(31 days)
The Baylis Medical RF Perforation Probe V2.0 is indicated for use to cut and/or coagulate soft tissue.
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.
Here's an analysis of the provided text regarding the Baylis Medical RF Perforation Probe V2.0, focusing on the acceptance criteria and supporting studies.
Important Note: The provided text is a 510(k) summary and FDA clearance letter. This type of document is a submission for substantial equivalence to a previously cleared device, not typically a report of a de novo clinical trial with detailed acceptance criteria and performance metrics for a novel technology demonstrating clinical efficacy. Therefore, many of the requested points, particularly those related to human reader studies, ground truth establishment for AI models, and explicit performance metrics against clinical acceptance criteria, will not be present in this type of submission.
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not specify explicit numerical acceptance criteria for clinical performance that would typically be seen in a clinical trial for a new, non-substantially equivalent device. Instead, the "acceptance criteria" for this submission are rooted in demonstrating substantial equivalence to a predicate device and meeting applicable engineering and safety standards.
| Acceptance Criteria Category (Implied by Substantial Equivalence) | Reported Device Performance against Criteria |
|---|---|
| Intended Use (Identical to predicate) | Met – "Identical" |
| Indications for Use (Identical to predicate) | Met – "Identical" |
| Fundamental Scientific Technology (Identical to predicate) | Met – "Identical" |
| Operating Principle (Identical to predicate) | Met – "Identical" |
| Mechanism of Action (Identical to predicate) | Met – "Identical" |
| Materials (Similar to predicate) | Met – "Similar" (implies no new safety/effectiveness concerns) |
| Dimensions (Similar to predicate) | Met – "Similar" (implies no new safety/effectiveness concerns) |
| Compatible Devices & Accessories (Identical to predicate) | Met – "Identical" |
| Packaging Configuration (Identical to predicate) | Met – "Identical" |
| Sterility Assurance Level & Sterilization Method (Identical to predicate) | Met – "Identical" |
| Biocompatibility (Compliance with standards) | Met – "Performed" and implicit compliance |
| Mechanical Integrity (Compliance with standards) | Met – "Performed" and implicit compliance |
| Electrical Safety (Compliance with standards) | Met – "Performed" and implicit compliance |
| Arc Integrity (Compliance with standards) | Met – "Performed" and implicit compliance |
| General Physical Properties (Compliance with standards) | Met – "Performed" and implicit compliance |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (of substantial equivalence and safety/performance) is documented as "Performance Testing."
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Sample Size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the "verification tests." These tests typically involve a defined number of units or test articles run through a protocol. For example, biocompatibility might involve specific animal models or in-vitro tests, and mechanical tests would involve a set number of devices. The document states "the following verification tests were performed," implying the standard sample sizes and methodologies for these engineering and biological tests were followed.
- Data Provenance: The tests were conducted internally or by contracted labs by Baylis Medical Company Inc., based in Mississauga, Ontario, Canada. The nature of these tests (biocompatibility, mechanical, electrical, etc.) means they are prospective engineering and biological evaluations, not retrospective clinical data analysis.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission details engineering and biocompatibility testing for a medical device. There is no "ground truth" in the sense of clinical interpretations or diagnoses requiring expert consensus. The "truth" is established by adherence to recognized standards and protocols for device testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As there's no "ground truth" derived from expert interpretation, there is no adjudication method like 2+1 or 3+1. Test results are typically compared against pre-defined engineering specifications and standards.
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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:
- No. This is a medical device for tissue cutting and coagulation, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance metrics are not applicable to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical, electrosurgical device, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the clinical sense. The "ground truth" for the device's performance is established by engineering specifications, recognized national and international standards for medical device safety and performance (e.g., electrical safety, biocompatibility, mechanical durability), and comparison to the characteristics of the legally marketed predicate device. For example, the "ground truth" for biocompatibility is whether the materials meet ISO 10993 standards.
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The sample size for the training set:
- Not Applicable. As this is not an AI/ML device, there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. No training set exists.
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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 RFPerforation 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 Sterilizationmethod | 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
Page 1 of 1
§ 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.