(50 days)
These instruments are manually operated surgical devices intended for abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and endoscopes.
The MTP Disposable Trocars body contact material is polycarbonate.
This submission pertains to the MTP Disposable Trocars, which are manually operated surgical devices. The provided documents focus on the 510(k) submission process for these devices, asserting their substantial equivalence to predicate devices already on the market. Crucially, the documents do not contain information about specific acceptance criteria or a study demonstrating that the device meets such criteria.
Therefore, I cannot provide the requested table or detailed study information.
Here's why and what information is available:
- Type of Device: The MTP Disposable Trocars are a surgical instrument. For devices like these, substantial equivalence is often established based on similarities in materials, design, intended use, and performance characteristics to legally marketed predicate devices. This typically involves demonstrating that the new device does not raise new questions of safety or effectiveness.
- Missing Information: The provided text is a 510(k) summary and the FDA's clearance letter. These documents confirm the regulatory pathway and clearance but do not contain detailed performance study data, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies that would be found in a comprehensive clinical or performance validation study report.
Summary of available information as per your request, indicating where information is lacking:
-
A table of acceptance criteria and the reported device performance:
- Not provided. The document focuses on demonstrating substantial equivalence, not on specific performance metrics or acceptance criteria for a new, unique performance claim.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. No performance study is detailed.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not provided. No test set or related ground truth establishment is described.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided. No test set or adjudication method is described.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. This device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool with human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is a manual surgical instrument, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. No ground truth establishment for performance is described. The "ground truth" for regulatory assessment here is typically the established safety and effectiveness of the predicate devices.
-
The sample size for the training set:
- Not applicable/Not provided. This is not an AI/algorithm-based device and thus does not have a training set in that context.
-
How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set is relevant for this type of device in the context of the provided documentation.
In essence, the provided documents represent the regulatory clearance of a medical device based on substantial equivalence, rather than a detailed performance study with specific acceptance criteria and results for an AI or diagnostic tool.
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Image /page/0/Picture/0 description: The image shows a logo for "mtp technical medical promotion". The logo is in black and white and has a stylized font. The image also has the number K994066 written on the top.
JAN 2 0 2000 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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: Disposable Trocars
Trade Name: (optional) MTP Disposable Trocars
Indication: The MTP Disposable Trocars are manually operated surgical devices intended for abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and endoscopes
Device Description: The MTP Disposable Trocars body contact material ispolycarbonate.
Substantial Equivalence: The MTP Disposable Trocars are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same.
Signed:
Signed:
Kevin Kennan
Kevin Kennan
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads facing to the right, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
JAN 2 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MTP Medical Technical Promotion GmbH C/O Mr. Kevin Kennan P.O. Box 1954 Culver City, California 90232
Re: K994066 Trade Name: MTP Disposable Trocars Regulatory Class: II Product Code: GCJ Dated: November 30, 1999 Received: December 1, 1999
Dear Mr. Kennan:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices 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 Devices 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 devices, 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 devices 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 devices 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 (OS) 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 devices 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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
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Page 2 - Mr. Kevin Kennan
If you desire specific advice for your devices 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 devices, 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,
Styp A. Rhodes
Image /page/2/Picture/4 description: The image shows a close-up of a handwritten text. The text appears to be in cursive and is written in black ink on a white background. The letters are not very clear, but it seems to be a word or a phrase. The handwriting is somewhat messy and difficult to read.
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Devices 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 "m," "t," and "p" stacked on top of each other. The words "technical" and "medical promotion" are written below the letters.
K994066 510(k) Number (if known):
Device Name: MTP Disposable Trocars
Indications for Use: These instruments are manually operated surgical devices intended for abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and endoscopes.
(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 | K994066 |
|---|---|
| --------------- | --------- |
| Prescription Use: | OR Over-The-Counter Use: |
|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
・・・・
: :
§ 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.