(27 days)
No
The document describes a set of bipolar electrosurgical instruments and compatible generators. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The testing described is focused on electrical, mechanical, and functional performance, as well as generator compatibility and cutting equivalency.
No.
A therapeutic device is one that treats a disease or condition. This device is used for resection and coagulation of soft tissue and blood vessels during surgical procedures, which are actions performed during a surgery rather than a treatment for a disease.
No
Explanation: The device is an electrosurgical instrument indicated for resection, cutting, and coagulation of soft tissue and blood vessels, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a bipolar electrosurgical instrument with physical components (needle, spatula, J-hook, handle, buttons, plug) that perform the intended function of resecting, cutting, and coagulating tissue. It is a hardware device that connects to a generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a "bipolar electrosurgical instrument" that "pass through a 5mm cannula or operating laparoscope working channel" and is "activated via buttons on the handle or by a foot pedal." This further confirms its use as a surgical instrument.
- Anatomical Site: The anatomical site is "Soft tissue and blood vessels in laparoscopic and general surgical procedures," which are parts of the living body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on samples.
The device is a surgical instrument used in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, blood vessels
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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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)
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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 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 (IEC 60601-1:2005, MOD) | 19-4
07/09/2014 |
| 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 essential
performance of high frequency surgical equipment
and high frequency surgical accessories | 08/21/2017 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| ANSI AAMI ISO
14971 2019 | Medical devices – Application of risk management
to medical devices | 5-125
12/23/2019 |
| ISO 11135: 2014 | Sterilization of health care products - Ethylene
oxide - Requirements for development, validation
and routine control of a sterilization process for
medical devices | 14-529
07/15/2019 |
| ISO 15223-1:2016 | Medical devices - Symbols to be used with medical
device labels, labeling, and information to be
supplied – Part 1 General requirements | 5-117
08/21/2017 |
| ISO 11607-1 Second
Edition 2019-2 | Packaging for terminally sterilized medical devices
- Part 1: Requirements for materials, sterile barrier
systems and packaging systems | 14-530
07/15/2019 |
| ISO 10993-1:2018 | Biological Evaluation of Medical Devices, Part 1:
Evaluation and testing within a risk management
process | 2-258
01/14/2019 |
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices, Part 5:
Tests for In Vitro Cytotoxicity | 2-245
12/23/2016 |
| ISO 10993-10:2010 | Biological Evaluation of Medical Devices, Part 10:
Tests for Irritation and Skin Sensitization | 2-174
07/26/2016 |
| ISO 10993-7 Second
Edition 2008-10-15 | Biological evaluation of medical devices - Part 7:
Ethylene oxide sterilization residuals | 14-408
01/30/2014 |
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.