(24 days)
No
The device description focuses on mechanical components and their function as a laparoscopic access port. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is an access port used to facilitate the insertion of other instruments and maintain pneumoperitoneum during laparoscopic surgery; it does not directly treat a disease or condition.
No
The device is described as an access port for instruments and cameras during laparoscopic surgery, with functions like retracting an incision and maintaining pneumoperitoneum, not for diagnosing conditions.
No
The device description clearly states it is a physical laparoscopic access device comprised of retracting and valve portions, intended for use during surgery. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery." This describes a surgical tool used during a procedure, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description details a physical device used to create and maintain access to the abdominal cavity during surgery. It talks about retracting incisions, maintaining pneumoperitoneum, and allowing instruments to pass through. These are all functions related to surgical access, not diagnostic testing of biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The device is clearly a surgical instrument designed for use in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The ASC R-Port II Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Advanced Surgical Concepts (ASC) R-Port II Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The proposed ASC R-Port II Laparoscopic Access Device is identical in design to the R-Port Laparoscopic Access Device, which has been cleared for marketing under K070158. Two modifications have been made to the use of the proposed ASC R-Port II Laparoscopic Access device. ASC has made very minor changes to the indications for use and the recommended method for delivery of the device although the design of the device is identical to the one described in K070158. The proposed ASC R-Port II Laparoscopic Access Device and the original R-Port Laparoscopic Access Device are otherwise identical in design, mechanism of action and operating principles.
The proposed ASC R-Port II Laparoscopic Access Device is a laparoscopic instrumentation access port that is used to perform the same function as other port systems and standard trocars. The original R-Port was offered with four different Introducer components for deployment but the proposed ASC R-Port II is offered with only one Introducer and a new delivery method. The new recommended delivery method for the proposed ASC R-Port II consists of initially insufflating the abdomen using a standard Verres Needle before creating the port incision. This is common practice with standard trocar insertions. In addition, as described in K070158, the ASC R-Port II can also be deployed after the creation of a Hasson cut-down incision. This type of incision is also commonly used for the deployment of standard trocars. The Distal Ring of the ASC R-Port II is delivered through the Hasson incision using the Introducer component of the ASC R-Port II which is the same Injector Introducer cleared for marketing under K070158.
The ASC R-Port II Laparoscopic Access Port is a sterile, disposable laparoscopic instrument port which performs two functions, as follows:
- . It retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen
- It ensures that pneumoperitoneum is maintained in the abdomen during the surgical procedure whether or not a laparoscopic instrument is passing through the port
Like the predicate R-Port Laparoscopic Access Device, the ASC R-Port II Laparoscopic Access Device is comprised of the following:
- a retracting portion which retracts an abdominal incision to allow the passage of . laparoscopic instruments
- . a valve portion which maintains the pneumoperitoneum established for the surgical procedure
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen
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)
Biocompatibility and verification testing have been performed which demonstrated that the ASC R-Port II Laparoscopic Access Device functions as intended and is safe and effective for its intended use.
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.
K070158, K010007, K032676, K010711
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
510(k) Summary for the Advanced Surgical Concepts (ASC) R-Port II Laparoscopic Access Device
1. SUBMITTER/510(K) HOLDER
| Advanced Surgical Concepts | ||
|---|---|---|
| Unit 4 Sunnybank Centre | ||
| Upper Dargle Road | ||
| Bray, County Wicklow | ||
| Ireland | ||
| Establishment Registration Number: | 9616720 | DEC 03 2007 |
| Contact Person: | Tanya Kavanagh | |
| Telephone: | 353-(0)1-2864777 | |
| Date Prepared: | November 8, 2007 |
2. DEVICE NAME
| Proprietary Name: | ASC R-Port II Laparoscopic Access Device |
|---|---|
| Common/Usual Name: | Laparoscopic Accessory |
| Classification Name: | Endoscopic Accessory and Surgical Retractor |
3. PREDICATE DEVICES
- . R-Port Laparoscopic Access Device subject of K070158
- . Taut Inc. ADAPt Laparoscopic Port and Accessory subject of K010007
- . Ethicon Endopath III Trocar System subject of K032676
- ASC Ecotract Device subject of K010711 .
DEVICE DESCRIPTION 4.
