VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM by MITEK PRODUCTS

The Mitek VAPR™ System, when used with a VAPR™ 2.3mm End Effect Electrode, is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

Device Description

The devices described in this 510(k) are sterile, disposable electrodes designed for use with the Mitek VAPRTM System.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VAPR™ 2.3mm End Effect Electrode.

Note: The provided document is a 510(k) summary for a Special 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device for a device modification. This type of submission typically does not contain detailed performance studies with acceptance criteria, ground truth, expert reviews, or MRMC studies in the same way a de novo or PMA submission for a novel AI/software device would. The performance assessment here is primarily framed around the established safety and performance of the predicate device and the validation of the modification.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Safety and Performance (General): Device modification maintains the safety and performance characteristics of the predicate device.	"Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification."	The document states that validation testing was conducted for the device modification to demonstrate continued safety and performance. Specific quantifiable performance metrics or acceptance thresholds are not detailed in this summary, as is typical for a Special 510(k) where the primary argument is substantial equivalence to a pre-existing, approved device. The "results of validation testing" are not explicitly presented.
Substantial Equivalence to Predicate Device	"Based on the indications for use, technological characteristics, and comparison to predicate devices, the modified VAPT™ 2.3mm End Effect Electrodes have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act."	This is the overarching "acceptance criterion" for a 510(k) submission. The performance is deemed acceptable because it is demonstrably similar to a device already deemed safe and effective.
Indications for Use (Unchanged)	"The Mitek VAPR™ System, when used with a VAPR™ 2.3mm End Effect Electrode, is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist."	The indications for use are identical to those of the predicate and are maintained with the modified device.

Study Details (as inferable from the document)

Given the nature of this 510(k) submission (a Special 510(k) for a device modification), the detailed "study" as one might expect for a novel AI/software device is not present in the public summary. The "study" mentioned here refers to the internal validation and verification processes conducted by the manufacturer to ensure the modified device still meets its design requirements and is substantially equivalent to the predicate.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided summary. Validation testing would involve a certain number of test units or trials, but these specifics are not public in this type of document.
- Data Provenance: Not specified. This would be internal Mitek testing.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts/Qualifications: Not applicable for this type of submission focused on hardware modification and substantial equivalence. "Ground truth" in the context of device performance refers to objective physical measurements or functional assessments, not human expert interpretation of data.
Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Performance testing for an electrosurgical electrode would typically involve engineering tests, bench testing, and potentially animal or cadaver studies, not expert adjudication in the manner of diagnostic image interpretation.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No. This type of study is for diagnostic devices where human readers interpret data, often with and without AI assistance. This device is an electrosurgical electrode, not a diagnostic AI system.
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This device is hardware (an electrosurgical electrode) that inherently requires a human operator for its intended use. There is no "algorithm only" performance to speak of.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For an electrosurgical electrode, ground truth would relate to measurable physical parameters (e.g., tissue temperature, ablation depth, cutting speed, hemostasis efficacy) and functional performance criteria verified through bench testing, pre-clinical (animal/cadaver) studies, and potentially clinical observation (though clinical data is not explicitly mentioned as being generated for this specific 510k). The summary mentions "validation testing" and "performance testing," which implies objective, measurable outcomes rather than subjective expert consensus.
The sample size for the training set:
- Sample Size: Not applicable. This is a hardware device, not an AI/ML model that requires a training set.
How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for a hardware device.

Summary

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510(k) Summary

K992406 VAPRTM 2.3mm End Effect Electrode Trade Name: Mitek Products Sponsor: 60 Glacier Drive Westwood, MA 02090 Registration #1221934 Contact Person: Paula E. Bulger Manager, Regulatory Affairs Mitek Products 60 Glacier Drive Westwood, MA 02090 Phone: (781) 251-2746 (781) 461-9166 Fax: Date: July 21, 1999 Electrosurgical electrode Device Generic Name: Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. GEI (21 CFR 878.4400) Product Code: K974022 - Mitek VAPR™ T Thermal Electrode Predicate Devices: K963783 - Mitek VAPR™ System

Product Description: The devices described in this 510(k) are sterile, disposable electrodes designed for use with the Mitek VAPRTM System.

Indications for Use:

The Mitek VAPR™ System, when used with a VAPRTM 2.3mm End Effect Electrode, is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

Safety and Performance:

This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification.

Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the modified VAPT™ 2.3mm End Effect Electrodes have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -6 1999

Ms. Paula E. Bulger Regulatory Affairs Manager Mitek Products 60 Glacier Drive Westwood. Massachussetts 02090

Re: K992406 Trade Name: VAPR™ 2.3mm End Effect Electrode Regulatory Class: II Product Code: GEI Dated: June 19, 1999 Received: June 20, 1999

Dear Ms. Bulger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Paula E. Bulger

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin M. Wilson, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification: Device Modification July 19, 1999

Page 1 _ of __ 1___

510(k) Number (if known): _ K992406

Device Name: _VAPR™ 2.3mm End Effect Electrode

Indications for Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ × (Per 21 CFR 801.109)

Over-the -Counter Use _

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(Division neral Res Division of G 510(k) Numb

Regulation Number and Section

§ 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.