(89 days)
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.
The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.
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.
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.
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.
I am sorry, but the provided text focuses on the regulatory submission (510(k) summary) of the Modulap® Disposable Unipolar Electrosurgical Probes and Inserts. This type of document is about demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving performance against specific acceptance criteria.
Therefore, the information you requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. The document confirms that the device provides "electrosurgical cutting and coagulation capabilities", but it does not detail how this performance was measured or how acceptance criteria were met through a specific study.
The FDA's 510(k) review process primarily focuses on comparing a new device to an existing, legally marketed predicate device to ensure it is as safe and effective, rather than requiring a full-scale clinical trial to establish de novo performance criteria for every new submission, especially for accessories like these.
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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.
(781) 939-0725
3. Contact Person
Paul C. Kierce, President
Summary Preparation Date 4.
December 19, 1999
B. Device Name
-
- Trade/Proprietary Name
Modulap®
- Trade/Proprietary Name
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 (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,
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use_XX | OR | Over-The-Counter Use ____ |
|---|---|---|
| --------------------- | ---- | --------------------------- |
(Per 21 CFR 801.109)
(Division Sign-Off)
(Optional Format 1-2-96)
Division of General Restorative Devices
| SKI Number | 2994319 |
|---|---|
| ------------ | --------- |
§ 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.