(48 days)
No
The description focuses on the electrosurgical mechanism and mechanical aspects of the device, with no mention of AI or ML.
Yes
The device is intended for cutting of soft tissue obstructions and providing electrosurgical hemostasis in the upper airways and tracheobronchial tree, which are therapeutic interventions.
No
The device is described as an electrosurgical instrument for cutting, ablation, and hemostasis of soft tissue obstructions, and for evacuation of surgical smoke. These are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components like an electrode, shaft, and cabling, and mentions bench testing for physical attributes like sterilization, mechanical testing, and electrical safety. It is a hardware device.
Based on the provided information, the CoreCath 2.7S is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "cutting of soft tissue obstructions in upper airways and tracheobronchial tree, providing electrosurgical hemostasis, and evacuation of surgical smoke during such procedures." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The description details a "monopolar RF (radiofrequency) surgical device" used for "ablation and hemostasis of soft tissue obstructions." This further reinforces its use in a surgical context.
- Anatomical Site: The specified anatomical site is "upper airways and tracheobronchial tree," which are parts of the living body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) outside of the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CoreCath 2.7S is a surgical tool used for direct intervention on the patient.
N/A
Intended Use / Indications for Use
The CoreCath 2.7S is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, providing electrosurgical hemostasis, and evacuation of surgical smoke during such procedures.
Product codes
GEI
Device Description
The CoreCath 2.7S is a disposable, single-use monopolar RF (radiofrequency) surgical device intended to be use for ablation and hemostasis of soft tissue obstructions in upper airways and tracheobronchialtree. The CoreCath 2.7S is terminally sterilized via ETO. It is comprised of a cylindrically shaped, disposable monopolar cutting and coagulation electrode affixed to the distal end of a polymeric. flexible multi lumen shaft and cabling, intended for connection to the monopolar output port of the Medtronic Advanced Energy AEX Generator (K143175). The CoreCath 2.7S is intended to be energized for use by the footswitch accessory supplied with the AEX Generator. It has an active length of approximately 750 mm and a maximum diameter crossing profile of 2.68 mm. It is sized such that may be delivered through the working channel of a flexible bronchoscope 2.8 mm diameter working channel and working length of 600 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airways and tracheobronchial tree
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
The design and performance of the modified CoreCath 2.7S were verified and validated through bench testing.
Bench testing included the following:
- Sterilization
- Transit
- Shelf Life
- Biocompatibility
- Electrical Safety
- EMC
- Endoscope Compatibility
- Mechanical Testing
- Activation Testing
- Suction Testing
Comparative performance testing was conducted in an in-vivo animal model. Ex-vivo tissue testing was also completed. Thermal effect of the CoreCath 2.7S in both the in-vivo and ex-vivo model was substantially equivalent to that of the predicate device.
Clinical testing was not required for this product.
Key Metrics
Not Found
Predicate Device(s)
EC 2.7 Endoscopic Cutter (K120909)
Reference Device(s)
Medtronic Advanced Energy AEX Generator (K143175)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2017
Medtronic Advanced Energy Ms. Lydia Sakakeeny Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801
Re: K170296
Trade/Device Name: Corecath 2.7s Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 27, 2017 Received: January 31, 2017
Dear Ms. Sakakeeny:
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 of medical device
1
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/ResourcesforYou/Industry/default.htm. 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
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.
Sincerely.
Jennifer R. Stevenson -S
For 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
2
Indications for Use
510(k) Number (if known) K170296
Device Name
CoreCath 2.7S
Indications for Use (Describe)
The CoreCath 2.7S is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, providing electrosurgical hemostasis, and evacuation of surgical smoke during such procedures.
| 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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3
CoreCath2.7S
Submitter: Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801 Contact Person: Lydia Sakakeeny, PhD Principal Requlatory Affairs Specialist Phone: (603) 294-5482 Fax: (603) 742-1488 E-mail: lydia.sakakeeny@medtronic.com Date Summary Prepared: January 27, 2017 Device Trade Name: CoreCath 2.7S (K170296) Common Name: Electrosurgical Instrument Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400) Product Code: GEI Predicate Device: EC 2.7 Endoscopic Cutter (K120909) DeviceDescription: The CoreCath 2.7S is a disposable, single-use monopolar RF (radiofrequency) surgical device intended to be use for ablation and hemostasis of soft tissue obstructions in upper airways and tracheobronchialtree. The CoreCath 2.7S is terminally sterilized via ETO. It is comprised of a cylindrically shaped, disposable monopolar cutting and coagulation electrode affixed to the distal end of a polymeric. flexible multi lumen shaft and cabling, intended for connection to the monopolar output port of the Medtronic Advanced Energy AEX Generator (K143175). The CoreCath 2.7S is intended to be energized for use by the footswitch accessory supplied with the AEX Generator. It has an active length of approximately 750 mm and a maximum diameter crossing profile of 2.68 mm. It is sized such that may be delivered through the working channel of a flexible bronchoscope 2.8 mm diameter working channel and working length of 600 mm. Indications for use: The CoreCath 2.7S is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, providing electrosurgical hemostasis, and evacuation of surgical smoke during such procedures.
510(k) Summary (K170296)
Technoloqical Characteristics:
The CoreCath 2.7S is similar to the predicate device in that they are single use, sterile, electrosurgical instruments used to cut and coagulate soft tissue obstructions in upper airways and tracheobronchial tree, while providing electrosurgical hemostasis. In addition, the subject device includes a suction feature enabling the suction of smoke during the
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CoreCath 2.7S
indicated procedures. This additional feature does not impact the safety or effectiveness of the device.
Summary of Non-Clinical Testing:
The design and performance of the modified CoreCath 2.7S were verified and validated through bench testing.
Bench testing included the following:
- Sterilization ●
- Transit
- Shelf Life
- Biocompatibility ●
- Electrical Safety ●
- EMC .
- Endoscope Compatibility ●
- Mechanical Testing ●
- Activation Testing .
- Suction Testing ●
Comparative performance testing was conducted in an in-vivo animal model. Ex-vivo tissue testing was also completed. Thermal effect of the CoreCath 2.7S in both the in-vivo and ex-vivo model was substantially equivalent to that of the predicate device.
Summary of Clinical Tests: Clinical testing was not required for this product.
Conclusion: The indications for use, technology and performance characteristics of the CoreCath 2.7S device are equivalent to the predicate device and therefore Medtronic Advanced Energy claims substantial equivalence to the predicate devices.