(14 days)
For use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by instrumentation. Trocars may be placed through the Gel Seal Cap to allow instrument access to the surgical site. The device may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, wological and general surgery to access.the surgical site.
The subject device is a modified version of the predicate . device. It has a simpler design, specific indications for use and allows a surgeon to choose an alternate method of accessing body cavities. It also improves patient safety by reducing the size of an abdominal incision. The subject device is designed for surgeons who prefer to perform laparascopic surgery without a hand in the peritoneum. There is no slit, thus simplifying the role of the Gel-Cap to a means of accommodating trocars only. The trocars are clustered near the center of the Gel-Cap which allows the abdominal incision to be smaller. The indications for use changes from "hand access plus trocars" to "trocars only". APPLIED refers to the resulting device as a Single Incision Access System. The new system will be available in diameters of 40-120mm for use in incisions ranging from 15-90mm. The predicate and subject device consists of a Gel-Cap and wound retractor. The Gel-Cap is constructed of a semirigid polycarbonate ring and a flexible gel-like material. An attachment lever locks the cap onto the wound retractor. The wound retractor consists of a thin-film flexible cylinder that has semi-rigid polyurethane rings at each end. The inner ring - which is placed in the patient's abdominal cavity - has a tether that aids removal of the wound retractor at the end of the procedure. The Gel-Cap attaches to the outer ring of the wound retractor via the attachment lever. APPLIED plans to market the subject device individually and also in a convenience kit. The kit will include trocars from APPLIED's extensive trocar model family. Those trocars will have a flange at the distal end of the cannula to prevent the cannulas from migrating during instrument exchanges.
The provided 510(k) summary for the GelPort Single Incision Access System (K090275) describes nonclinical performance testing rather than a clinical study involving human readers or ground truth established by experts. Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC study, ground truth type for training set) are not applicable or cannot be extracted from this document as it focuses on device functionality and safety in a laboratory setting.
Here's an analysis based on the available information:
K090275 - GelPort Single Incision Access System
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the tests. Instead, it frames the tests as demonstrating "safety and efficacy of the subject device relative to the predicate device" and concludes with "substantially equivalent to the predicate device... and introduces no new safety and effectiveness issues." This implies that the acceptance criterion was generally "performance comparable to or better than the predicate device," without specific numerical thresholds being listed in this summary.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Minimum Incision Size: Ability to install inner ring of wound retractor with minimal incision. | Testing determined the minimum incision required to install the inner ring of the wound retractor. (Specific sizes/comparison not detailed in this summary, but presumably met or exceeded predicate performance). |
| Leak Testing: Ability to maintain pneumoperitoneum before and after multiple trocar insertions. | Testing demonstrated the ability of the system to maintain pneumoperitoneum. (Details on exact pressure maintained, number of insertions, or comparison to predicate not provided in this summary, but implicitly acceptable). |
| Particulate Testing: Ability to resist gel particulation from trocar insertions. | Testing demonstrated the ability of the system to resist gel particulation caused by inserting trocars through the Gel-Cap. (No quantitative results or comparison to predicate provided in this summary, but implicitly acceptable). |
| Leak Testing after Vigorous Manipulation of Trocars: Ability to maintain pneumoperitoneum despite active use. | Testing performed to assess leak resistance after vigorous manipulation of trocars. (No quantitative results or comparison to predicate provided in this summary, but implicitly acceptable). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. As this was nonclinical testing of a physical device, the "sample size" would refer to the number of devices or components tested. This information is not detailed in the summary.
- Data Provenance: Not applicable in the context of clinical data. This was nonclinical, laboratory-based performance testing conducted by Applied Medical Resources Corporation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This was nonclinical performance testing of a physical device, not a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method
- Not applicable. This was nonclinical performance testing, not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This 510(k) summary describes nonclinical device performance testing.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical medical instrument (a single incision access system), not an algorithm or AI software, so standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
- Not applicable. As this was nonclinical performance testing, the "ground truth" was based on objective physical measurements and observations of the device's functional integrity (e.g., whether it leaked, whether it allowed particulation, whether it fit a certain incision size).
8. Sample Size for the Training Set
- Not applicable. This was nonclinical performance testing of a physical device. There is no "training set" in the context of device performance in the way there would be for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated above.
In summary, this 510(k) pertains to a physical medical device and its nonclinical performance testing. The requested information regarding clinical studies, AI algorithms, human readers, and expert-established ground truth is not relevant to this type of submission. The manufacturer conducted laboratory-based tests to demonstrate that the new device performs comparably to its predicate device in terms of safety and basic functionality.
{0}------------------------------------------------
Page 1 of 4
K090275
510(k) SUMMARY
FEB 1 8 2009
SUBMITTED BY:
Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 (949) 713-8000 (949) 713-8205 (FAX)
Frans VandenBroek Vice President, Regulatory Affairs fvandenbroek@appliedmedical.com
DATE OF PREPARATION:
The 1
COMMON NAME:
PREDICATE DEVICE:
TRADE NAME:
CONTACT PERSON:
CLASSIFICATION NAME:
To be determined
January 8, 2009
Single Incision Access System
Laparoscope, General & Plastic Surgery (21CFR 876.1500, product code GCJ)
K014047, Applied GelPort Laparoscopic Hand Access Device
DEVICE DESCRIPTION: The subject device is a modified version of the predicate . device. It has a simpler design, specific indications for use and allows a surgeon to choose an alternate method of accessing body cavities. It also improves patient safety by reducing the size of an abdominal incision.
Image /page/0/Figure/17 description: The image shows two medical devices, labeled as "PREDICATE DEVICE K014047" and "SUBJECT DEVICE". Both devices are attached to an abdominal wall and consist of a gel-cap, outer ring, wound retractor film, and inner ring. The predicate device has a hand interacting with it, while the subject device has three gel-caps.
