(100 days)
The Gyrus ACMI PK® Superpulse® System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The proposed PK ® SuperPulse® System Generator and its software will be modified to allow the use of the Olympus TURis resectoscope and associated instruments. This functionality would be in addition to the existing released support for the Gyrus ACMI resectoscopes and compatible electrodes.
Modifications include:
- Modification to the Superpulse® software to add an additional instrument .
band to allow the connection of a TURis specific connector cable.Addition
of a saline monitoring facility to ensure that energisation is only applied to
the TURis connector cable when a saline environment is
sensed.Modification to User Manual to cover the above changes
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Gyrus ACMI PK® SuperPulse® System, based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria and then presenting performance data against those criteria. The primary "acceptance criteria" presented are the technological characteristics of the modified device being sufficiently similar to the predicate and not raising new questions of safety or efficacy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics: | |
| - Addition of an instrument band for TURis specific connector cable. | - A new ID band has been assigned for a new instrument connection cable that will support the range of Olympus TURis instruments. |
| - Saline monitoring facility to ensure energization only with saline. | - A new saline detection feature will be incorporated in the SuperPulse® software. This feature's purpose is to prevent activation in non-approved irrigants other than saline (e.g., glycine) and will result in a warning message if impedance is sensed above a fixed threshold. The performance is expected to be similar to the existing Olympus UES-40 generator. |
| Safety and Efficacy: | |
| - No new questions of safety or efficacy. | - The technical risk for the software release is low because it replicates a feature already available on the Olympus UES-40 generator, with readily available implementation information. - The power level for saline detection is similar to the clinically accepted low level of the UES-40. - The proposed Gyrus ACMI PK® SuperPulse® System will have the same indications for use as the existing/predicate device, with the only difference being support for the additional Olympus TURis cable and electrodes. - The FDA's 510(k) clearance states that the device is "substantially equivalent... and presents no new questions of safety or efficacy." |
| Intended Use: | |
| - Unchanged from previously marketed PK® Superpulse® System, but now supporting Olympus TURis electrodes. | - "The target applications and intended use for the PK® Superpulse® System Generator with the new software are unchanged from the previously marketed PK® Superpulse® System." - The intended use will differ only in that it will be intended to support the additional Olympus TURis cable and electrodes. The FDA's clearance confirms the device is substantially equivalent for the indications for use stated. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission is a 510(k) for a modified electrosurgical generator, focusing on substantial equivalence based on technological characteristics and previously accepted clinical performance of the predicate and similar technologies (Olympus UES-40). It does not describe a clinical study with a "test set" in the traditional sense of evaluating a diagnostic or predictive algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. As noted above, there's no described "test set" or explicit ground truth establishment process involving experts for a study. The basis for safety and effectiveness relies on comparison to existing legally marketed devices.
4. Adjudication Method for the Test Set
This information is not provided. There is no "test set" or adjudication method described for a study in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not described or referenced in this 510(k) submission. This type of study is typically associated with evaluating reader performance (human or AI-assisted) in diagnostic imaging, which is not the nature of this electrosurgical device modification.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. The "algorithm" here refers to the software controlling the electrosurgical generator, specifically the saline detection feature. Its performance is evaluated in terms of its functional similarity to a predicate device (Olympus UES-40) and its ability to prevent activation in non-saline environments, rather than as a standalone diagnostic or predictive algorithm. The document emphasizes it's a "low technical risk" replication of an existing, clinically accepted feature.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for the modifications (specifically the saline detection feature) is the established clinical acceptance and performance of the Olympus UES-40 generator's saline detection feature. The submission states: "The performance of the saline detection feature should be such that it operates in a similar manner to that of the existing Olympus UES-40 generator used for TURis accessories. The power level used to sense the impedance is to be kept similar to the same low level as the UES-40 as this has been clinically accepted in the marketplace."
8. The Sample Size for the Training Set
This information is not provided. This 510(k) is not about a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the software modifications comes from existing knowledge of the Olympus UES-40 system.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there is no traditional "training set" for an AI/ML algorithm. The "ground truth" equivalent for the development of the saline detection feature is the design and operational specifications of the equivalent feature in the Olympus UES-40 generator, which has been "clinically accepted in the marketplace." This implies that the UES-40's performance in distinguishing saline from non-saline environments was the established benchmark.
{0}------------------------------------------------
PK® SuperPulse® Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
JUL - I 2010
Traditional 510(k) Notification Executive Summary March 19, 2010
510(k) Summary of Safety and Effectiveness
Gyrus ACMI, Inc. Gyrus ACMI PK® SuperPulse® System
9617070
Gyrus ACMI, Inc. 136 Turnpike Rd.
