(42 days)
Not Found
No
The device description and performance studies focus on the electrical and structural integrity of a simple cable, with no mention of AI/ML terms or functionalities.
No.
The device is a cable that delivers electrical current to electrosurgical devices or accessories; it does not directly provide a therapeutic effect itself.
No
The device is a Reusable Monopolar Active Cord, which is used to deliver electrical current from an electrosurgical unit to electrosurgical devices or accessories. Its function is to provide energy for surgical procedures, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical cord with connectors and an insulated cable, which are hardware components. The performance studies also focus on physical and electrical testing of this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering electrical current during endoscopic procedures. This is a therapeutic/surgical function, not a diagnostic one performed on in vitro samples.
- Device Description: The description reinforces its role in connecting an electrosurgical unit to an endoscopic accessory for delivering energy. This is consistent with a surgical tool, not an IVD.
- Lack of IVD Characteristics: The description does not mention anything about analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
The Reusable Monopolar Active Cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Reusable Monopolar Active Cord is used during endoscopic procedures to provide monopolar energy from an Electrosurgical Generator Unit (ESU) to an Active Endoscopic accessory.
The Reusable Monopolar Active Cord consists of a male ESU end and a female device end connected via an insulated cable. The male ESU end uses a bovie style connector to connect to an ESU. The female device side connects to the active connector of an Active Endoscopic accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing included:
- Structural Integrity Testing: All Reusable Monopolar Active Cord structural components must, minimally, meet or exceed the structural integrity limits by the predicate active cord. Result: PASS
- Dimensional: All Reusable Monopolar Active Cord dimensional components must meet the dimensional specification for each active cord. Result: PASS
- Functional Testing: The Reusable Monopolar Active Cord must function as intended. Result: PASS
- Simulation Testing: The Reusable Monopolar Active Cord must provide monopolar energy to hot devices. Result: PASS
- Electrical Testing: All Reusable Monopolar Active Cord electrical requirements must meet current industry standards according to IEC 60601-2-2:2017 and IEC 60601-1:2005. Result: PASS
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.
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name written out in a smaller font next to it.
October 25, 2019
United States Endoscopy Group Inc. Mr. Gregory Land Sr. Regulatory Affairs Specialist 5976 Heisley Road Mentor, Ohio 44060
Re: K192518
Trade/Device Name: Reusable Monopolar Active Cord Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 12, 2019 Received: September 13, 2019
Dear Mr. Land:
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. 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/cdrh/cfdocs/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
542 of the Act); 21 CFR 1000-1050.
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-
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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) K192518
Device Name Reusable Monopolar Active Cord
Indications for Use (Describe)
The Reusable Monopolar Active Cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic 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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3
Image /page/3/Picture/0 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in a light blue color, resembling water waves.
510(k) Summary For Reusable Monopolar Active Cord K192518
United States Endoscopy Group Inc A Division of STERIS Corporation 5976 Heisley Road Mentor, OH 44060
Contact: Mr Gregory Land Senior Regulatory Affairs Specialist Tel: 440-392-7424 Fax: 440-357-9198 Email: greg_land@steris.com
Summary Date: September 12, 2019
US Endoscopy ■ 5976 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
STERIS Traditional 510(k) PREMARKET NOTIFICATION Reusable Monopolar Active Cord - K192518
1. Device Name
| Trade Name: | Reusable Monopolar Active Cord |
|---|---|
| Device Classification: | Class II |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and |
| Accessories | |
| Classification Number: | 21 CFR 878.4400 |
| Product Code: | GEI |
2. Predicate Device
K982748 New Deantronics, Inc. Model SB 223 and SB 224 BiPolar Cord Sets
3. Description of Device
The Reusable Monopolar Active Cord is used during endoscopic procedures to provide monopolar energy from an Electrosurgical Generator Unit (ESU) to an Active Endoscopic accessory.
The Reusable Monopolar Active Cord consists of a male ESU end and a female device end connected via an insulated cable. The male ESU end uses a bovie style connector to connect to an ESU. The female device side connects to the active connector of an Active Endoscopic accessory.
4. Indications for Use
The Reusable Monopolar Active Cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic procedures.
Description of Technological Similarities and Differences ട്.