{1}------------------------------------------------
ﺗ
Page 2 of (4)
The predicate device of K014047 accommodates insertion of a hand during a Hand Assisted Laparascopic (HAL) procedure. It consists of a disk-like Gel-Cap that is positioned over an incision in the patient's abdomen. The Gel-Cap is constructed of a gel material and has a slit in the center. The slit is normally closed, thus allowing insufflation of the peritoneum. When a hand is placed through the slit, the gel material conforms and seals against the hand, thus preventing loss of peritoneal pressure. The Gel-Cap also accepts placement of trocars around the periphery.
The subject device is designed for surgeons who prefer to perform laparascopic surgery without a hand in the peritoneum. There is no slit, thus simplifying the role of the Gel-Cap to a means of accommodating trocars only. The trocars are clustered near the center of the Gel-Cap which allows the abdominal incision to be smaller. The indications for use changes from "hand access plus trocars" to "trocars only". APPLIED refers to the resulting device as a Single Incision Access System. The new system will be available in diameters of 40-120mm for use in incisions ranging from 15-90mm.
INTENDED USE: For use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by instrumentation. Trocars may be placed through the Gel Seal Cap to allow instrument access to the surgical site. The (device) may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, urological and general surgery to access the surgical site.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The predicate and subject device consists of a Gel-Cap and wound retractor. The Gel-Cap is constructed of a semirigid polycarbonate ring and a flexible gel-like material. An attachment lever locks the cap onto the wound retractor.
Image /page/1/Figure/6 description: The image shows two medical devices, the GelPort Hand Access System and the GelPort Single Incision System. Both devices have a circular base with a triangular opening in the center, labeled as 'Gel'. An 'X-Slit' is visible near the base of the GelPort Hand Access System. An 'Attachment Lever' is present on both devices, connecting the base to a 'Gel-Cap'.
{2}------------------------------------------------
Page 3 of (4)
The wound retractor consists of a thin-film flexible cylinder that has semi-rigid polyurethane rings at each end. The inner ring - which is placed in the patient's abdominal cavity - has a tether that aids removal of the wound retractor at the end of the procedure.
ﺔ ﺗ
Image /page/2/Figure/2 description: The image shows two medical devices called GelPort Hand Access System Wound Retractor and GelPort Single Incision System Wound Retractor. Both devices have an outer ring, an inner ring, and a film. The GelPort Single Incision System Wound Retractor also has a removal tether.
The Gel-Cap attaches to the outer ring of the wound retractor via the attachment lever. The graphic below shows the assembled GelPort system. However, in an actual procedure, the Gel-Cap would be attached to the wound retractor only after the retractor has been placed in the patient's abdomen.
Image /page/2/Figure/4 description: The image contains two medical devices, the GelPort Hand Access System Wound Retractor and Gel-Cap and the GelPort Single Incision System Wound Retractor and Gel-Cap. Both devices appear to be circular with a cylindrical extension. The GelPort Single Incision System Wound Retractor and Gel-Cap has a string attached to it with a ring at the end.
APPLIED plans to market the subject device individually and also in a convenience kit. The kit will include trocars from APPLIED's extensive trocar model family. Those trocars will have a flange at the distal end of the cannula to prevent the cannulas from migrating during instrument exchanges (See graphic, next page).
{3}------------------------------------------------
K0 90.275
Page 4 g(4)
Image /page/3/Picture/2 description: The image shows a round, dark-colored object being held in a person's hand. The object has several white, cylindrical components attached to its top and bottom surfaces. The components appear to be evenly spaced around the circumference of the object. The background is a neutral gray color, which helps to highlight the object and the hand holding it.
Bottom view of Gel-Cap with trocars inserted; white disks are retention flanges
DISCUSSION OF NONCLINICAL TESTS SUBMITTED: There are currently no recognized standards that specify performance characteristics of Single Incision Access Systems. Therefore, APPLIED set up testing to confirm safety and efficacy of the subject device relative to the predicate device of K014047. These tests include determination of:
- Minimum Incision Size the minimum incision required to install the inner ring of the . wound retractor.
- Leak Testing -- the ability of the system to maintain pneumoperitoneum before and after . multiple insertions of trocars through the Gel-Cap.
- Particulate Testing the ability of the system to resist gel particulation caused by . inserting trocars through the Gel-Cap.
- Leak testing after vigorous manipulation of trocars. �
A discussion of the test method and results is in Section 15.
CONCLUSIONS DRAWN FROM TESTING: APPLIED's performance and functional testing demonstrated that the GelPort Single Incision Access System is substantially equivalent to the predicate device of K014047 and introduces no new safety and effectiveness issues.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Applied Medical Resources Corporation % Underwriters Laboratories, Inc. Mr. Morten S. Christensen 455 E. Trimble Road San Jose, California 95131-1230
FEB 1 8 2009
Re: K090275
Trade/Device Name: .. GelPort Single Incision Access .System Regulation Number: 21 CFR 876.1500 -Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 2, 2009 Received: Febriaru 4, 2009
Dear Mr. Christensen:
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
{5}------------------------------------------------
Page 2 - Mr. Morten S. Christensen
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 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 postmarketsuracillance, 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,
David Krone
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): Noteget assigned.
Device Name: GelPort Single Incision Access System.
Indications for Use:
For use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by instrumentation. Trocars may be placed through the Gel Seal Cap to allow instrument access to the surgical site. The device may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, wological and general surgery to access.the surgical site.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page 1 of
Concurrence of CDRH, Office of Device Evaluation (ODE)
1-1
Neil Klossner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K090275
§ 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.