(58 days)
The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and therapeutic procedures by using additional accessories.
The subject device is inserted into the rectum to establish an access port into the lower sigmoid colon in preparation for transanal endoscopic microsurgery. The port lumen measures 40mm in diameter and may be capped off with an airtight lid. The lid allows the colon to be insufflated, thus enlarging the operative space. The airtight lid is constructed of a gel material through which multiple trocars may be placed. These trocars establish multiple ports that allow passage of laparoscopes and laparoscopic instruments without loss of insufflation. The design has all the functionality of a simple, two-piece proctoscope but with significant additional versatility, capability and effectiveness.
The provided text is a 510(k) summary for the GelPOINT Path Transanal Access Platform, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data to prove novel performance criteria. Therefore, many of the requested details about acceptance criteria and study design are not explicitly available in this document as would be for a de novo device or a more complex medical AI/ML product.
However, I can extract information related to the demonstration of "substantial equivalence," which is the core of this submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document describes the device's technological characteristics and its comparison to a predicate device for the purpose of demonstrating "substantial equivalence." It does not define specific quantifiable acceptance criteria in the way one might for a diagnostic test (e.g., sensitivity, specificity thresholds) or for a new therapeutic intervention. Instead, the "acceptance criteria" are implied by the regulatory standard of substantial equivalence, meaning the device performs similarly to or better than a legally marketed predicate device without raising new questions of safety or effectiveness.
| Acceptance Criteria (Implied for Substantial Equivalence to a Proctoscope) | Reported Device Performance (GelPOINT Path) |
|---|---|
| Ability to dilate the anus for access to the rectal cavity | Meets: Diliates the anus to allow access to the rectal cavity. |
| Insertion using a dilator | Meets: Inserted using a dilator. |
| Allows insertion of instruments (including endoscopes) | Meets: Allows insertion of instruments including endoscopes. |
| Made of polymers | Meets: Made of polymers. |
| Disposable | Meets: Disposable. |
| Capable of insufflation | Meets: Capable of insufflation (with a CO2 pump, superior to predicate's handheld bulb). |
| Safety and efficacy previously established (for predicate device) | Meets: Safety and efficacy were previously established for the predicate device, and the subject device is considered substantially equivalent. The subject device has "numerous superior technological capabilities" that increase effectiveness without compromising safety. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "There are no recognized standard tests that can challenge and compare these technological differences. Therefore, substantial equivalence was established based on a dimensional analysis of each device."
This indicates that a "test set" in the traditional sense of patient data or clinical samples was not used for this submission. The evaluation was based on a dimensional analysis and comparison of technological characteristics between the new device and the predicate device.
- Sample Size: Not applicable as no clinical test set was used for this specific comparison to demonstrate substantial equivalence.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As no clinical test set was used, there were no experts used to establish ground truth for a test set. The comparison was based on engineering and design specifications.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission is focused on demonstrating substantial equivalence based on design and function, not on comparative clinical effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is a physical surgical access platform, not an algorithm or AI/ML device. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate device (Sapimed S.P.A. Disposable Sigmoidoscope/proctoscope; K070915 and Applied Medical Resources GelPOINT Path Transanal Access Platform; K110792), combined with engineering and design specifications for both devices. The "dimensional analysis" served as the primary method to compare the new device to this established baseline.
8. The Sample Size for the Training Set
Not applicable, as this is a physical medical device and not an AI/ML system requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a physical medical device and not an AI/ML system requiring a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):
The "study" in this 510(k) submission is a non-clinical comparison based on technological characteristics and dimensional analysis between the new GelPOINT Path Transanal Access Platform and its predicates (especially the Sapimed proctoscope and the previously cleared GelPOINT Path K110792).
The key points of this "study" are:
- Objective: To demonstrate that the GelPOINT Path Transanal Access Platform is "substantially equivalent" to legally marketed predicate devices.
- Methodology:
- Identification of Predicate Devices: K070915 (Sapimed S.P.A. Disposable Sigmoidoscope/proctoscope) and K110792 (Applied Medical Resources GelPOINT Path Transanal Access Platform). The submission states the current device's design is unchanged from K110792.
- Comparison of Intended Use: The intended use of the current device is unchanged from K110792, and it is compared to the Sapimed proctoscope.
- Comparison of Technological Characteristics: A detailed comparison was made on features like:
- Dilation of the anus
- Insertion method (dilator)
- Ability to allow instrument insertion (including endoscopes)
- Materials (polymers)
- Disposability
- Insufflation capability
- Identification of Differences and Their Impact: The differences (e.g., larger cannula, CO2 pump insufflation, suturing capability, more access ports) were analyzed. The conclusion was that these differences provided "superior technological capabilities" and "increased effectiveness" (e.g., larger operative field via better insufflation) without raising new questions of safety or effectiveness, essentially making the device a more versatile and capable proctoscope.
- Lack of Clinical Testing: The document explicitly states, "There are no recognized standard tests that can challenge and compare these technological differences. Therefore, substantial equivalence was established based on a dimensional analysis of each device." This means no new clinical trials or patient data studies were conducted as part of this specific submission to demonstrate performance against acceptance criteria.