Graham A. L. Baillie
March 19, 2010
Senior Regulatory Specialist
3003790304
General Information
Manufacturer:
Gyrus Medical Ltd Fortran Road. St Mellons Cardiff, CF3 0LT, UK
Southborough, MA 01772-2104
Establishment Registration Number:
510(k) Submitter:
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification:
Endoscopic Electrosurgical Unit and Accessories Class 2, 21 CFR 876.4300 Gastroenterology-Urology Panel, and
Electrosurgical Cutting and Coagulation Device and Accessories Class 2, 21 CFR 878.4400 General and Plastic Surgery Panel
Product Code(s):
Project Name:
Trade Name(s):
Generic/Common Name:
GEI and KNS
PK® SuperPulse® System Generator® with TURis Electrodes
Gyrus ACMI PK® Superpulse® System (Generator, accessories)
Electrosurgical Generator and Accessories
9
{1}------------------------------------------------
PK® SuperPulse® Gyrus ACMI. Inc. 136 Turnpike Road Southborough, MA 01772 Traditional 510(k) Notification Executive Summary March 19, 2010
Predicate Devices
| Gyrus PlasmaKinetic™ SuperPulse® System | K031085 |
|---|---|
| Olympus XUES-41 Electrosurgical Unit and accessories | K030194 |
| Gyrus ACMI PK® SuperPulse® System | K082054 |
Intended Use
The Gyrus ACMI PK® Superpulse® System Generator is intended for use with Gyrus ACMI PK® Bipolar Instruments, Olympus TURis Bipolar Electrodes, PK® Endourology Electrodes with PK @ resectoscope or urological endoscope with 5 Fr or larger working channels and PK® Electrodes used in open, laparoscopic, and endourology procedures for cutting, coagulation, removal or ablation of soft tissue and where associated hemostasis is required in urological electrosurgical procedures.
Product Description
The proposed PK ® SuperPulse® System Generator and its software will be modified to allow the use of the Olympus TURis resectoscope and associated instruments. This functionality would be in addition to the existing released support for the Gyrus ACMI resectoscopes and compatible electrodes.
Modifications include:
- Modification to the Superpulse® software to add an additional instrument .
band to allow the connection of a TURis specific connector cable.Addition
of a saline monitoring facility to ensure that energisation is only applied to
the TURis connector cable when a saline environment is
sensed.Modification to User Manual to cover the above changes
The target applications and intended use for the PK® Superpulse® System Generator with the new software are unchanged from the previously marketed PK® Superpulse® System.
Technological Characteristics and Substantial Equivalence
A new ID band has been assigned for a new instrument connection cable that will support the range of Olympus TURis instruments (The name TURis is derived from transurethral resection in saline).
Default settings and adjustments will be available to all Olympus TURis instruments connected to this TURis cable. The default settings and range of adjustment for these instruments have been provided by OWI (Olympus Winter und Ibe) located in Hamburg, Germany.
A new saline detection feature will be incorporated in the SuperPulse® software to ensure that saline is present before activation will be allowed to occur with Olympus TURis electrodes.
{2}------------------------------------------------
PK® SuperPulse® Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772 Traditional 510(k) Notification Executive Summary March 19, 2010
Continued...Technological Characteristics and Substantial Equivalence
The technical risk for the software release is low. This is because the project is replicating a feature already available on the Olympus UES-40 generator; information about the implementation of this feature is readily available. The performance of the saline detection feature should be such that it operates in a similar manner to that of the existing Olympus UES-40 generator used for TURis accessories. The power level used to sense the impedance is to be kept similar to the same low level as the UES-40 as this has been clinically accepted in the marketplace.
The purpose of the saline detection feature is to prevent activation in non-approved irrigants other than saline (e.g. glycine) that are typically used in monopolar based urology procedures. The saline detection facility will result in a warning message if the impedance of the tissue / saline is sensed above a fixed threshold. The new feature will be specific to the Olympus TURis band and existing alternative non-TURis product performance will be unchanged.
The proposed Gyrus ACMI PK® SuperPulse® System will have the same indications for use as the existing/predicate and its intended use will differ only in that it will be intended to support the additional Olympus TURis cable and electrodes. In summary, the PK® SuperPulse® System Generator is substantially equivalent to the predicate device and presents no new questions of safety or efficacy.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
1JUL - 1 2010
Gyrus Acmi, Inc. % Mr. Graham A.L. Baillie 136 Turnpike Road Southborough, Massachusetts 01772
Re: K100816
Trade/Device Name: Gyrus ACMI PK® SuperPulse® System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, KNS Dated: June 24, 2010 Received: June 25, 2010
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 (reporting of medical 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.
{4}------------------------------------------------
Page 2 - Mr. Graham Baillie
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark McMullen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
PK® SuperPulse® Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510{k} Notification Intended Use Statement March 19, 2010
Indications for Use
510(k) Number:
Device Name: Gyrus ACMI PK® SuperPulse® System
Indications for Use:
The Gyrus ACMI PK® Superpulse® System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Prescription Use: ___ X __ (Per 21 CFR 801.109)
OR Over-the-Counter Use:
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100816
§ 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.