(27 days)
- The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures.
- The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
- The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
The Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook are bipolar electrosurgical instruments with the capability to resect, cut, and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. They pass through a 5mm cannula or operating laparoscope working channel of 5mm or larger diameter. The devices are activated via buttons on the handle or by a foot pedal and plug into compatible Olympus generators (ESG-400 and ESG-410). The generator and device make up a medical electrical system.
This FDA 510(k) summary (K213831) describes the Olympus PK Electrosurgical Instruments (PK Needle, PK Spatula, PK J-Hook). The submission is a modification to the device labeling to add compatibility with an Olympus generator, ESG-410 cleared under K203277. The document states that the devices themselves are unchanged from their original clearances in terms of intended use, design, performance, and technological characteristics.
Therefore, the study information requested is based on the original clearances of these devices (K142154 for PK Needle, K142289 for PK Spatula, and K142350 for PK J-Hook) and the specific testing performed for the current submission to confirm compatibility with the new generator.
Here's the breakdown of the acceptance criteria and study information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria with reported numerical device performance as typically expected for software or diagnostic device studies. Instead, it refers to compliance with recognized consensus safety standards and successful completion of non-clinical testing.
| Acceptance Criteria Category | Specific Standard/Test Ref. | Reported Device Performance |
|---|---|---|
| Safety and Essential Performance | AAMI/ANSI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | The design of the subject device complies with this standard. |
| High Frequency Surgical Equipment Safety | IEC 60601-2-2 Ed. 6.0:2017-03 (Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) | The design of the subject device complies with this standard. |
| Risk Management | ANSI AAMI ISO 14971 2019 (Medical devices – Application of risk management to medical devices) | A risk analysis was completed to identify any new risks associated with the update. The design of the subject device complies with this standard. |
| Sterilization (Ethylene Oxide) | ISO 11135: 2014 (Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices) | The product and packaging materials as well as the sterilization mode has not changed since the original clearance, therefore no additional testing was needed. The design complies with this standard. |
| Labeling Symbols | ISO 15223-1:2016 (Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1 General requirements) | The design of the subject device complies with this standard. |
| Sterile Barrier Packaging | ISO 11607-1 Second Edition 2019-2 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems) | The design of the subject device complies with this standard. |
| Biocompatibility (General) | ISO 10993-1:2018 (Biological Evaluation of Medical Devices, Part 1: Evaluation and testing within a risk management process) | Full biocompatibility information was provided in original clearance. The design complies with this standard. |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 (Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity) | Full biocompatibility information was provided in original clearance. The design complies with this standard. |
| Biocompatibility (Irritation/Sensitization) | ISO 10993-10:2010 (Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization) | Full biocompatibility information was provided in original clearance. The design complies with this standard. |
| Biocompatibility (Ethylene Oxide Residuals) | ISO 10993-7 Second Edition 2008-10-15 (Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals) | Full biocompatibility information was provided in original clearance. The design complies with this standard. |
| Non-clinical Performance | Electrical, mechanical, functional, and cutting equivalency to predicate in original clearances. | Testing was conducted and the performance criteria were met when used with the additional compatible generator. |
| Generator Compatibility | Specific tests for compatibility with the Olympus ESG-410 generator. | Testing was conducted and the performance criteria were met when used with the additional compatible generator. The generator recognizes and automatically presets the default output settings. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to electrosurgical instruments and their compatibility with a new generator. The testing described is primarily non-clinical (electrical, mechanical, functional). Therefore, the concept of a "test set sample size" as applied to patient data or images (common in AI/ML devices) is not directly applicable here. The document mentions "testing was conducted" on the subject device. Details on the specific number of devices tested for each non-clinical performance category are not provided within this summary.
Data provenance: Not applicable as this submission primarily concerns non-clinical hardware compatibility performance rather than patient data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth, in the context of expert review for medical imaging or diagnostic devices, is not relevant for this type of electrosurgical instrument compatibility submission. The "ground truth" for electrosurgical instruments is their ability to perform cutting and coagulation safely and effectively, and this is assessed through engineering testing against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for expert consensus on clinical findings in diagnostic studies. This is a non-clinical performance and compatibility submission.
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 or a diagnostic device. It is an electrosurgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The performance of the device is described as "algorithm only" in the sense that its electrosurgical function is inherent to its design and energy delivery, rather than requiring human interpretation of an output. However, it is an instrument used by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the typical sense. The "ground truth" for this device's performance is established by engineering specifications, recognized international safety and performance standards (e.g., IEC 60601 series, ISO 14971), and the original performance characteristics of the predicate devices. Performance is measured against these technical benchmarks.
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device that requires a training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 4, 2022
Dolan Mills Program Manager, Regulatory Affairs Gyrus ACMI, Inc. 9600 Louisiana Ave. North Brooklyn Park, MN 55445 USA
Re: K213831
Trade/Device Name: Olympus PK Electrosurgical Instruments: PK Needle, 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 7, 2021 Received: December 8, 2021
Dear Dolan Mills:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrb/ofdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
{1}------------------------------------------------
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K213831
Device Name Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, PK J-Hook
Indications for Use (Describe)
-
The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures.
