MODULAP

K994319 · Atc Technologies, Inc. · GEI · Mar 20, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994319
• Device Name: MODULAP
• Applicant: Atc Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic surgical procedures, (e.q. laparoscopic cholecystectorny, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube.

Device Story

Modulap disposable unipolar electrosurgical probes and inserts provide irrigation, suction, and electrosurgical cutting/coagulation during laparoscopic surgery. Device connects to external irrigation pump, suction source, and electrosurgical generator. Operates by delivering high-frequency electric current to operative site. Used in OR by surgeons. Benefits include disposable design reducing cross-contamination risk compared to reusable counterparts.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel cannula and connector. Sterile, disposable. Monopolar electrosurgical energy delivery. No software or electronic components.

Indications for Use

Indicated for patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures. Not for hysteroscopy or contraceptive coagulation of the Fallopian tube.

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

• Modulap Reusable Unipolar Electrosurgical Inserts
• Modulap Reusable Unipolar Electrosurgical Attachments

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VIII.

#### A Submitter's Name

### 1. Address

ATC Technologies, Inc. 80 Cummings Park Woburn, Massachusetts 01801

# Phone Number 2.

[phone]

#### 3. Contact Person

Paul C. Kierce, President

# Summary Preparation Date 4.

December 19, 1999

#### B. Device Name

- 1. Trade/Proprietary Name
Modulap®

### Common/Usual Name 2.

Disposable Unipolar Electrosurgical Probes and Disposable Unipolar Electrosurgical Inserts

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# Classification Name 3.

General and Plastic Surgery Electrosurgical Cutting and Coaqulation Device and Accessories

## C. Predicate Devices

Modulap Reusable Unipolar Electrosurgical Inserts and Modulap Reusable Unipolar Electrosurgical Attachments

## D. Device Description

## 1. Function

When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, electrosurgical generator and suction/irrigation trumpet valve, the Candidate Devices provide irrigation, suction and electrosurgical cutting and coagulation capabilities to the operative site during general laparoscopic surgical procedures.

## 2. Scientific Basis

Provides electrosurgical cutting and coagulation to the surgical site during general laparoscopic surgical procedures by communicating the high-frequency electric current generated by a legally-marketed electrosurgical generator to the operative site.

## 3. Significant Physical/Performance Characteristics

## a) Design

Sterile, disposable.

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## b) Materials

Information regarding the materials from which the Candidate Devices are constructed is proprietary.

### Physical Properties c)

Not applicable.

#### E. Intended Use Statement

#### Disease/Conditions 1.

The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic surgical procedures, (e.q. laparoscopic cholecystectorny, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube.

#### 2. Patient Population

The Candidate Devices are intended for use in patient populations eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.

#### r. Technological Characteristics Summary

The Candidate Devices consist of a stainless steel cannula and connector used to communicate electrosurgical, suction, and irrigation capabilities to the operative site during laparoscopic surgical procedures.

®Registered Trademark of ATC Technologies, Inc.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping eagles' heads facing to the right.

MAR 2 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ATC Technologies, Inc. c/o Marian Harding Cochran, Esq. 1034 Lincoln Street Hollywood. Florida 33019

Re: K994319 Trade Name: Modulap® Regulatory Class: II Product Code: GEI Dated: December 19, 1999 Received: December 22,1999

Dear Ms. Cochran:

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 (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 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.

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Page 2 - Ms. Marian Harding Cochran, Esq.

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,

Hpt Bludia

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT IX.

510(k) Number (if known): Not yet assigned. Modulap® Disposable Unipolar Electrosurgical Device Name: Probes and Disposable Unipolar

Electrosurgical Inserts

Indications for Use:

The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.

®Registered Trademark of ATC Technologies, Inc.

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| Prescription Use_XX | OR | Over-The-Counter Use ____ |
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(Per 21 CFR 801.109)

(Division Sign-Off)

(Optional Format 1-2-96)

Division of General Restorative Devices

| SKI Number | 2994319 |
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