- Conclusion: The subject device is substantially equivalent in performance to the Sapimed proctoscope but has numerous technological advantages that increase effectiveness. Therefore, the indications for use could be updated by incorporating the indications of the Sapimed device.
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K133393 Page 1 of 2
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510(k) SUMMARY
Applied Medical Resources Corporation 510(k) OWNER: 22872 Avenida Empresa Rancho Santa Margarita, CA, 92688 (949) 713-8000 CONTACT PERSON: Frans VandenBroek Principal Specialist, Regulatory Affairs (949) 713-8369 (949) 713-8205 (FAX) DATE OF PREPARATION: November 1, 2013 TRADE NAME: GelPOINT Path Transanal Access Platform COMMON NAME: Transanal Endoscopic Microsurgery (TEM) device
CLASSIFICATION NAME: Endoscope and Accessories, Gastroenterology and Urology Devices, 21CFR 876.1500. Product code FER, Anoscope and accessories.
K070915, SAPIMED S.P.A. Disposable Sigmoidoscope/ PREDICATE DEVICE: proctoscope; product code KOG, Endoscope and accessories. K110792, Applied Medical Resources GelPOINT Path Transanal Access Platform; product code FER, Anoscope
DEVICE DESCRIPTION: The subject device is inserted into the rectum to establish an access port into the lower sigmoid colon in preparation for transanal endoscopic microsurgery. The port lumen measures 40mm in diameter and may be capped off with an airtight lid. The lid allows the colon to be insufflated, thus enlarging the operative space.
and accessories.
The airtight lid is constructed of a gel material through which multiple trocars may be placed. These trocars establish multiple ports that allow passage of laparoscopes and laparoscopic instruments without loss of insufflation. The design has all the functionality of a simple, two-piece proctoscope but with significant additional versatility, capability and effectiveness.
INTENDED USE: The subject device was previously cleared in K 110792 and its intended use is unchanged. It provides access to the rectal cavity to perform surgery, which is also the intended use of the Sapimed disposable proctoscope, cleared in K070915. The subject device has all the functionality of the Sapimed proctoscope with the additional benefit of
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delivering greater access and operative space. Therefore, the indications for the Sapimed device may be incorporated into the indications for the subject device as follows:
The GelPOINT Path is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional accessories.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The design of the subject device is unchanged since it was cleared in K110792. Similarities to the predicate Sapimed proctoscope are:
- . Both dilate the anus to allow access to the rectal cavity
- Both are inserted using a dilator ●
- Both allow insertion of instruments including endoscopes .
- Both are made of polymers .
- Both are disposable .
- � Both are capable of insufflation
The predicate Sapimed proctoscope consists of two simple injection molded components, a 17mm cannula and an insertion dilator. By comparison, the subject device is more versatile. Differences include:
- The cannula is larger in diameter (40mm vs. 17mm) and shorter (4.5cm vs 14cm) .
- . Insufflates with a CO2 pump. The predicate device insufflates with a hand held bulb
- May be sutured to the patient to assist retention .
- Allows instrumentation to be articulated over a greater range of motion .
- Has three access ports, each of which can accommodate standard laparoscopic . instruments 10mm and smaller
- A detachable airtight cap allows removing specimens that are too large to be . removed through the proctoscope's lumen
Safety and efficacy of the subject device and the Sapimed proctoscope were previously established in K110792 and K070915. In spite of the differences in design, the subject device functions-in essence-as a proctoscope with greater insufflation capability. Insufflation enlarges the operative field and therefore more effectively allows execution of medical procedures in the colon.
DISCUSSION OF NONCLINICAL TESTS SUBMITTED: Subject and predicate device were both previously cleared for accessing the rectum. However, the subject device has numerous superior technological capabilities, not available in the Sapimed proctoscope. There are no recognized standard tests that can challenge and compare these technological differences. Therefore, substantial equivalence was established based on a dimensional analysis of each device.
CONCLUSIONS DRAWN FROM TESTING: The subject device is substantially equivalent in performance to the Sapimed proctoscope but has numerous technological advantages that increase effectiveness. Therefore, the indications for use of the subject device may be undated by incorporating the indications of the Sapimed device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 2, 2014
Applied Medical Resources Corporation Frans VandenBroek Principal Specialist, Regulatory Affairs 22872 Avenida Empresa Rancho Santa Margarita, CA 92688
- Re: K133393
Trade/Device Name: GelPOINT Path Transanal Access Platform Regulation Number: 21 CFR8 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER Dated: November 1, 2013 Received: November 5, 2013
Dear Frans 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. 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 statutes and regulations administered by other Federal agencies.
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Page 2 - Frans VandenBroek
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers0ffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K133393
Device Name: GelPOINT Path Transanal Access Platform
Indications for Use: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and therapeutic procedures by using additional accessories.
x Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R=Eisher -S 2014.01.02 14.29 40 -05'00'
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§ 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.