(31 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on the physical components and energy delivery mechanism.
Yes
The device is indicated for use to cut and/or coagulate soft tissue, which are therapeutic actions.
No
The device is indicated for cutting and/or coagulating soft tissue, which is a therapeutic function, not a diagnostic one. It delivers radiofrequency power to its electrode, a common method for tissue ablation or coagulation.
No
The device description clearly states it is a physical probe with a distal electrode and connects to a generator, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut and/or coagulate soft tissue." This is a therapeutic or surgical function performed directly on the patient's body.
- Device Description: The device delivers radiofrequency power to a distal electrode for tissue modification. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Baylis Medical RF Perforation Probe V2.0 is indicated for use to cut and/or coaqulate soft tissue.
Product codes
GEI
Device Description
The Baylis Medical RF Perforation Probe V2.0 is a sterile, single-use device that delivers radiofrequency power in a monopolar mode to its distal electrode. The device consists of an insulated core nitinol wire with a rounded tip. The distal active tip is uncoated to deliver radiofrequency energy. The device connects to a separately cleared Baylis Medical Company Radiofrequency Puncture Generator at its proximal end through a compatible BMC Connector Cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
To demonstrate substantial equivalence of the Baylis Medical RF Perforation Probe V2.0 to the cleared predicate device, the following verification tests were performed: biocompatibility, mechanical, electrical, arc integrity, and general physical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
.. / . . . . .
7. 510(k) Summary
Submitter Information
- A. Company Name: Baylis Medical Company Inc.
- B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario Canada L4W 5S4
- C. Company Phone: (905) 602-4875
- D. Company Facsimile: (905) 602-5671
- E. Contact Person: Meqhal Khakhar
- F. Summary Prepared on: 26-July-2013
AUG 3 0 2013
Device Identification
- A. Device Trade Name: Baylis Medical RF Perforation Probe V2.0
- B. Device Common Name: RF Perforation Probe
- C. Classification Name: 21 CFR 878.4400 Electrosurqical Cutting and Coagulation Device and Accessories
- D. Product Code: GEI
- E. Device Class: Class II
Identification of Legally Marketed Predicate Device
| Device Name | Manufacturer | 510(k) |
|---|---|---|
| Baylis Medical RF | ||
| Perforation Probe | Baylis Medical Company Inc. | K010265 |
Indications for Use
The Baylis Medical RF Perforation Probe V2.0 is indicated for use to cut and/or coaqulate soft tissue.
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Device Description
The Baylis Medical RF Perforation Probe V2.0 is a sterile, single-use device that delivers radiofrequency power in a monopolar mode to its distal electrode. The device consists of an insulated core nitinol wire with a rounded tip. The distal active tip is uncoated to deliver radiofrequency energy. The device connects to a separately cleared Baylis Medical Company Radiofrequency Puncture Generator at its proximal end through a compatible BMC Connector Cable.
Comparison to Predicate Device
The Baylis Medical RF Perforation Probe V2.0 has the following similarities to the predicate device:
| Characteristic | Comment |
|---|---|
| Intended Use | Identical |
| Indication for Use | Identical |
| Fundamental scientific technology | Identical |
| Operating Principle | Identical |
| Mechanism of action | Identical |
| Materials | Similar |
| Dimensions | Similar |
| Compatible devices and accessories | Identical |
| Packaging configuration | Identical |
| Sterility assurance level and Sterilization | |
| method | Identical |
Performance Testing
To demonstrate substantial equivalence of the Baylis Medical RF Perforation Probe V2.0 to the cleared predicate device, the following verification tests were performed: biocompatibility, mechanical, electrical, arc integrity, and general physical.
Conclusions
The Baylis Medical RF Perforation Probe V2.0 is determined to be substantially equivalent to the cleared predicate device with respect to intended use, principles of operation, and technological characteristics. The subject device met all requirements as specified by applicable standards and the test protocols. The differences between the subject and predicate devices do not raise any new concerns of safety or effectiveness.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-002
Baylis Medical Company, Inc. Dr. Meghal Khakhar. MBBS. CerRAP, RAC Director, Regulatory and Scientific Affairs 2645 Matheson Boulevard, East Mississauga, Ontario Canada L4W 5S4
August 30, 2013
Re: K132374
Trade/Device Name: Baylis Medical RF Perforation Probe V2.0 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 26, 2013 Received: August 05, 2013
Dear Dr. Khakhar:
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
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Page 2 - Dr. Meghal Khakhar, MBBS, CerRAP, RAC
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.
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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K132374 510(k) Number (if known):
Device Name: Baylis Medical RF Perforation Probe V2.0
Indications For Use:
The Baylis Medical RF Perforation Probe V2.0 is indicated for use to cut and/or coagulate soft tissue.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joshua C. Nipper -S
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