(50 days)
Not Found
Not Found
No
The summary describes a manually operated surgical device with no mention of software, image processing, AI, or ML.
No
Explanation: The device is a surgical instrument used to establish a path of entry for other instruments, not to treat a disease or condition itself.
No
Explanation: The device is described as a surgical device used to establish a path of entry for endoscopic instruments, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states it is a "manually operated surgical device" and mentions "polycarbonate" as a body contact material, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these 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." This describes a surgical tool used in vivo (within the body) for accessing surgical sites.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
- Device Description: The description focuses on the physical characteristics and materials of a surgical instrument.
- Lack of IVD-related information: The document does not mention any aspects related to sample analysis, testing, or diagnostic purposes.
Therefore, this device falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
GCJ
Device Description
The MTP Disposable Trocars body contact material is polycarbonate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, and gynecologic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 gmbh
p.o. box 4529 • d-78510 tuttlingen
tel.: +49/7461/96630 - 0
fax: +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
1
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.
2
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)
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