(77 days)
The MTP Hamou Endomat Disposable Tubing Sets are intended for use by qualified surgeons for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures.
The MTP Hamou Endomat Disposable Tubing Set is intended to be utilized with the Karl Storz Hamou Endomat Irrigation System for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures.
The MTP Hamou Endomat Disposable Tubing Sets are intended for use by qualified surgeons for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures. The body contact materials are PVC, silicone, polyolefin, and Makrolon.
The provided document is a 510(k) Summary of Safety and Effectiveness for the MTP Hamou Endomat Disposable Tubing Sets. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and performance data for the device itself.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, ground truth type for test and training sets, training set sample size, and ground truth establishment for training set) is not available in the provided text.
The document states:
"The MTP Hamou Endomat Disposable Tubing Sets are substantially equivalent to the predicate device since the basic features, design and intended uses are the same."
This means the submission relies on the established safety and effectiveness of a previously cleared device (the predicate device) because the new device shares fundamental characteristics and intended use. There is no new performance study described in this 510(k) summary.
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Image /page/0/Picture/0 description: The image contains a logo with the letters 'mtp' stacked vertically. Below the letters, the words 'technical' and 'medical promotion' are written in a smaller font size. The logo is set against a dark, textured background. The overall design appears to be for a company or organization related to medical or technical promotion.
1990910 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS JUN 3
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of MTP's knowledge.
| Applicant: | mtp medical technical promotion gmbhp.o. box 4529 • d-78510 tuttlingentel.: +49/7461/96630 - 0fax: +49/7461/96630 - 25 |
|---|---|
| Contact: | Kevin Kennan(310) 410-2769 |
| Device Identification: | Common Name:Irrigation Tubing Sets |
| Trade Name: (optional)MTP Hamou Endomat Disposable Tubing Sets |
Indication: The MTP Hamou Endomat Disposable Tubing Sets are intended for use by qualified surgeons for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures.
Device Description: The MTP Hamou Endomat Disposable Tubing Sets are intended for use by qualified surgeons for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures. The body contact materials are PVC, silicone, polyolefin, and Makrolon.
Substantial Equivalence: The MTP Hamou Endomat Disposable Tubing Sets are substantially equivalent to the predicate device since the basic features, design and intended uses are the same.
Signed:
Kevin Kennan
Kevin Kennan
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
6 1999 .JUL
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Kennan Senior Regulatory Affairs Specialist MTP Medical Technical Promotion GMBH P.O. Box 4529 D-78510 tuttlingen
K990910 Re: MTP Hamou Endomat Disposable Tubing Sets Dated: February 26, 1999 Received: March 18, 1999 Regulatory Class: II 21 CFR 884.1690/procode: 85 HIH 21 CFR 884.1720/Procode: 85 HET
Dear Mr. Kennan:
This letter corrects our substantially equivalent letter of June 3, 1999, regarding the address being This letter corrects out substantainly equiralism it has not caused any inconvenience.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we We have reviewed your Section 510(K) notination on the matications for use stated in the enclosure)
have determined the device is substantially equivals assements print to Ma have delermined the device is substantially equivals (to commente prior to May 28, 1976, the to legally marketed predicate devices managements or to devices that have been reclassified in
enactment date of the Medical Device Amendments of to Casestia Act (Act) , You enactment date of the Medical Device Allientified of to are tic Act (Act, You may, therefore,
accordance with the provisions of the liederal Food, True reperal controls prov accordance with the provisions of the rederal root, in the Act. The general controls provisions of
market the device, subject to the general controls provisions of the Actual market the device, subject to the general controls provisions of distinction of devices, good manufacturing practice, the Act incrude requirements in ishranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (see above) mit ethis. Existing major regulations affecting your device
Approval) it may be subject to such additional controls. Extrastially e Approval) it may be subject in sinch additions, Title. 21, Parts 800 to 895. A substantially equivalent can be found in the Code of regulations/ the Good Manufacturing Practice requirements, as set forth in determination assumes compliance with the Good nianal (QS) regulation (21 CFR Part 820) and the Quality 5ystem Kegulation (Q3) for Medit Devices: Stature to Cailure to comply with the that, through periodic Q5 inspections, LDA will version and Drug Administration (FDA)
GMP regulation may result in regulatory action. In addition, the Food and Pagister Pl GMP regulation may result in regulatory action. In the lederal Register. Register. Regared in the may publish further announcements concerning your cevice affect any obligation you might have under
response to your premarket notification submission does Radiation Control response to your premarket nothication submission aber any work of the only of the most of the most of the most or other Federal laws or regulations.
This letter will allow you to continue marketing your device as described in your 510(k) premarketed pred This letter will allow you to continue marketing your device to a legally marketed predicate notification. The PD7 miding of substantial equivalence in your device to proceed to the market.
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Page –2 – Mr. Kevin Kennan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally n you desire specific atavec devices), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
( 2/2 -------------------------------------------------------------------------------------------------------------------------------------------------------------------------the may سمسلمس
CAPT Daniel Schultz, M.D. Acting Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows a logo for MTP, which stands for Medical Technical Promotion. The logo is in black and white and features the letters "mtp" in a stylized font. The word "technical" is written below the letters "mtp", and the word "medical promotion" is written below the word "technical". The logo is set against a dark background.
510(k) Number (if known):
Device Name: Hamou Endomat Disposable Tubing Set
Indications for Use: The MTP Hamou Endomat Disposable Tubing Set is intended to be utilized with the Karl Storz Hamou Endomat Irrigation System for the controlled infusion of sterile irrigant solution into body cavities during laparoscopic and hysteroscopic procedures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | X |
|---|---|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | |
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K990916 |
003
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.