The Reusable Monopolar Active Cord is very similar to Model SB 223 BiPolar Cord Set in Indications for Use and mode of operation. The differences between the Reusable Monopolar Active Cord and the Predicate are the type of energy provided to the device, connection to the Active Endoscopic accessories, and the use life. The predicate device and the proposed device differ in the application of energy. The predicate device is used for Bipolar applications whereas the proposed device is used for Monopolar applications. Monopolar and Bipolar
5
applications differ in the path the energy takes. In Bipolar applications the active device transmits the energy to an electrosurgical device and completes the electric circuit. In Monopolar applications the active device transmits the energy to an electrosurgical device and a separate return device completes the electric circuit. The differences between Monopolar and Bipolar applications are inconsequential to an Active Cord device because both devices transmit energy from an electrosurgical generator to an electrosurgical device. The connections to Active Endoscopic accessory are different geometries between the proposed and predicate device. Both connections have a conductive insert with an internal diameter capable of connecting to Active Endoscopic accessories, but the proposed device has a step feature to provide an audible click and tactile feedback when connected to an Active Endoscopic accessory. Another difference between the proposed and predicate devices is the use life of the devices. The predicate device is single use and the proposed device is reusable. Although the predicate is single use, the devices are not patient contacting and cleaning instructions are provided to the user in the Instructions for Use. These proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.
6. Description of Safety and Substantial Equivalence
Table 5-1 summarizes the difference between the proposed device and the predicate.
| Feature | Proposed
Reusable Monopolar
Active Cord | Predicate K982748
New Deantronics, Inc.
Model SB 223 and SB
224 BiPolar Cord Sets | Comparison |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The active cord is
intended to deliver
monopolar electrical
current from the
electrosurgical unit to
accessories requiring
monopolar electrical
current during endoscopic
procedures | Electrosurgical accessory.
The BiPolar Cord Set for
use with foot switching
electrosurgical accessories
to conduct high-frequency
electrical current intended
to remove tissue and
control bleeding. | Both devices provide
a conduit for
electrical energy from
an electrosurgical unit
(ESU) to an accessory
requiring electrical
current to function.
However, the
proposed indications
are specific for the
proposed device and
do not mention
indications of the
devices it may be
connected to. |
| Length | 10 feet | 10 feet | Identical |
| Feature | Proposed
Reusable Monopolar
Active Cord | Predicate K982748
New Deantronics, Inc.
Model SB 223 and SB
224 BiPolar Cord Sets | Comparison |
| Monopolar/Bipolar | Monopolar | Bipolar | Predicate device is
Bipolar whereas the
proposed device is
monopolar |
| ESU connection | 8mm Bovie Style Pin | 8mm Bovie Style Pin | Identical |
| Active
Endoscopic
accessory
connection | Hollow connector with
0.115inch ID and a
0.110inch ID step feature | Hollow connector with a
0.113inch ID | The proposed device
has a feature in the
Active Endoscopic
accessory end to
provide the user with
audible/tactile
feedback when the
cord is connected |
| Provides
Audible/Tactile
feedback when
connected to
Active
Endoscopic
Accessory | Yes | No | The proposed device
has a feature in the
Active Endoscopic
accessory end to
provide the user with
audible/tactile
feedback when the
cord is connected |
| Reusable | Yes | No | The proposed device
is reusable and the
predicate device is
not. |
| Sterility | Non-sterile | Sterile and non-sterile
configurations | The proposed device
is supplied non-sterile
and the predicate
device is supplied in
both sterile and non-
sterile configurations. |
Table 5-1. Predicate Device Comparison Table
6
STERIS Traditional 510(k) PREMARKET NOTIFICATION Reusable Monopolar Active Cord - K192518
7. Performance Testing
Table 5-2 summarizes the verification activity that was performed with its respective acceptance criteria to verify the safety or effectiveness of the Reusable Monopolar Active Cord.
7
| Testing | Acceptance Criteria | Proposed Reusable
Monopolar Active
Cord |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Structural
Integrity Testing | All Reusable Monopolar Active Cord
structural components must, minimally, meet
or exceed the structural integrity limits by the
predicate active cord | PASS |
| Dimensional | All Reusable Monopolar Active Cord
dimensional components must meet the
dimensional specification for each active cord | PASS |
| Functional
Testing | The Reusable Monopolar Active Cord must
function as intended. | PASS |
| Simulation
Testing | The Reusable Monopolar Active Cord must
provide monopolar energy to hot devices. | PASS |
| Electrical
Testing | All Reusable Monopolar Active Cord electrical
requirements must meet current industry
standards according to IEC 60601-2-2:2017
and IEC 60601-1:2005 | PASS |
Table 5-2. Summary of Verification Activities.
8. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K982748), Class II (21 CFR 878.4400), product code GEI.