(83 days)
Not Found
No
The device description focuses on mechanical components and their function in providing surgical access. There is no mention of software, data processing, or any capabilities that would suggest the use of AI or ML.
No
The device is described as a "Laparoscopic Hand Access Device" used to obtain abdominal access for the surgeon's hand and instrumentation during surgery. Its function is to facilitate surgical procedures, not to treat a disease or condition itself.
No
This device is a surgical access device designed to facilitate abdominal access for a surgeon's hand and instruments during laparoscopic procedures. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components (Gel Seal Cap, Base Ring Assembly, Retracting Sheath) and their physical interaction with the patient and surgical instruments. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Applied GelPort Laparoscopic Hand Access Device is a surgical tool used to provide access for a surgeon's hand and instruments during laparoscopic procedures. It facilitates the surgical process itself, rather than analyzing biological samples.
- Intended Use: The intended use clearly states it's for "obtaining abdominal access by the surgeon's hand and instrumentation" during surgery.
- Device Description: The description focuses on the physical components and how they are used to create a seal and allow access during surgery. There is no mention of analyzing biological samples.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Applied GelPort Laparoscopic Hand Access Device is indicated for use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by the surgeon's hand and instrumentation. Additional slits may be made using a trocar at the periphery of the Gel Seal Cap to allow instrument access to the surgical site. The Applied GelPort Laparoscopic Hand Access Device may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, urological and general surgery to access the surgical site.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Applied GelPort Laparoscopic Hand Access Device is designed with a slit for the hand at the center of the Gel Seal Cap. In addition to providing hand access, an instrument or trocar can also be inserted through this port during surgery to access the surgical site. The gel material conforms to the shape of the hand, instrument or trocar inserted through it providing a seal during laparoscopic surgery. Trocars can also be placed at the periphery of the Gel Seal Cap to allow for additional ports for instrument access during Hand Assisted Laparoscopy reducing the number of incisions required during surgery.
The Applied GelPort Laparoscopic Hand Access Device consists of a Gel Seal Cap, a Base Ring Assembly, and a Retracting Sheath. To set up, an incision line is marked at the surgery site. Once the incision is made, the retracting sheath is placed in position. The base ring assembly is then attached to the sheath. To complete the set up the Gel Seal Cap is snapped onto the base ring assembly. A sterile lubricant is provided to lube the surgeon's glove and the top of the Gel Seal Cap to make insertion of the hand into the port easy. Instruments may also be placed through the center slit if desired during surgery. If additional ports of entry are required for instrument access to the surgical site, slits can be made at desired locations on the periphery of the Gel Seal Cap using a non-threaded trocar. Instruments can then be inserted through the trocar cannula placed at the peripheral slit.
The Applied GelPort Laparoscopic Hand Access Device is a disposable, single-use device, packaged inside a PETG Tray with a Mylar peel cover.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / Clinical Setting
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
K014047 510(k) SUMMARY
FEB 2 8 2002 PENDING 510(k) NUMBER: Applied Medical Resources Corporation SUBMITTED BY: 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 (949) 713-8000 CONTACT PERSON: Anil Bhalani Vice President of Regulatory Affairs and Clinical Programs December 6, 2001 DATE OF PREPARATION: Laparoscopic Hand Access Port NAME OF DEVICE: Laparoscope, General & Plastic Surgery. CLASSIFICATION NAME: (Regulation Number 21CFR 876.1500, Endoscope and accessories). Applied GelPort Laparoscopic Hand Access Device TRADE NAME: 1. Smith & Nephew Handport System (K990414), Smith & PREDICATE DEVICE: Nephew, Inc., Andover, MA. 2. Applied Intromit Laparoscopic Hand Access Port (K990663), Medtech Ltd., Ireland. Marketed by Applied Medical Resources, Rancho Santa Margarita, CA.
SUMMARY STATEMENT: The Applied GelPort Laparoscopic Hand Access Device is indicated for use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by the surgeon's hand and instrumentation. Additional slits may be made using a trocar at the periphery of the Gel Seal Cap to allow instrument access to the surgical site. The Applied GelPort Laparoscopic Hand Access Device may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, urological and general surgery to access the surgical site.. With the use of the Applied GelPort Laparoscopic Hand Access Device, the surgeon regains tactile sense and feedback along with the increased hand-eye and instrumentation manipulation capacity of open surgery. The device allows the surgeon multiple passages of the hand to access the surgical site without losing pneumoperitoneum. Instruments and Trocars may also be placed through the port in the center of the device and at the periphery of the device to allow instrument access to the surgical site, thereby reducing the need for additional incisions to the patient.
1
The device is designed with a slit for the hand at the center of the Gel Seal Cap. In addition to providing hand access, an instrument or trocar can also be inserted through this port during surgery to access the surgical site. The gel material conforms to the shape of the hand, instrument or trocar inserted through it providing a seal during laparoscopic surgery. Trocars can also be placed at the periphery of the Gel Seal Cap to allow for additional ports for instrument access during Hand Assisted Laparoscopy reducing the number of incisions required during surgery.
The Applied GelPort Laparoscopic Hand Access Device is very simple in design. It is simple to set up, easy to use and has a lower profile to maximize comfort. It consists of a Gel Seal Cap, a Base Ring Assembly, and a Retracting Sheath. The simple design makes installation of the Applied GelPort Laparoscopic Hand Access Device during clinical use very easy. Using a sterile skin marker an incision line is marked at the surgery site. Once the incision is made the retracting sheath is placed in position. The base ring assembly is then attached to the sheath. To complete the set up the Gel Seal Cap is snapped onto the base ring assembly. The sterile lubricant is provided to lube the surgeon's glove and the top of the Gel Seal Cap to make insertion of the hand into the port easy. Instruments may also be placed through the center slit if desired during surgery. If additional ports of entry are required for instrument access to the surgical site, slits can be made at desired locations on the periphery of the Gel Seal Cap using a non-threaded trocar. Instruments can then be inserted through the trocar cannula placed at the peripheral slit.
The Applied GelPort Laparoscopic Hand Access Device is a disposable, single-use device, packaged inside a PETG Tray with a Mylar peel cover, which is standard packaging material for medical products.
The Applied GelPort Laparoscopic Hand Access Device is substantially equivalent to predicate devices in design methodology, principle of operation and clinical utility. The Applied GelPort Laparoscopic Hand Access Device introduces no new safety and effectiveness issues when used as instructed.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
Mr. Anil Bhalani Vice President of Regulatory Affairs and Clinical Programs Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688
Re: K014047
Trade/Device Name: Applied GelPort Laparoscopic Hand Access Device Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 6, 2001 Received: December 7, 2001
Dear Mr. Bhalani:
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. Iisting 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.
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Page 2 - Mr. Anil Bhalani
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
to Mark N. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applied Medical Resources is providing this separate cover page for the Applied GelPort Laparoscopic Hand Access Device's "Indications for Use" as required.
510(k) Number:
K 014047
Device Name:
Applied GelPort Laparoscopic Hand Access Device
Indications for Use: The Applied GelPort Laparoscopic Hand Access Device is indicated for use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by the surgeon's hand and instrumentation. Additional slits may be made using a trocar at the periphery of the Gel Seal Cap to allow instrument access to the surgical site. The Applied GelPort Laparoscopic Hand Access Device may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, urological and general surgery to access the surgical site.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓ OR Over-The -Counter Use __
for
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number __K014047
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