(57 days)
Not Found
No
The summary describes a mechanical device (cannula and seal system) and does not mention any software, image processing, AI, or ML capabilities.
No.
The device is used to create a point of entry for laparoscopic instruments and maintain pneumoperitoneum during surgery, neither of which is a therapeutic function. These are considered accessory devices used for surgical access.
No
The device, MultAport Cannulas and AccuPort Seal/Orbital Reducer Seal, is used for creating a point of entry and maintaining pneumoperitoneum during laparoscopy, which is a procedural function, not a diagnostic one.
No
The device description explicitly states it 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:
- Intended Use: The intended use clearly states that the device is used for creating a point of entry for laparoscopic instruments into the abdominal cavity and maintaining pneumoperitoneum during laparoscopy. This is a surgical procedure performed on the patient's body.
- Device Description: The description details a reusable cannula and disposable seals made of various materials, designed for surgical access.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Cannulas are to be used with a Dexide seal package and spike for creating a point of entry for laparoscopic instruments into the abdominal cavity.
MultAport Cannulas:
The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar for creating a point of entry for laparoscopic instruments into the abdominal cavity.
AccuPort 5-12mm Seal:
The AccuPort Seal is a single-use device 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The "candidate device" is a reusable, stainless steel Cannula and disposable, single-use reduction seal system that threads into the Cannula. The reducer system is composed of silicon rubber, thermoplastic rubber, and plastics.
Accessories: Cannulas & Reduction Systems
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
F: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 510(k) SUMMARY
| 1) | Submitter: | Dexide, Inc.
7509 Flagstone Drive
Fort Worth, TX 76118-6995
Phone No.: (817) 589-1454 | |
|----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Contact Person: | Lynette Caldwell
Director of Quality Assurance | |
| | Date Prepared: | Friday, May 29, 1998 | |
| 2) | Name of Device: | Cannula, Reducer and Accessories. | |
| | Common Name: | Trocar Cannula | |
| 3) | Predicate Devices: | Dexide, Inc. - K912980
Aesculap - K942053 | |
| 4) | Description of Device: | The "candidate device" is a reusable, stainless steel Cannula
and disposable, single-use reduction seal system that threads
into the Cannula. The reducer system is composed of silicon
rubber, thermoplastic rubber, and plastics. | |
| | | Accessories:
Cannulas & Reduction Systems | |
| 5) | Intended Use: | The Cannulas are to be used with a Dexide seal package and
spike for creating a point of entry for laparoscopic instruments
into the abdominal cavity. | |
| 6) | Technological characteristics of this device are comparable to the predicate device in that
predicate device(s) is also used to provide a pathway or point of entry for laparoscopic
instruments into the abdominal cavity. | | |
1
SECTION G:
MANUFACTURER'S STATEMENT OF SUBSTANTIAL EQUIVALENCE
(To be provided with 510(k) notification for tier II devices)
The Cannulas arc to be used with a Dexide seal STATEMENT OF INDICATIONS FOR USE: STATEMENT OF INDICATIONS I OF entry for laparoscopic instruments into the abdominal cavity.
Provides a pathway for entry of laparoscopic instruments of equal size and smaller CLAIMS: into the abdominal cavity. The Cannula is reusable and the seal package is single-use disposable. into the addominal cavity. The Cannula secommended sterilization methods are listed on the
data insert.
This notification contains all of the information required by 21 CFR 807.87. This notification of the "DRAERD Premarket Notification 510(k) Reviewer's Screening Checklist" is attached.
The candidate device conforms to the following voluntary and mandatory standards:
There are no mandatory existing performance standards that Dexide, Inc is aware.
The candidate device has the same technological characteristics as a legally marketed predicate I he candidate device has the the materials, and mode of action are equivalent. If device. Specifically, the reallers, open.contents of the kit are either pre-Amendment devices or have been cleared for marketing through previous 510(k)'s. The kit contains no drug or biologic products.
The above statements are accurate representations of this 510(k) Premarket Notification and of the device this firm intends to market. All data and information submitted in this Premarket Notification is truthful and accurate and no material fact has been omitted (21 CFR 807.87(J).
| MANUFACTURER: | Dexide, Inc. |
|---|---|
| OFFICIAL CORRESPONDENT: | Lynette Caldwell (signature) |
| Lynette Caldwell (printed name) | |
| TITLE: | Director of Quality Assurance |
| DATE: | May 29, 1998 |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.
Public Health Service
Food and Drug Administration 9200 Corporato Boulevard Rockville MD 20850
Inf 2 9 1998
Ms. Lynette Caldwell ·Director of Quality Assurance Dexide, Inc. 7509 Flagstone Drive Fort Worth, Texas 76118
K981941 Re: R981941
Trade Name: Multaport Cannula Reducer and Accessories Regulatory Class: II Product Code: GCJ Dated: May 29, 1998 Received: June 2, 1998
Dear Ms. Caldwell:
We have reviewed your Section 510(k) notification of intent to market the device referenced
in the indication bit a baland in incientially equivalent (for the indications fo We have reviewed your Section 3 iv(k) noundedour of them users of the indications for
above and we have determined the device is substantially equivalent (for to above and we have determined the uce not in interstate comments on to de use stated in the enclosure) to devices intaked bevice Americans, or to devices that May 28, 1976, the enactment adaly of the Meetical Ferient Food, Drug, and have been reclassitied in accordance with the provisions of the general controls
Cosmetic Act (Act). You may, therefore, market the device, subject to the generals for Cosmetic Act (Act). You may, thereone, thanks and to to the Act include requirements for
provisions of the Act. The general controls provisions of the Activel and provisions of the Act. The gelectares, good manifacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
n and the many of the may of any cases additional controls. Existing major (Premarket Approval), it may be subject to such additions (existing major (Premarket Approval), it itlar be sugges to sales of Federal Regulations. Title 21,
regulations affecting your device can be found in the costsmes compliance with the regulations affecting your device can or round in the other sessmes compliance with the Parts 800 to 895. A substantally equivalians set forth in the Quality System
current Good Manufacturing Practice requirement, as set fort in the Quality System current Good Manufacturing Fraction regulation (21 CFR Part 820) and that, Regulation (QS) for Medical Devices: "God and Drug. Administration (FDA) will verify such assumptions. Failure to comply with the CMP regulation may result in regulation such assumptions. Fallure to comply with the SHIP regenents concerning your device in the action. In addition, FDA may ploinst turner and to your premarket notification submission does
Federal Register. Please note: this response to your set of the Act for Federal Register. Please note. under sections 531 through 542 of the Act for not affect any obligation you might have union securements or other Federal laws or regulations.
3
Page 2 - Ms. Lynette Caldwell
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,
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
510(k) Number (if known): K981941
Device Name: Cannula, Reducer and Accessories ________________________________________________________________________________________________________________________________
Indications For Use:
MultAport Cannulas:
MultAport Califords:
The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar The Multi port reasure callining as assaroscopic instruments into the abdominal cavity.
AccuPort 5-12mm Seal:
Accur on 9 Tellin Gad.
The AccuPort Seal is a single-use device 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.
(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 | 12981941 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |