(292 days)
Not Found
No
The device description and performance studies focus solely on the mechanical and sealing properties of a surgical access platform, with no mention of AI or ML capabilities.
No
The device is used to establish a path of entry or gain access for endoscopic instruments during surgery; it does not directly treat a disease or condition.
No
The device is an access platform for surgical procedures, designed to create a path for endoscopic instruments, and it does not perform any diagnostic function.
No
The device description clearly outlines physical components made of polyurethane and polycarbonate, and the performance studies involve bench testing of these physical components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for establishing a path of entry or gaining access through tissue planes for endoscopic instruments during surgical procedures. This is a surgical access device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical instrument with a wound retractor, cap, and access ports for laparoscopic tools. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
Therefore, the GelPOINT Mini Advanced Access Platform is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GelPOINT Mini Advanced Access Platform is indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.
Product codes
GCJ
Device Description
The proposed device is an iteration of Applied Medical's GelPort Blunt Tip Trocar System. The predicate GelPort system provides a single access port and must therefore be used in combination with additional ports. Three ports is common, each requiring a dedicated incision. The proposed device, in essence, combines three of the single port predicates into one compact construct that requires but a single incision. A fourth port is included in the package as an option. The proposed device is a sterile, single-use instrument intended to access abdominal, thoracic and pelvic cavities in preparation for endoscopic surgical procedures. It features a sleeve type wound retractor and a detachable cap. The wound retractor consists of a flexible polyurethane cylindrical sheath that has a semi-rigid polyurethane inner ring attached at each end. The detachable Gel-cap is constructed of a semi-rigid polycarbonate ring and a flexible gel-like material. The Gel-cap is fastened to the wound retractor with a locking attachment lever. The Gel-cap can accommodate up to four access ports that are inserted through the gel in a formation preferred by the user. The ports accommodate laparoscopic tools ranging from 4.8 to 13.2mm and have sealing features that allow insufflation of the surgical space.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general, abdominal, gynecological, and thoracic
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
Functional Performance: Side-by-side bench testing was performed on the proposed and predicate devices to demonstrate substantial equivalence. The tests focused on the functional performance of an endoscopic access device. Proposed and predicate devices were evaluated for: Resistance to detachment from the patient while operated as intended. System leak test with and without instruments. Seal particulation during instrument exchanges. The ability of the sealing system to reseal after removal instruments. The drag force created by inserting and removing instruments. Results and Conclusions: Predicate and proposed devices met all testing acceptance criteria. Test results demonstrate substantial equivalence between the predicate and proposed device.
Biocompatibility: A biocompatibility evaluation of the GelPOINT Mini Advanced Access Platform was conducted in accordance with the FDA's guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. " The proposed device contacts tissue for less than 24 hours and was found compatible after being subjected to these tests: Cytotoxicity, Intracutaneous reactivity, Sensitization.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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April 29, 2020
Applied Medical Resources Corp. Mr. Frans Vandenbroek Principal Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K191866
Trade/Device Name: GelPOINT Mini Advanced Access Platform Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 27, 2020 Received: March 31, 2020
Dear Mr. Vandenbroek:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191866
Device Name GelPOINT Mini Advanced Access Platform
Indications for Use (Describe)
The GelPOINT Mini Advanced Access Platform is indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K191866, 510(K) Summary
| 510(K) Submitter: | Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, California, 92688
contact@appliedmedical.com
(949) 713-8000 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Frans VandenBroek, BSME
Principal Regulatory Affairs Specialist
Applied Medical Resources
fvandenbroek@appliedmedical.com
Tel: (949) 713-8369, Fax: (949) 713-8205 |
| Date of Preparation: | April 28, 2020 |
| Trade Name: | GelPOINT Mini Advanced Access Platform |
| Common Name: | Endoscopic Access Device |
| Classification: | 21CFR876.1500, Endoscope and Accessories. |
| Product Code: | GCJ, Laparoscope, General and Plastic Surgery |
| Predicate Device: | K060629, Applied Medical GelPort Blunt Tip Trocar System |
| Device Description: | The proposed device is an iteration of Applied Medical's
GelPort Blunt Tip Trocar System. The predicate GelPort system
provides a single access port and must therefore be used in
combination with additional ports. Three ports is common, each
requiring a dedicated incision. The proposed device, in essence,
combines three of the single port predicates into one compact
construct that requires but a single incision. A fourth port is
included in the package as an option.
