VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM

K992876 · Mitek Products · HRX · Sep 24, 1999 · Orthopedic

Device Facts

• Record ID: K992876
• Device Name: VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
• Applicant: Mitek Products
• Product Code: HRX · Orthopedic
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Sterile, disposable electrosurgical electrode; used with Mitek VAPR System; performs resection, ablation, excision, hemostasis, and coagulation of soft tissue; utilized in arthroscopic procedures (knee, shoulder, ankle, elbow, wrist); operated by surgeons; provides therapeutic benefit through controlled tissue interaction; modification of existing VAPR electrode line.

Clinical Evidence

Bench testing only; no clinical data provided. Validation testing performed per design control requirements.

Technological Characteristics

Sterile, disposable electrosurgical electrode; 2.3mm diameter; designed for use with Mitek VAPR System; Class II device (21 CFR 878.4400).

Indications for Use

Indicated for resection, ablation, excision, hemostasis, and coagulation of soft tissue during arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

Regulatory Classification

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.

Predicate Devices

• Mitek VAPR™ T Thermal Electrode (K974022)
• Mitek VAPR™ System (K963783)

Submission Summary (Full Text)

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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: [phone] | |
| | Fax: [phone] | |
| Date: | August 25, 1999 | |
| Device Generic Name: | Electrosurgical electrode | |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. | |
| Product Code: | GEI (21 CFR 878.4400) | |
| Predicate Devices: | K974022 - Mitek VAPR™ T Thermal Electrode<br>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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

يَا تي

:

。 ・・・

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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.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| | <img alt="Signature" src="signature.png"/> |
| | (Division Sign-Off) |
| Division of General Restorative Devices | K992876 |
| 510(k) Number | |

| Prescription Use <span style="text-decoration:underline;">✓</span><br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use ______ |
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