(55 days)
Modulap™ Probe Tips may be used with legally-marketed trumpet valves designed to provide pressurized irrigation solution to the operative site during laparoscopic/endoscopic procedures. The hollow channel present in some of the Modulap™ Probe Tips can also be used to introduce other laparoscopic instruments into the surgical site.
When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, and Trumpet Valve, the Candidate Device communicates the Trumpet Valve's suction and irrigation capabilities to the operative site during general laparoscopic surgical procedures.
This 510(k) submission describes an aspiration/irrigation cannula called "ModulapTM". The device is a relatively simple surgical tool. The provided text does not include information about acceptance criteria or a study proving the device meets said criteria.
It only describes the device's function, scientific basis, physical/performance characteristics, and intended use. There is no mention of any quantitative performance metrics, clinical trials, or any form of study results.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is absent from the provided text.
The closest information provided is about its "Technological Characteristics Summary" which indicates it's a hollow tube and connector used to communicate suction and irrigation capabilities. This is a descriptive summary of its design, not a performance study result.
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SEP 8 1998
982445
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VIII.
Submitter's Name A.
1. Address
ATC Technologies, Inc. 80 Cummings Park Woburn, Massachusetts 01801
2. Phone Number
(781) 939-0725
Contact Person 3.
Paul C. Kierce, President
Summary Preparation Date 4.
May 1, 1998
Device Name B.
- Trade/Proprietary Name 1.
ModulapTM
Common/Usual Name 2.
Aspiration/Irrigation Cannula
3. Classification Name
General and Plastic Surgery Laparoscope and Accessories
C. Predicate Device(s)
Nezhat-Dorsey Hydro-Dissection System and Accessories
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Device Description D.
1. Function
When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, and Trumpet Valve, the Candidate Device communicates the Trumpet Valve's suction and irrigation capabilities to the operative site during general laparoscopic surgical procedures.
2. Scientific Basis
Provides pinpoint suction and irrigation to the surgical site during laparoscopic procedures by communicating the suction and irrigation capabilities of a legally-marketed Trumpet Valve to the operative site during general laparoscopic surgical procedures.
3. Significant Physical/Performance Characteristics
Design a)
Non-sterile, reusable.
b) Materials
Information regarding the materials from which the Candidate Device is constructed is proprietary.
Physical Properties c)
Not applicable.
E. Intended Use Statement
1. Disease/Conditions
The Candidate Device is intended for use in the treatment of disease conditions via general laparoscopic surgical procedures.
2. Patient Population
The Candidate Device is intended for use in patient populations eligible for treatment via general laparoscopic surgical procedures.
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Technological Characteristics Summary F.
The Candidate Device consists of a hollow tube and connector used to communicate the suction and irrigation capabilities of a legally-marketed Trumpet Valve to the operative site during laparoscopic surgical procedures. This device is designed for use with legally-marketed irrigation pumps, irrigant bags and bottles, Trumpet Valves and suction sources.
TMTrademark of ATC Technologies Inc.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 1998
ATC Technology, Inc. Ms. Marian Harding-Cochran, Esquire 1034 Lincoln Street Hollywood, Florida 33019
Re: K982445 Trade Name: Modulap™ Regulatory Class: II Product Code: GCJ Dated: June 30, 1998 Received: July 15, 1998
Dear Ms. Harding-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 (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. Harding-Cochran
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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INDICATIONS FOR USE STATEMENT IX.
510(k) Number (if known): K982445 Device Name: Modulap™
Indications for Use:
Modulap™ Probe Tips may be used with legally-marketed trumpet valves designed to provide pressurized irrigation solution to the operative site during laparoscopic/endoscopic procedures. The hollow channel present in some of the Modulap™ Probe Tips can also be used to introduce other laparoscopic instruments into the surgical site.
TMTrademark 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)
(Optional Format 1-2-96)
Diotule
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.