The Advanced Surgical Concepts (ASC) R-Port II Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The proposed ASC R-Port II Laparoscopic Access Device is identical in design to the R-Port Laparoscopic Access Device, which has been cleared for marketing under K070158. Two modifications have been made to the use of the proposed ASC R-Port II Laparoscopic Access device. ASC has made very minor
1
changes to the indications for use and the recommended method for delivery of the device although the design of the device is identical to the one described in K070158. The proposed ASC R-Port II Laparoscopic Access Device and the original R-Port Laparoscopic Access Device are otherwise identical in design, mechanism of action and operating principles.
The proposed ASC R-Port II Laparoscopic Access Device is a laparoscopic instrumentation access port that is used to perform the same function as other port systems and standard trocars. The original R-Port was offered with four different Introducer components for deployment but the proposed ASC R-Port II is offered with only one Introducer and a new delivery method. The new recommended delivery method for the proposed ASC R-Port II consists of initially insufflating the abdomen using a standard Verres Needle before creating the port incision. This is common practice with standard trocar insertions. In addition, as described in K070158, the ASC R-Port II can also be deployed after the creation of a Hasson cut-down incision. This type of incision is also commonly used for the deployment of standard trocars. The Distal Ring of the ASC R-Port II is delivered through the Hasson incision using the Introducer component of the ASC R-Port II which is the same Injector Introducer cleared for marketing under K070158.
The ASC R-Port II Laparoscopic Access Port is a sterile, disposable laparoscopic instrument port which performs two functions, as follows:
- . It retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen
- It ensures that pneumoperitoneum is maintained in the abdomen during the . surgical procedure whether or not a laparoscopic instrument is passing through the port
Like the predicate R-Port Laparoscopic Access Device, the ASC R-Port II Laparoscopic Access Device is comprised of the following:
- a retracting portion which retracts an abdominal incision to allow the passage of . laparoscopic instruments
- . a valve portion which maintains the pneumoperitoneum established for the surgical procedure
2
5. INTENDED USE
The ASC R-Port II Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The ASC R-Port II provides an access path for laparoscopic instruments through a small incision in the abdominal wall identical to the function of the predicate ASC R-Port Laparoscopic Access Device (K070158) and similar to the predicate trocars. A standard trocar consists of a bladeless dissecting-tipped component for creating a small incision in an abdominal wall, and a rigid cannula, which keeps the small incision open, thereby providing an access path for laparoscopic instruments through the small incision in the abdominal wall. To deploy a trocar, a skin incision is created at the desired location in the patient's abdomen. The trocar creates its own incision through to the abdomen using its bladeless dissecting-tipped member which is rotated back and forth as it is advanced through the tissue layers. Once it has penetrated through to the abdomen, the bladeless dissecting-tipped member is removed, leaving the rigid cannula through which the laparoscopic instruments can be introduced. There is a valve system on the trocar to maintain pneumoperitoneum, whether an instrument is present in the trocar or not.
The proposed ASC R-Port II and the predicate ASC R-Port Laparoscopic Access Device are laparoscopic instrument access ports that are used to perform the same function as a trocar. The ASC R-Port II functions to both retract a small abdominal incision to allow laparoscopic instruments to pass through to the abdomen, and to maintain the pneumoperitoneum in the abdomen during the surgical procedure whether or not a laparoscopic instrument is passing through the port. The only difference between the proposed ASC R-Port II device and the predicate ASC R-Port Laparoscopic Access Device (K070158) is that the ASC R-Port II allows for insertion of multiple instruments or cameras at one time, and provides an additional method of delivery. Other than those modifications, the proposed ASC R-Port II and predicate ASC R-Port Laparoscopic Access Device are identical.
Like the predicate devices, the ASC R-Port II is a sterile, single-use device. The use of the ASC R-Port II and the predicates are identical in that they allow the passage of laparoscopic instrumentation while maintaining pneumoperitoneum. Although insertion of the ASC R-Port II and the predicate trocars differs, the ASC R-Port II insertion does not affect safety and effectiveness of the device incisions are made consistently and safely during laparoscopic surgery.
3
7. PERFORMANCE TESTING
Biocompatibility and verification testing have been performed which demonstrated that the ASC R-Port II Laparoscopic Access Device functions as intended and is safe and effective for its intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEC 0 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Surgical Concepts % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane 49 Plain Street North Attleboro, Massachusetts 02760
Re: K073170
Trade/Device Name: ASC R-Port II Laparoscopic Access Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 8, 2007 Received: November 13, 2007
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Ms. Mary McNamara-Cullinane
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Muriel M. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: ASC R-Port II Laparoscopic Access Device
Indications for Use:
The ASC R-Port II Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(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, and Neurological D
510(k) Number
November 8, 2007