(29 days)
The Mitek VAPR™ System, when used with a VAPR™ 2.3mm Side 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 devices described in this 510(k) are sterile, disposable electrodes designed for use with the Mitek VAPRTM System.
The provided text describes a Special 510(k) Premarket Notification for a device modification, the Mitek Products VAPR™ 2.3mm Side Effect Electrode. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria or comparing the device to a human reader. Therefore, much of the requested information regarding acceptance criteria, study details, and human-in-the-loop performance is not present in this type of regulatory document.
Here's a breakdown of the information that can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. A Special 510(k) for a device modification typically focuses on demonstrating that changes made to a previously cleared device do not alter its fundamental safety and effectiveness. The acceptance criteria here are implicitly related to meeting design control requirements and showing that the modified device performs as intended and is equivalent to the predicate. The document states: "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 for the device modification." The specific "results of validation testing" are not detailed.
2. Sample Size Used for the Test Set and the Data Provenance:
This information is not provided as a typical clinical study with a test set. The "validation testing" likely refers to engineering or bench testing, not a clinical trial with a patient test set. Therefore, details about data provenance (e.g., country of origin, retrospective/prospective) are not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided. As this is not a study requiring human interpretation (e.g., image analysis), there is no "ground truth" to be established by experts in that context. The "truth" in this submission relates to the device meeting engineering specifications and being safe and effective for its intended use, as demonstrated through design controls and validation testing.
4. Adjudication Method for the Test Set:
This information is not provided. No clinical test set requiring adjudication in this manner is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not provided. The device in question is an electrosurgical electrode, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not provided. The device is an instrument used by a surgeon, not a standalone algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this type of submission is in adherence to regulatory standards, design control requirements, and validated performance specifications (which are not detailed in this document). It is not based on expert consensus, pathology, or outcomes data in the context of a clinical trial.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This is not a machine learning or AI device that would have a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided.
In summary, the provided document is a regulatory submission for a device modification, focusing on demonstrating substantial equivalence through compliance with design controls and validation testing, rather than a clinical study evaluating diagnostic performance or AI effectiveness. Therefore, most of the requested information pertaining to clinical study design and AI evaluation is absent.
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SEP 24 1999
Mitek Products VAPRTM 2.3mm Side Effect Electrode Special 510(k) Premarket Notification: Device Modification August 25, 1999
Image /page/0/Picture/3 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'k', followed by the numbers '99', then '28', and finally '76'. The characters are written in a cursive style, with varying stroke thicknesses.
510(k) Summary
| Trade Name: | VAPR™ 2.3mm Side Effect Electrode | |
|---|---|---|
| Sponsor: | Mitek Products | |
| 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 | ||
| Fax: (781) 461-9166 | ||
| Date: | August 25, 1999 | |
| Device Generic Name: | Electrosurgical electrode | |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II. | |
| Product Code: | GEI (21 CFR 878.4400) | |
| Predicate Devices: | K974022 - Mitek VAPR™ T Thermal ElectrodeK963783 – 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 VAPRTM System, when used with a VAPR™ 2.3mm Side 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) for the device modification.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the modified VAPT™ 2.3mm Side Effect Electrodes have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are formed by curved lines that create a sense of movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Ms. Paula E. Bulger Regulatory Affairs Manager MITEK Products 60 Glacier Drive Westwood, Massachusetts 02090
Re: K992876
Trade Name: VAPR™ 2.3mm Side Effect Electrode for use with VAPR™ System Regulatory Class: II Product Code: HRX, GEI Dated: August 25, 1999 Received: August 26, 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 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.
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) 594-4595. 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,
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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Mitek Products VAPR™ 2.3mm Side Effect Electrode Special 510(k) Premarket Notification: Device Modification August 25, 1999
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Page __ 1___ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _VAPR™ 2.3mm Side Effect Electrode
Indications for Use:
The Mitek VAPR™ System, when used with a VAPR™ 2.3mm Side 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | K992876 |
| 510(k) Number |
| Prescription Use ✓(Per 21 CFR 801.109) | OR | Over-the-Counter Use ______ |
|---|---|---|
| -------------------------------------------------------------------------------------------- | ---- | ----------------------------- |
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.