(83 days)
Not Found
No
The summary describes a physical device (extraction bag) used in laparoscopic surgery and makes no mention of software, algorithms, or AI/ML terms.
No
The device is described as an "Extraction Bag" used for "tissue extraction procedures during laparoscopic surgery," which is a surgical tool, not a therapeutic device designed to treat a disease or condition.
No
The device is described as an "Extraction Bag" used for tissue extraction during laparoscopic surgery, not for diagnosing medical conditions.
No
The device description explicitly states the body contact materials are high density polyethylene and polyurethane film, indicating it is a physical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "tissue extraction procedures during laparoscopic surgery." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description focuses on the physical components and their use in a surgical context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body) to provide information about a physiological state, health, disease, or congenital abnormality. There is no mention of analyzing blood, urine, tissue samples, or any other biological material for diagnostic purposes.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical tool used during a procedure on the body itself.
N/A
Intended Use / Indications for Use
The Extraction Bag for use in Laparoscopy is intended for use by qualified surgeons during laparoscopic procedures, including cholecystectomy, appendectomy, nephrectomy, lymphadenectomy, intestinal resection, oophorocystectomy and myomectomy.
Product codes
GCJ
Device Description
The MTP Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The body contact materials are high density polyethylene and polyurethane film.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons / laparoscopic surgery setting
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 letters "m", "t", and "p" are stacked on top of each other, with "t" in white and the other letters in black. Below the letters, the words "technical medical promotion" are written in a smaller font. The logo is set against a dark background.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 129909122
JUN
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 g 1999 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: Extraction Bag
Trade Name: (optional) MTP Extraction Bag
Indication: The MTP Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery
Device Description: The MTP Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery. The body contact materials are high density polyethylene and polyurethane film.
Substantial Equivalence: The MTP Extraction Bag for tissue extraction procedures during laparoscopic surgery is substantially equivalent to the predicate device since the basic features, design and intended uses are the same.
Signed:
Kevin Kennan
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 9 1999
MTP Medical Technical Promotion GmbH c/o Mr. Kevin A. Kennan P.O. Box 1954 Culver City, California 90232
K990912 Re: Trade Name: MTP Extraction Bag Regulatory Class: II Product Code: GCJ Dated: February 16, 1999 Received: March 18, 1999
Dear Mr. Kennan:
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.
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.
2
Page 2 - Mr. Kevin A. Kennan
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
3
Image /page/3/Picture/0 description: The image shows a logo for MTP, which stands for Technical Medical 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 black background.
510(k) Number (if known):
Device Name: Extraction Bag for use in Laparoscopy
Indications for Use: The Extraction Bag for use in Laparoscopy is intended for use by qualified surgeons during laparoscopic procedures, including cholecystectomy, appendectomy, nephrectomy, lymphadenectomy, intestinal resection, oophorocystectomy and myomectomy.
(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 | K990912 |
| Prescription Use: | X | OR Over-The-Counter Use: | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
000003