-
The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
-
The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K213831 510(k) Summary Gyrus ACMI, Inc. Olympus PK Electrosurgical Instruments
Date Prepared:
Dec 22, 2021
General Information
Manufacturer:
Gyrus ACMI, Inc. 9600 Louisiana Blvd. North Brooklyn Park, MN 55455 USA
Establishment Registration Number:
Contact Person:
3011050570
Dolan Mills Program Manager, Regulatory Affairs 901-355-0007 Dolan.mills@olympus.com
Device Description
| Proprietary names: | Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, PK J-Hook |
|---|---|
| Device Classification Name: | Electrosurgical Cutting and Coagulation device and Accessories |
| Regulations number: | 21 CFR 878.4400 |
| Regulation Medical Specialty: | General and Plastic Surgery |
| Regulatory Class: | Class II |
| Product Code: | GEI |
| Generic/Common Name: | Electrosurgical Cutting and Coagulation device and Accessories |
Predicate Devices
The Olympus PK Electrosurgical Instruments: PK Needle (model # PK-NE0533), PK Spatula (model # PK-SP0533), and PK J-Hook (model # PK-JH0533), were cleared under K142154 (PK Needle), K142289 (PK Spatula), and K142350 (PK J-Hook). This submission is a modification to the device labeling to add compatibility with an Olympus generator, ESG-410 cleared under K203277.
{4}------------------------------------------------
The predicate device has not been subject to any recalls.
Product Description
PK-NE0533: The PK Needle is a bipolar electrosurgical instrument with the capability to resect soft tissue and blood vessels in laparoscopic and general surgical procedures. 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 blunt needle shaped tip and is activated via a button on the handle, or by a foot pedal. The device plugs into the Olympus ESG-400 generator (K141225), and the Olympus ESG-410 generator (K203277). The generator and device make up a medical electrical system. The instrument is to be used only with the compatible Generators.
PK-SP0533: 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 used with a 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment. The device plugs into the Olympus ESG-400 generator (K141225), and the Olympus ESG-410 generator (K203277). The generator and device make up a medical electrical system. The instrument is to be used only with the compatible Generators.
PK-JH0533: 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 device plugs into the Olympus ESG-400 generator (K141225), and the Olympus ESG-410 generator (K203277). The generator and device make up a medical electrical system. The instrument is to be used only with the compatible Generators.
The device is compliant with FDA recognized consensus safety standards as listed below.
Technological Characteristics
The Olympus PK Electrosurgical Instruments are unchanged from the original clearance in terms of intended use, design, performance, and technological characteristics. The only difference is in the labeling that identifies an additional compatible Olympus generator.
For safety and convenience the compatible generator recognizes and automatically presets the default output settings once the instrument is connected.
{5}------------------------------------------------
The PK Needle is activated using a button located on the device handle, or via a foot pedal. The device is a bipolar electrosurgical instrument with the capability to resect soft tissue and blood vessels in laparoscopic and general surgical procedures. The active tip is exposed in a blunt "needle" like electrode tip which is the active portion of the device allowing for cutting.
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.
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 materials have not changed for these devices since their original clearance, in which full biocompatibility information was provided.
Indications for Use
-
- The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures.
-
- The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
-
- The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
| The design of the subject device complies with the following standards: | ||
|---|---|---|
| Standards Number | Standard Title | FDA Recognition no+ date |
| AAMI/ANSI ES60601-1:2005/(R)2012and C1:2009/(R)2012and, A2:2010/(R)2012 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD) | 19-407/09/2014 |
| IEC 60601-2-2 Ed. | Medical electrical equipment - Part 2-2: Particular | 6-389 |
Compliance to Voluntary Standards
{6}------------------------------------------------
| 6.0:2017-03 | requirements for the basic safety and essentialperformance of high frequency surgical equipmentand high frequency surgical accessories | 08/21/2017 |
|---|---|---|
| ANSI AAMI ISO14971 2019 | Medical devices – Application of risk managementto medical devices | 5-12512/23/2019 |
| ISO 11135: 2014 | Sterilization of health care products - Ethyleneoxide - Requirements for development, validationand routine control of a sterilization process formedical devices | 14-52907/15/2019 |
| ISO 15223-1:2016 | Medical devices - Symbols to be used with medicaldevice labels, labeling, and information to besupplied – Part 1 General requirements | 5-11708/21/2017 |
| ISO 11607-1 SecondEdition 2019-2 | Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barriersystems and packaging systems | 14-53007/15/2019 |
| ISO 10993-1:2018 | Biological Evaluation of Medical Devices, Part 1:Evaluation and testing within a risk managementprocess | 2-25801/14/2019 |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices, Part 5:Tests for In Vitro Cytotoxicity | 2-24512/23/2016 |
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices, Part 10:Tests for Irritation and Skin Sensitization | 2-17407/26/2016 |
| ISO 10993-7 SecondEdition 2008-10-15 | Biological evaluation of medical devices - Part 7:Ethylene oxide sterilization residuals | 14-40801/30/2014 |
Summary of Sterilization and Shelf Life Discussion
The product and packaging materials as well as the sterilization mode has not changed since the original clearance, therefore no additional testing was needed.
Summary of Performance Testing
Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and to ensure that the performance criteria was met when used with the additional compatible generator. A risk analysis was completed to identify any new risks associated with the update. The following tests associated with the device modification were performed on the subject device according to the methods and acceptance criteria established in the original clearances noted above:
- . Non-clinical (electrical, mechanical, functional, generator compatibility, cutting equivalency to predicate)
Comparison to Predicate Discussion
The Olympus PK Electrosurgical Instruments have identical indications for use as the previously cleared devices. There have been no changes in the devices as compared to the previously cleared devices in K142154, K142289, and K142350. The
{7}------------------------------------------------
only difference is the compatibility with an additional cleared Olympus generator, ESG-410. The labeling has been updated to reflect this additional compatible generator.
Conclusion:
In summary, the Olympus PK Electrosurgical Instruments are equivalent to the predicate devices and present no new questions of safety or effectiveness.
§ 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.