(24 days)
Not Found
No
The device description and intended use focus on mechanical components for laparoscopic procedures and do not mention any software, algorithms, or AI/ML capabilities.
No.
Explanation: The device is used to create an entry point and maintain pneumoperitoneum during laparoscopic procedures, which are instrumental and preparatory steps for treatments, rather than providing therapy itself.
No
The device is described as being used for creating a point of entry and maintaining pneumoperitoneum for laparoscopic instruments, which is a surgical function not a diagnostic one.
No
The device description clearly states the device is a reusable, stainless steel cannula and disposable, single-use reduction seal system made of silicon rubber, thermoplastic rubber, and plastics. These are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is used for creating a point of entry into the abdominal cavity for surgical instruments and maintaining pneumoperitoneum during laparoscopic procedures. This is a surgical tool used on the body, not for analyzing samples from the body.
- Intended Use: The intended use is entirely focused on facilitating a surgical procedure within the abdominal cavity.
- Device Description: The materials and components described (stainless steel cannula, seals, spike, cone) are consistent with surgical instruments, not diagnostic reagents or analyzers.
Therefore, this device falls under the category of surgical instruments, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Cannulas and accessories are to be used with a Dexide seal package and spike for creating a point of entry for laparoscopic instruments into the abdominal cavity and maintaining pneumoperitoneum.
MultAport Cannulas:
The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar Spike for creating a point of entry for laparoscopic instruments into the abdominal cavity.
AccuPort 5-12mm Seal:
The AccuPort Seal is a single-used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments with diameters ranging from 5mm to 12mm.
Orbital Reducer Seal:
The Orbital Reducer is a single used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments of equal and smaller size.
Blunt Spike:
The reusable Blunt Trocar spike is used with the MultAport Cannulas and AccuPort or Orbital Reducer Seal for creating a point of entry for laparoscopic instruments into the abdominal cavity.
Sealing Cone:
The Sealing Cone is a reusable product designed for use during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum.
Shaft Seal (replacement part for Sealing Cone):
The Sealing Cone is a reusable product designed for used during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum. The shaft seal is designed for use when sealing the cone to the cannula.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The "candidate device" is a reusable, stainless steel Cannula anc disposable, single-use reduction seal system that threads into the Cannula. The reducer system is composed of silicon rubber, thermoplastic rubber, and plastics. The reusable Sealing Cone and its Seal accommodate the cannula to assist the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
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.
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
3/4/99
Attachment 3
990379
SUMMARY OF SAFETY AND EFFECTIVENESS
SPECIAL 510(k) SUMMARY
| 1) | Submitter: | Dexide, Inc.
7509 Flagstone Drive
Fort Worth, TX 76118-6995
Phone No.: (817) 589-1454 |
|----|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | John Corzine
Vice President, Research and Development |
| | Date Prepared: | February 1, 1999 |
| 2) | Name of Device: | MultAport™ Cannula, Reducer and Accessories |
| | Common Name: | Cannula, Reducer Seal, and Spike |
| | Classification Name: | Laparoscopic, General & Plastic Surgery |
| 3) | Predicate Device: | Dexide Inc., MultAport™ Cannula, Reducer and Accessories,
K981941 |
| 4) | Description of Device: | The "candidate device" is a reusable, stainless steel Cannula anc
disposable, single-use reduction seal system that threads into the
Cannula. The reducer system is composed of silicon rubber,
thermoplastic rubber, and plastics. The reusable Sealing Cone
and its Seal accommodate the cannula to assist the surgical
procedure. |
| 5) | Intended Use: | The Cannulas and accessories are to be used with a Dexide seal
package and spike for creating a point of entry for laparoscopic
instruments into the abdominal cavity and maintaining
pneumoperitoneum. |
- The candidate device has comparable technological characteristics to the predicate device in () that it has the same intended use and operating principle. The same basic design principles and incorporates the same basic materials. The same shelf life, similar packaging and the instructions for sterilization are identical.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1999
Mr. John Corzine Vice President, Research and Development Dexide, Inc. 7509 Flagstone Drive Fort Worth, Texas 76118
Re: K990379
Trade Name: MultAport™ Cannula, Reducer and Accessories Regulatory Class: II Product Code: GCJ Dated: February 1. 1999 Received: February 8, 1999
Dear Mr. Corzine:
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.
2
Page 2 - Mr. John Corzine
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.
Stipt Quvelo
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
510(k) Number (if known): K 990379
Device Name: MultAport™ Cannula, Reducer and Accessories
Indications For Use:
MultAport Cannulas:
The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar Spike for creating a point of entry for laparoscopic instruments into the abdominal cavity.
AccuPort 5-12mm Seal:
The AccuPort Seal is a single-used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments with diameters ranging from 5mm to 12mm.
Orbital Reducer Seal:
The Orbital Reducer is a single used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments of equal and smaller size.
Blunt Spike:
The reusable Blunt Trocar spike is used with the MultAport Cannulas and AccuPort or Orbital Reducer Seal for creating a point of entry for laparoscopic instruments into the abdominal cavity.
Sealing Cone:
The Sealing Cone is a reusable product designed for use during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum.
Shaft Seal (replacement part for Sealing Cone):
The Sealing Cone is a reusable product designed for used during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum. The shaft seal is designed for use when sealing the cone to the cannula.
(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 | K990379 | |
| Prescription Use X | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ____ |
| (Optional Format 1-2-96) |