(58 days)
Not Found
No
The device description and performance studies focus on mechanical access and insufflation capabilities, with no mention of AI/ML terms or image processing.
Yes
The device is indicated for performing various diagnostic and therapeutic procedures.
No
The device is described as an access platform used to perform various diagnostic and therapeutic procedures, but it itself is not a diagnostic device. It facilitates access for other tools that may be diagnostic.
No
The device description clearly describes a physical medical device (a platform inserted into the rectum) and its components (lumen, lid, gel material, trocars). 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 providing access for diagnostic and therapeutic procedures within the body (transanal access to the lower sigmoid colon). IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to diagnose conditions.
- Device Description: The device is a surgical access platform inserted into the body to facilitate procedures. It does not perform any tests or analyses on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, using reagents, or providing diagnostic information based on laboratory testing.
The device is a surgical instrument designed to provide access for procedures, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FER
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectum, lower sigmoid colon, anus
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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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
1
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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