modified/proposed PK AIM device, as described in its labeling, has not changed as a result of the cable modification.
The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.
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Compliance to Voluntary Standards
The design of the Olympus PK AIM 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
Like the predicate Olympus PK AIM, (K161825), the proposed Olympus PK AIM will be distributed in a sterile state and is intended for single patient use only. The sterilization method used continues to be ethylene oxide and will now be labeled with a shelf life of 3 years.
| Description | Specification/objective |
|---|---|
| Cable/Cord Length | Meet length specification |
| Electrical Functionality | Generator confirmation |
| Package Testing | ISTA-2A, ASTMD4169-09 |
| IEC 60601 | Meet relevant requirements |
| Label/Package damage | Visual inspection |
| Bubble Leak | ASTM-F2906-11 |
| Continuity | Meet specification |
| Hi-Pot | Meet specification |
| HF Leakage | Meet monopolar HF leakage |
| from bipolar electrodes | |
| Electrical Characterization | Meet internal comparable |
| power outputs |
Summary of bench, Performance Testing (no clinical testing was conducted)
All performance testing passed or met prescribed acceptance criteria
Substantial Equivalence
The proposed Olympus PK AIM has the same intended use, scientific technology and similar design as its predicate Olympus PK AIM device. The predicate PK AIM and proposed PK AIM device are both a pencil and a forceps device with a dual cord. 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 the following substantial equivalence comparison table.
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| Design
Feature | Proposed
Olympus PK AIM | Predicate
Olympus PK AIM
K161825 | Comments |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Function of
Device | Forceps/Pencil | Forceps/Pencil | Same as predicate
PK AIM |
| Tip Size | Forceps
1mm tip, 2mm base
Pencil
2mm | Forceps
1mm tip, 2mm base
Pencil
2mm | Same |
| Energy | Monopolar/Bipolar | Monopolar/Bipolar | Same |
| Activation | Hand / Footpedal | Hand / Footpedal | Same |
| Plug | Dual (mono/bi) | Dual (mono/bi) | Same |
| Electrode
Materials | Stainless Steel | Stainless Steel | Same |
| Sterility | 10-6
EtO | 10-6
EtO | Same |
| Single Use | Yes | Yes | Same |
| Intended Use | The PK AIM is
intended for mono polar
cutting & coagulation,
grasping, bipolar
coagulation of selected
soft tissues and sealing
vessels up to and
including 3.0 mm in
diameter during electro
surgery. This device is
not intended to be used
for tubal ligation or
female sterilization. | The PK AIM is
intended for mono polar
cutting & coagulation,
grasping, bipolar
coagulation of selected
soft tissues and sealing
vessels up to and
including 3.0 mm in
diameter during electro
surgery. This device is
not intended to be used
for tubal ligation or
female sterilization. | Predicate and
proposed PK AIM
devices have
identical intended
uses. |
Equivalence Comparison Table:
Conclusion:
In summary, the Olympus PK AIM is substantially equivalent to its predicate device and presents no new questions of safety or efficacy.