The proposed device is a sterile, single-use instrument intended
to access abdominal, thoracic and pelvic cavities in preparation
for endoscopic surgical procedures. It features a sleeve type
wound retractor and a detachable cap. The wound retractor
consists of a flexible polyurethane cylindrical sheath that has a
semi-rigid polyurethane inner ring attached at each end. The
detachable Gel-cap is constructed of a semi-rigid polycarbonate
ring and a flexible gel-like material. The Gel-cap is fastened to
the wound retractor with a locking attachment lever. |
4
The Gel-cap can accommodate up to four access ports that are inserted through the gel in a formation preferred by the user. The ports accommodate laparoscopic tools ranging from 4.8 to 13.2mm and have sealing features that allow insufflation of the surgical space. Intended Use: The GelPOINT Mini Advanced Access Platform is indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.
Summary of Technological Characteristics:
The predicate and proposed device share these technological characteristics:
- . Both establish access ports for laparoscopic procedures executed in parts of the body ranging from the thorax to the pelvis.
- Both are inserted through incisions ranging from 1.5 4cm based on user preference. ●
- Both accommodate laparoscopic instruments ranging from 4.8 to 13.2mm.
- Both allow insufflation of the surgical space.
- Both have mechanisms for anchoring the device to the patient.
Compared to the predicate, the proposed device has these technological updates:
- . Up to four endoscopic access ports delivered in a compact construct that is placed through a single incision.
- The lower portion of the device serves as a wound protector/retractor. ●
- The upper portion accommodates up to four access ports in a cap made of a flexible gel-type material. The quantity and location of the ports is based on user preference.
- . The Gel-cap is exceptionally flexible which allows superior articulation of instruments placed through the ports.
- The Gel-cap closes the wound opening to allow insufflation of surgical spaces. ●
- The Gel-cap is detachable to accommodate removal of specimen.
Technological Similarities, Predicate and Proposed Device
| | GelPort Blunt Tip
Trocar System
(Predicate) | GelPOINT Mini Advanced
Access Platform
(Proposed Device) |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Create an access channel for
placing endoscopic instruments
into body cavities under
insufflated conditions | Same |
| | GelPort Blunt Tip | GelPOINT Mini Advanced |
| | Trocar System | Access Platform |
| | (Predicate) | (Proposed Device) |
| Indications
for use | For use in general, abdominal,
gynecological, and thoracic
minimally invasive surgical
procedures to establish a path of
entry or to gain access through
tissue planes, extraperitoneal
spaces and/or potential spaces
for endoscopic instruments | Same |
| Anatomy | Area ranging from the pelvis to
the thorax including the breast. | Same |
| Insertion | Through an incision based on
surgeons experience with 12mm
ports. | Through an incision ranging from
15 to 40mm. |
| Port
requirement | The device delivers a single port.
Since most endoscopic
procedures require multiple
ports, additional ports (and
incisions) are required | The device provides three access
ports in a single construct and
requires but a single incision. A
4th port is included as an option. |
| Port size | Single port, 12mm | Three 10mm, one 12mm port |
| Anchoring | Device is secured to the patient
via a sliding bolster and an
inflatable balloon. Loops for
adding sutures (if desired) are
provided | Device is secured to the patient
via a sleeve type wound
protector/retractor |
| Insufflation | Allows insufflation | Same |
| Visualization | Standard endoscope placed
through access port | Same |
| Instrument
capability | Endoscopic instruments ranging
from 4.8 to 13.2mm | Same |
| Instruments
articulation | Articulation and positioning of
instruments is limited by rigidity
of patient tissue | Articulation and positioning of
instruments is superior due to
flexibility of gel cap |
| Specimen
removal | Limited. Oversize specimen
requires removal of port | Superior. Detaching the gel cap
provides a larger opening through
a protected wound |
| Materials | Various polymers | Polymers and stainless steel |
| Sterility | E-beam irradiation, 25-60kGy | Gamma Irradiation, 27.5-40kGy |
5
6
Discussion of Non-clinical Performance Testing:
Biocompatibility
A biocompatibility evaluation of the GelPOINT Mini Advanced Access Platform was conducted in accordance with the FDA's guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. " The proposed device contacts tissue for less than 24 hours and was found compatible after being subjected to these tests:
- Cytotoxicity
- Intracutaneous reactivity
- Sensitization ●
Functional Performance:
Side-by-side bench testing was performed on the proposed and predicate devices to demonstrate substantial equivalence. The tests focused on the functional performance of an endoscopic access device. Proposed and predicate devices were evaluated for:
- Resistance to detachment from the patient while operated as intended. ●
- System leak test with and without instruments.
- Seal particulation during instrument exchanges.
- The ability of the sealing system to reseal after removal instruments. ●
- The drag force created by inserting and removing instruments. ●
Results and Conclusions
Predicate and proposed devices met all testing acceptance criteria. Test results demonstrate substantial equivalence between the predicate and proposed device.