(135 days)
No
The document describes a standard electrosurgical instrument and generator system with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is described as an electrosurgical instrument for cutting and coagulating tissue during surgery, which are procedural functions rather than therapeutic ones aimed at treating a disease or condition.
No
The device description clearly states it is an electrosurgical instrument used for "resection and coagulation of soft tissue and blood vessels," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a bipolar electrosurgical instrument, which is a hardware device. It also mentions physical characteristics like passing through a cannula and being used with a generator and cable.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- PK Spatula Function: The description clearly states the PK Spatula is used for "resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures." This is a surgical instrument used directly on the patient's tissues during a procedure.
The device's function is entirely focused on surgical intervention within the body, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.
Product codes
GEI
Device Description
The PK Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The instrument is to be used only with the ESG-400 electrosurgical generator. The generator and device make up a medical electrical system. The instrument is to be used only with the Gyrus ESG-400 Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and blood vessels in laparoscopic and general surgical procedures
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
The following performance tests were conducted:
- Dimensional Measurements
- Cutting and Coagulation equivalency to predicate
- Expected forces on devices
- Design feature testing (rotation and button activation)
- Shelf Life
- Sterilization
- Biocompatibility
Key Metrics
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 31, 2014
Gyrus ACMI, Incorporated Mr. Neil Kelly MBA, RAC Senior Regulatory Affairs Specialist 6655 Wedgwood Road Maple Grove, Minnesota 55311
Re: K142289
Trade/Device Name: PK Spatula 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 5, 2014
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
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.
Sincerely yours,
David Krause -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) TBD K142289
Device Name PK Spatula
Indications for Use (Describe)
The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc.
Olympus PK Spatula
General Information
| Manufacturer: | Gyrus ACMI, Inc.
6655 Wedgwood Road
Maple Grove, MN 55311
Phone: 508-804-2600 |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 2183680 |
| 510(k) Submitter: | Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Neil Kelly
Regulatory Affairs Specialist
508-804-2690
Neil.kelly@olympus-osta.com |
| Date Prepared: | August 15, 2014 |
| Device Description | |
| Classification Name:
Regulation Number
Product Code
Regulatory Class
Review Panel | Electrosurgical cutting and coagulation
device and accessories
21 CFR 878.4400
GEI
Class II
General and Plastic Surgery |
| Trade Name: | PK Spatula |
| Generic/Common Name: | Spatula Electrode |
Predicate Devices
Gyrus PlasmaCision Laparoscopic Spatula K041633
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Comparison to Predicate Devices:
The PK Spatula has been compared to our own legally marketed Gyrus PlasmaCision Laparoscopic Spatula (K041633) with respect to intended use and technological characteristics. The comparison and testing results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and raises no new concerns or safety or effectiveness.
Product Description
The PK Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The instrument is to be used only with the ESG-400 electrosurgical generator. The generator and device make up a medical electrical system. The instrument is to be used only with the Gyrus ESG-400 Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment.
Technological Characteristics
The PK Spatula uses bipolar energy in order to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. The PK Spatula is activated using buttons located on the device handle. This allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. Historically foot pedals have been used for such devices and are also available for the proposed device. A nosecone located at the distal end of the handle and at the proximal end of the device shaft allows the physician to alter the orientation of the electrode tip without altering the orientation of the handle.
Material
The predicate and proposed devices share many common materials. The two patient contact material differences are the sheath, which is now flouropolymer rather than Polyimide tubing, and a new ink was added on the device shaft as well. Biocompatibility testing has been carried out with passing results. As for the electrode tip and insulation all materials remain the same as the predicate.
Intended Uses
The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.
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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 Olympus PK Spatula 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 three(3) years.
Summary of Performance Testing
The following performance tests were conducted:
- Dimensional Measurements ●
- Cutting and Coagulation equivalency to predicate
- Expected forces on devices ●
- Design feature testing (rotation and button activation)
- Shelf Life
- Sterilization ●
- Biocompatibility ●
Substantial Equivalence
The proposed PK Spatula has the same intended use, design, and scientific technology as the Predicate PlasmaCision Laparoscopic Spatula (K041633). Both devices are of the same design, intended for the same patient population, have the identical indications for use, and use the same scientific technology. In addition there were no new issues of safety or effectiveness found with the proposed device.
Conclusion:
In summary, the PK Spatula is substantially equivalent to the predicate device and presents no new questions of safety or efficacy.