(139 days)
The PK J-Hook 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.
The PK J-Hook 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 device has an active "J" shaped tip and is activated via buttons on the handle, or by a foot pedal. 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 Gyrus ESG-400 Generator.
This document describes a 510(k) premarket notification for the "PK J-Hook," an electrosurgical cutting and coagulation device. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission does not involve proving the device meets acceptance criteria in the same way an AI/ML medical device would be evaluated for its diagnostic or prognostic accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously approved device.
Therefore, many of the requested categories for acceptance criteria and study details for an AI/ML device are not applicable to this 510(k) submission. Below, I will address the applicable points and explain why others cannot be answered from the provided text.
1. A table of acceptance criteria and the reported device performance
For a 510(k) for an electrosurgical device, the "acceptance criteria" are typically related to meeting established performance standards for electrosurgical devices and demonstrating equivalence to a predicate device across various parameters. The reported performance is generally a confirmation that the device meets these standards and functions equivalently.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Measurements | Confirmed |
| Cutting & Coagulation | Equivalency to predicate demonstrated |
| Expected Forces on Devices | Confirmed |
| Design Feature Testing | Rotation and button activation confirmed |
| Shelf Life | Three (3) years |
| Sterilization | Ethylene oxide method confirmed effectiveness |
| Biocompatibility | Passing results confirmed for all patient contact materials |
| Compliance to Standards | Confirmed compliance with listed ISO and IEC standards |
| Intended Use | Matches predicate and supports stated indication |
2. Sample size used for the test set and the data provenance
The document mentions "performance tests" and "bench testing." These are likely laboratory tests on physical samples of the device. The exact sample size for these tests is not specified in the provided text. The data provenance is internal testing by Gyrus ACMI, Inc. specific to the device being submitted. It is prospective testing of their device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to a 510(k) for an electrosurgical device. "Ground truth" in this context would be established by objective physical measurements and adherence to engineering and medical device standards rather than expert clinical consensus on interpretations or outcomes. The performance tests would be evaluated against pre-defined engineering specifications and relevant ISO/IEC standards.
4. Adjudication method for the test set
Not applicable in the context of this 510(k) submission for an electrosurgical device. Performance is assessed against objective engineering and safety standards, not by an adjudication process as would be used for subjective interpretations or diagnostic outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be defined by engineering specifications, established medical device standards (e.g., ISO, IEC), and objective physical measurements. For example, for "cutting and coagulation equivalency," the ground truth would be the measurable performance of the predicate device under controlled laboratory conditions. For "biocompatibility," the ground truth is defined by the passing criteria of the ISO 10993 series of standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2015
Gyrus ACMI Incorporated Mr. Neil Kelly Senior Regulatory Affairs Specialist 136 Turnpike Road Southborough, Massachusetts 01772
Re: K142350
Trade/Device Name: PK J-Hook Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 2, 2014 Received: December 3, 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
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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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Indications for Use
510(k) Number (if known) K142350
Device Name
PK J-Hook
Indications for Use (Describe)
The PK J-Hook 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------- |
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510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc.
Olympus PK J-Hook
General Information
| Manufacturer: | Gyrus ACMI, Inc.6655 Wedgwood RoadMaple Grove, MN 55311Phone: 508-804-2739 |
|---|---|
| Establishment Registration Number: | 2183680 |
| 510(k) Submitter: | Gyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Neil KellySenior Regulatory Affairs Specialist508-804-2690Neil.kelly@olympus-osta.com |
| Date Prepared: | August 22, 2014 |
| Device Description | |
| Classification Name:Regulation numberProduct codeRegulatory classReview Panel | Electrosurgical cutting and coagulationdevice and accessories21 CFR 878.4400GEIClass IIGeneral and Plastic Surgery |
| Trade Name: | Olympus - PK J-Hook |
| Generic/Common Name: | Electrosurgical cutting and coagulationdevice |
| Predicate Devices |
Gyrus Plasmacision and Plasmablend Electrodes
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Comparison to Predicate Devices:
The Olympus - PK J-Hook has been compared to our own legally marketed Gyrus PlasmaCision and Plasmablend Electrodes (K050460) 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 J-Hook 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 device has an active "J" shaped tip and is activated via buttons on the handle, or by a foot pedal. 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 Gyrus ESG-400 Generator.
Technological Characteristics
The PK J-Hook uses bipolar energy in order to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. For safety and convenience the ESG-400 generator recognizes and automatically presets the default output settings once the proposed PK J-Hook is connected.
The PK J-Hook is activated using buttons located on the device handle, or via a foot pedal. This allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. 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 all materials remain the same as the predicate.
Intended Uses
The PK J-Hook 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 J-Hook 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 Olympus - PK J-Hook has the same intended use, design, and scientific technology as the Predicate Gyrus ACMI Plasmacision and Plasmablend electrodes (K050460). Both devices are of similar design and technology and have been shown to perform substantially equivalent in bench testing. There were no new issues of safety or effectiveness with the proposed device.
Conclusion:
In summary, the Olympus - PK J-Hook is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.
§ 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.