(218 days)
The ASC R-Port Laparoscopic Access Device is intended for use as an endoscopic instrument or camera port during minimally invasive abdominal laparoscopic surgery.
The ASC R-Port Laparoscopic Access Device (ASC R-Port) is a laparoscopic instrument access port that is used to perform the same function as a standard trocar. The ASC R-Port is offered with four different Introducer components which can be used to deploy the ASC R-Port. The surgeon will select the appropriate Introducer based on whether the first ASC R-Port, second or subsequent ASC R-Port is being introduced and the size of the instruments to be passed through the ASC R-Port.
The ASC R-Port is a sterile, latex-free, disposable laparoscopic instrument port which performs two functions as follows:
- It retracts a small abdominal incision to allow laparoscopic instruments 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.
The ASC R-Port 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.
Deployment of the first ASC R-Port is accomplished using a Hasson cut-down incision. This is also common practice for the deployment of a first trocar. Deployment of the second and subsequent ASC R-Ports is very similar to the deployment of standard trocars in that the incision is created by a bladeless dissecting-tipped introducer which is removed following creation of the abdominal incision.
The provided 510(k) summary for the Advanced Surgical Concepts R-Port Laparoscopic Access Device does not contain detailed information about specific acceptance criteria, performance metrics, or the study design that typically proves a device meets such criteria.
Instead, this document is a regulatory submission focused on demonstrating substantial equivalence to existing predicate devices. It describes the device's function and intended use, and briefly mentions that "Biocompatibility and verification testing have been performed which demonstrated that the ASC R-Port functions as intended and is safe and effective for its intended use." However, it does not provide the specifics of these tests.
Therefore, I cannot populate most of the requested fields based on the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Biocompatibility and verification testing have been performed," but does not list any specific acceptance criteria (e.g., minimum seal integrity, maximum insertion force, leakage rates) or their corresponding results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention sample sizes for any testing, nor the provenance of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable for this type of device. This question is typically relevant for AI/imaging devices where expert interpretation establishes a "ground truth" for diagnostic or classification tasks. The R-Port is a surgical access device, and its performance is evaluated through engineering and biocompatibility testing, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device. Similar to point 3, adjudication methods are used to resolve disagreements among human experts in diagnostic or classification tasks, which is not relevant to the R-Port.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable for this type of device. MRMC studies are specific to AI-assisted diagnostic or imaging devices. The R-Port does not involve human "readers" or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable for this type of device. This question is for AI/algorithm performance. The R-Port is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated, but implicitly related to engineering specifications and biocompatibility standards. For a device like the R-Port, "ground truth" for performance would be compliance with validated engineering specifications (e.g., ability to maintain pneumoperitoneum, material strength, sealing properties) and established biocompatibility standards. The document only generically mentions "Biocompatibility and verification testing."
8. The sample size for the training set
- Not applicable. This question pertains to AI/machine learning models which require training sets. The R-Port is a physical medical device.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, the provided 510(k) document is a high-level regulatory summary for a physical surgical device and does not delve into the detailed performance study specifics that your questions are designed to uncover for AI/diagnostic devices.
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510(k) Summary for the Advanced Surgical Concepts R-Port Laparoscopic Access Device
AUG 2 3 2007
SUBMITTER/510(K) HOLDER 1.
Advanced Surgical Concepts Unit 4 Sunnybank Centre Upper Dargle Road Bray, County Wicklow Ireland
Establishment Registration Number: 9616720
| Contact Person: | Tanya Kavanagh |
|---|---|
| Telephone: | 353-(0)1-2864777 |
January 15, 2007 Date Prepared:
DEVICE NAME 2.
| Proprietary Name: | R-Port Laparoscopic Access Device |
|---|---|
| Common/Usual Name: | Laparoscopic Accessory |
| Classification Name: | Endoscopic Accessory and Surgical Retractor |
3. PREDICATE DEVICES
- Ethicon Endo-Surgery LLC BASX Bladeless Trocar subject of K062209 .
- 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 ASC R-Port Laparoscopic Access Device (ASC R-Port) is a laparoscopic instrument access port that is used to perform the same function as a standard trocar. The ASC R-Port is offered with four different Introducer components which can be used to deploy the ASC R-Port. The surgeon will select the appropriate Introducer based on whether the first ASC R-Port, second or subsequent ASC R-Port is being introduced and the size of the instruments to be passed through the ASC R-Port.
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K070158 P2 of 3
The ASC R-Port is a sterile, latex-free, disposable laparoscopic instrument port which performs two functions as follows:
- It retracts a small abdominal incision to allow laparoscopic instruments 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.
The ASC R-Port 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.
Deployment of the first ASC R-Port is accomplished using a Hasson cut-down incision. This is also common practice for the deployment of a first trocar. Deployment of the second and subsequent ASC R-Ports is very similar to the deployment of standard trocars in that the incision is created by a bladeless dissecting-tipped introducer which is removed following creation of the abdominal incision.
INTENDED USE ડ.
The ASC R-Port Laparoscopic Access Device is intended for use as an endoscopic instrument or camera port during minimally invasive abdominal laparoscopic surgery.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The ASC R-Port provides an access path for laparoscopic instruments through a small incision in the abdominal wall very similar to the function of 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
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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 ASC R-Port is a laparoscopic instrument access port that is used to perform the same function as a trocar. The ASC R-Port 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 first ASC R-Port is deployed via a Hasson cut-down incision which is created at the desired location in the patient's abdomen. The ASC R-Port is delivered through this incision with a blunt "Hasson Hook Introducer". The second and subsequent ASC R-Ports are deployed via a skin incision created at the desired location in the patient's abdomen. The ASC R-Port is mounted to the relevant bladeless dissecting tipped introducer (Injector Introducer or 5mm Hook Introducer or 12mm hook Introducer). The bladeless dissecting-tipped introducer creates its own incision through to the abdomen by rotating it back and forth as it is advanced through the tissue layers. Once it has penetrated through to the abdomen, the distal ring of the ASC R-Port is separated from the bladeless dissecting-tipped member. The bladeless dissecting-tipped member is now removed from the incision.
When the ASC R-Port is deployed, the Distal Ring and the Outer Proximal Ring are drawn as close together as the abdominal wall will allow. This sets up tension in the Retracting Sleeve between these two rings, and it is this tension that opens the incision and creates an access path for laparoscopic instruments. There is a valve system on the ASC R-Port to maintain pneumoperitoneum, whether an instrument is present in the ASC R-Port or not.
Like the predicate devices, the ASC R-Port is a sterile, single-use device. The use of the ASC R-Port and the predicates are identical in that they allow the passage of laparoscopic instrumentation while maintaining pneumoperitoneum. Although insertion of the ASC R-Port and the predicate trocars differs, the ASC R-Port insertion does not affect safety and effectiveness of the device since incisions are made consistently and safely during laparoscopic surgery.
PERFORMANCE TESTING 7.
Biocompatibility and verification testing have been performed which demonstrated that the ASC R-Port functions as intended and is safe and effective for its intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Surgical Concepts % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760
AUG 2 3 2007
Re: K070158
Trade/Device Name: ASC R-Port Laparoscopic Access Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 6, 2007 Received: August 8, 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
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Page 2 - Ms. Mary McNamara-Cullinane
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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/odrh/industry/support/index.html.
Sincerely vours Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K070158 Indications for Use
510(k) Number (if known): K070158
Device Name: ASC R-Port Laparoscopic Access Device
Indications for Use:
The ASC R-Port Laparoscopic Access Device is intended for use as an endoscopic instrument 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-C Division of General, Restorative, and Neurological
510(k) Number
§ 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.