VAPR

K974022 · Mitek Products · GEI · Jan 12, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974022
• Device Name: VAPR
• Applicant: Mitek Products
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek Vapr Generator and Accessories, in combination with Vapr thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues.

Device Story

Mitek Vapr System is an electrosurgical device for arthroscopic and orthopaedic surgery; comprises electrosurgical generator, footswitch, handpiece, and five electrode tip configurations. System uses high-frequency bipolar electrosurgical current to perform soft tissue resection, ablation, excision, and hemostasis. Operated by surgeons in clinical/OR settings. Surgeon controls energy delivery via footswitch and handpiece; output effect is thermal tissue modification/coagulation. Benefits include precise soft tissue management during minimally invasive arthroscopic procedures.

Clinical Evidence

Bench testing and preclinical animal studies were conducted to evaluate device function and safety. No clinical data was provided or deemed necessary for this 510(k) notification.

Technological Characteristics

Electrosurgical system; bipolar energy delivery; includes generator, footswitch, handpiece, and five electrode tip configurations. Operates via high-frequency electrosurgical current. Intended for use with saline or Ringer's lactate irrigation.

Indications for Use

Indicated for general surgical use, including orthopaedic and arthroscopic soft tissue resection, ablation, excision, and hemostasis. Contraindicated for non-arthroscopic procedures, procedures without saline or Ringer's lactate irrigation, patients contraindicated for arthroscopy, and patients with heart pacemakers or other electronic implants.

Regulatory Classification

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.

Predicate Devices

• Oratec Interventions™ Model ORA 50 Electrothermal Generator and Accessories

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Mitek Products. The word "mitek" is in bold, black letters, with the "k" slightly raised. Below the word "mitek" is the word "PRODUCTS" in smaller, black letters.

JAN 12 1998

**ETHICON**,INC.
a Johnson&Johnson company

60 GEAUIEN DHIVE - WEUTH OSBER ... FAX [phone] • FAX [phone]

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## SUMMARY OF SAFETY AND EFFECTIVENESS

#### DATE

November 7, 1997

510(k) Summary of

Safety and Effectiveness

Information supporting claims of substantial equivalence a defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule" ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

Mitek Vapr™ System DEVICE NAME CLASSIFICATION NAME Arthroscope and Accessories (21CFR 888.1100) TRADE NAME/PROPRIETARY NAME Vapr™

### PREDICATE DEVICE NAME

Oratec Interventions™ Model ORA 50 Electrothermal Generator and Accessories.

#### SUMMARY

Device Indications:

The Mitek Vapr"M Generator and Accessories, in combination with Vapr thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostastis of blood vessels and in coagulating soft tissues.

#### Technological Characteristics:

The Mitek Vapr system is technologically the same as the predicate device. Both devices use high frequency electrosurgical current to achieve the intended clinical purpose. The predicate device is mono-polar and the Mitek device is bi-polar. This difference does not raise any new question of safety and effectiveness.

### Device Description:

The Mitek Vapr™ system is comprised of four components: the electrosurgical generator, a footswitch, a handpiece with a cable to connect to the generator and five types of electrode tip configurations used in the arthroscopic procedure.

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#### PERFORMANCE DATA

Preclinical animal studies and laboratory evaluations were conducted to show that the device functions as intended. In preclinical laboratory evaluations, the Oratec system was used for comparison. Clinical data was deemed unnecessary to support the Premarket Notification. Sufficient data has been obtained from preclinical animal testing to assess safety and effectiveness characteristics of the device when compared to the predicate device.

### CONCLUSIONS

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act.

#### CONTACT

Mr. Edward F. Kent Vice President Regulatory Affairs / QA Mitek Products 60 Glacier Drive Westwood, MA 02090

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1998

Mr. Edward F. Kent Vice President, Regulatory Affairs Mitek Products 60 Glacier Drive Westwood, Massachusetts 02090

Re: K974022 Trade Name: VAPR™ Regulatory Class: II Product Code: GEI Dated: October 10, 1997 Received: October 14, 1997

Dear Mr. Kent:

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 requirements , as set forth in the Quality System Regulation (OS) 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

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Page 2 - Mr. Kent

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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| | Participant Property |
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K974022

510(k) Number (if known):___

Mitek Vapr System Device Name:

Indications For Use:

The Mitek Vapr Generator and Accessories, in combination with Vapr thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and
arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues.

(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

| 510(k) Number | K974022 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align: center;">X</div> |
|------------------------------------------|------------------------------------------|
|------------------------------------------|------------------------------------------|

OR
Over-The-Counter Use ____
(Optional Format 1-2-96)

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#### Section 2

# INDICATIONS FOR USE, CONTRAINDICATIONS

### INDICATIONS FOR USE

The Mitek VAPR Generator and Accessories, in combination with Vapt thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery could include, for example, the following:

Knee

Meniscectomy Lateral Release Chondroplasty Synovectorny ACL Debridement Plica Removal Meniscal Cystectomy Ankle Fracture Debridement Excision of Scar Tissue Synovectomy Chondroplasty Wrist Synovectomy Carilage Drbridement Fracture Debridement Shoulder Labral Tear Resection Synovectomy Excision of Scar Tissue Acromioplasty Bursectomy Subacromial Decompresion Chondropiasy Elbow Synovectomy Tendom Debridement Chondroplasty

## CONTRAINDICATIONS

The Mitek Vapr system is contraindicated in any non-arthroscopic surgical procedure and in procedures where saline of Ringer's lactate is not used as an irrigant. The System is also not appropriate for patiens for whom an arthroscopic procedure is contraindicated for any reason. Use of the System is also contraindicated in patients with heart pacestakers or other electronic device implants.

Picollo

(Division Sign-Off)
Division of General Restorative Devices k974022
510(k) Number

Prescription Use (Per 21 CFR 801.109)